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1.  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
2.  One year comparison of costs of coronary surgery versus percutaneous coronary intervention in the stent or surgery trial 
Heart  2004;90(7):782-788.
Objectives: To compare initial and one year costs of coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in the stent or surgery trial.
Design: Prospective, unblinded, randomised trial.
Setting: Multicentre study.
Patients: 988 patients with multivessel disease.
Interventions: CABG and stent assisted PCI.
Main outcome measures: Initial hospitalisation and one year follow up costs.
Results: At one year mortality was 2.5% in the PCI arm and 0.8% in the CABG arm (p  =  0.05). There was no difference in the composite of death or Q wave myocardial infarction (6.9% for PCI v 8.1% for CABG, p  =  0.49). There were more repeat revascularisations with PCI (17.2% v 4.2% for CABG). There was no significant difference in utility between arms at six months or at one year. Quality adjusted life years were similar 0.6938 for PCI v 0.6954 for PCI, Δ  =  0.00154, 95% confidence interval (CI) −0.0242 to 0.0273). Initial length of stay was longer with CABG (12.2 v 5.4 days with PCI, p < 0.0001) and initial hospitalisation costs were higher (£7321 v £3884 for PCI, Δ  =  £3437, 95% CI £3040 to £3848). At one year the cost difference narrowed but costs remained higher for CABG (£8905 v £6296 for PCI, Δ  =  £2609, 95% CI £1769 to £3314).
Conclusions: Over one year, CABG was more expensive and offered greater survival than PCI but little added benefit in terms of quality adjusted life years. The additional cost of CABG can be justified only if it offers continuing benefit at no further increase in cost relative to PCI over several years.
doi:10.1136/hrt.2003.015057
PMCID: PMC1768324  PMID: 15201249
coronary angioplasty; coronary bypass surgery; health care cost
3.  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
4.  Three-Year Outcomes of Multivessel Revascularization in Very Elderly Acute Coronary Syndrome Patients 
The Annals of thoracic surgery  2010;89(6):1889-1895.
Background
Comparative effectiveness of interventional treatment strategies for the very elderly with acute coronary syndrome remains poorly defined due to study exclusions. Interventions include percutaneous coronary intervention (PCI), usually with stents, or coronary artery bypass grafting (CABG). The elderly are frequently directed to PCI because of provider perceptions that PCI is at therapeutic equipoise with CABG and that CABG incurs increased risk. We evaluated long-term outcomes of CABG versus PCI in a cohort of very elderly Medicare beneficiaries presenting with acute coronary syndrome.
Methods
Using Medicare claims data, we analyzed outcomes of multivessel PCI or CABG treatment for a cohort of 10,141 beneficiaries age 85 and older diagnosed with acute coronary syndrome in 2003 and 2004. The cohort was followed for survival and composite outcomes (death, repeat revascularization, stroke, acute myocardial infarction) for three years. Logistic regressions controlled for patient demographics and comorbidities with propensity score adjustment for procedure selection.
Results
Percutaneous coronary intervention showed early benefits of lesser morbidity and mortality, but CABG outcomes improved relative to PCI outcomes by three years (p < 0.01). At 36 months post-initial revascularization, 66.0% of CABG recipients survived (versus 62.7% of PCI recipients, p < 0.05) and 46.1% of CABG recipients were free from composite outcome (versus 38.7% of PCI recipients, p < 0.01).
Conclusions
In very elderly patients with ACS and multivessel CAD, CABG appears to offer an advantage over PCI of survival and freedom from composite endpoint at three years. Optimizing the benefit of CABG in very elderly patients requires absence of significant congestive heart failure, lung disease, and peripheral vascular disease.
doi:10.1016/j.athoracsur.2010.03.003
PMCID: PMC2908496  PMID: 20494044
5.  Drug-eluting stents vs. coronary artery bypass-grafting in coronary heart disease 
Background
Coronary artery bypass graft (CABG) and percutaneous revascularisations with implantation of drug-eluting stents (DES) are important treatment methods in coronary heart disease (CHD).
Research questions
The evaluation addresses questions on medical efficacy, health economic parameters as well as ethic, social and legal implications in the use of DES vs. CABG in CHD patients.
Methods
A systematic literature search was conducted in December 2006 in the most important electronic databases beginning from 2004. Register data and controlled clinical studies were included in the evaluation. Additionally, a health economic modelling was conducted.
Results
Medical evaluation
The literature search yielded 2,312 hits. 14 publications about six controlled clinical studies and five publications about two registers were included into the evaluation.
Register data showed low mortality (0.2% to 0.7%) and low rates of myocardial infarction (0.5% to 1.4%) during hospital stay.
In patients with stenosis of the left anterior descending coronary artery one study showed in several analyses a significantly higher rate of reinterventions and a significantly higher rate of repeated angina pectoris for DES up to two years after the implantation (16.8% vs. 3.6% and 35% vs. 8%).
In patients with left main coronary artery stenosis two studies revealed a significantly higher survival without myocardial infarction and stroke for DES up to one year (96% vs. 79% and 95% vs. 91%) and two studies a significantly higher rate of revascularisations up to two years (20% vs. 4% and 25% vs. 5%) after the primary intervention.
In patients with multivessel disease, one study found a significantly higher mortality and myocardial infarction rate for CABG at one year (2.7% vs. 1.0% and 4.2% vs. 1.3%). The rate of revascularisations was significantly higher in two studies up to two years after DES implantation (8.5% vs. 4.2% and 14.2% vs. 5.3%). The rate at repeated angina pectoris was significantly higher in one study in DES patients during two-years follow-up (28% vs. 12%).
Health economic evaluation
The one-year total costs per patient after CABG were calculated to be 13,373 euro and after DES 10,443 euro, leading to a difference of 2,930 euro in favour of DES implantation. The three-year total costs per patient after CABG were estimated to be 13,675 euro and after DES 10,989 euro, showing a cost difference of 2,686 euro in favour of DES implantation. In the performed sensitivity analyses no break even point was reached.
Discussion
Existing data should be viewed only as limited evidence for possible medical and health economic effects.
Conclusions
There is limited evidence for the possible advantage of DES vs. CABG with respect to mortality and the rate of myocardial infarction in some indications as well as disadvantages with regard to the rate of revascularisations and the rate of repeated angina pectoris. Moreover there is also a limited evidence for possible economic advantage of DES vs. CABG in multivessel disease. Existing data should be proven in long-term follow-up and in randomised studies.
