The SYNTAX Trial
Coronary heart disease (CHD) is a major cause of morbidity and mortality throughout the world, and both surgical revascularisation (coronary artery bypass grafting, CABG) and percutaneous coronary intervention (PCI) are established treatment options. The rapid developments in both surgical and percutaneous techniques have been such that the choice of the optimum revascularisation strategy is changing, often without an established evidence base; this is particularly true in complex conditions including patients with three-vessel and left main stem anatomy. The widespread use of drug eluting stents has resulted in a significant reduction in patients referred for CABG although published data favours the surgical approach in this high-risk group.
The SYNTAX Trial aims to explore the interface between treatment with CABG and PCI in patients with three-vessel and left main stem disease, comparing CABG using contemporary techniques and PCI using drug eluting TAXUS stents. The aim of the trial is to establish non-inferiority of PCI with CABG. The unique feature of the SYNTAX trial is the ‘all comers’ strategy. A team comprising a cardiac surgeon and an interventional cardiologist assesses each patient; if equivalent revascularisation is applicable using both techniques, the patient is accepted for randomization; if either CABG or PCI is deemed unsuitable for technical reasons or the presence of co-morbidities, then the patient is recruited into one of two parallel registries which will track these patients undergoing either CABG or PCI. The patient will not be included in the randomized cohort. 1800 patients will be randomized (1:1) between CABG and PCI. The primary end-point is a major adverse, cardiac and cerbrovascular event at one year. All patients will be followed for five years. Of the 1800 patients, 710 with left main stem disease will be randomized between CABG and PCI. In this sub-group, repeat cardiac catheterisation will be undertaken after the one-year primary endpoint to determine graft and native vessel patency (the Le Mans sub-study).
The SYNTAX Trial is one of the most important trials ever undertaken in the field of coronary revascularisation and will provide a rational basis for choosing the optimum revascularisation strategy in patients with coronary disease for many years to come.