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1.  Outcomes following coronary artery bypass grafting and percutaneous transluminal coronary angioplasty in the stent era: a prospective study of all 9890 consecutive patients operated on in Scotland over a two year period 
Heart  2001;85(6):662-666.
OBJECTIVE—To determine current outcomes of percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass grafting (CABG).
DESIGN—The Scottish coronary revascularisation register provided prospectively collected data on case mix and in-hospital complications for all revascularisation procedures between April 1997 and March 1999 (4775 PTCA; 5115 CABG). Linkage to routine hospital discharge and death data provided follow up information on survival and repeat revascularisation.
RESULTS—Stents were used in 51% of PTCA procedures. CABG patients were older, had more severe coronary disease, and had greater comorbidity. PTCA was more likely to be undertaken as an urgent or emergency procedure. Perioperative death and urgent surgery followed 0.3% and 0.6% of PTCA procedures, respectively. Case fatality rates were higher following CABG, with 6.7% dead within two years compared with 3.4% following PTCA. PTCA was more often followed by readmission for ischaemic heart disease, repeat angiography, or revascularisation: 22.8% of patients had repeat revascularisation within two years, compared with 1.8% following CABG.
CONCLUSIONS—The severity of coronary heart disease was greater than in previously published registry studies and randomised trials. Despite this, overall survival figures were comparable and repeat revascularisation rates lower, particularly following PTCA. Perioperative death and urgent surgery following PTCA were also lower. These favourable outcomes may be attributable, in part, to increased use of bail out and elective stenting.


Keywords: percutaneous transluminal coronary angioplasty; coronary artery bypass grafting; survival; outcome
doi:10.1136/heart.85.6.662
PMCID: PMC1729765  PMID: 11359748
2.  Secondary prevention of ischaemic cardiac events 
Clinical Evidence  2011;2011:0206.
Introduction
Coronary artery disease is the leading cause of mortality in resource-rich countries, and is becoming a major cause of morbidity and mortality in resource-poor countries. Secondary prevention in this context is long-term treatment to prevent recurrent cardiac morbidity and mortality in people who have had either a prior acute myocardial infarction (MI) or acute coronary syndrome, or who are at high risk due to severe coronary artery stenoses or prior coronary surgical procedures. Secondary prevention in people with an acute MI or acute coronary syndrome within the past 6 months is not included.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of antithrombotic treatment; other drug treatments; cholesterol reduction; blood pressure reduction; non-drug treatments; and revascularisation procedures? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 137 systematic reviews or RCTs that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: advice to eat less fat, advice to eat more fibre, advice to increase consumption of fish oils, amiodarone, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, angiotensin II receptor blockers plus ACE inhibitors, antioxidant vitamin combinations, antiplatelet agents, aspirin, beta-blockers, beta-carotene, blood pressure reduction, calcium channel blockers, cardiac rehabilitation including exercise, class I antiarrhythmic agents, coronary artery bypass grafting (CABG), fibrates, hormone replacement therapy (HRT), Mediterranean diet, multivitamins, non-specific cholesterol reduction, oral anticoagulants, oral glycoprotein IIb/IIIa receptor inhibitors, percutaneous coronary intervention (PCI), psychosocial treatment, smoking cessation, statins, vitamin C, and vitamin E.
Key Points
Coronary artery disease is the leading cause of mortality in resource-rich countries, and is becoming a major cause of morbidity and mortality in resource-poor countries. Secondary prevention in this context is long-term treatment to prevent recurrent cardiac morbidity and mortality in people who have had either a prior MI or acute coronary syndrome, or who are at high risk due to severe coronary artery stenoses or prior coronary surgical procedures.
Of the antithrombotic treatments, there is good evidence that aspirin (especially combined with clopidogrel in people with acute coronary syndromes or MI), clopidogrel (more effective than aspirin), and anticoagulants all effectively reduce the risk of cardiovascular events. Oral anticoagulants substantially increase the risk of haemorrhage. These risks may outweigh the benefits when combined with antiplatelet treatments.Adding oral glycoprotein IIb/IIIa receptor inhibitors to aspirin seems to increase the risk of mortality compared with aspirin alone.
Other drug treatments that reduce mortality include beta-blockers (after MI and in people with left ventricular dysfunction), ACE inhibitors (in people at high risk, after MI, or with left ventricular dysfunction), and amiodarone (in people with MI and high risk of death from cardiac arrhythmia). There is conflicting evidence on the effect of calcium channel blockers. Some types may be effective at reducing mortality in the absence of heart failure, whereas others may be harmful.Contrary to decades of large observational studies, multiple RCTs show no cardiac benefit from HRT in postmenopausal women.
Lipid-lowering treatments effectively reduce the risk of cardiovascular mortality and non-fatal cardiovascular events in people with CHD.
There is good evidence that statins reduce the risk of mortality and cardiac events in people at high risk, but the evidence is less clear for fibrates.
The magnitude of cardiovascular risk reduction in people with coronary artery disease correlates directly with the magnitude of blood pressure reduction.
Cardiac rehabilitation (including exercise) and smoking cessation reduce the risk of cardiac events in people with CHD. Antioxidant vitamins (such as vitamin E, beta-carotene, or vitamin C) have no effect on cardiovascular events in high-risk people, and in some cases may actually increase risk of cardiac mortality.We don't know whether changing diet alters the risk of cardiac episodes, although a Mediterranean diet may have some survival benefit over a Western diet. Advice to increase fish oil consumption or fish oil consumption may be beneficial in some population groups. However, evidence was weak.Some psychological interventions may be more effective than usual care at improving some cardiovascular outcomes. However, evidence was inconsistent.
In selected people, such as those with more-extensive coronary disease and impaired left ventricular function, CABG may improve survival compared with an initial strategy of medical treatment. We don't know how PTCA compares with medical treatment.
We found no consistent difference in mortality or recurrent MI between CABG and PTCA with or without stenting, because of varied results among subgroups and insufficient evidence on stenting when comparing the interventions. CABG may be more effective than PTCA with or without stenting at reducing some composite outcomes, particularly those including repeat revascularisation rates. PTCA with stenting may be more effective than PTCA alone.
PMCID: PMC3217663  PMID: 21875445
3.  Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review 
Systematic Reviews  2013;2:94.
Background
Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published.
Methods
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature.
Results
This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting.
Conclusions
Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities.
doi:10.1186/2046-4053-2-94
PMCID: PMC3853687  PMID: 24112460
Post-marketing surveillance; Medical device; Incident; Adverse event; Malfunction
4.  Revascularisation versus medical treatment in patients with stable coronary artery disease: network meta-analysis 
Objective To investigate whether revascularisation improves prognosis compared with medical treatment among patients with stable coronary artery disease.
Design Bayesian network meta-analyses to combine direct within trial comparisons between treatments with indirect evidence from other trials while maintaining randomisation.
Eligibility criteria for selecting studies A strategy of initial medical treatment compared with revascularisation by coronary artery bypass grafting or Food and Drug Administration approved techniques for percutaneous revascularization: balloon angioplasty, bare metal stent, early generation paclitaxel eluting stent, sirolimus eluting stent, and zotarolimus eluting (Endeavor) stent, and new generation everolimus eluting stent, and zotarolimus eluting (Resolute) stent among patients with stable coronary artery disease.
Data sources Medline and Embase from 1980 to 2013 for randomised trials comparing medical treatment with revascularisation.
Main outcome measure All cause mortality.
Results 100 trials in 93 553 patients with 262 090 patient years of follow-up were included. Coronary artery bypass grafting was associated with a survival benefit (rate ratio 0.80, 95% credibility interval 0.70 to 0.91) compared with medical treatment. New generation drug eluting stents (everolimus: 0.75, 0.59 to 0.96; zotarolimus (Resolute): 0.65, 0.42 to 1.00) but not balloon angioplasty (0.85, 0.68 to 1.04), bare metal stents (0.92, 0.79 to 1.05), or early generation drug eluting stents (paclitaxel: 0.92, 0.75 to 1.12; sirolimus: 0.91, 0.75 to 1.10; zotarolimus (Endeavor): 0.88, 0.69 to 1.10) were associated with improved survival compared with medical treatment. Coronary artery bypass grafting reduced the risk of myocardial infarction compared with medical treatment (0.79, 0.63 to 0.99), and everolimus eluting stents showed a trend towards a reduced risk of myocardial infarction (0.75, 0.55 to 1.01). The risk of subsequent revascularisation was noticeably reduced by coronary artery bypass grafting (0.16, 0.13 to 0.20) followed by new generation drug eluting stents (zotarolimus (Resolute): 0.26, 0.17 to 0.40; everolimus: 0.27, 0.21 to 0.35), early generation drug eluting stents (zotarolimus (Endeavor): 0.37, 0.28 to 0.50; sirolimus: 0.29, 0.24 to 0.36; paclitaxel: 0.44, 0.35 to 0.54), and bare metal stents (0.69, 0.59 to 0.81) compared with medical treatment.
Conclusion Among patients with stable coronary artery disease, coronary artery bypass grafting reduces the risk of death, myocardial infarction, and subsequent revascularisation compared with medical treatment. All stent based coronary revascularisation technologies reduce the need for revascularisation to a variable degree. Our results provide evidence for improved survival with new generation drug eluting stents but no other percutaneous revascularisation technology compared with medical treatment.
doi:10.1136/bmj.g3859
PMCID: PMC4066935  PMID: 24958153
5.  Secondary prevention of ischaemic cardiac events 
Clinical Evidence  2009;2009:0206.
