Fast track — ArticlesCoronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials
Introduction
Coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are alternative revascularisation procedures for patients with multivessel coronary artery disease. The effects of these two procedures on patient outcomes (mortality, myocardial infarction, angina symptoms, repeat procedures) over long-term follow-up have been compared in several randomised clinical trials,1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 in analyses of large clinical registries,13, 14, 15, 16, 17 and in meta-analyses of the published trial results.18, 19, 20 However, the outcomes of the procedures might vary according to patient characteristics, such as the presence of diabetes or the number of diseased vessels. This possibility has been difficult to assess because no randomised trial has been large enough to provide adequate statistical power, meta-analyses in patient subgroups have been limited by inconsistent reporting in published trials,20 and observational studies have been confounded by treatment selection biases.
Pooling of individual patient data from randomised trials substantially increases the number of patients within clinical subgroups of interest and provides a more precise assessment of the effects of treatment.21, 22, 23, 24 Previous collaborations among clinical trial groups have provided information about variation in the efficacy of other cardiovascular treatments according to baseline clinical characteristics.25, 26 We undertook a collaborative analysis of data from randomised trials of patients with multivessel coronary artery disease to assess whether the effects of CABG and PCI on mortality are modified by patient characteristics.
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Patients and procedures
Details of the search strategy that was used to identify relevant trials for inclusion in this collaborative analysis have been reported elsewhere.20 Briefly, we searched Medline, Embase, and Cochrane databases for studies published between January, 1966, and August, 2006, by use of terms including “angioplasty”, “coronary”, and “coronary artery bypass surgery”. We also reviewed the reference lists of retrieved articles, conference abstracts, and the bibliographies of expert advisers. We did
Results
The ten participating trials provided data on 7812 patients. The median age of the study population was 61 years (IQR 53–67), with 389 (5%) patients aged 75 years or older (only 19 patients were aged 80 years or older). Table 1 shows the baseline characteristics of patients included in the trials. Median follow-up time in surviving patients was 5·9 years, and varied among trials from 3·0 years to 13·0 years (table 1).
Most patients received the assigned treatment within 60 days of randomisation.
Discussion
Randomised clinical trials provide the reference standard for comparing the effectiveness of treatments for a given clinical condition. The effectiveness of treatments might vary among patients included in randomised trials, but this possibility cannot be tested adequately in a single study because of limited statistical power. Combining individual patient data from several randomised trials helps to overcome this limitation by increasing the number of patients available for analysis in
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