PMCID: PMC3011302  PMID: 21289918
6.  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
7.  Coronary stenting versus coronary bypass surgery in patients with multiple vessel disease and significant proximal LAD stenosis: results from the ERACI II study 
Heart  2003;89(2):184-188.
Purpose: To compare percutaneous coronary intervention (PCI) using stent implantation versus coronary artery bypass graft (CABG) in patients with multiple vessel disease with involvement of the proximal left anterior descending coronary artery (LAD).
Methods: 230 patients with multiple vessel disease and severe stenosis of the proximal LAD (113 with PCI, 117 with CABG). They were a cohort of patients from the randomised ERACI (Argentine randomized trial of percutaneous transluminal coronary angioplasty versus coronary artery bypass surgery in multivessel disease) II study.
Results: Both groups had similar baseline characteristics. There were no significant differences in 30 day major adverse cardiac events (death, myocardial infarction, stroke, and repeat procedures) between the strategies (PCI 2.7% v CABG 7.6%, p = 0.18). There were no significant differences in survival (PCI 96.4% v CABG 95%, p = 0.98) and survival with freedom from myocardial infarction (PCI 92% v CABG 89%, p = 0.94) at 41.5 (6) months’ follow up. However, freedom from new revascularisation procedures (CABG 96.6% v PCI 73%, p = 0.0002) and frequency of angina (CABG 9.4% v PCI 22%, p = 0.025) were superior in the CABG group.
Conclusion: Patients with multivessel disease and significant disease of the proximal LAD randomly assigned in the ERACI II trial to PCI or CABG had similar survival and survival with freedom from myocardial infarction at long term follow up. Repeat revascularisation procedures were higher in the PCI group.
PMCID: PMC1767529  PMID: 12527674
coronary artery bypass; proximal LAD intervention; multivessel coronary stenting; multivessel revascularisation
8.  Will Drug-Eluting Stents Replace Coronary Artery Bypass Surgery? 
Texas Heart Institute Journal  2005;32(3):323-330.
Although coronary artery bypass grafting (CABG) remains the treatment of choice for certain types of coronary artery disease (CAD), percutaneous coronary intervention (PCI)—particularly coronary angioplasty with stenting—has become the most popular nonmedical treatment approach to CAD. Some have speculated that, with the advent of drug-eluting stents (DESs), PCI will replace CABG entirely. However, the complete disappearance of CABG is both unlikely and unwarranted, for several reasons. Published randomized trials of CABG, PCI, and medical approaches to CAD compared only highly selected subgroups of patients because of strict exclusion criteria that often favored the PCI cohorts. Therefore, their results do not constitute sufficient evidence for the superiority of PCI over CABG in all CAD patients requiring revascularization. As PCI indications broaden to include more complex lesions and more high-risk patients, outcomes will not remain as favorable. In addition, although PCI is less invasive than surgery, CABG offers more complete revascularization and better freedom from repeat revascularization. Furthermore, no long-term patency data on DESs yet exist, whereas excellent 10- and 20-year patency rates have been reported for the left internal mammary artery-to-left anterior descending artery graft used in most CABG procedures. While PCI has been changing, CABG has not been stagnant; recently, advances in many aspects of the CABG procedure have improved short- and long-term outcomes in CABG patients. Both CABG and PCI technologies will continue to advance, not necessarily exclusive of one another, but no data yet exist to suggest that DESs will render CABG obsolete any time soon.
PMCID: PMC1336702  PMID: 16392212
Angioplasty, transluminal, percutaneous coronary; coronary artery bypass; stents
9.  Revascularization for coronary artery disease in diabetes mellitus: Angioplasty, stents and coronary artery bypass grafting 
Patients with diabetes mellitus (DM) are prone to a diffuse and rapidly progressive form of atherosclerosis, which increases their likelihood of requiring revascularization. However, the unique pathophysiology of atherosclerosis in patients with DM modifies the response to arterial injury, with profound clinical consequences for patients undergoing percutaneous coronary intervention (PCI). Multiple studies have shown that DM is a strong risk factor for restenosis following successful balloon angioplasty or coronary stenting, with greater need for repeat revascularization and inferior clinical outcomes. Early data suggest that drug eluting stents reduce restenosis rates and the need for repeat revascularization irrespective of the diabetic state and with no significant reduction in hard clinical endpoints such as myocardial infarction and mortality. For many patients with 1- or 2-vessel coronary artery disease, there is little prognostic benefit from any intervention over optimal medical therapy. PCI with drug-eluting or bare metal stents is appropriate for patients who remain symptomatic with medical therapy. However, selection of the optimal myocardial revascularization strategy for patients with DM and multivessel coronary artery disease is crucial. Randomized trials comparing multivessel PCI with balloon angioplasty or bare metal stents to coronary artery bypass grafting (CABG) consistently demonstrated the superiority of CABG in patients with treated DM. In the setting of diabetes CABG had greater survival, fewer recurrent infarctions or need for re-intervention. Limited data suggests that CABG is superior to multivessel PCI even when drug-eluting stents are used. Several ongoing randomized trials are evaluating the long-term comparative efficacy of PCI with drug-eluting stents and CABG in patients with DM. Only further study will continue to unravel the mechanisms at play and optimal therapy in the face of the profoundly virulent atherosclerotic potential that accompanies diabetes mellitus.
doi:10.1007/s11154-010-9135-3
PMCID: PMC3076727  PMID: 20221852
Coronary artery bypass graft; Diabetes mellitus; Percutaneous coronary intervention; Revascularization; Stents
10.  Trends in two year risk of repeat revascularisation or death from cardiovascular disease after coronary artery bypass grafting or percutaneous coronary intervention in Western Australia, 1980–2001 
Heart  2004;90(9):1042-1046.
Aims: To investigate whether, over the 21 year period 1980–2001, there had been a reduction in the risk of repeat revascularisation or death from cardiovascular disease in the cohort of all patients who were treated by coronary revascularisation in Western Australia.
Setting: State of Western Australia.
Patients: All patients treated by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) between 1980 and 2001.
Design: Cohort study.
Main outcome measures: Risk of repeat coronary artery revascularisation procedures (CARP) and risk of death from cardiovascular disease after first CARP.