Introduction
Coronary artery disease is the leading cause of mortality in resource-rich countries, and is becoming a major cause of morbidity and mortality in resource-poor countries. Secondary prevention in this context is long-term treatment to prevent recurrent cardiac morbidity and mortality in people who have had either a prior acute myocardial infarction (MI) or acute coronary syndrome, or who are at high risk due to severe coronary artery stenoses or prior coronary surgical procedures.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of antithrombotic treatment; other drug treatments; cholesterol reduction; blood pressure reduction; non-drug treatments; and revascularisation procedures? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 154 systematic reviews or RCTs that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review. we present information relating to the effectiveness and safety of the following interventions: advice to eat less fat; advice to eat more fibre; advice to increase consumption of fish oils; amiodarone; angiotensin-converting enzyme (ACE) inhibitors; angiotensin II receptor blockers; angiotensin II receptor blockers plus ACE inhibitors; antioxidant vitamin combinations; antiplatelet agents; beta-blockers; beta-carotene; blood pressure reduction; calcium channel blockers; cardiac rehabilitation including exercise; class I antiarrhythmic agents; coronary artery bypass grafting (CABG); percutaneous coronary intervention (PCI); fibrates; hormone replacement therapy (HRT); Mediterranean diet; multivitamins; non-specific cholesterol reduction; oral anticoagulants; oral glycoprotein IIb/IIIa receptor inhibitors; psychosocial treatment; smoking cessation; statins; vitamin C; and vitamin E.
Key Points
Coronary artery disease is the leading cause of mortality in resource-rich countries, and is becoming a major cause of morbidity and mortality in resource-poor countries. Secondary prevention in this context is long-term treatment to prevent recurrent cardiac morbidity and mortality in people who have had either a prior MI or acute coronary syndrome, or who are at high risk due to severe coronary artery stenoses or prior coronary surgical procedures.
Of the antithrombotic treatments, there is good evidence that aspirin (especially combined with clopidogrel in people with acute coronary syndromes or MI), clopidogrel (more effective than aspirin), and anticoagulants all effectively reduce the risk of cardiovascular events. Oral anticoagulants substantially increase the risk of haemorrhage. These risks may outweigh the benefits when combined with antiplatelet treatments. Adding oral glycoprotein IIb/IIIa receptor inhibitors to aspirin seems to increase the risk of mortality compared with aspirin alone.
Other drug treatments that reduce mortality include beta-blockers (after MI and in people with left ventricular dysfunction), ACE inhibitors (in people at high risk, after MI, or with left ventricular dysfunction), angiotensin II receptor blockers (in people with coronary artery disease), and amiodarone (in people with MI and high risk of death from cardiac arrhythmia). There is conflicting evidence on the effect of calcium channel blockers. Some types may be effective at reducing mortality in the absence of heart failure, whereas other may be harmful.Contrary to decades of large observational studies, multiple RCTs show no cardiac benefit from HRT in postmenopausal women.
Lipid-lowering treatments effectively reduce the risk of cardiovascular mortality and non-fatal cardiovascular events in people with CHD.
There is good evidence that statins reduce the risk of mortality and cardiac events in people at high risk, but the evidence is less clear for fibrates.
The magnitude of cardiovascular risk reduction in people with coronary artery disease correlates directly with the magnitude of blood pressure reduction.
Cardiac rehabilitation (including exercise), and smoking cessation all reduce the risk of cardiac events in people with CHD. Antioxidant vitamins (such as vitamin E, beta-carotene, or vitamin C) have no effect on cardiovascular events in high-risk people, and in some cases may actually increase risk of cardiac mortality.We don't know whether changing diet alters the risk of cardiac episodes, although a Mediterranean diet may have some survival benefit over a Western diet.
In selected people, such as those with more-extensive coronary disease and impaired left ventricular function, CABG may improve survival compared with an initial strategy of medical treatment. We don't know how PTCA compares with medical treatment.
We found no consistent difference in mortality or recurrent MI between CABG and PTCA with or without stenting,due to varied results among subgroups and insufficient evidence on stenting when comparing the interventions. PTCA with stenting may be more effective than PTCA alone.
PMCID: PMC2907785
6.  Revascularization therapy for coronary artery disease. Coronary artery bypass grafting versus percutaneous transluminal coronary angioplasty. 
Texas Heart Institute Journal  1995;22(2):145-161.
Coronary artery bypass surgery relieves the symptoms of myocardial ischemia and prolongs survival of patients with more severe coronary artery disease. Randomized trials of surgical therapy have consistently shown that the benefits of surgical revascularization are proportional to the amount of myocardium affected by, or at risk for, ischemic injury. This risk is inferred from angiographically delineated coronary anatomy, estimates of left ventricular function, and physiologic testing. The population that may see a survival benefit from surgical revascularization has probably been expanded beyond that reported in the VA, CASS, and ECSS trials, due to improved perioperative care, longer graft survival, and the use of internal mammary artery grafts. Percutaneous transluminal coronary angioplasty revascularizes myocardium by dilating a stenotic segment of coronary artery. While successful in relieving the symptoms of myocardial ischemia, PTCA is hindered by the occurrence of abrupt vessel closure and the frequent development of restenosis. Furthermore, firm proof of a survival benefit, outside of emergency therapy for acute myocardial infarction, is not yet available. However, because the risk of procedure-related death or serious complication is lower than that seen with bypass surgery, PTCA provides a useful alternative revascularization method for patients with less extensive disease, in whom the risk of surgery may equal or exceed any beneficial effect. New technology and growing experience are widening the scope of percutaneous revascularization by extending the hope of symptomatic relief and survival benefit even to patients with extensive, severe coronary artery disease. Comparisons between surgical therapy and PTCA in select populations with single- and multivessel coronary artery disease have shown that PTCA is not as effective as surgery for long-term symptomatic control, and that it often requires repeat PTCA or cross-over to bypass surgery; however, long-term outcomes (i.e., death and myocardial infarction) are similar. The cost of treatment beginning with PTCA may be lower than that of initial surgery, even when the increased need for repeat revascularization is taken into account. Despite this, surgical bypass remains the mainstay of therapy for patients with severe coronary artery disease and a poor prognosis for survival, and will remain the fallback procedure for patients who repeatedly undergo failed PTCA. At the present time, revascularization should be offered on the basis of symptom severity (in the presence of medical therapy) and in accordance with the prognosis for survival as judged by the extent and severity of disease (Table VI). Percutaneous transluminal coronary angioplasty is preferred in patients who require revascularization but can obtain no proven benefit from bypass surgery. Coronary artery bypass surgery, using the internal mammary artery when possible, remains the revascularization method of choice for patients with more severe disease or whose disease is not amenable to treatment using percutaneous methods (Table VII).
PMCID: PMC325234  PMID: 7647598
7.  The invasive management of angina: issues for consumers and commissioners. 
OBJECTIVE--To review, from the purchaser's perspective, the current state of knowledge of techniques for investigation and treating coronary artery disease. The study was based on evidence from past and continuing randomised controlled trials (RCTs). CRITERIA FOR INCLUSION OF REPORTS--Articles listed on Medline (1990-3) with the keywords coronary disease, angina, and unstable angina (combined with surgery, economics, therapy, or drug therapy) and percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass grafting (CABG) were included. Articles published before 1990 were obtained from two comprehensive literature reviews published by the Rand organisation in 1991 and from the papers obtained using the Medline search. A hand search of relevant journals published between July 1993 and June 1994 was also undertaken. Results from more recently published RCTs are included. RESULTS--CABG provides improved angina relief compared with drug treatment and may prolong life in patients with more severe illness. PTCA is also better than drug treatment, but less so than CABG, and its cost advantages over CABG decrease with time. Repeat intervention for return of symptoms is more frequently required after PTCA, but increasing numbers of patients are also undergoing second and third repeat CABG for graft occlusion in the years after the original operation. Newer PTCA techniques are not, as yet, fully evaluated. One technique, atherectomy, has been shown to be no more effective, and more expensive, than conventional balloon angioplasty. In the short term intracoronary stents reduce the problems associated with vessel occlusion after PTCA and therefore reduce the need for further intervention. PTCA should not be performed without ready access to cardiothoracic support. There is an increasing trend towards the development of coronary catheterisation units at peripheral sites. This may lead to increasing, inappropriate use of this investigation in suboptimal circumstances. CONCLUSIONS--Ischaemic heart disease is an important cause of morbidity and mortality and invasive management techniques are developing rapidly; some service expansion is occurring without trial evidence. More research is required to determine the optimum balance of PTCA, CABG, and angiography and population requirements for these procedures. In the meantime, in the absence of firm long term evidence of the superior cost effectiveness of PTCA compared with CABG, the rapid expansion of this procedure should be limited. Patients should be fully informed of the benefits and disadvantages of CABG and PTCA, where either procedure is indicated, to enable them to make fully informed choices.
PMCID: PMC1060119  PMID: 7650455
8.  Completeness of revascularisation by percutaneous coronary intervention 
Netherlands Heart Journal  2001;9(1):3-9.
Objective
To evaluate the relationship between the completeness of revascularisation by percutaneous coronary intervention and the one-year occurrence of adverse cardiac events in patients with multivessel disease.
