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1.  Intravascular Ultrasound to Guide Percutaneous Coronary Interventions 
Executive Summary
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.
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.
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
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.
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.
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.
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
2.  Impact of the introduction of drug eluting stents on clinical outcomes in patients undergoing percutaneous and surgical coronary artery revascularisation procedures in Western Australia 
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.
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).
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.
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.
PMCID: PMC3704943  PMID: 23826870
Coronary artery disease; Coronary revascularisation; Clinical outcome; Population study; Drug eluting stents; Percutaneous coronary intervention
3.  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.
PMCID: PMC1768324  PMID: 15201249
coronary angioplasty; coronary bypass surgery; health care cost
4.  Quality of Life after PCI vs. CABG among Patients with Diabetes and Multivessel CAD: Results from the FREEDOM Trial 
JAMA  2013;310(15):1581-1590.
The FREEDOM trial demonstrated that among patients with diabetes mellitus (DM) and multivessel coronary artery disease (CAD), coronary artery bypass graft (CABG) surgery results in lower rates of death and MI but a higher risk of stroke as compared with percutaneous coronary intervention using drug-eluting stents (DES-PCI). Whether there are benefits in terms of health status as assessed from the patient's perspective is unknown.
To compare the impact of CABG vs. DES-PCI on health status among patients with DM and multivessel CAD.
Design, Setting and Participants
Between 2005 and 2010, 1900 patients from 18 countries with DM and multivessel CAD were randomized to undergo either CABG (n=947) or DES-PCI (n=953) as an initial treatment strategy. Of these, a total of 1880 patients had baseline health status assessed (935 CABG, 945 DES-PCI) and comprised the primary analytic sample.
Initial revascularization with CABG or DES-PCI.
Main Outcome Measure
Health status was assessed using the angina frequency (AF), physical limitations (PL), and quality of life (QOL) domains of the Seattle Angina Questionnaire (SAQ) at baseline, 1, 6, and 12 months, and annually thereafter. For each scale, scores range from 0 to 100 where higher scores represent better health. The effect of CABG vs. DES-PCI was evaluated using longitudinal mixed effect models.
At baseline, mean (± standard deviation) scores were 70.9±25.1, 67.3±24.4 and 47.8±25.0 for the SAQ-AF, SAQ-PL and SAQ-QOL subscales for the CABG group and 71.4±24.7, 69.9±23.2 and 49.2±25.7 for the DES-PCI group. At 2 year follow up, mean scores were 96.0±11.9, 87.8±18.7 and 82.2±18.9 after CABG and 94.7±14.3, 86.0±19.3 and 80.4±19.6 after DES-PCI with significantly greater benefit of CABG on each domain (mean treatment benefit 1.3 [95% CI 0.3 to 2.2], 4.4 [95% CI 2.7 to 6.1], and 2.2 [95% CI 0.7 to 3.8] points, respectively; p<0.01 for each comparison). Beyond 2 years, there were no consistent differences between the 2 revascularization strategies.
For patients with diabetes and multivessel CAD, CABG provides slightly better intermediate term health status and quality of life than DES-PCI—mainly between 6 months and 2 years after initial treatment. However, the magnitude of benefit is small and may not be clinically meaningful.
Trial Registration
PMCID: PMC4370776  PMID: 24129463
5.  Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents in patients with multivessel coronary artery disease compared to coronary artery bypass surgery five-years after intervention 
Cost-effectiveness of percutaneous coronary intervention (PCI) using drug-eluting stents (DES), and coronary artery bypass surgery (CABG) was analyzed in patients with multivessel coronary artery disease over a 5-year follow-up.
DES implantation reducing revascularization rate and associated costs might be attractive for health economics as compared to CABG.
Consecutive patients with multivessel DES-PCI (n = 114, 3.3 ± 1.2 DES/patient) or CABG (n = 85, 2.7 ± 0.9 grafts/patient) were included prospectively. Primary endpoint was cost-benefit of multivessel DES-PCI over CABG, and the incremental cost-effectiveness ratio (ICER) was calculated. Secondary endpoint was the incidence of major adverse cardiac and cerebrovascular events (MACCE), including acute myocardial infarction (AMI), all-cause death, revascularization, and stroke.
