Two landmarks, contemporary trials on mechanical revascularization therapies in patients with multivessel coronary artery disease (CAD) have been presented, discussed and published recently.1–4 This common viewpoint explores the potential impact of these trials on clinical decision making and how this may affect the interaction between interventional cardiologists and cardiac surgeons.
Lessons from SYNTAX
SYNTAX stands for SYNergy between percutaneous coronary intervention (PCI) with TAXus and cardiac surgery. The trial compared the outcome of surgical and catheter-based revascularization in 3075 patients with multivessel and/or left main CAD. At each of the 85 participating sites (62 in Europe, 23 in USA), a team involving cardiac surgeon(s) and interventional cardiologist(s) evaluated both the coronary lesions and the clinical data for treatment suitability either by PCI using drug-eluting stents (DES) or by coronary artery bypass grafting (CABG). When both approaches were deemed feasible, a 1:1 randomization to either therapy was proposed (PCI = 903, CABG = 897). If not, two prospective registries of preferred PCI (n = 198) or preferred CABG (n = 1077) were constructed. Severity and extent of CAD were quantified prospectively by the newly designed SYNTAX score.5
At 1 year follow-up, the trial failed to confirm the non-inferiority hypothesis with respect to the composite endpoint of death, non-fatal myocardial infarction, cerebro-vascular accident, repeat revascularization by PCI or CABG. While the pre-specified margin of non-inferiority was 6.6%, the observed difference in major adverse cardiac and cerebro-vascular events (MACCE) rate was 5.7%, with a 95% confidence interval at 8.3% (P = 0.0015 in favour of surgery). With respect to individual components of the primary endpoint, death and myocardial infarction were neutral (P = 0.37 for all cause mortality, P = 0.11 for myocardial infarction), cerebro-vascular accident favoured PCI (0.06% after PCI, 2.2% after CABG, P = 0.003) while repeat revascularization was significantly …