Patients
Patients with stable or unstable angina pectoris, or with exercise-induced ischaemia, were enrolled in the Coronary Angioplasty versus Bypass Revascularisation Investigation (CABRI).
Methods
In CABRI, patients were randomised to coronary bypass grafting (CABG; n=513) or angioplasty (PTCA; n=541). Revascularisation in patients randomised to PTCA was defined as complete if no lesions with a diameter stenosis <50% remained post-procedure. Patients with complete revascularisation were distinguished from those with one, two, and three or more remaining lesions, respectively. Differences in baseline characteristics and in the one-year occurrence of death, myocardial infarction, (re)CABG, and (re)PTCA between these subgroups were evaluated. Comparisons were made with patients randomised to CABG.
Results
Complete revascularisation was obtained in 148 patients randomised to PTCA (27%). In 147 (27%) cases one lesion remained, while there were 122 (23%) and 119 (22%) patients with two and three or more remaining lesions, respectively. Five (1%) patients could not be classified. The one-year rates of either death or MI were 9.5%, 5.4%, 8.2%, and 12.6% in the respective PTCA subgroups (p=0.225), and 6.2% in patients randomised to CABG (comparison with three or more remaining lesions after PTCA: p=0.017). The percentages of repeat interventions during one-year follow-up were 29.7%, 29.3%, 39.3%, and 51.3% (p<0.001), much higher than after CABG (3.5%; p<0.001).
Conclusion
Complete revascularisation by PTCA in multivessel coronary disease did not result in a lower death or MI rate compared with incomplete revascularisation. Overall the patient's prognosis after PTCA is similar to CABG, but patients with three or more remaining lesions after PTCA had a worse prognosis than CABG patients.
Images
PMCID: PMC2499577
stable angina pectoris; unstable angina pectoris; multivessel coronary disease; revascularisation; follow-up
9.  Clinical outcomes of patients with diabetes mellitus and acute myocardial infarction treated with primary angioplasty or fibrinolysis 
Heart  2002;88(3):260-265.
Objective: To compare the early and late outcomes of primary percutaneous transluminal coronary angioplasty (PTCA) with fibrinolytic treatment among diabetic patients with acute myocardial infarction (AMI).
Design: Retrospective observational study with data obtained from prospective registries.
Setting: Tertiary cardiovascular institution with 24 hour acute interventional facilities.
Patients: 202 consecutive diabetic patients with AMI receiving reperfusion treatment within six hours of symptom onset.
Interventions: Fibrinolytic treatment was administered to 99 patients, and 103 patients underwent primary PTCA. Most patients undergoing PTCA received adjunctive stenting (94.2%) and glycoprotein IIb/IIIa inhibition (63.1%).
Main outcome measures: Death, non-fatal reinfarction, and target vessel revascularisation at 30 days and one year were assessed.
Results: Baseline characteristics were similar in these two treatment groups except that the proportion of patients with Killip class III or IV was considerably higher in those treated with PTCA (15.5% v 6.1%, p = 0.03) and time to treatment was significantly longer (103.7 v 68.0 minutes, p < 0.001). Among those treated with PTCA, the rates for in-hospital recurrent ischaemia (5.8% v 17.2%, p = 0.011) and target vessel revascularisation at one year (19.4% v 36.4%, p = 0.007) were lower. Death or reinfarction at one year was also reduced among those treated with PTCA (17.5% v 31.3%, p = 0.02), with an adjusted relative risk of 0.29 (95% confidence interval 0.15 to 0.57) compared with fibrinolysis.
Conclusion: Among diabetic patients with AMI, primary PTCA was associated with reduced early and late adverse events compared with fibrinolytic treatment.
PMCID: PMC1767339  PMID: 12181218
angioplasty; diabetes; fibrinolysis; myocardial infarction
10.  Six-month clinical outcomes of the Tryton Side Branch Stent for the treatment of bifurcation lesions 
Netherlands Heart Journal  2012;20(11):439-446.
Aims
Percutaneous coronary intervention (PCI) of a bifurcation lesion (BL) is still associated with poorer clinical outcomes when compared with PCI of a non-BL. Therefore, several dedicated coronary bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA), were developed to improve clinical outcomes. We investigated 6-month clinical outcomes after placement of a Tryton stent in 91 patients treated for 93 BLs in our centre.
Methods and results
All consecutive patients who have undergone PCI of a BL treated with the Tryton stent in our centre were included. Outcomes were defined as any death, cardiac death, myocardial infarction (MI), any revascularisation, ischaemia-driven target vessel revascularisation (TVR), ischaemia-driven target lesion revascularisation (TLR), stent thrombosis, and target vessel failure (TVF; composite of cardiac death, MI, and ischaemia-driven TVR). Event rates were estimated using the Kaplan-Meier method. Thirty-eight (42 %) patients with acute coronary syndrome (ACS) were included (16 % ST-segment elevation MI (STEMI)). The 6-month event rates were 5.4 % (death), 4.3 % (cardiac death), 2.2 % (MI), 4.5 % (any revascularisation), 4.5 % (TVR), 4.5 % (TLR) and 9.7 % (TVF).
Conclusion
In a real-world all-comers single-centre registry, the use of the Tryton Side Branch Stent was associated with acceptable procedural and promising clinical outcomes at 6 months, including ACS and STEMI patients.
doi:10.1007/s12471-012-0302-x
PMCID: PMC3491128  PMID: 22763848
Percutaneous coronary intervention; Coronary artery disease; Bifurcation lesions; Dedicated bifurcation device
11.  Diabetes: prevention of cardiovascular events  
Clinical Evidence  2006;2006:0601.
Introduction
Diabetes mellitus is a major risk factor for cardiovascular disease. In the USA, a survey of deaths in 1986 suggested that 60−75% of people with diabetes die from cardiovascular causes.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of promoting smoking cessation; controlling blood pressure; treating dyslipidaemia; blood glucose control; treating multiple risk factors; revascularisation procedures; and antiplatelet drugs in people with diabetes? We searched: Medline, Embase, The Cochrane Library and other important databases up to November 2004 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 63 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antihypertensive drugs, antihypertensive treatment, aspirin, clopidogrel, coronary artery bypass graft, diet, fibrates, glycaemic control (intensive versus conventional control), heparin (with or without glycoprotein IIb/IIIa inhibitors, or clopidogrel), lower target blood pressures, metformin, multiple risk factor treatment (intensive), percutaneous transluminal coronary angioplasty (plus stent), smoking cessation, statins (aggressive or moderate lipid lowering, low or standard dose), stent (plus glycoprotein IIb/IIIa inhibitors), thrombolysis.
Key Points
People with diabetes mellitus have 2−4 times the risk of cardiovascular disease, and are up to 3 times more likely to die after a myocardial infarction, compared with normoglycaemic people.
Intensive treatment of multiple risk factors in people with type 2 diabetes and microalbuminuria reduces the risk of cardiovascular disease compared with conventional treatment. Promotion of smoking cessation is likely to reduce cardiovascular events in people with diabetes, although no studies have specifically studied this.
Tight control of blood pressure and reduction of cholesterol reduces the risk of cardiovascular events in people with hypertension and diabetes. Angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, beta-blockers, calcium channel blockers and diuretics have all been shown to have similar antihypertensive effects.Reduction of cholesterol with statins reduces cardiovascular morbidity and mortality in people with diabetes regardless of initial cholesterol levels, and fibrates may also be beneficial. Aspirin and clopidogrel have not been consistently shown to reduce cardiovascular events or mortality in people with diabetes and cardiovascular disease compared with controls, and increase the risk of bleeding.Intensive blood glucose control reduces the risk of cardiovascular events in people with type 1 diabetes, but has not been consistently shown to reduce cardiovascular morbidity or mortality in people with type 2 diabetes.
Coronary artery bypass grafts reduce 4 year mortality compared with percutaneous transluminal coronary angioplasty (PTCA) in people with diabetes, although longer term benefits are unclear. PTCA may reduce short term mortality or myocardial infarction compared with thrombolysis in people with diabetes and acute myocardial infarction.Adding glycoprotein IIb/IIIa inhibitors reduces cardiovascular morbidity and mortality compared with placebo in people with acute coronary syndrome or undergoing PTCA plus stenting.
PMCID: PMC2907631
12.  Emergency surgical revascularisation for coronary angioplasty complications. 
British Heart Journal  1994;72(5):428-435.