Results: After a CABG procedure, the two year risk of repeat revascularisation remained low (less than 2%) across the period 1980–2001. For PCI, however, this risk declined significantly from 33.6% in 1985–9 to 12.4% in 2000–1. The risk of death from cardiovascular disease after a CARP declined by about 50% between 1985 and 2001.
Conclusions: Outcomes such as the risk of repeat revascularisation and the risk of death from cardiovascular disease have improved significantly for patients who underwent CARPs across the period 1980–2001. This has occurred despite an increasing trend in first CARP rates among older people and those with a recent history of myocardial infarction.
doi:10.1136/hrt.2003.022178
PMCID: PMC1768428  PMID: 15310696
coronary artery bypass; angioplasty; survival analysis
11.  Significance of off-pump coronary artery bypass grafting compared with percutaneous coronary intervention: a propensity score analysis 
OBJECTIVE
Although there have been several studies that compared the efficacy of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), the impact of off-pump CABG (OPCAB) has not been well elucidated. The objective of the present study was to compare the outcomes after PCI, on-pump CABG (ONCAB), and OPCAB in patients with multivessel and/or left main disease.
METHODS
Among the 9877 patients undergoing first PCI using bare-metal stents or CABG who were enrolled in the CREDO-Kyoto Registry, 6327 patients with multivessel and/or left main disease were enrolled into the present study (67.9 ± 9.8 years old). Among them, 3877 patients received PCI, 1388 ONCAB, and 1069 OPCAB. Median follow-up was 3.5 years.
RESULTS
Comparing PCI with all CABG (ONCAB and OPCAB), propensity-score-adjusted all-cause mortality after PCI was higher than that CABG (hazard ratio (95% confidence interval): 1.37 (1.15–1.63), p < 0.01). The incidence of stroke was lower after PCI than that after CABG (0.75 (0.59–0.96), p = 0.02). CABG was associated with better survival outcomes than PCI in the elderly (interaction p = 0.04). Comparing OPCAB with PCI or ONCAB, propensity-score-adjusted all-cause mortality after PCI was higher than that after OPCAB (1.50 (1.20–1.86), p < 0.01). Adjusted mortality was similar between ONCAB and OPCAB (1.18 (0.93–1.51), p = 0.33). The incidence of stroke after OPCAB was similar to that after PCI (0.98 (0.71–1.34), p > 0.99), but incidence of stroke after ONCAB was higher than that after OPCAB (1.59 (1.16–2.18), p < 0.01).
CONCLUSIONS
In patients with multivessel and/or left main disease, CABG, particularly OPCAB, is associated with better survival outcomes than PCI using bare-metal stents. Survival outcomes are similar between ONCAB and OPCAB.
doi:10.1016/j.ejcts.2011.04.004
PMCID: PMC3241114  PMID: 21676626
Coronary artery bypass grafting; Percutaneous coronary intervention; Off-pump
12.  Hypotheses, rationale, design, and methods for prognostic evaluation of cardiac biomarker elevation after percutaneous and surgical revascularization in the absence of manifest myocardial infarction. A comparative analysis of biomarkers and cardiac magnetic resonance. The MASS-V Trial 
Background
Although the release of cardiac biomarkers after percutaneous (PCI) or surgical revascularization (CABG) is common, its prognostic significance is not known. Questions remain about the mechanisms and degree of correlation between the release, the volume of myocardial tissue loss, and the long-term significance. Delayed-enhancement of cardiac magnetic resonance (CMR) consistently quantifies areas of irreversible myocardial injury. To investigate the quantitative relationship between irreversible injury and cardiac biomarkers, we will evaluate the extent of irreversible injury in patients undergoing PCI and CABG and relate it to postprocedural modifications in cardiac biomarkers and long-term prognosis.
Methods/Design
The study will include 150 patients with multivessel coronary artery disease (CAD) with left ventricle ejection fraction (LVEF) and a formal indication for CABG; 50 patients will undergo CABG with cardiopulmonary bypass (CPB); 50 patients with the same arterial and ventricular condition indicated for myocardial revascularization will undergo CABG without CPB; and another 50 patients with CAD and preserved ventricular function will undergo PCI using stents. All patients will undergo CMR before and after surgery or PCI. We will also evaluate the release of cardiac markers of necrosis immediately before and after each procedure. Primary outcome considered is overall death in a 5-year follow-up. Secondary outcomes are levels of CK-MB isoenzyme and I-Troponin in association with presence of myocardial fibrosis and systolic left ventricle dysfunction assessed by CMR.
Discussion
The MASS-V Trial aims to establish reliable values for parameters of enzyme markers of myocardial necrosis in the absence of manifest myocardial infarction after mechanical interventions. The establishments of these indices have diagnostic value and clinical prognosis and therefore require relevant and different therapeutic measures. In daily practice, the inappropriate use of these necrosis markers has led to misdiagnosis and therefore wrong treatment. The appearance of a more sensitive tool such as CMR provides an unprecedented diagnostic accuracy of myocardial damage when correlated with necrosis enzyme markers. We aim to correlate laboratory data with imaging, thereby establishing more refined data on the presence or absence of irreversible myocardial injury after the procedure, either percutaneous or surgical, and this, with or without the use of cardiopulmonary bypass.
doi:10.1186/1471-2261-12-65
PMCID: PMC3468382  PMID: 22898311
Cardiopulmonary bypass; Necrosis markers; Myocardial infarction; PCI; CABG
13.  CABG in 2012: Evidence, practice and the evolution of guidelines 
Abstract: In the management of coronary artery disease (CAD) it is important to ensure that all patients are receiving optimal medical therapy irrespective of whether any intervention, by stents or surgery, is planned. Furthermore it is important to establish if a proposed intervention is for symptomatic and/or prognostic reasons. The latter can only be justified if there is demonstration of a significant volume of ischaemia (>10% of myocardial mass). Taking together evidence from the most definitive randomized trial and its registry component (SYNTAX), almost 79% of patients with three vessel CAD and almost two thirds of patients with LMS disease have a survival benefit and marked reduction in the need for repeat revascularisation with CABG in comparison to stents, implying that CABG is still the treatment of choice for most of these patients. This conclusion which is apparently at odds with the results of most previous trials of stenting and surgery but entirely consistent with the findings of large propensity matched registries can be explained by the fact that SYNTAX enrolled ‘real life’ patients rather than the highly select patients usually enrolled in previous trials. SYNTAX also shows that for patients with less severe coronary artery disease there is no difference in survival between CABG and stents but a lower incidence of repeat revascularisation with CABG. At three years, SYNTAX shows no difference in stroke between CABG and stents for three-vessel disease but a higher incidence of stroke with CABG in patients with left main stem disease. In contrast the PRECOMBAT trial of stents and CABG in patients with left main stem disease showed no excess of mortality or stroke with CABG in comparison to stents in relatively low risk patients. Finally the importance of guidelines and multidisciplinary/heart teams in making recommendations for interventions is emphasised.
