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Bypass surgery versus percutaneous coronary intervention for the treatment of unprotected left main disease: a meta-analysis of randomized controlled trials |
Desch S, Boudriot E, Rastan A, Buszman PE, Bochenek A, Mohr FW, Schuler G, Thiele H |
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CRD summary For patients with significant unprotected left main disease, no significant differences in mortality and myocardial infarction were found, between coronary artery bypass surgery and percutaneous coronary intervention. Stroke was more frequent with surgery, and repeat revascularisation more frequent with percutaneous coronary intervention. There were only four trials, but the conclusions reflect the evidence and are likely to be reliable. Authors' objectives To compare coronary artery bypass surgery with percutaneous coronary intervention, in patients with significant unprotected left main disease. Searching MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL) and ClinicalTrials.gov were searched for articles from January 2000 to April 2011. The references of relevant studies and conference abstracts were consulted for additional studies. There were no language restrictions, and the search terms were reported. Study selection Randomised controlled trials (RCTs) comparing percutaneous coronary intervention, with coronary artery bypass graft surgery, were eligible for inclusion. Trials had to be of patients with unprotected left main disease, who were eligible for revascularisation with either strategy. The minimum follow-up was 12 months. The outcomes of interest were all-cause deaths, myocardial infarctions, strokes, and repeat revascularisations. The definitions of these outcomes were provided and varied across the trials. In the included trials, where reported, the patients' mean age ranged from 61 to 65 years; one trial reported a median age of 66 years. About one third of patients had diabetes mellitus at baseline, and most were male. Most had distal left main disease, and most had at least one diseased vessel in addition to left main disease. The percentage of patients with previous myocardial infarction ranged from four to 29; other comorbidities were reported. Nearly all patients who underwent percutaneous coronary intervention were given drug-eluting stents. All trials excluded patients with acute myocardial infarction. Two reviewers independently selected the trials for inclusion. Assessment of study quality Trial quality was assessed, using a modified version of the Cochrane risk of bias tool, by two reviewers, working independently. Data extraction The outcomes of interest were extracted separately and combined into one outcome (death, myocardial infarction, stroke, or repeat revascularisation) to calculate risk ratios and 95% confidence intervals. Two reviewers independently extracted the data. Methods of synthesis Trial outcomes were combined in a meta-analysis (random-effects model) to calculate pooled risk ratios and 95% confidence intervals, using the last follow-up data. Heterogeneity was assessed using Χ² and Ι². Subgroup analyses were conducted by length of follow-up. Results of the review Four RCTs (1,611 patients) were included. Follow-up ranged from one to two years. All trials were conducted in multiple centres and were found to be of high quality, with a low risk of bias for all except performance, due to a lack of blinding of patients and investigators. There were no statistically significant differences in the risk of death, and the risk of myocardial infarction, between the two interventions. Compared with coronary artery bypass surgery, the risk of stroke was significantly lower for patients undergoing percutaneous coronary intervention (RR 0.26, 95% CI 0.10 to 0.69), but the risk of repeat revascularisation was significantly higher (RR 1.94, 95% CI 1.43 to 2.61). The combined risk of death, myocardial infarction, stroke, or repeat revascularisation was higher in the group undergoing percutaneous coronary intervention (RR 1.26, 95% CI 1.02 to 1.57). No evidence of statistical heterogeneity was found. Subgroup analyses showed that the reduced risk of stroke was statistically significant at one year (RR 0.28, 95% CI 0.09 to 0.84), but not at two years. Authors' conclusions For patients with significant unprotected left main disease, there were no significant differences in mortality and myocardial infarction, between coronary artery bypass surgery and percutaneous coronary intervention. Stroke was more frequent with the surgery, but repeat revascularisation was more frequent with percutaneous coronary intervention. CRD commentary The review had a clear question and reproducible selection criteria. Several bibliographic sources were searched for published and unpublished trials, with date restrictions. Steps were taken to minimise the risk of reviewer bias and error throughout the review. Trial quality was assessed and was considered to be high, but only four trials were included. The methods of analysis appear to have been appropriate. There were some differences in patient characteristics at baseline and in the outcome definitions, but there was no evidence of statistical heterogeneity. The authors noted that their findings were only applicable to the type of patient who entered the trials. Despite the relatively limited number of trials, the conclusions of the review reflect the evidence and are likely to be reliable. Implications of the review for practice and research Practice: The authors stated that the results further underscore the recent guideline upgrades of unprotected left main percutaneous coronary intervention as an alternative to coronary artery bypass surgery in anatomically suited patients at increased risk of adverse surgical outcomes. Research: The authors stated that follow-up data beyond two years following randomisation are needed. They stated that a large trial which has started enrolling patients will provide further insight into which revascularisation strategy is most appropriate for a given patient. Bibliographic details Desch S, Boudriot E, Rastan A, Buszman PE, Bochenek A, Mohr FW, Schuler G, Thiele H. Bypass surgery versus percutaneous coronary intervention for the treatment of unprotected left main disease: a meta-analysis of randomized controlled trials. Herz 2013; 38(1): 48-56 Indexing Status Subject indexing assigned by NLM MeSH Coronary Artery Bypass /mortality; Coronary Artery Disease /mortality /surgery; Humans; Percutaneous Coronary Intervention /mortality; Prevalence; Randomized Controlled Trials as Topic /statistics & Risk Factors; Survival Analysis; Survival Rate; Treatment Outcome; numerical data AccessionNumber 12013014038 Date bibliographic record published 20/03/2013 Date abstract record published 24/06/2013 Record Status This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn. |
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