OBJECTIVES--To evaluate trends in referrals for emergency operations after percutaneous transluminal coronary angioplasty (PTCA) complications; to analyse morbidity and mortality and assess the influence of PTCA backup on elective surgery. DESIGN--A retrospective analysis of patients requiring emergency surgical revascularisation within 24 hours of percutaneous transluminal coronary angioplasty. PATIENTS--Between January 1980 and December 1990, 75 patients requiring emergency surgery within 24 hours of percutaneous transluminal coronary angioplasty. SETTING--A tertiary referral centre and postgraduate teaching hospital. RESULTS--57 patients (76%) were men, the mean age was 55 (range 29-73) years, and 30 (40%) had had a previous myocardial infarction. Before PTCA, 68 (91%) had severe angina, 59 (79%) had multivessel disease, and six (8%) had a left ventricular ejection fraction of less than 40%. A mean of 2.1 grafts (range one to five) were performed; the internal mammary artery was used in only one patient. The operative mortality was 9% and inhospital mortality was 17%. There was a need for cardiac massage until bypass was established in 19 patients (25%): this was the most important outcome determinant (P = 0.0051) and was more common in those patients with multivessel disease (P = 0.0449) and in women (P = 0.0388). In 10 of the 19 cases a vacant operating theatre was unavailable, the operation being performed in the catheter laboratory or anaesthetic room. These 19 patients had an operative mortality of 32% and inhospital mortality of 47%, compared with 2% and 7% respectively for the 56 patients who awaited the next available operating theatre. Complications included myocardial infarction, 19 patients (25%); arrhythmias, 10 patients (3%); and gross neurological event, two patients (3%). The mean intensive care unit stay was 2.6 days (range 1 to 33 days) and the mean duration of hospital admission was 13 days (range 5-40 days). CONCLUSIONS--Patients undergoing emergency surgery after PTCA complications have a substantially increased inhospital mortality and morbidity. PTCA in this unit continues to require surgical cover. Delays in operating on stable patients in centres which operate a "next available theatre" backup policy may not differ from some units performing PTCA with offsite cover for PTCA complications. Particularly in the presence of multivessel disease, however, PTCA complications may be associated with the need for "crash" bypass and such patients are unlikely to survive hospital transfer. The proportion of patients requiring "crash" bypass has increased during the period reviewed because of the extent of disease in the emergency surgical group increased. These results indicate that surgery should not be denied to these patients.
Images
PMCID: PMC1025609  PMID: 7818959
13.  Are “Treatment” Bare Metal Stents Superior to “Control” Bare Metal Stents? A meta-analytic approach 
American heart journal  2008;155(4):624-629.e2.
Background
It has been suggested that the benefits of drug-eluting stents compared to bare metal stents (BMS) have been over-estimated in part because target lesion/vessel revascularization (TLR/TVR) rates in the BMS control group of these trials were spuriously high.
Methods
We used meta-analytic techniques to systematically compare clinical event rates among patients treated with BMS in trials where BMS were the experimental (BMSexperimental) rather than the control (BMScontrol) intervention. MEDLINE searches were performed to identify eligible randomized trials comparing either drug-eluting stents with BMScontrol, or BMSexperimental with balloon angioplasty in patients with non-acute coronary artery disease. Trial characteristics and 6 to 12 month rates for death, myocardial infarction, TLR/TVR and major adverse cardiac events (MACE) were extracted and assessed.
Results
Eligible trials yielded 50 BMS cohorts: 19 in the BMScontrol group (4 046 patients) and 31 in the BMSexperimental group (5 068 patients). Summary death and infarction rates did not differ between groups. The summary TLR/TVR rates were 16.2% (95% confidence interval, CI: 13.5, 19.3) versus 13.8% (95% CI: 12.0, 15.7) in BMScontrol versus BMSexperimental groups, respectively (p=0.15). Among 39 BMS cohorts with ≤250 patients, TLR/TVR rates were significantly higher in BMScontrol versus BMSexperimental groups (18.9% [95% CI: 16.0, 22.2] versus 13.7% [95% CI: 11.5, 16.3], p=0.01). There were no between-group differences among larger BMS cohorts (p=0.98).
Conclusions
While overall clinical event rates did not differ in the BMScontrol and the BMSexperimental groups, a higher rate of TVR/TLR was seen in the BMScontrol group among smaller trials.
doi:10.1016/j.ahj.2007.11.005
PMCID: PMC3065934  PMID: 18371468
14.  Prospective randomised comparison between thrombolysis, rescue PTCA, and primary PTCA in patients with extensive myocardial infarction admitted to a hospital without PTCA facilities: a safety and feasibility study 
Heart  1999;82(4):426-431.
OBJECTIVE—To assess the safety and feasibility of acute transport followed by rescue percutaneous transluminal coronary angioplasty (PTCA) or primary PTCA in patients with acute myocardial infarction initially admitted to a hospital without PTCA facilities.
DESIGN—In a multicentre randomised open trial, three regimens of treatment of acute large myocardial infarction were compared for patients admitted to hospitals without angioplasty facilities: thrombolytic treatment with alteplase (75 patients), alteplase followed by transfer to the PTCA centre and (if indicated) rescue PTCA (74 patients), or transfer for primary PTCA (75 patients).
RESULTS—Between 1995 and 1997 224 patients were included. Baseline characteristics were distributed evenly. Transport to the PTCA centre was without severe complications in all patients. Mean (SD) delay from onset of symptoms to randomisation was 130 (75) minutes and from randomisation to angiography 90 (25) minutes. Death or recurrent infarction within 42 days occurred in 12 patients in the thrombolysis group, in 10 patients in the rescue PTCA group, and in six patients in the primary PTCA group. These differences were not significant.
CONCLUSIONS—Acute transfer for rescue PTCA or primary PTCA in patients with extensive myocardial infarction is feasible and safe. Efficacy of rescue PTCA or primary PTCA in this setting will have to be tested in larger series before this approach can be implemented as "routine treatment" for patients with extensive myocardial infarction.


Keywords: myocardial infarction; percutaneous transluminal coronary angioplasty; primary PTCA; rescue PTCA; reperfusion
PMCID: PMC1760265  PMID: 10490554
15.  Myocardial infarction (ST-elevation) 
Clinical Evidence  2011;2011:0202.
Introduction
About one quarter of people having an acute myocardial infarction (MI) in the USA will die of it, half of them within 1 hour of the onset of symptoms. Cardiogenic shock develops in over 5% of people surviving the first hour after an acute MI, with a mortality of 50% to 80% in the first 48 hours.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: Which treatments improve outcomes in acute MI? Which treatments improve outcomes for cardiogenic shock after MI? We searched: Medline, Embase, The Cochrane Library, and other important databases up to October 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 52 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: angiotensin-converting enzyme (ACE) inhibitors, aspirin, beta-blockers, calcium channel blockers, early cardiac surgery, early invasive cardiac revascularisation, glycoprotein IIb/IIIa inhibitors, intra-aortic balloon counterpulsation, nitrates (with or without thrombolysis), positive inotropes, primary percutaneous transluminal coronary angioplasty (PTCA), pulmonary artery catheterisation, thrombolysis (with or without low molecular weight heparin, with or without unfractionated heparin), vasodilators, and ventricular assistance devices and cardiac transplantation.
Key Points
About one quarter of people who have a myocardial infarction (MI) in the USA will die from it, half of them within 1 hour of the onset of symptoms. Cardiogenic shock develops in over 5% of people who survive the first hour after an MI, with a mortality of 50% to 80% in the first 48 hours.
Aspirin reduces mortality, reinfarction, and stroke at 1 month compared with placebo in people with an acute MI. Thrombolysis within 6 hours reduces mortality but increases the risk of stroke or major bleeding in people with acute MI, with different agents seeming to have similar efficacy.Adding low molecular weight heparin to thrombolytics may reduce the risk of further cardiovascular events, but the combination has not been shown to improve survival.
Beta-blockers reduce reinfarction in people with acute MI, but have no effect on mortality in the short term, and increase cardiogenic shock.
ACE inhibitors reduce mortality in people with acute MI compared with placebo. Nitrates reduce mortality and improve symptoms in people not receiving thrombolysis, but may not be beneficial in people after thrombolysis. Calcium channel blockers have not been shown to reduce mortality after an acute MI, and early treatment with nifedipine may increase mortality.
Primary PTCA within 12 hours of onset of chest pain reduces the risk of death, reinfarction, and stroke compared with thrombolysis.
In people with cardiogenic shock, invasive cardiac revascularisation within 48 hours of acute MI reduces mortality at 12 months compared with medical treatment alone, but people aged over 75 years may not benefit. We don't know whether thrombolysis, vasodilators, intra-aortic balloon counterpulsation, ventricular assistance devices and cardiac transplantation, or early cardiac surgery improve survival in people with cardiogenic shock.There is a consensus that positive inotropes and pulmonary artery catheterisation are beneficial, but we found no trials that confirmed this.
PMCID: PMC3217814  PMID: 21477402
16.  One-year clinical follow-up of a registry evaluating a percutaneous revascularisation strategy combining a pre-specified simple selection process with the use of a new thin-strut bare cobalt-chromium stent 
Netherlands Heart Journal  2010;18(10):486-492.
Objectives. To evaluate clinical events in a specifically selected cohort of patients with obstructive coronary artery disease (CAD), using a new generation thin-strut bare cobalt-chromium coronary stent.
Methods. Patients with single- or multi-vessel, stable or unstable CAD eligible for percutaneous implantation of at least one bare cobalt-chromium stent were evaluated in a single-centre registry. Prospective pre-specified criteria for bare cobalt-chromium stent implantation in our centre were: any acute ST-elevation myocardial infarction (MI), otherwise 1) de novo coronary lesion, and 2) lesion length <20 mm, and 3) reference vessel diameter >2.6 mm, and 4) no diabetes, unless reference vessel diameter >3.5 mm. Endpoints, retrospectively collected, were death, MI and clinically driven target-lesion revascularisation (TLR) and target-vessel revascularisation (TVR) after 12 months.
Results. Between September 2005 and June 2007, 712 patients (48.7% one-vessel, 29.9% two-vessel, 20% three-vessel and 1.4% left main disease; 7.9% diabetics) were treated with 800 bare cobalt-chromium stents, for stable angina (40.9%), unstable angina (20.9%) or acute ST-elevation MI (38.2%). The procedural success rate was 99.3%. Peri-procedural MI rate was 2.2% in the semi-elective group. At 12 months there were 17 deaths (2.4%), of which nine non-cardiac, 20 (2.8%) MI, 19 (2.7%) TLR and 29 (4.1%) TVR. Early and late definite stent thrombosis occurred in four (0.6%) and three (0.4%) patients, respectively.