doi:10.5339/gcsp.2012.20
PMCID: PMC3963716  PMID: 24688987
multivessel coronary artery disease; left main stem; SYNTAX trial; coronary artery bypass grafting; drug eluting stents
14.  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
15.  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
16.  Enhanced External Counterpulsation (EECP) 
Executive Summary
Objective
To assess the effectiveness, and cost effectiveness of EECP in patients with severe anginal symptoms, secondary to chronic coronary disease, who are unresponsive to exhaustive pharmacotherapy and not candidates for surgical/percutaneous revascularization procedures (e.g., angioplasty, coronary bypass surgery).
To assess the effectiveness, and cost effectiveness of EECP in patients with heart failure.
Clinical Need
Angina
Angina is a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back or arm. Angina usually occurs in patients with coronary artery disease (CAD) involving ≥1 large epicardial artery. However it can also occur in people with valvular heart disease, hypertrophic cardiomyopathy, and uncontrolled hypertension.
Conventional approaches to restoring the balance between oxygen supply and demand focus on the disruption of the underlying disease through: drug therapy (β blockers, calcium channel blockers, nitrates, antiplatelet agents, ACE inhibitors, statins); life-style modifications (smoking cessation, weight loss); or revascularization techniques such as coronary artery bypass graft surgery (CABG) or percutaneous coronary interventions (PCI). (1) Limitations of each of these approaches include: adverse drug effects, procedure-related mortality and morbidity, restenosis after PCI, and time dependent graft attrition after CABG. Furthermore, an increasing number of patients are not appropriate candidates for standard revascularization options, due to co-morbid conditions (HF, peripheral vascular disease), poor distal coronary artery targets, and patient preference. The morbidity and mortality associated with repeat surgical revascularization procedures are significantly higher, and often excludes these patients from consideration for further revascularizations. (2)
Patients with CAD who have chronic ischemic symptoms that are unresponsive to both conventional medical therapy and revascularization techniques have refractory angina pectoris. It has been estimated that greater than 100,000 patients each year in the US may be diagnosed as having this condition. (3) Patients with refractory angina have marked limitation of ordinary physical activity or are unable to perform any ordinary physical activity without discomfort (CCS functional class III/IV). Also, there must be some objective evidence of ischemia as demonstrated by exercise treadmill testing, stress imaging studies or coronary physiologic studies. (1)
Dejongste et al. (4)estimated that the prevalence of chronic refractory angina is about 100,000 patients in the United States. This would correspond to approximately 3,800 (100,000 x 3.8% [Ontario is approximately 3.8% of the population of the United States]) patients in Ontario having chronic refractory angina.
Heart Failure
Heart failure results from any structural or functional cardiac disorder that impairs the ability of the heart to act as a pump.
A recent study (5) revealed 28,702 patients were hospitalized for first-time HF in Ontario between April 1994 and March 1997. Women comprised 51% of the cohort. Eighty-five percent were aged 65 years or older, and 58% were aged 75 years or older.
Patients with chronic HF experience shortness of breath, a limited capacity for exercise, high rates of hospitalization and rehospitalization, and die prematurely. (6) The New York Heart Association (NYHA) has provided a commonly used functional classification for the severity of HF (7):
Class I: No limitation of physical activity. No symptoms with ordinary exertion.
Class II: Slight limitations of physical activity. Ordinary activity causes symptoms.
Class III: Marked limitation of physical activity. Less than ordinary activity causes symptoms. Asymptomatic at rest.
Class IV: Inability to carry out any physical activity without discomfort. Symptoms at rest.
The National Heart, Lung, and Blood Institute (7) estimates that 35% of patients with HF are in functional NYHA class I; 35% are in class II; 25%, class III; and 5%, class IV. Surveys (8) suggest that from 5% to 15% of patients with HF have persistent severe symptoms, and that the remainder of patients with HF is evenly divided between those with mild and moderately severe symptoms.
To date, the diagnosis and management of chronic HF has concentrated on patients with the clinical syndrome of HF accompanied by severe left ventricular systolic dysfunction. Major changes in treatment have resulted from a better understanding of the pathophysiology of HF and the results of large clinical trials. Treatment for chronic HF includes lifestyle management, drugs, cardiac surgery, or implantable pacemakers and defibrillators. Despite pharmacologic advances, which include diuretics, angiotensin-converting enzyme inhibitors, beta-blockers, spironolactone, and digoxin, many patients remain symptomatic on maximally tolerated doses. (6)
The Technology
Patients are typically treated by a trained technician in a medically supervised environment for 1 hour daily for a total of 35 hours over 7 weeks. The procedure involves sequential inflation and deflation of compressible cuffs wrapped around the patient’s calves, lower thighs and upper thighs. In addition to 3 sets of cuffs, the patient has finger plethysmogram and electrocardiogram (ECG) attachments that are connected to a control and display console.
External counterpulsation was used in the United States to treat cardiogenic shock after acute myocardial infarction. (9;10) More recently, an enhanced version namely “enhanced external counterpulsation” (EECP) was introduced as a noninvasive procedure for outpatient treatment of patients with severe, uncontrollable cardiac ischemia. EECP is said to increase coronary perfusion pressure and reduce the myocardial oxygen demand. Currently, EECP is not applicable for all patients with refractory angina pectoris. For example, many patients are considered ineligible for therapy due to co-morbidities, including those with severe pulmonary vascular disease, deep vein thrombosis, phlebitis and irregular heart rhythms, and heart failure. (1)
Very recently, investigation began into EECP as an adjunctive treatment for patients with HF. Anecdotal reports suggested that EECP may benefit patients with coronary disease and left ventricular dysfunction. The safety and effectiveness of EECP in patients with symptomatic heart failure and coronary disease and its role in patients with nonischemic heart failure secondary to LV dysfunction is unclear. Furthermore, the safety and effectiveness of EECP in the different stages of HF and whether it is only for patients who are refractive to pharmacotherapy is unknown.
