Clinical and Angiographic Analysis With a Cobalt Alloy Coronary Stent (Driver) in Stable and Unstable Angina Pectoris

Abstract

The Clinical and Angiographic analysis with a Cobalt Alloy Coronary Stent (Driver) (CLASS) study was a prospective, nonrandomized, multicenter study designed to assess the safety and efficacy of a cobalt-chromium alloy-based stent in patients with stable or unstable angina pectoris. A total of 203 lesions were treated in 202 enrolled patients. The percentage of major adverse cardiac event-free patients was 87.6% (177 of 202) at 6 months (primary safety end point; major adverse cardiac events were defined as death, myocardial infarction, emergency bypass surgery, or target lesion revascularization [percutaneous transluminal coronary angioplasty or coronary artery bypass grafting]). The angiographic success rate (primary efficacy end point) was 100%, and the procedural success rate was 98%. The binary in-stent restenosis rate at 6 months was 12.6%. Our results have demonstrated that the Driver cobalt-chromium alloy stent can be used with a low 6-month incidence of major adverse cardiac events, a low 6-month binary restenosis rate, and high angiographic and procedural success rates.