Conclusion. A strategy aimed at minimising drug-eluting stent use and combining a pre-specified simple selection process with the use of a new thin-strut bare cobalt-chromium stent is safe and effective at one-year clinical follow-up. (Neth Heart J 2010;18:486–92.)
PMCID: PMC2954301  PMID: 20978593
Bare Metal Stent; Coronary Artery Disease; Stable Angina; Non Stable Angina; STEMI
17.  Stenting for Peripheral Artery Disease of the Lower Extremities 
Executive Summary
Background
Objective
In January 2010, the Medical Advisory Secretariat received an application from University Health Network to provide an evidentiary platform on stenting as a treatment management for peripheral artery disease. The purpose of this health technology assessment is to examine the effectiveness of primary stenting as a treatment management for peripheral artery disease of the lower extremities.
Clinical Need: Condition and Target Population
Peripheral artery disease (PAD) is a progressive disease occurring as a result of plaque accumulation (atherosclerosis) in the arterial system that carries blood to the extremities (arms and legs) as well as vital organs. The vessels that are most affected by PAD are the arteries of the lower extremities, the aorta, the visceral arterial branches, the carotid arteries and the arteries of the upper limbs. In the lower extremities, PAD affects three major arterial segments i) aortic-iliac, ii) femoro-popliteal (FP) and iii) infra-popliteal (primarily tibial) arteries. The disease is commonly classified clinically as asymptomatic claudication, rest pain and critical ischemia.
Although the prevalence of PAD in Canada is not known, it is estimated that 800,000 Canadians have PAD. The 2007 Trans Atlantic Intersociety Consensus (TASC) II Working Group for the Management of Peripheral Disease estimated that the prevalence of PAD in Europe and North America to be 27 million, of whom 88,000 are hospitalizations involving lower extremities. A higher prevalence of PAD among elderly individuals has been reported to range from 12% to 29%. The National Health and Nutrition Examination Survey (NHANES) estimated that the prevalence of PAD is 14.5% among individuals 70 years of age and over.
Modifiable and non-modifiable risk factors associated with PAD include advanced age, male gender, family history, smoking, diabetes, hypertension and hyperlipidemia. PAD is a strong predictor of myocardial infarction (MI), stroke and cardiovascular death. Annually, approximately 10% of ischemic cardiovascular and cerebrovascular events can be attributed to the progression of PAD. Compared with patients without PAD, the 10-year risk of all-cause mortality is 3-fold higher in patients with PAD with 4-5 times greater risk of dying from cardiovascular event. The risk of coronary heart disease is 6 times greater and increases 15-fold in patients with advanced or severe PAD. Among subjects with diabetes, the risk of PAD is often severe and associated with extensive arterial calcification. In these patients the risk of PAD increases two to four fold. The results of the Canadian public survey of knowledge of PAD demonstrated that Canadians are unaware of the morbidity and mortality associated with PAD. Despite its prevalence and cardiovascular risk implications, only 25% of PAD patients are undergoing treatment.
The diagnosis of PAD is difficult as most patients remain asymptomatic for many years. Symptoms do not present until there is at least 50% narrowing of an artery. In the general population, only 10% of persons with PAD have classic symptoms of claudication, 40% do not complain of leg pain, while the remaining 50% have a variety of leg symptoms different from classic claudication. The severity of symptoms depends on the degree of stenosis. The need to intervene is more urgent in patients with limb threatening ischemia as manifested by night pain, rest pain, ischemic ulcers or gangrene. Without successful revascularization those with critical ischemia have a limb loss (amputation) rate of 80-90% in one year.
Diagnosis of PAD is generally non-invasive and can be performed in the physician offices or on an outpatient basis in a hospital. Most common diagnostic procedure include: 1) Ankle Brachial Index (ABI), a ratio of the blood pressure readings between the highest ankle pressure and the highest brachial (arm) pressure; and 2) Doppler ultrasonography, a diagnostic imaging procedure that uses a combination of ultrasound and wave form recordings to evaluate arterial flow in blood vessels. The value of the ABI can provide an assessment of the severity of the disease. Other non invasive imaging techniques include: Computed Tomography (CT) and Magnetic Resonance Angiography (MRA). Definitive diagnosis of PAD can be made by an invasive catheter based angiography procedure which shows the roadmap of the arteries, depicting the exact location and length of the stenosis / occlusion. Angiography is the standard method against which all other imaging procedures are compared for accuracy.
More than 70% of the patients diagnosed with PAD remain stable or improve with conservative management of pharmacologic agents and life style modifications. Significant PAD symptoms are well known to negatively influence an individual quality of life. For those who do not improve, revascularization methods either invasive or non-invasive can be used to restore peripheral circulation.
Technology Under Review
A Stent is a wire mesh “scaffold” that is permanently implanted in the artery to keep the artery open and can be combined with angioplasty to treat PAD. There are two types of stents: i) balloon-expandable and ii) self expandable stents and are available in varying length. The former uses an angioplasty balloon to expand and set the stent within the arterial segment. Recently, drug-eluting stents have been developed and these types of stents release small amounts of medication intended to reduce neointimal hyperplasia, which can cause re-stenosis at the stent site. Endovascular stenting avoids the problem of early elastic recoil, residual stenosis and flow limiting dissection after balloon angioplasty.
Research Questions
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting more effective than percutaneous transluminal angioplasty (PTA) in improving patency?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), does primary stenting provide immediate success compared to PTA?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), is primary stenting associated with less complications compared to PTA?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion), does primary stenting compared to PTA reduce the rate of re-intervention?
In individuals with PAD of the lower extremities (superficial femoral artery, infra-popliteal, crural and iliac artery stenosis or occlusion) is primary stenting more effective than PTA in improving clinical and hemodynamic success?
Are drug eluting stents more effective than bare stents in improving patency, reducing rates of re-interventions or complications?
Research Methods
Literature Search
A literature search was performed on February 2, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA). Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Inclusion Criteria
English language full-reports from 1950 to January Week 3, 2010
Comparative randomized controlled trials (RCTs), systematic reviews and meta-analyses of RCTs
Proven diagnosis of PAD of the lower extremities in all patients.
Adult patients at least 18 years of age.
Stent as at least one treatment arm.
Patency, re-stenosis, re-intervention, technical success, hemodynamic (ABI) and clinical improvement and complications as at least an outcome.
Exclusion Criteria
Non-randomized studies
Observational studies (cohort or retrospective studies) and case report
Feasibility studies
Studies that have evaluated stent but not as a primary intervention
Outcomes of Interest
The primary outcome measure was patency. Secondary measures included technical success, re-intervention, complications, hemodynamic (ankle brachial pressure index, treadmill walking distance) and clinical success or improvement according to Rutherford scale. It was anticipated, a priori, that there would be substantial differences among trials regarding the method of examination and definitions of patency or re-stenosis. Where studies reported only re-stenosis rates, patency rates were calculated as 1 minus re-stenosis rates.
Statistical Analysis
Odds ratios (for binary outcomes) or mean difference (for continuous outcomes) with 95% confidence intervals (CI) were calculated for each endpoint. An intention to treat principle (ITT) was used, with the total number of patients randomized to each study arm as the denominator for each proportion. Sensitivity analysis was performed using per protocol approach. A pooled odds ratio (POR) or mean difference for each endpoint was then calculated for all trials reporting that endpoint using a fixed effects model. PORs were calculated for comparisons of primary stenting versus PTA or other alternative procedures. Level of significance was set at alpha=0.05. Homogeneity was assessed using the chi-square test, I2 and by visual inspection of forest plots. If heterogeneity was encountered within groups (P < 0.10), a random effects model was used. All statistical analyses were performed using RevMan 5. Where sufficient data were available, these analyses were repeated within subgroups of patients defined by time of outcome assessment to evaluate sustainability of treatment benefit. Results were pooled based on the diseased artery and stent type.
Summary of Findings
Balloon-expandable stents vs PTA in superficial femoral artery disease
Based on a moderate quality of evidence, there is no significant difference in patency between primary stenting using balloon-expandable bare metal stents and PTA at 6, 12 and 24 months in patients with superficial femoral artery disease. The pooled OR for patency and their corresponding 95% CI are: 6 months 1.26 (0.74, 2.13); 12 months 0.95 (0.66, 1.38); and 24 months 0.72 (0.34. 1.55).
There is no significant difference in clinical improvement, re-interventions, peri and post operative complications, mortality and amputations between primary stenting using balloon-expandable bare stents and PTA in patients with superficial femoral artery. The pooled OR and their corresponding 95% CI are clinical improvement 0.85 (0.50, 1.42); ankle brachial index 0.01 (-0.02, 0.04) re-intervention 0.83 (0.26, 2.65); complications 0.73 (0.43, 1.22); all cause mortality 1.08 (0.59, 1.97) and amputation rates 0.41 (0.14, 1.18).