2003 Health Technology Assessment by the Medical Advisory Secretariat
The Medical Advisory Secretariat health technology assessment (originally published in February 2003) reported on the effectiveness of EECP for patients with angina and HF. The report concluded that there was insufficient evidence to support the use of EECP in patients with refractory stable CCS III/IV angina as well as insufficient evidence to support the use of EECP in patients with HF.
Review Strategy
The aim of this literature review was to assess the effectiveness, safety, and cost effectiveness of EECP for the treatment of refractory stable CCS III/IV angina or HF.
The standard search strategy used by the Medical Advisory Secretariat was used. This included a search of all international health technology assessments as well as a search of the medical literature from December 2002 to March 2006.
A modification of the GRADE approach (11) was used to make judgments about the quality of evidence and strength of recommendations systematically and explicitly. GRADE provides a framework for structured reflection and can help to ensure that appropriate judgments are made. GRADE takes into account a study’s design, quality, consistency, and directness in judging the quality of evidence for each outcome. The balance between benefits and harms, quality of evidence, applicability, and the certainty of the baseline risks are considered in judgments about the strength of recommendations.
Summary of Findings
The Cochrane and INAHTA databases yielded 3 HTAs or systematic reviews on EECP treatment (Blue Cross Blue Shield Technology Evaluation Center [BCBS TEC], ECRI, and the Centers for Medicare and Medicaid Services [CMS]). A search of Medline and Embase December 2005 – March 2006 (after the literature search cutoff from the most recent HTA) was conducted using key words enhanced external counterpulsation, EECP, angina, myocardial ischemia, congestive heart failure. This search produced 1 study which met the inclusion criteria. This level 4a study was inferior in quality to the RCT which formed the basis of the 2003 Medical Advisory Secretariat recommendation.
BCBS reviewed the evidence through November 2005 to determine if EECP improves health outcomes for refractory chronic stable angina pectoris or chronic stable HF. (12) BCBS concluded that the available evidence is not sufficient to permit conclusions of the effect of EECP on health outcomes. Both controlled trials had methodologic flaws (MUST EECP and MUST EECP quality of life studies). The case series and observational studies for both indications while suggestive of a treatment benefit from EECP have shortcomings as well.
On March 20 2006, CMS posted their proposed coverage decision memorandum for external counterpulsation therapy. (13) Overall, CMS stated that the evidence is not adequate to conclude that external counterpulsation therapy is reasonable and necessary for:
Canadian Cardiovascular Society Classification (CCSC) II angina
Heart failure
NYHA class II/III stable HF symptoms with an EF≤35%
NYHA class II/III stable HF symptoms with an EF≤40%
NYHA class IV HF
Acute HF
Cardiogenic shock
Acute MI
In January 2005, ECRI (14) stated that there was insufficient evidence available to draw conclusions about the long-term effectiveness of EECP, with respect to morbidity, survival, or quality of life, for any coronary indication (refractory angina, congestive heart failure, cardiogenic shock and acute MI).
GRADE Quality of the Studies
According to the GRADE Working Group criteria, the quality of the trials was examined (Table 1). (11)
Quality refers to the criteria such as the adequacy of allocation concealment, blinding and followup.
Consistency refers to the similarity of estimates of effect across studies. If there is important unexplained inconsistency in the results, our confidence in the estimate of effect for that outcome decreases. Differences in the direction of effect, the size of the differences in effect and the significance of the differences guide the decision about whether important inconsistency exists.
Directness refers to the extent to which the people interventions and outcome measures are similar to those of interest. For example, there may be uncertainty about the directness of the evidence if the people of interest are older, sicker or have more comorbidity than those in the studies.
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence. (11)
GRADE Quality of Studies
Economic Analysis - Literature Review
No economic analysis of EECP was identified in the published literature.
Estimated Prevalence of Angina in Ontario
3,800 patients with chronic refractory angina:
The number of patients with chronic refractory angina in the US is estimated to be approximately 100,000 (4), this corresponds to about 3,800 patients in Ontario (3.8% × 100,000) with refractory angina.
3,800 patients × $7,000 Cdn (approximate cost for a full course of therapy) ~ $26.6M Cdn.
Estimated Prevalence of Heart Failure in Ontario
23,700 patients EF ≤ 0.35:
This estimate is from an expert (personal communication) at the Institute for Clinical Evaluative Sciences (ICES), where they examined a sample of echocardiography studies drawn from a diagnostic lab in 2001. They found that the prevalence of EF ≤ 0.35 was 8.3%, and if generalized to all patients undergoing echocardiography, there would be 23,700 patients.
23,700 patients with EF ≤35% × $7,000 Cdn ~ $166 M Cdn.
Conclusions
There is insufficient evidence to support the effectiveness and safety of EECP treatment for patients with refractory stable CCS III-IV angina or HF.
As per the GRADE Working Group, overall recommendations consider 4 main factors. (11)
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence.
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. (11) Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 2 is the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For angina and heart failure, the overall GRADE and strength of the recommendations is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $26.6 M Cdn or $166 M Cdn respectively while the cost-effectiveness of EECP is unknown and difficult to estimate considering that there are no high quality studies of effectiveness.
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3379533  PMID: 23074496
17.  Percutaneous coronary intervention with optimal medical therapy vs. optimal medical therapy alone for patients with stable angina pectoris 
Scientific background
Stable Angina Pectoris (AP) is a main syndrome of chronic coronary artery disease (CAD), a disease with enormous epidemiological and health economic relevance. Medical therapy and percutaneous coronary interventions (PCI) are the most important methods used in the treatment of chronic CAD.
Research questions
The evaluation addresses questions on medical efficacy, incremental cost-effectiveness as well as ethic, social and legal aspects in the use of PCI in CAD patients in comparison to optimal medical therapy alone.
Methods
A systematic literature search was conducted in June 2010 in the electronic databases (MEDLINE, EMBASE etc.) and was completed by a hand search.
