A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported completion of enrollment in its SYNTAX clinical trial, calling it the first trial to compare the results of drug-eluting stents (DES) with those of cardiac surgery in the most complex patient subsets: those with de novo lesions involving all three coronary arteries, in the left main coronary artery, or both.

SYNTAX is designed to compare 12-month outcomes of such patients after treatment with percutaneous coronary intervention (PCI) using its Taxus Express2 paclitaxel-eluting DES, vs. the coronary artery bypass graft (CABG) procedure.

Previous studies comparing CABG to PCI have used balloon angioplasty or bare-metal stents, or have been limited to highly selected patient populations, excluding the type of patient enrolled in SYNTAX, according to Boston Scientific. SYNTAX, it says, "allowed wide latitude in enrolling these complex patients, with the final decision on whether to randomize a patient being made by the local interventional cardiologist and cardiothoracic surgeon."

The Taxus Express2 coronary stent system is indicated for improving luminal diameter for the treatment of de novo lesions less or equal to 28 mm in length in native coronary arteries greater or equal to 2.5 to less than or equal to 3.75 mm in diameter.

The primary endpoint of the study is the 12-month major adverse cardiac and cerebral event rate, including death, myocardial infarction, repeat revascularization and stroke.

No Comments