Self-expandable stents vs PTA in superficial femoral artery disease
Based on a moderate quality of evidence, primary stenting using self-expandable bare metal stents is associated with significant improvement in patency at 6, 12 and 24 months in patients with superficial femoral artery disease. The pooled OR for patency and their corresponding 95% CI are: 6 months 2.35 (1.06, 5.23); 12 months 1.54 (1.01, 2.35); and 24 months 2.18 (1.00. 4.78). However, the benefit of primary stenting is not observed for clinical improvement, re-interventions, peri and post operative complications, mortality and amputation in patients with superficial femoral artery disease. The pooled OR and their corresponding 95% CI are clinical improvement 0.61 (0.37, 1.01); ankle brachial index 0.01 (-0.06, 0.08) re-intervention 0.60 (0.36, 1.02); complications 1.60 (0.53, 4.85); all cause mortality 3.84 (0.74, 19.22) and amputation rates 1.96 (0.20, 18.86).
Balloon expandable stents vs PTA in iliac artery occlusive disease
Based on moderate quality of evidence, despite immediate technical success, 12.23 (7.17, 20.88), primary stenting is not associated with significant improvement in patency, clinical status, treadmill walking distance and reduction in re-intervention, complications, cardiovascular events, all cause mortality, QoL and amputation rates in patients with intermittent claudication caused by iliac artery occlusive disease. The pooled OR and their corresponding 95% CI are: patency 1.03 (0.56, 1.87); clinical improvement 1.08 (0.60, 1.94); walking distance 3.00 (12.96, 18.96); re-intervention 1.16 (0.71, 1.90); complications 0.56 (0.20, 1.53); all cause mortality 0.89 (0.47, 1.71); QoL 0.40 (-4.42, 5.52); cardiovascular event 1.16 (0.56, 2.40) and amputation rates 0.37 (0.11, 1.23). To date no RCTs are available evaluating self-expandable stents in the common or external iliac artery stenosis or occlusion.
Drug-eluting stent vs balloon-expandable bare metal stents in crural arteries
Based on a very low quality of evidence, at 6 months of follow-up, sirolimus drug-eluting stents are associated with a reduction in target vessel revascularization and re-stenosis rates in patients with atherosclerotic lesions of crural (tibial) arteries compared with balloon-expandable bare metal stent. The OR and their corresponding 95% CI are: re-stenosis 0.09 (0.03, 0.28) and TVR 0.15 (0.05, 0.47) in patients with atherosclerotic lesions of the crural arteries at 6 months follow-up. Both types of stents offer similar immediate success. Limitations of this study include: short follow-up period, small sample and no assessment of mortality as an outcome. Further research is needed to confirm its effect and safety.
PMCID: PMC3377569  PMID: 23074395
18.  Appropriateness of referral of coronary angiography patients in Sweden 
Heart  1999;81(5):470-477.
OBJECTIVE—To evaluate the appropriateness of referral following coronary angiography in Sweden. 
DESIGN—Prospective survey and review of medical records.
PATIENTS—Consecutive series of 2767 patients who underwent coronary angiography in Sweden between May 1994 and January 1995 and were considered for coronary revascularisation. 
MAIN OUTCOME MEASURES—Percentage of patients referred for coronary artery bypass graft surgery (CABG) and percutaneous transluminal coronary angioplasty (PTCA) for indications that were judged necessary, appropriate, uncertain, and inappropriate by a multispecialty Swedish national expert panel using the RAND/University of California Los Angeles (UCLA) appropriateness method, and the percentage of patients referred for continued medical management who met necessity criteria for revascularisation.
RESULTS—Half the patients were referred for CABG, 25% for PTCA, and 25% for continued medical therapy. CABG was judged appropriate or necessary for 78% of patients, uncertain for 12% and inappropriate for 10%. For PTCA the figures were 32%, 30% and 38%, respectively. Two factors contributed to the high inappropriate rate. Many of these patients did not have "significant" coronary artery disease (although all had at least one stenosis > 50%) or they were treated with less than "optimal" medical therapy. While 96% of patients who met necessity criteria for revascularisation were appropriately referred for revascularisation, 4% were referred for continued medical therapy.
CONCLUSIONS—Using the RAND/UCLA appropriateness method and the definitions agreed to by the expert panel, which may be considered conservative today, it was found that 19% of Swedish patients were referred for coronary revascularisation judged inappropriate. Since some cardiovascular procedures evolve rapidly, the proportion of patients referred for inappropriate indications today remains unknown. Nevertheless, physicians should actively identify those patients who will and will not benefit from coronary revascularisation and ensure that they are appropriately treated.


Keywords: coronary artery bypass graft surgery; angioplasty; quality of health care; health policy
PMCID: PMC1729044  PMID: 10212163
19.  Intravascular Ultrasound to Guide Percutaneous Coronary Interventions 
Executive Summary
Objective
The objective of this health technology policy assessment was to determine the effectiveness and cost-effectiveness of using intravascular ultrasound (IVUS) as an adjunctive imaging tool to coronary angiography for guiding percutaneous coronary interventions.
Background
Intravascular Ultrasound
Intravascular ultrasound is a procedure that uses high frequency sound waves to acquire 3-dimensional images from the lumen of a blood vessel. The equipment for performing IVUS consists of a percutaneous transducer catheter and a console for reconstructing images. IVUS has been used to study the structure of the arterial wall and nature of atherosclerotic plaques, and obtain measurements of the vessel lumen. Its role in guiding stent placement is also being investigated. IVUS is presently not an insured health service in Ontario.
Clinical Need
Coronary artery disease accounts for approximately 55% of cardiovascular deaths, the leading cause of death in Canada. In Ontario, the annual mortality rate due to ischemic heart disease was 141.8 per 100,000 population between 1995 and 1997. Percutaneous coronary intervention (PCI), a less invasive approach to treating coronary artery disease, is used more frequently than coronary bypass surgery in Ontario. The number of percutaneous coronary intervention procedures funded by the Ontario Ministry of Health and Long-term Care is expected to increase from approximately 17, 780 in 2004/2005 to 22,355 in 2006/2007 (an increase of 26%), with about 95% requiring the placement of one or more stents. Restenosis following percutaneous coronary interventions involving bare metal stents occurs in 15% to 30% of the cases, mainly because of smooth muscle proliferation and migration, and production of extracellular matrix. In-stent restenosis has been linked to suboptimal stent expansion and inadequate lesion coverage, while stent thrombosis has been attributed to incomplete stent-to-vessel wall apposition. Since coronary angiography (the imaging tool used to guide stent placement) has been shown to be inaccurate in assessing optimal stent placement, and IVUS can provide better views of the vessel lumen, the clinical utility of IVUS as an imaging tool adjunctive to coronary angiography in coronary intervention procedures has been explored in clinical studies.
Method
A systematic review was conducted to answer the following questions:
What are the procedure-related complications associated with IVUS?
Does IVUS used in conjunction with angiography to guide percutaneous interventions improve patient outcomes compared to angiographic guidance without IVUS?
Who would benefit most in terms of clinical outcomes from the use of IVUS adjunctive to coronary angiography in guiding PCIs?
What is the effectiveness of IVUS guidance in the context of drug-eluting stents?
What is the cost-effectiveness ratio and budget impact of adjunctive IVUS in PCIs in Ontario?
A systematic search of databases OVID MEDLINE, EMBASE, MEDLINE In-Process & Other Non-Indexed Citations, The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) database for the period beginning in May 2001 until the day of the search, November 4, 2005 yielded 2 systematic reviews, 1 meta-analysis, 6 randomized controlled trials, and 2 non-randomized studies on left main coronary arteries. The quality of the studies ranged from moderate to high. These reports were combined with reports from a previous systematic review for analysis. In addition to qualitative synthesis, pooled analyses of data from randomized controlled studies using a random effect model in the Cochrane Review Manager 4.2 software were conducted when possible.
Findings of Literature Review & Analysis
Safety
Intravascular ultrasound appears to be a safe tool when used in coronary interventions. Periprocedural complications associated with the use of IVUS in coronary interventions ranged from 0.5% in the largest study to 4%. Coronary rupture was reported in 1 study (1/54). Other complications included prolonged spasms of the artery after stenting, dissection, and femoral aneurysm.
Effectiveness
Based on pooled analyses of data from randomized controlled studies, the use of intravascular ultrasound adjunctive to coronary intervention in percutaneous coronary interventions using bare metal stents yielded the following findings:
For lesions predominantly at low risk of restenosis:
There were no significant differences in preintervention angiographic minimal lumen diameter between the IVUS-guided and angiography-guided groups.
IVUS guidance resulted in a significantly larger mean postintervention angiographic minimal lumen diameter (weighted mean difference of 0.11 mm, P = .0003) compared to angiographic guidance alone.
The benefit in angiographic minimal lumen diameter from IVUS guidance was not maintained at 6-month follow-up, when no significant difference in angiographic minimal lumen diameter could be detected between the two arms (weighted mean difference 0.08, P = .13).
There were no statistically significant differences in angiographic binary restenosis rates between IVUS-guidance and no IVUS guidance (Odds ratio [OR] 0.87 in favour of IVUS, 95% Confidence Interval [CI] [0.64–1.18], P = 0.37).
IVUS guidance resulted in a reduction in the odds of target lesion revascularization (repeat percutaneous coronary intervention or coronary bypass graft) compared to angiographic guidance alone. The reduction was statistically significant at a follow-up period of 6 months to 1 year, and at a follow-up period of 18 month to 2 years (OR 0.52 in favour of IVUS, 95% CI [0.33–0.81], P = .004).
Total revascularization rate (either target lesion or target vessel revascularization) was significantly lower for IVUS-guided patients at 18 months to 2.5 years after intervention (OR 0.43 in favour of IVUS, 95% CI [0.29–0.63], p < .0001).