The medical analysis was initially based on systematic reviews of randomized controlled trials (RCT) and was followed by the evaluation of RCT with use of current optimal medical therapy. The results of the RCT were combined using meta-analysis. The strength and the applicability of the determined evidence were appraised.
The health economic analysis was initially focused on the published studies. Additionally, a health economic modelling was performed with clinical assumptions derived from the conducted meta-analysis and economic assumptions derived from the German Diagnosis Related Groups 2011.
Results
Seven systematic reviews (applicability of the evidence low) and three RCT with use of optimal medical therapy (applicability of the evidence for the endpoints AP and revascularisations moderate, for further endpoints high) were included in the medical analysis. The results from RCT are used as a base of the evaluation. The routine use of the PCI reduces the proportion of patients with AP attacks in the follow-up after one and after three years in comparison with optimal medical therapy alone (evidence strength moderate); however, this effect was not demonstrated in the follow-up after five years (evidence strength low). The difference in effect in the follow-up after four to five years was not found for the further investigated clinical endpoints: death, cardiac death, myocardial infarction and stroke (evidence strength high) as well as for severe heart failure (evidence strength moderate).
Two studies were included in the health economic analysis. The costs estimations from these studies are not directly transferable to the corresponding costs in Germany. The average difference in the total costs for PCI in comparison with optimal medical therapy alone, which was calculated in the modelling, was found to be 4,217 Euro per patient. The incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was estimated to be 24,805 Euro (evidence strength moderate).
No publication was identified concerning ethical, social or legal aspects.
Discussion
Important methodical problems of the studies are a lack of blinding of the patients and incomplete data for several endpoints in the follow-up. The determined incremental cost-effectiveness ratio per life-year of a patient with avoided AP attacks was appraised not to be cost-effective.
Conclusions
From a medical point of view the routine use of PCI in addition to the optimal medicinal therapy in patients with stable AP can be recommended for the reduction of the proportion of patients with AP attacks after one year and after three years (recommendation degree weak). Otherwise, PCI is to be performed in patients with refractory or progressing AP despite of optimal medical therapy use; in this case PCI is expected to be applied in 27% to 30% of patients in five years.
From the health economic view the routine use of PCI in addition to an optimal medical therapy in patients with stable AP cannot be recommended.
No special considerations can be made concerning special ethical, social or legal aspects in the routine use of PCI in addition to optimal medical therapy in patients with stable AP.
doi:10.3205/hta000098
PMCID: PMC3244729  PMID: 22205918
acute coronary syndrom/therapy; angina pectoris/*; angioplasty; balloon-dilation/therapy; blood flow; blood supply; CAD; cardiac muscle; circulatory disorder; coronary heart disease; cost-benefit analysis; drug therapy/*; drug therapy/*economics; drug-eluting stents; drug-eluting stents/adverse effects; drug-eluting stents/economics; drug-eluting stents/utilization; Germany; health economic analysis; heart diseases/*; humans; ischemia; medicamental therapy; meta analysis; meta analysis as topic; myocardial insufficiency; myocardial ischemia; myocardium; PCI; percutaneous coronary intervention; perfusion; prevention; primary prevention; prophylaxis; randomized controlled trial; randomized controlled trial as topic; RCT; review literature; stable angina pectoris; stenting; systematic review; therapeutics; treatment
18.  Effectiveness of Percutaneous Coronary Intervention With Drug‐Eluting Stents Compared With Bypass Surgery in Diabetics With Multivessel Coronary Disease: Comprehensive Systematic Review and Meta‐analysis of Randomized Clinical Data 
Background
Controversy persists regarding the optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD). Coronary artery bypass grafting (CABG) has been compared with percutaneous coronary intervention (PCI) using drug‐eluting stents (DES) in recent randomized controlled trials (RCTs).
Methods and Results
RCTs comparing PCI with DES versus CABG in diabetic patients with MVD who met inclusion criteria were analyzed (protocol registration No. CRD42013003693). Primary end point (major adverse cardiac events) was a composite of death, myocardial infarction, and stroke at a mean follow‐up of 4 years. Analyses were performed for each outcome by using risk ratio (RR) by fixed‐ and random‐effects models. Four RCTS with 3052 patients met inclusion criteria (1539 PCI versus 1513 CABG). Incidence of major adverse cardiac events was 22.5% for PCI and 16.8% for CABG (RR 1.34, 95% CI 1.16 to 1.54, P<0.0001). Similar results were obtained for death (14% versus 9.7%, RR 1.51, 95% CI 1.09 to 2.10, P=0.01), and MI (10.3% versus 5.9%, RR 1.44, 95% CI 0.79 to 2.6, P=0.23). Stroke risk was significantly lower with DES (2.3% versus 3.8%, RR 0.59, 95% CI 0.39 to 0.90, P=0.01) and subsequent revascularization was several‐fold higher (17.4% versus 8.0%, RR 1.85, 95% CI 1.0 to 3.40, P=0.05).
Conclusions
These data demonstrate that CABG in diabetic patients with MVD at low to intermediate surgical risk (defined as EUROSCORE <5) is superior to MVD PCI with DES. CABG decreased overall death, nonfatal myocardial infarction, and repeat revascularization at the expense of an increase in stroke risk.
doi:10.1161/JAHA.113.000354
PMCID: PMC3828792  PMID: 23926119
CABG; diabetes; multivessel disease; PCI
19.  Changes in the safety paradigm with percutaneous coronary interventions in the modern era: Lessons learned from the ASCERT registry 
World Journal of Cardiology  2012;4(8):242-249.
