Boston Scientific reports encouraging results from heart stent trial

The overall results demonstrated no statistically significant differences between percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in rates of death or myocardial infarction (MI).

The Syntax trial enrolled 1,800 patients in its randomized arm, using an innovative consecutive enrollment methodology, said Boston Scientific. The Syntax trial is the first randomized, controlled clinical trial to compare PCI using drug-eluting stents (DES) to CABG in patients with left main disease and three-vessel disease, according to Boston Scientific.

These patient groups are typically treated with CABG and represent a population with far more complex anatomy and advanced disease than those studied in prior DES clinical trials. The goal of the trial is to expand the body of knowledge of PCI use and help inform physicians on appropriate treatment options for the sickest patients.

The results showed comparable safety for the two treatment groups, with a combined rate of all-cause death, stroke and MI of 7.6% for PCI and 7.7% for CABG (p=0.98). The rate of stroke itself was 0.6% for PCI as compared to 2.2% for CABG (p=0.003). Overall 12-month major adverse cardiovascular or cerebrovascular event rate, including all-cause death, stroke, MI and repeat revascularization) was significantly higher for PCI (17.8% compared to 12.1% for CABG, p=0.0015).

Keith Dawkins, associate chief medical officer of Boston Scientific, said: “For PCI patients to do so well with such complex anatomy and advanced disease is extraordinary. These patients, the majority of whom are normally treated with surgery, are the most challenging group ever studied in a DES clinical trial.”