Methods

The major aspects and differences among the 3 trials are as follows. All the trials were conducted in multicenter, and patients eligible for both CABG and PCI were randomized to treatment with either strategy. The BEST trial included 880 patients with 2- or 3-vessel CAD, and the PRECOMBAT trial included 600 patients with left main CAD. The SYNTAX trial included 1,800 patients with 3-vessel and/or left main CAD. Everolimus-eluting stents were used in the BEST trial, sirolimus-eluting stents were used in the PRECOMBAT trial, and paclitaxel-eluting stents were used in the SYNTAX trial. Individual patient-level data were pooled from the BEST, PRECOMBAT, and SYNTAX trials, and 672 patients with previous MI were included in this study.

A protocol with prespecified outcomes and a common set of baseline variables were established by principal investigators for each trial (SJP and PWS). Individual patient data from each trial was sent to the coordinating institution, Asan Medical Center in Seoul, Korea, to be merged. An independent clinical event committee that was blind to the randomization adjudicated all the end points in each study. The pooled database was checked for completeness and consistency by responsible investigators from Asan Medical Center.

The merged database included demographics, clinical history, risk factors, angiographic and echocardiographic findings, revascularization strategies, medication history, and clinical outcomes during follow-up. Unless specified, previously reported definitions from each study were used as variables. The primary outcome, from available follow-up information, was a composite of death from any causes, MI, or stroke. Secondary outcomes included individual components of the primary outcome, any coronary revascularization, and a composite of death from any causes or MI. Previously reported definitions from each study were used for individual clinical outcomes.

Data were analyzed according to the intention-to-treat principle. The databases from 3 trials were combined for an overall pooled analysis, and time-to-event outcomes were displayed using Kaplan–Meier method, compared by the log-rank test. The stratified Cox proportional hazards model was used to analyze the impact of revascularization strategy on clinical outcomes. A forward stepwise Cox regression model was used to identify independent predictors of primary outcome. Analyses were performed by an independent statistician who was unaware of the treatment assignments. All reported p values were 2-sided, and p values <0.05 were considered statistically significant. Statistical analyses were conducted with SPSS software, version 18.0 (SPSS Inc., Chicago, Illinois).

Results

Of the 3,280 study patients, 672 (20.5%) had previous MI, of whom 349 underwent CABG and 323 underwent PCI with DES. The baseline characteristics were well balanced across the 2 groups ( Table 1 ). The mean age of the patients was 64.9 years; 79.8% of the patients were men, and 28.6% had diabetes mellitus. The extent of CAD was similar in the 2 groups. Most patients received optimal medical therapy at discharge, which was less frequent in the CABG group than in the PCI group; namely, aspirin (89.8% vs 95.7%, respectively, p = 0.004), statins (77.8% vs 85.4%, respectively, p = 0.013), and β blockers (74.3% vs 81.7%, respectively, p = 0.022).

The median follow-up time was 59.8 months (interquartile range: 50.7 to 60.3 months). The primary outcome of death from any causes, MI, or stroke occurred in 56 patients (16.0%) in the CABG group compared with 87 (26.9%) in the PCI group (hazard ratio [HR] 0.59, 95% CI 0.42 to 0.82; p = 0.002; Figure 1 , Table 2 ). This difference was mainly attributed to a reduction in the rate of MI. In the subgroup analyses, there was no significant interaction between treatment effects and major baseline variables ( Figure 2 ). By multivariate analysis, age, revascularization strategy, peripheral artery disease, SYNTAX scores, and optimal medical therapies at discharge were independently related to the primary outcome ( Table 3 ).

Time-to-event curves comparing the outcomes of CABG and PCI with DES. (A) Death from any causes, MI, or stroke; (B) death from any causes; (C) myocardial infraction; (D) stroke. The p values were calculated using the log-rank test with all available follow-up data. The percentages denote 5-year event rates.

Primary outcome stratified by major subgroups. Subgroup analyses were performed using Cox proportional hazards regression. ACS = acute coronary syndrome; LM = left main; pLAD = proximal left anterior descending coronary artery.

Table 3

Predictors of primary outcome by Cox regression analyses

Variables	Univariate analysis			Multivariate analysis
	HR	95% CI	p-value	HR	95% CI	p-value
Age	1.06	1.04-1.08	<0.001	1.05	1.03-1.08	<0.001
CABG vs. PCI	0.59	0.42-0.82	0.002	0.41	0.28-0.59	<0.001
Peripheral artery disease	1.99	1.24-3.20	0.004	1.99	1.23-3.23	0.005
SYNTAX score	1.03	1.01-1.04	0.001	1.02	1.01-1.04	0.004
Discharge medications
∗ Antiplatelet therapy	0.25	0.14-0.45	<0.001	0.20	0.10-0.38	<0.001
Statin	0.45	0.31-0.65	<0.001	0.39	0.26-0.56	<0.001
β-blocker	0.63	0.44-0.91	0.015
EuroSCORE	1.17	1.11-1.24	<0.001
Diabetes mellitus	1.44	1.02-2.03	0.037

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