There were no statistically significant differences in the odds of death (OR 1.36 in favour of no IVUS, P =0.65) or myocardial infarction (OR 0.95 in favour of IVUS, P = 0.93) between IVUS-guidance and angiographic guidance alone at up to 2.5 years of follow-up
The odds of having a major cardiac event (defined as death, myocardial infarction, and target lesion or target vessel revascularization) were significantly lower for patients with IVUS guidance compared to angiographic guidance alone during follow-up periods of up to 2.5 years (OR 0.53, 95% CI [0.36–0.78], P = 0.001). Since there were no significant reductions in the odds of death or myocardial infarction, the reduction in the odds of combined events reflected mainly the reduction in revascularization rates.
For lesions at High Risk of Restenosis:
There is evidence from one small, randomized controlled trial (n=150) that IVUS-guided percutaneous coronary intervention in long de novo lesions (>20 mm) of native coronary arteries resulted in statistically significant larger minimal lumen Diameter, and statistically significant lower 6-month angiographic binary restenosis rate. Target vessel revascularization rate and the rate of combined events were also significantly reduced at 12 months.
A small subgroup analysis of a randomized controlled trial reported no benefit in clinical or angiographic outcomes for IVUS-guided percutaneous coronary interventions in patients with diabetes compared to those guided by angiography. However, due to the nature and size of the analysis, no firm conclusions could be reached.
Based on 2 small, prospective, non-randomized controlled studies, IVUS guidance in percutaneous coronary interventions of left main coronary lesions using bare metal stents or drug-eluting stents did not result in any benefits in angiographic or clinical outcomes. These findings need to be confirmed.
Interventions Using Drug-Eluting Stents
There is presently no evidence on whether the addition of IVUS guidance during the implantation of drug-eluting stents would reduce incomplete stent apposition, or improve the angiographic or clinical outcomes of patients.
Ontario-Based Economic Analysis
Cost-effectiveness analysis showed that PCIs using IVUS guidance would likely be less costly and more effective than PCIs without IVUS guidance. The upfront cost of adjunctive use of IVUS in PCIs ranged from $1.56 million at 6% uptake to $13.04 million at 50% uptake. Taking into consideration cost avoidance from reduction in revascularization associated with the use of IVUS, a net saving of $0.63 million to $5.2 million is expected. However, since it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS can be generalized to clinical settings in Ontario, further analysis on the budget impact and cost-effectiveness need to be conducted once Ontario-specific revascularization rates are verified.
Factors to be Considered in the Ontario Context
Applicability of Findings to Ontario
The interim analysis of an Ontario field evaluation that compared drug-eluting stents to bare metal stents showed that the revascularization rates in low-risk patients with bare metal stents were much lower in Ontario compared to rates reported in randomized controlled trials (7.2% vs >17 %). Even though IVUS is presently not routinely used in the stenting of low-risk patients in Ontario, the revascularization rates in these patients in Ontario were shown to be lower than those reported for the IVUS groups reported in published studies. Based on this information and previous findings from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rates from IVUS guidance can be generalized to Ontario. In light of the above findings, it is advisable to validate the reported benefits of IVUS guidance in percutaneous coronary interventions involving bare metal stents in the Ontario context.
Licensing Status
As of January 16, 2006, Health Canada has licensed 10 intravascular ultrasound imaging systems/catheters for transluminal intervention procedures, most as class 4 medical devices.
Current Funding
IVUS is presently not an insured procedure under the Ontario Health Insurance Plan and there are no professional fees for this procedure. All costs related to the use of IVUS are covered within hospitals’ global budgets. A single use IVUS catheter costs approximately $900CDN and the procedure adds approximately 20 minutes to 30 minutes to a percutaneous coronary intervention procedure.
Diffusion
According to an expert consultant, current use of IVUS in coronary interventions in Ontario is probably limited to high-risk cases such as interventions in long lesions, small vessels, and bifurcated lesions for which images from coronary angiography are indeterminate. It was estimated that IVUS is being used in about 6% of all percutaneous coronary interventions at a large Ontario cardiac centre.
Expert Opinion
IVUS greatly enhances the cardiac interventionists’ ability to visualize and assess high-risk lesions such as long lesions, narrow lesions, and bifurcated lesions that may have indeterminate angiographic images. Information from IVUS in these cases facilitates the choice of the most appropriate approach for the intervention.
Conclusion
The use of adjunctive IVUS in PCIs using bare metal stents in lesions predominantly at low risk for restenosis had no significant impact on survival, myocardial infarction, or angiographic restenosis rates up to 2.5 years after intervention.
The use of IVUS adjunctive to coronary angiography in percutaneous coronary interventions using bare metal stents in lesions predominantly at low risk for restenosis significantly reduced the target lesion and target vessel revascularization at a follow-up period of 18 months to 2.5 years.
One small study suggests that adjunctive IVUS in PCIs using bare metal stents in long lesions (>20 mm) significantly improved the 6-month angiographic restenosis rate and one-year target lesion revascularization rate. These results need to be confirmed with large randomized controlled trials.
Based on information from the Ontario field evaluation on stenting, it is uncertain whether the reduction in revascularization rate resulting from the use of IVUS in the placement of bare metal stents can be generalized to clinical settings in Ontario.
There is presently insufficient evidence available to determine the impact of adjunctive IVUS in percutaneous interventions in high-risk lesions (other than long lesions) or in PCIs using drug-eluting stents.
PMCID: PMC3379536  PMID: 23074482
20.  Treatment for Stable Coronary Artery Disease: A Network Meta-Analysis of Cost-Effectiveness Studies 
PLoS ONE  2014;9(6):e98371.
Introduction and Objectives
Numerous studies have assessed cost-effectiveness of different treatment modalities for stable angina. Direct comparisons, however, are uncommon. We therefore set out to compare the efficacy and mean cost per patient after 1 and 3 years of follow-up, of the following treatments as assessed in randomized controlled trials (RCT): medical therapy (MT), percutaneous coronary intervention (PCI) without stent (PTCA), with bare-metal stent (BMS), with drug-eluting stent (DES), and elective coronary artery bypass graft (CABG).
Methods
RCT comparing at least two of the five treatments and reporting clinical and cost data were identified by a systematic search. Clinical end-points were mortality and myocardial infarction (MI). The costs described in the different trials were standardized and expressed in US $ 2008, based on purchasing power parity. A network meta-analysis was used to compare costs.
Results
Fifteen RCT were selected. Mortality and MI rates were similar in the five treatment groups both for 1-year and 3-year follow-up. Weighted cost per patient however differed markedly for the five treatment modalities, at both one year and three years (P<0.0001). MT was the least expensive treatment modality: US $3069 and 13 864 after one and three years of follow-up, while CABG was the most costly: US $27 003 and 28 670 after one and three years. PCI, whether with plain balloon, BMS or DES came in between, but was closer to the costs of CABG.
Conclusions
Appreciable savings in health expenditures can be achieved by using MT in the management of patients with stable angina.
doi:10.1371/journal.pone.0098371
PMCID: PMC4045726  PMID: 24896266
21.  Endothelium dependent and independent responses in coronary artery disease measured at angioplasty. 
British Heart Journal  1993;70(1):35-42.
OBJECTIVE--To investigate the effects of substance P and papaverine, two drugs that increase coronary blood flow by different mechanisms, on vasomotion in stenotic coronary arteries at percutaneous transluminal coronary angioplasty (PTCA). DESIGN--Coronary blood flow responses to substance P and papaverine were measured in stenotic coronary arteries at the time of PTCA with quantitative angiography and a Doppler flow probe. SETTING--A cardiothoracic referral centre. PATIENTS--15 patients undergoing elective PTCA of a discrete epicardial coronary artery stenosis. INTERVENTIONS--Pharmacological coronary flow reserve was determined with papaverine 5-10 minutes before and after successful PTCA. Endothelium dependent responses to 2 minute infusions of substance P (10-15 pmol.min-1) were assessed immediately before PTCA. MAIN OUTCOME MEASURES--Coronary blood flow responses and changes in epicardial coronary artery area at stenotic, proximal, and distal sites with papaverine and substance P. RESULTS--Stenotic sites dilated with papaverine before PTCA (17.7%(6.9%) (mean (SEM)) area increase, p < 0.05 v baseline). Substance P dilated stenotic sites (16.8%(5.7%) area increase, p < 0.05) and proximal (14.3%(5.4%), p < 0.05) and distal sites (41.7%(9.3%), p < 0.005). Coronary flow reserve increased but did not reach normal values after PTCA (2.3(0.4) before PTCA v 3.0(0.4) after PTCA, p < 0.05) and was associated with an increase in peak flow with papaverine. Angioplasty did not alter baseline flow. After PTCA papaverine caused significant vasoconstriction at the stenotic site (-13.6%(4.3%) area decrease, p < 0.05). There was a negative correlation (r = -0.68, p < 0.05) between the dilator response with papaverine before PTCA and the constrictor response after PTCA. CONCLUSIONS--Substance P causes endothelium dependent dilatation in atheromatous coronary arteries, even at sites of overt atheroma. The cause of the paradoxical constrictor response to papaverine after PTCA is uncertain, but unopposed flow mediated vasoconstriction (the myogenic response) after balloon induced endothelial denudation may be one of several contributory factors.