Despite multiple uses for DES, in-hospital costs were significantly less for PCI than CABG, with 4551 €/patient difference between the groups. At 5-years, the overall costs remained higher for CABG patients (mean difference 5400 € between groups). Cost-effectiveness planes including all patients or subgroups of elderly patients, diabetic patients, or Syntax score >32 indicated that CABG is a more effective, more costly treatment mode for multivessel disease. At the 5-year follow-up, a higher incidence of MACCE (37.7% vs. 25.8%; log rank P = 0.048) and a trend towards more AMI/death/stroke (25.4% vs. 21.2%, log rank P = 0.359) was observed in PCI as compared to CABG. ICER indicated 45615 € or 126683 € to prevent one MACCE or AMI/death/stroke if CABG is performed.
Cost-effectiveness analysis of DES-PCI vs. CABG demonstrated that CABG is the most effective, but most costly, treatment for preventing MACCE in patients with multivessel disease. © 2014 Wiley Periodicals, Inc.
PMCID: PMC4262069  PMID: 24403120
coronary artery bypass surgery; percutaneous coronary intervention; drug-eluting stent; cost-benefit; follow-up study
6.  Percutaneous coronary intervention strategies and prognosis for graft lesions following coronary artery bypass grafting 
The purpose of this study was to compare the prognosis of graft-percutaneous coronary intervention (PCI) and native vessel (NV)-PCI, drug-eluting stents (DESs) and bare-metal stents (BMSs) for the treatment of graft lesions following coronary artery bypass grafting (CABG), and to determine the risk factors for major adverse cardiac events (MACEs). A total of 289 patients who underwent PCI following CABG between August 2005 and March 2010 were retrospectively analyzed. The effects on survival were compared among patients who underwent NV- and graft-PCI, and DES and BMS implantation. Additionally, the risk factors for MACEs following PCI for graft lesions were analyzed. The findings showed that MACE-free and revascularization-free survival rates were significantly higher in the NV-PCI group compared with those in the graft-PCI group. There were 63 cases (29.0%) of MACEs in the DES group and 25 cases (52.1%) in the BMS group. In patients undergoing NV-PCI, the DES group had significantly fewer MACEs and less target vessel revascularization (TVR) than the BMS group. In patients undergoing graft-PCI, the DES group showed a tendency for fewer MACEs and a lower incidence of cardiac mortality, myocardial infarction and TVR compared with the BMS group. Diabetes, an age of >70 years and graft-PCI were independent risk factors for MACEs in patients post-PCI. It is concluded that NV-PCI has superior long-term outcomes compared with graft-PCI, and should therefore be considered as the first-line treatment for graft disease following CABG. Despite this, graft-PCI remains a viable option. DESs are the first choice for graft-PCI due to their safety and efficacy and their association with reduced mortality and MACE rate. Diabetes, older age and graft-PCI are independent risk factors for MACEs in patients post-CABG who are undergoing revascularization.
PMCID: PMC4471697  PMID: 26136874
coronary artery bypass grafting; percutaneous coronary intervention; multivariate risk factors; prognosis; follow-up
7.  Drug-eluting stents vs. coronary artery bypass-grafting in coronary heart disease 
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.
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.
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.
Existing data should be viewed only as limited evidence for possible medical and health economic effects.
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
8.  Long-term follow-up results in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents: results from a single high-volume PCI centre 
BMJ Open  2014;4(8):e004892.
To assess both short-term and long-term prognosis in consecutive patients with coronary heart disease treated with drug-eluting stents in a high-volume percutaneous coronary intervention (PCI) centre.
Observational cohort study.
A hospital in the Henan province, China, between 2009 and 2011.
A total of 2533 patients were enrolled. Patients with ST-elevation myocardial infarction (STEMI) treated with urgent PCI accounted for 3.9% of cases; patients with STEMI treated with delayed PCI accounted for 20.5% of cases; patients with stable angina accounted for 16.5% of cases; and patients with non-ST elevation acute coronary syndrome (NSTE-ACS) accounted for 58.6% of cases.
Primary outcomes
Death, major adverse cardiac and cerebrovascular events (MACCE: death/myocardial infarction/stroke), and target vessel revascularisation.
Follow-up after a median of 29.8 months was obtained for 2533 patients (92.6%). The mortality rate during hospitalisation was highest in the urgent PCI group (p<0.001). During follow-up, although the incidences of death and MACCE were highest in the urgent PCI group, no significant differences were observed among the different groups. The incidences of cardiac death and myocardial infarction were significantly higher in the paclitaxel-eluting stent (PES) group than in the sirolimus-eluting stent (SES) group. Independent predictors of death during follow-up were age, left ventricular ejection function <40%, diabetes mellitus, prior coronary artery bypass graft and chronic total occlusion.