In the past, comparative effectiveness trials evaluating percutaneous coronary interventions (PCI), using either balloon angioplasty or bare metal stent (BMS) implantation, versus coronary artery bypass surgery (CABG) found similar survival rates at long-term follow-up with both revascularization strategies. Two major meta-analyses of these trials reported 5- and 6-year comparative effectiveness between PCI and CABG: one included only four trials that compared PCI with BMS implantation versus CABG whereas the largest one also included trials using balloon angioplasty. In these studies, the authors observed no survival differences between groups although a significant survival advantage was seen in diabetics treated with CABG and this benefit was also perceived in elderly patients. In both reports, number of involved vessels, presence of left anterior descending artery stenosis or poor left ventricular ejection fraction were no predictors of poor survival with PCI. Therefore, extent of the coronary artery disease (CAD) was not associated with poor outcome after PCI in the pre-drug eluting stent (DES) era. Recently, the ASCERT (Database Collaboration on the Comparative Effectiveness of Revascularization Strategies) registry found higher mortality rate with PCI in patients ≥ 65 years old in comparison with CABG, and advantages of surgery were seen in all subgroups including those at low risk. In this registry, PCI was accomplished by implantation of the first type of DES designs in 78% of cases. The intriguing observation of high mortality rate with PCI, including for non-diabetics and patients with two-vessel CAD, meaning a lack of clinical benefit with DES implantation, had not been seen previously. The study was not randomized, although its results are largely strengthened by its sample size. In this manuscript, the authors describe other registries and randomized trials reporting similar results supporting the findings of the aforementioned study and explore the reasons for these results, while also searching for potential solutions.
doi:10.4330/wjc.v4.i8.242
PMCID: PMC3432881  PMID: 22953021
Percutaneous coronary interventions; Coronary artery bypass surgery; Drug eluting stents; Coronary artery disease; Elderly patients
20.  Comparison of Coronary Artery Bypass Grafting with Percutaneous Coronary Intervention for Unprotected Left Main Coronary Artery Disease 
Yonsei Medical Journal  2011;53(1):58-67.
Purpose
Coronary artery bypass grafting (CABG) is the optimal treatment option for left main coronary artery disease (LMCAD). However, LMCAD remains a constant topic of discussion between cardiac surgeons and interventional cardiologists. The aim of this study was to assess the efficacy of LMCAD treatments by comparing the mid-term outcomes of CABG and percutaneous coronary intervention (PCI) using bare metal stents or drug-eluting stents (DESs).
Materials and Methods
The study population was comprised of 199 consecutive patients admitted with unprotected LMCAD. All of the patients were assigned to PCI (88 patients) or CABG (111 patients). The primary clinical end point indicated death, stroke of acute coronary syndrome (ACS).
Results
Patients assigned to PCI were at higher operative risk than patients scheduled for CABG (6.49±4.09 vs. 4.81±2.67, p=0.0032). Comparison of the group that received DESs with the CABG group did not reveal any differences in major adverse cardio-cerebral events (MACCE) occurrence (21% vs. 16%, p=NS). Patients in the CABG and PCI groups died with similar frequency (11% vs. 16%, p=NS). The mortality rate in the CABG group was higher than among those treated with DES (11% vs. 3%, p=0.049). The rate of ACS was higher in the PCI group than in the CABG group (13% vs. 4%, p=0.016).
Conclusion
Despite the fact that patients treated with PCI were at higher operative risk, PCI with DES was shown to be comparable to CABG in terms of mortality, stroke and ACS. However, the frequency of repeat revascularizations remains a constant concern with PCI.
doi:10.3349/ymj.2012.53.1.58
PMCID: PMC3250341  PMID: 22187233
Left main; PCI; DES; CABG
21.  Unprotected left main revascularization in patients with acute coronary syndromes 
European Heart Journal  2009;30(19):2308-2317.
Aims
In acute coronary syndromes (ACS), the optimal revascularization strategy for unprotected left main coronary disease (ULMCD) has been little studied. The objectives of the present study were to describe the practice of ULMCD revascularization in ACS patients and its evolution over an 8-year period, analyse the prognosis of this population and determine the effect of revascularization on outcome.
Methods and results
Of 43 018 patients enrolled in the Global Registry of Acute Coronary Events (GRACE) between 2000 and 2007, 1799 had significant ULMCD and underwent percutaneous coronary intervention (PCI) alone (n = 514), coronary artery bypass graft (CABG) alone (n = 612), or no revascularization (n = 673). Mortality was 7.7% in hospital and 14% at 6 months. Over the 8-year study, the GRACE risk score remained constant, but there was a steady shift to more PCI than CABG over time. Patients undergoing PCI presented more frequently with ST-segment elevation myocardial infarction (STEMI), after cardiac arrest, or in cardiogenic shock; 48% of PCI patients underwent revascularization on the day of admission vs. 5.1% in the CABG group. After adjustment, revascularization was associated with an early hazard of hospital death vs. no revascularization, significant for PCI (hazard ratio (HR) 2.60, 95% confidence interval (CI) 1.62–4.18) but not for CABG (1.26, 0.72–2.22). From discharge to 6 months, both PCI (HR 0.45, 95% CI 0.23–0.85) and CABG (0.11, 0.04–0.28) were significantly associated with improved survival in comparison with an initial strategy of no revascularization. Coronary artery bypass graft revascularization was associated with a five-fold increase in stroke compared with the other two groups.
Conclusion
Unprotected left main coronary disease in ACS is associated with high mortality, especially in patients with STEMI and/or haemodynamic or arrhythmic instability. Percutaneous coronary intervention is now the most common revascularization strategy and preferred in higher risk patients. Coronary artery bypass graft is often delayed and performed in lower risk patients, leading to good 6-month survival. The two approaches therefore appear complementary.
doi:10.1093/eurheartj/ehp353
PMCID: PMC2755115  PMID: 19720640
Left main disease; Acute coronary syndrome
22.  Factors Related to the Selection of Surgical versus Percutaneous Revascularization in Diabetic Patients with Multivessel Coronary Artery Disease in the BARI 2D Trial 
Objectives
We evaluated demographic, clinical and angiographic factors influencing the selection of coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in diabetic patients with multivessel coronary artery disease (CAD) in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.
Background
Factors guiding selection of mode of revascularization for patients with DM and multivessel CAD are not clearly defined.
Methods
In BARI 2D, the selected revascularization strategy, CABG or PCI, was based on physician discretion, declared independent of randomization to either immediate or deferred revascularization if clinically warranted. We analyzed factors favoring selection of CABG versus PCI in 1593 diabetic patients with multivessel CAD enrolled between 2001 and 2005.
Results
Selection of CABG over PCI was declared in 44% of patients and was driven by angiographic factors including: triple vessel disease (OR=4.43), left anterior descending (LAD) stenosis ≥70% (OR=2.86), proximal LAD stenosis ≥50% (OR=1.78), total occlusion (OR=2.35), and multiple class C lesions (OR=2.06), (all p< 0.005). Non-angiographic predictors of CABG included: age ≥ 65 years (OR=1.43, p=0.011), and non-US region (OR=2.89, p=0.017). Absence of prior PCI (OR=0.45, p<0.001), and the availability of drug-eluting stents (DES) conferred a lower probability of choosing CABG (OR=0.60, p=0.003).