PMCID: PMC1025226  PMID: 7518687
22.  Impact of the introduction of drug eluting stents on clinical outcomes in patients undergoing percutaneous and surgical coronary artery revascularisation procedures in Western Australia 
Background
Increasing rates of percutaneous coronary intervention (PCI) and decreasing rates of coronary artery bypass graft (CABG) surgery followed the introduction of drug eluting stents in Western Australia in 2002. We assessed the impact of these changes on one-year outcomes for the total population of patients undergoing coronary artery revascularisation procedures (CARP) in Western Australia between 2000-2004.
Methods
Clinical and linked administrative data (inpatient admissions and death) were merged for all patients who had their first CARP with stent or CABG in Western Australia between 2000-2004. The clinical data were collected from all hospitals in Western Australia where CARP procedures are performed. We calculated the unadjusted (Kaplan-Meier) and adjusted (Cox) risks for one-year death (all-cause), death (all-cause) or admission for myocardial infarction (MI), target vessel revascularisation (TVR) and the composite outcome of death/MI/TVR (major adverse cardiac events, MACE).
Results
Over the study period, there were 14,118 index CARPs. The use of drug eluting stents increased from 0% to 95.8% of PCI procedures, and PCI procedures increased from 61.1% to 74.4% of all CARPS. There were no temporal changes in adjusted one-year mortality or death/MI. Overall, adjusted one-year MACE fell from 11.3% in 2000 to 8.5% in 2004 (p<0.0001) due to a significant reduction in TVR in the PCI group.
Conclusion
The introduction of drug eluting stents and resulting changes in coronary revascularisation strategies were not associated with changes in the one-year risk of major clinical endpoints (death or death/MI), but were associated with a significant reduction in the risk of MACE, driven entirely by a reduction in TVR after PCI. This real world study supports the effectiveness of drug eluting stents in reducing repeat procedures in the total CARP population without increasing the risk of death or MI.
doi:10.1186/1471-2261-13-47
PMCID: PMC3704943  PMID: 23826870
Coronary artery disease; Coronary revascularisation; Clinical outcome; Population study; Drug eluting stents; Percutaneous coronary intervention
23.  Factors affecting the therapeutic choice in patients with multivessel coronary artery disease. The Studio Lombardo Angiografia Multivasali (SLAM) Study Group. 
Heart  1997;77(5):443-448.
OBJECTIVE: To assess how clinical and angiographic findings are related to the decision to carry out coronary angioplasty (PTCA) or coronary bypass grafting in patients with multivessel coronary artery disease. DESIGN: Prospective survey carried out in 14 centres in the Lombardia region of Italy. PATIENTS: 1468 consecutive patients under going coronary arteriography for known or suspected ischaemic heart disease between May and October 1994, who were found to have multivessel coronary artery disease. MAIN OUTCOME MEASURES: Multivariate analysis was undertaken using stepwise logistic regression to identify the clinical and angiographic variables correlated with revascularisation (v medical treatment) in all of patients, and with surgery (v angioplasty) in the subset of revascularised patients. RESULTS: In all patients the clinical decision after coronary arteriography was made by physicians of each participating centre on the basis of their experience and clinical judgment: 53% of patients had bypass surgery, 28% had PTCA, and 19% continued medical treatment. The choice of a revascularisation procedure was directly related to a clinical diagnosis of unstable angina (P < < 0.001), the presence of left anterior descending artery disease (P < < 0.001), and to an ejection fraction > or = 40% (P < < 0.001), and inversely related to history of previous coronary bypass surgery (P < < 0.001). In revascularised patients, bypass surgery was the preferred treatment in patients with left anterior descending artery disease (P < < 0.001), three-vessel disease (P < < 0.001), and in those with at least one occluded vessel (P = 0.008). The choice of PTCA was significantly related to history of previous PTCA (P < < 0.001) or coronary bypass surgery (P < < 0.001), to a clinical diagnosis of non-Q wave myocardial infarction (P = 0.002), and to the possibility of implanting an intracoronary stent (P = 0.01). CONCLUSIONS: Bypass surgery is still the most widely used treatment for patients with multivessel coronary artery disease. This analysis provides a basis for comparison with future developments in the treatment of such patients. Further advancements in PTCA technology are needed to tilt the balance in favour of this less invasive procedure.
PMCID: PMC484767  PMID: 9196415
24.  Myocardial infarction (ST-elevation) 
Clinical Evidence  2009;2009:0202.
Introduction
About a quarter of people having an acute myocardial infarction (MI) in the USA will die of it, half of them within 1 hour of the onset of symptoms. Cardiogenic shock develops in over 5% of people surviving the first hour after an acute MI, with a mortality of 50-80% in the first 48 hours.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: Which treatments improve outcomes in acute MI? Which treatments improve outcomes for cardiogenic shock after MI? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 50 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: angiotensin-converting enzyme (ACE) inhibitors, aspirin, beta-blockers, calcium channel blockers, early cardiac surgery, early invasive cardiac revascularisation, glycoprotein IIb/IIIa inhibitors, intra-aortic balloon counterpulsation, nitrates (with or without thrombolysis), positive inotropes, primary percutaneous transluminal coronary angioplasty (PTCA), pulmonary artery catheterisation, thrombolysis (with or without low molecular weight heparin, with or without unfractionated heparin), vasodilators, and ventricular assistance devices and cardiac transplantation.
Key Points
About a quarter of people who have a myocardial infarction (MI) in the USA will die from it, half of them within 1 hour of the onset of symptoms. Cardiogenic shock develops in over 5% of people who survive the first hour after an MI, with a mortality of 50-80% in the first 48 hours.
Aspirin reduces mortality, reinfarction, and stroke at 1 month compared with placebo in people with an acute MI. Thrombolysis within 6 hours reduces mortality but increases the risk of stroke or major bleeding in people with acute MI, with different agents seeming to have similar efficacy.Adding low molecular weight heparin or glycoprotein IIb/IIIa inhibitors to thrombolytics may reduce the risk of further cardiovascular events, but these treatments have not been shown to improve survival.
Beta-blockers reduce reinfarction in people with acute MI, but have no effect on mortality in the short term, and increase cardiogenic shock.
ACE inhibitors reduce mortality in people with acute MI compared with placebo. Nitrates reduce mortality and improve symptoms in people not receiving thrombolysis, but may not be beneficial in people after thrombolysis. Calcium channel blockers have not been shown to reduce mortality after an acute MI, and early treatment with nifedipine may increase mortality.
Primary PTCA within 12 hours of onset of chest pain reduces the risk of death, reinfarction, and stroke compared with thrombolysis.
In people with cardiogenic shock, invasive cardiac revascularisation within 48 hours of acute MI reduces mortality at 12 months compared with medical treatment alone, but people aged over 75 years may not benefit. We don't know whether thrombolysis, vasodilators, intra-aortic balloon counterpulsation, ventricular assistance devices and cardiac transplantation, or early cardiac surgery improve survival in people with cardiogenic shock.There is a consensus that positive inotropes and pulmonary artery catheterisation are beneficial, but we found no studies that confirmed this.
PMCID: PMC2907827  PMID: 19445779
25.  Intermediate term outcomes with bifurcation coronary stenting using the paclitaxel drug-eluting stent: A single centre experience 
BACKGROUND:
Percutaneous treatment of bifurcation coronary artery disease (BCD) is complex and, in the era of bare metal stents (BMS), was reported to have a high rate of repeat target lesion revascularization (TLR). Paclitaxel drug-eluting stents (PES) have been used in the treatment of BCD, with better overall outcomes than BMS. Also, acute stent thrombosis (AST), with an incidence ranging from 2.7% to 4.3%, has been reported with the use of bifurcation PES, and remains a concern in treating these patients. In the present report, intermediate term outcomes with BCD stenting using TAXUS Express (Boston Scientific, USA) PES are presented from the Genesis Medical Center.
METHODS:
In the present retrospective study, 518 consecutive de novo bifurcation stenting procedures are reported. They were performed in 2005 at the present institution using the TAXUS Express PES. Follow-up data on 312 patients (60.2%) was achieved through telephone interviews and reviews of medical records after a mean of 6.7 months. The primary end point of the present study was the combined end points of cardiac death, nonfatal myocardial infarction (MI) and TLR. Secondary outcomes included the individual end points of death, cardiac death, AST, target vessel revascularization (TVR), TLR, ST elevation MI and non-ST elevation MI on intermediate term follow-up.
RESULTS:
The mean (± SD) age of the patients was 66±12 years. Acute procedural success was 95% (main branch, 99%; side branch, 95.9%). The following intermediate term outcomes with bifurcation drug-eluting stents were: TLR, 6.7%; TVR, 12.2%; definite and probable AST, 1.6%; death, 6.7%; cardiac death, 2.9%; non-ST elevation MI, 0.7%; ST elevation MI, 2.0%; and the combined primary end point, 9.9%. The outcomes for patients who underwent main branch stenting were not statistically different from those with bifurcation stenting, with an overall combined end point favouring main branch stenting alone (5.8% versus 10.8%, P not significant).
CONCLUSION:
The TAXUS Express PES carry acceptable intermediate term outcomes in the treatment of BCD compared with historic controls with BMS, with low TLR, TVR and overall primary combined end point. Main branch stenting alone is safe, with a trend toward fewer adverse events than bifurcation stenting.
PMCID: PMC2728416  PMID: 22477394
Bifurcation lesions; Outcome; Paclitaxel; Registry

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