PCI patients with STEMI had the worst hospital and long-term prognosis. The mortality rate after hospital increased markedly in patients with NSTE-ACS. SESs seem to be more effective than PESs.
PMCID: PMC4127920  PMID: 25113554
9.  Three-Year Outcomes of Multivessel Revascularization in Very Elderly Acute Coronary Syndrome Patients 
The Annals of thoracic surgery  2010;89(6):1889-1895.
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.
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.
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).
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.
PMCID: PMC2908496  PMID: 20494044
10.  Coronary artery bypass grafting or percutaneous revascularization in acute myocardial infarction? 
A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was as follows: is coronary artery bypass graft (CABG) surgery superior to percutaneous coronary intervention (PCI) in terms of in-hospital mortality and morbidity and long-term outcomes in patients with acute myocardial infarction (MI)? A total of 104 papers were returned using the selected search. Of these, six represented the best evidence to answer the clinical question. The selection criteria were comparative studies with only PCI and CABG groups in patients with acute MI. Case reports, reviews, recommendations and studies on a specific population or out of the context of acute MI were excluded. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. Almost all PCI patients received stents. One study used drug-eluting stents (DES). Two randomized studies showed similar short- and mid-term morbidities and mortalities in patients with acute MI in the PCI and CABG groups but higher repeat revascularization rates after PCI. Three observational studies found comparable survival, but one of them found more periprocedural events with CABG and the other two found more recurrent ischaemia requiring repeat revascularization in the PCI group. In one cohort study, CABG appeared to be an independent risk factor for death in N-STEMI according to the European Society/American College of Cardiology 2000 definition. The results are strongly influenced by the definition of acute MI. In an institution offering the two techniques with an equivalent accessibility, the principal advantage of PCI is a lower incidence of periprocedural and short-term morbidities. CABG, on the other hand, offers a better durability with less mid-term repeat revascularization required, especially when compared with PCI with DES implantation. Choice had to weight up coronary artery anatomy, number and localization of coronary artery stenosis and accessibility of both PCI and CABG treatments. Medical and surgical discussion within the Heart Team is required to make the best medical decision for each patient.
PMCID: PMC3829498  PMID: 23962854
Review; Coronary artery bypass; Myocardial infarction; Coronary disease
11.  Long-term Outcome after Percutaneous Coronary Intervention Compared with Minimally Invasive Coronary Artery Bypass Surgery in the Elderly 
Elderly patients with unstable coronary artery disease (CAD) have better outcomes with coronary revascularization than conservative treatment. With the improvement in percutaneous coronary intervention (PCI) techniques using drug eluting-stents, this became an attractive option in elderly. Minimally invasive coronary artery bypass grafting (MICS-CABG) is a safe and effective alternative to conventional CABG. We aimed to explore the long-term outcomes after PCI vs MICS-CABG in ≥75 year-old patients with severe CAD.
A total of 1454 elderly patients (≥75 year-old patients) underwent coronary artery revascularization between January 2005 and December 2009. Patients were selected in the study if they have one of the Class-I indications for CABG. Groups were divided according to the type of procedure, PCI or MICS-CABG, and 5 year follow-up.
Among 175 elderly patients, 109 underwent PCI and 66 had MICS-CABG. There was no significant difference observed in both groups with long-term all-cause mortality (31 PCI vs 21% MICS-CABG, p=0.151) and the overall 5 year survival was similar on Kaplan-Meier curve (Log rank p=0.318). The average length of stay in hospital was significantly shorter in the PCI than in the MICS-CABG group (4.3 vs 7.8 days, p<0.001). Only 4.7% of the PCI group were discharged to rehabilitation facility compared with 43.9% of the MICS-CABG group (p<0.001). The rate of repeat revascularization was significantly higher in the PCI group than in the MICS-CABG group (15 vs 3%, p=0.014).
Among elderly patients, long-term all-cause mortality is similar after PCI and MICS-CABG. However, there is a significantly higher rate of repeat revascularization after PCI.
PMCID: PMC4780507  PMID: 27014373
Coronary artery disease; Elderly; MICS-CABG; PCI
12.  Impact of Drug-Eluting Stents on the Comparative Effectiveness of Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention 
American heart journal  2014;169(1):149-154.
Drug-eluting stents (DES) have largely replaced bare-metal stents (BMS) for percutaneous coronary intervention (PCI). It is uncertain, however, whether introduction of DES had a significant impact the comparative effectiveness of PCI versus coronary artery bypass graft surgery (CABG) for death and myocardial infarction (MI).