Conclusions
The majority of diabetic patients with multivessel disease were selected for PCI rather than CABG. Preference for CABG over PCI was largely based on angiographic features related to the extent, location, and nature of CAD, as well as geographic, demographic and clinical factors.
doi:10.1016/j.jcin.2009.01.009
PMCID: PMC3625397  PMID: 19463459
Revascularization selection; Diabetes; Percutaneous Coronary Intervention; Coronary Artery Bypass Graft
23.  Percutaneous Coronary Interventions for Nonacute Coronary Artery Disease: A Quantitative Twenty-Year Synopsis 
Lancet  2009;373(9667):911-918.
Summary
Background
Over the last 20 years, percutaneous transluminal balloon coronary angioplasty (PTCA), bare metal stents (BMS) and drug eluting stents (DES) succeeded each other as catheter-based treatments for coronary artery disease (CAD). We present an overview of randomised trials comparing these interventions with each other and with medical therapy in patients with nonacute CAD.
Methods
We searched Medline for trials contrasting at least two of the aforementioned interventions. Outcomes of interest were death, myocardial infarction (MI), coronary artery bypass grafting (CABG), target lesion or vessel revascularisation (TLR/TVR), and any revascularisation. Random effects meta-analyses summarised head-to-head (direct) comparisons, and network meta-analyses integrated direct and indirect evidence.
Findings
61 eligible trials (25 388 patients) investigated 4 of 6 possible comparisons between the 4 interventions. No trials directly compared DES with medical therapy or PTCA. In all direct or indirect comparisons, succeeding advancements in PCI did not yield detectable improvements in deaths and MI. The risk ratio for indirect comparisons between DES and medical therapy was 0·96 (95% confidence interval: 0·60, 1·52) for death and 1·15 (0·73, 1·82) for MI. In contrast, there were sequential significant reductions in TLR/TVR with BMS compared to PTCA and with DES compared to BMS. The risk ratio for the indirect comparison between DES and PTCA for TLR/TVR was 0·30 (0·17, 0·51).
Interpretation
Sequential innovations in the catheter-based treatment of nonacute CAD showed no evidence of an impact on death or MI when compared with medical therapy.
doi:10.1016/S0140-6736(09)60319-6
PMCID: PMC2967219  PMID: 19286090
24.  Rescue percutaneous coronary intervention for failed thrombolysis: results from a district general hospital 
Postgraduate Medical Journal  2002;78(920):330-334.
Objective: To assess the outcome of a policy of emergency percutaneous coronary intervention (PCI) in patients with acute myocardial infarction and electrocadiographic (ECG) evidence of failed reperfusion after thrombolysis.
Design: Observational study.
Setting: District general hospital.
Patients: A total of 109 consecutive patients with acute myocardial infarction who underwent emergency angiography and angioplasty for failed reperfusion diagnosed on the basis of standard ECG criteria.
Main outcome measures: In-hospital mortality; death, infarct territory reinfarction, and reintervention by PCI or coronary artery bypass graft (CABG) during follow up; in-lab resource utilisation.
Results: At initial angiography, 76 patients had Thrombolysis in Myocardial Infarction (TIMI) trial 0/1 flow and 33 had TIMI 2/3 flow. Fourteen patients were in cardiogenic shock. TIMI 3 flow was established or maintained in 93 patients (85%). Overall in-hospital mortality was 9%. It was 3% in non-shock patients, 50% in shocked patients, and 40% when the procedure was unsuccessful (TIMI 0/1 flow post-procedure). Over a mean follow up of 30 months (>12 months of follow up in all patients) there were 19 further events (one death, five reinfarctions, and 13 revascularisations (nine CABG and four PCI)). The cost of rescue PCI was not significantly higher than comparable elective interventions.
Conclusion: A policy of emergency angiography and PCI for failed reperfusion in acute myocardial infarction can be carried out in a hospital without on-site surgical backup with good medium term clinical outcomes.
doi:10.1136/pmj.78.920.330
PMCID: PMC1742391  PMID: 12151685
25.  Red Blood Cell Distribution Width and Long-Term Outcome in Patients Undergoing Percutaneous Coronary Intervention in the Drug-Eluting Stenting Era: A Two-Year Cohort Study 
PLoS ONE  2014;9(4):e94887.
Background
Previous studies suggest the higher the red blood cell distribution width (RDW) the greater the risk of mortality in patients with coronary artery disease (CAD). However, the relationship between RDW and long-term outcome in CAD patients undergoing percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) remains unclear. This study was designed to evaluate the long-term effect of RDW in patients treated with drug-eluting stent for CAD.
Methods
In total of 2169 non-anemic patients (1468 men, mean age 60.2±10.9 years) with CAD who had undergone successful PCI and had at least one drug-eluting stent were included in this study. Patients were grouped according to their baseline RDW: Quartile 1 (RDW<12.27%), Quartile 2 (12.27%≤RDW<13%), Quartile 3 (13%≤RDW<13.5%), and Quartile 4 (RDW≥13.5).
Results
The incidence of in-hospital mortality and death or myocardial infarction was significantly higher in Quartiles 3 and 4 compared with Quartile 1 (P<0.05). After a follow-up of 29 months, the incidence of all-cause death and stent thrombosis in Quartile 4 was higher than in Quartiles 1, 2, and 3 (P<0.05). The incidence of death/myocardial infarction/stroke and cardiac death in Quartile 4 was higher than in Quartiles 1 and 2 (P<0.05). Multivariate Cox regression analysis showed that RDW was an independent predictor of all-cause death (hazard ratio (HR) = 1.37, 95% confidence interval (CI) = 1.15–1.62, P<0.001) and outcomes of death/myocardial infarction/stroke (HR = 1.21, 95% CI = 1.04–1.39, P = 0.013). The cumulative survival rate of Quartile 4 was lower than that of Quartiles 1, 2, and 3 (P<0.05).
Conclusion
High RDW is an independent predictor of long-term adverse clinical outcomes in non-anemic patients with CAD treated with DES.
doi:10.1371/journal.pone.0094887
PMCID: PMC3983260  PMID: 24722190

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