Percutaneous coronary intervention (PCI) with Taxus (paclitaxel-eluting) stenting was inferior to coronary artery bypass graft (CABG) with respect to the primary composite of death, stroke, myocardial infarction (MI), or repeat revascularization among patients with left main or 3-vessel coronary artery disease (CAD), as reported by researchers from the international SYNTAX trial (The SYNergy between Percutaneous Coronary Intervention with TAXus and Cardiac Surgery; NCT00114972) at the European Society of Cardiology Congress 2008 in Munich.

“In the randomized cohort, we saw comparable overall safety outcomes in terms of MI, cerebrovascular accident, or death for CABG and PCI,” said investigator and copresenter Patrick Serruys, MD, PhD, Interuniversity Cardiological Institute, Rotterdam, The Netherlands. “But there was a significantly higher rate of revascularization in the PCI group and a significantly higher rate of stroke in the CABG group,” he added.

The trial was conducted at 62 sites in Europe and 23 sites in the United States and had an “all-comers” design instead of a highly selected patient population to reflect, as much as possible, real-world conditions. Patients had either left main stenosis or 3-vessel CAD with the intent to revascularize all 3 vascular territories. The investigators relied on a cardiologist and surgeon consensus to determine whether each subject was eligible for both coronary interventions. Limited exclusion criteria included previous interventions, acute MI with creatine phosphokinase (CPK)-myocardial band >2X, or concomitant cardiac surgery.

After establishing eligibility for either intervention, investigators randomized 1800 subjects to CABG (n=897) or PCI (n=903). Approximately 28% had diabetes, 33% prior MI, and 29% recent unstable angina. The average number of lesions was 4.4, with 66% qualifying on the basis of 3-vessel disease only, 3% with left main only, and 31% with both left main and 3-vessel disease.

The primary endpoint of the trial, the rate of MACCE (Major Cardiovascular or Cerebrovascular Event Rate) as defined by all-cause death, cerebrovascular accident (CVA), documented MI, or any repeated revascularization (PCI or CABG) at 12 months, occurred in more patients who were undergoing PCI than CABG (17.8% vs 12.1%; p=0.0015). There was a significantly higher rate of revascularization in the PCI group (13.7% vs 5.9%; p<0.0001) but a significantly higher rate of CVA in the CABG group (2.2% vs 0.6%; p=0.003). The composite rates of all-cause death, CVA, and MI were nearly identical (7.6% for PCI vs 7.7% for CABG; p=0.98). Individual rates of death, MI, and thrombosed vessel (bypass graft vs stented vessel) at 12 months were each similar in both cohorts. Among the subgroups that were presented, patients with diabetes, isolated 3-vessel CAD, and left main plus involvement of an additional 2 or 3 vessels tended to have better outcomes with CABG, while outcomes in patients with isolated left main disease and left main plus a single additional vessel tended to favor PCI. A possible explanation is that the risk of complication with PCI is more closely related to the number of vessels undergoing revascularization than to the risk of complication with CABG.

SYNTAX Registries

Friedrich Mohr, MD, PhD, University of Leipzig, Leipzig, Germany, presented the results of the registries. There were 1275 patients who were eligible for only one of the interventions, of which 649 were enrolled in the CABG registry and 198 in the PCI registry.

“The treatment schedule and follow-up visits in the registries were identical with the subjects in the randomized groups, and major adverse cardio- and cerebrovascular events were completely monitored,” Prof. Mohr said. “No statistical comparisons between the randomized and registry groups were performed,” he added.

For the 12-month endpoint, Prof. Mohr reported a total MACCE rate for PCI registry subjects of 20.4%. This included all-cause death (7.3%), stroke (0%), MI (4.2%), death by stroke or MI (10.5%), and revascularization (12.0%).

For the same endpoint, he reported a total MACCE rate for CABG registry subjects of 8.8%. This included all-cause death (2.5%), stroke (2.2%), MI (2.5%), death from stroke or MI (6.6%), and revascularization (3.0%).

“While repeat revascularization drove the higher MACCE for the PCI group, it is notable and surprising that there were no strokes reported in the PCI group,” Prof. Mohr said.

Prof. Mohr noted that SYNTAX showed that CABG remains the only interventional option for one-third of patients but that for patients who are not eligible for CABG, PCI is a good option instead of medical therapy. “Likewise, for patients who are not candidates for PCI, surgery results are excellent.”