We identified Medicare beneficiaries 66 years of age and older who underwent multivessel CABG or multivessel PCI, and matched PCI and CABG patients on propensity score. We defined the BMS era as January 1999 through April 2003 and the DES era as May 2003 through December 2006. We compared five-year outcomes of CABG and PCI using Cox proportional hazards models, adjusting for baseline characteristics and year of procedure, and tested for an interaction (Pint) of DES era with treatment (CABG or PCI).
Five-year survival improved from the BMS era to the DES era by 1.2% for PCI and by 1.1% for CABG, and the CABG:PCI hazard ratio was unchanged (0.90 vs. 0.90, Pint = 0.96). Five-year MIfree survival improved by 1.4% for PCI and 1.1% for CABG, with no change in the CABG:PCI hazard ratio (0.81 vs. 0.82, Pint = 0.63). By contrast, survival-free of MI or repeat coronary revascularization improved from the BMS era to the DES era by 5.7% for PCI and 0.9% for CABG, and the CABG:PCI hazard ratio changed significantly (0.50 vs. 0.57, Pint ≤ 0.0001).
The introduction of drug-eluting stents did not alter the comparative effectiveness of CABG and PCI with respect to hard cardiac outcomes.
PMCID: PMC4268548  PMID: 25497260
comparative effectiveness research; outcomes research; percutaneous coronary intervention; coronary artery bypass
13.  Secondary prevention of ischaemic cardiac events 
BMJ Clinical Evidence  2011;2011:0206.
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).
We found 137 systematic reviews or RCTs that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
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
14.  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
15.  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
16.  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.
PMCID: PMC1768428  PMID: 15310696
coronary artery bypass; angioplasty; survival analysis
17.  Has the difference in mortality between percutaneous coronary intervention and coronary artery bypass grafting in people with heart disease and diabetes changed over the years? A systematic review and meta-regression 
BMJ Open  2015;5(12):e010055.
To examine the difference in outcome between percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), to see if it has changed over the years in diabetics deemed eligible for both treatments; and to contrast the long-term mortality findings with those in non-diabetics.
Meta-analyses using data from randomised controlled trials found by searches on MEDLINE, EMBASE and the Cochrane Controlled Trials Register, from their inception until March 2015.
Studies had to be randomised controlled trials comparing PCI with CABG.
Those taking part in the studies had to have multivessel cardiac or left main artery cardiac disease and be deemed eligible for both treatments.
Primary and secondary outcomes
The primary outcome was all cause mortality. Secondary outcomes were a composite of mortality, stroke and myocardial infarction; cardiovascular death; and MACCE (Major Adverse Cardiac or Cerebrovascular Event). The longest follow-up was used in the analysis.
Among 14 studies (4868 diabetics) reported over three decades, meta-regression shows no relationship between the year of publication and the difference in long term all cause mortality between PCI and CABG. CABG has maintained an approximately 30% mortality advantage compared to PCI. The other outcomes used showed the same lack of change over the years. These findings held true among insulin-requiring and non-insulin-requiring diabetics. However, among non-diabetics included in the 14 studies, there was no difference in mortality outcome between PCI and CABG.
The difference in outcome between PCI and CABG in diabetics has not narrowed from the beginning—with balloon angioplasty to current PCI—with the second generation of drug eluting stents. In contrast to the non-diabetics, there is a persistent 30% benefit in all cause mortality favouring CABG in diabetics, and this should be a major factor in treatment recommendation.
PMCID: PMC4710812  PMID: 26719324
meta-regression; Systematic review; Multi-vessel disease
18.  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.
PMCID: PMC3076727  PMID: 20221852
Coronary artery bypass graft; Diabetes mellitus; Percutaneous coronary intervention; Revascularization; Stents
19.  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.
PMCID: PMC4066935  PMID: 24958153
20.  Impact of the Residual SYNTAX Score on Outcomes of Revascularization in Patients with ST-Segment Elevation Myocardial Infarction and Multivessel Disease 
Primary percutaneous coronary intervention (P-PCI) has become the preferred reperfusion strategy in ST-elevation myocardial infarction (STEMI) when performed by an experienced team in a timely manner. However, no consensus exists regarding the management of multivessel coronary disease detected at the time of P-PCI.
The aim of this study was to evaluate the use of the residual SYNTAX score (rSS) following a complete vs. culprit-only revascularization strategy in patients with STEMI and multivessel disease (MVD) to quantify the extent and complexity of residual coronary stenoses and their impact on adverse ischemic outcomes.
Between October 1, 2012, and November 30, 2013, we enrolled 120 consecutive STEMI patients with angiographic patterns of multivessel coronary artery disease (CAD) who had a clinical indication to undergo PCI. The patients were subdivided into those who underwent culprit-only PCI (60 patients) and those who underwent staged-multivessel PCI during the index admission or who were staged within 30 days of the index admission (60 patients). Both the groups were well matched with regard to clinical statuses and lesion characteristics. Clinical outcomes at one year were collected, and the baseline SYNTAX score and rSS were calculated.
The mean total stent length (31.07 ± 12.7 mm vs. 76.3 ± 14.1 mm) and the number of stents implanted per patient (1.34 ± 0.6 vs. 2.47 ± 0.72) were higher in the staged-PCI group. The rSS was higher in the culprit-only PCI group (9.7 ± 5.7 vs. 1.3 ± 1.99). The angiographic and clinical results after a mean follow-up of 343 ± 75 days demonstrated no significant difference in the occurrence of in-hospital Major Adverse Cardiac and Cerebrovascular Events (MACCE) between both the groups (6.7% vs. 5%, P = 1.000). However, patients treated with staged PCI with an rSS ≤8 had significant reductions in one-year MACCE (10.7% vs. 30.5%, P = 0.020*), death/Myocardial infarction (MI)/Cerebrovascular accident (CVA) (5% vs. 13.8%, P = 0.016*), and repeat revascularization (4.8% vs. 25%, P = 0.001*). We found that culprit-only, higher GRACE risk scores at discharge and an rSS >8 were independent predictors of MACCE at one year.
Staged PCI that achieves reasonable complete revascularization (rSS ≤8) improves mid-term survival and reduces the incidence of repeat PCI in patients with STEMI and MVD. Nonetheless, large-scale randomized trials are required to establish the optimal revascularization strategy for these high-risk patients.
PMCID: PMC4786097  PMID: 26997875
multivessel CAD; STEMI; syntax score
21.  Optimal Choice of Coronary Revascularization and Stent Type in Diabetic Patients with Coronary Artery Disease 
Cardiology and Therapy  2013;2(1):69-84.
Patients with diabetes mellitus (DM) are prone to a diffuse and accelerated form of coronary artery disease (CAD), which in turn is a major cause of cardiac-related morbidity and mortality. Compared with patients without diabetes, patients with diabetes undergoing coronary revascularization are at higher risk of procedural, short-, and long-term cardiovascular events and mortality. Although coronary artery bypass grafting (CABG) has been regarded as the primary revascularization strategy in diabetic patients with complex CAD, percutaneous coronary intervention (PCI) is an effective revascularization alternative, due to remarkable advances in stent devices and adjunctive drug therapies. Outcomes data, from subgroup analyses and small-sized clinical trials and large registries, have suggested that PCI with current stent technology showed comparable long-term risks of mortality and hard endpoints, but higher risk of repeat revascularization for the diabetic population compared to CABG. However, the recent landmark International Future REvascularization Evaluation in patients with diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial provides compelling evidence of the superiority of CABG over PCI in reducing the rates of death, myocardial infarction, at the expense of stroke, in patients with diabetes with advanced CAD. When opting for PCI in patients with diabetes, currently used drug-eluting stents (DES) are more efficient in reducing the risk of repeat revascularization without compromising safety outcomes, compared to bare-metal stents. The selection of a specific type of DES in patients with diabetes is controversial and therefore more data comparing second- and newer-generation DES for patients with diabetes are currently needed. Also, efforts to make more advanced DES platforms suitable for patients with diabetes with complicated angiographic features are still ongoing.
PMCID: PMC4107438  PMID: 25135290
Coronary artery bypass grafting; Coronary artery disease; Diabetes mellitus; Drug-eluting stents; Percutaneous coronary intervention
22.  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.
PMCID: PMC3963716  PMID: 24688987
multivessel coronary artery disease; left main stem; SYNTAX trial; coronary artery bypass grafting; drug eluting stents
23.  Significance of off-pump coronary artery bypass grafting compared with percutaneous coronary intervention: a propensity score analysis 
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.
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.
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).
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.
PMCID: PMC3241114  PMID: 21676626
Coronary artery bypass grafting; Percutaneous coronary intervention; Off-pump
24.  Enhanced External Counterpulsation (EECP) 
Executive Summary
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 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.
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
25.  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 
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.
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.
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.
PMCID: PMC3468382  PMID: 22898311
Cardiopulmonary bypass; Necrosis markers; Myocardial infarction; PCI; CABG

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