Evaluation of the Medtronic (Driver) cobalt-chromium alloy coronary stent system

Abstract

The Driver Registry was a prospective, multicenter, nonrandomized study to evaluate the clinical safety and efficacy of the Driver cobalt-chromium alloy stent. Use of the cobalt-chromium alloy in place of stainless steel offers enhanced visibility and radial strength with thinner structural elements. The registry enrolled 298 patients with symptomatic ischemic heart disease attributable to de novo or restenotic nonstented native lesions of a single vessel amenable to percutaneous stenting. The primary composite end point was the incidence of major adverse cardiac events (death, myocardial infarction, emergency bypass surgery, or target lesion revascularization) 180 days after enrollment. Quantitative coronary angiography was performed before and after the index stent deployment and repeated at 6 months in 83 patients. Mean patient age was 62.6 years, mean reference vessel diameter was 3.07 mm before the procedure, and mean lesion length was 11.04 mm. Fifty-one patients received multiple stents. Angiographic success rate was 100% and procedural success rate was 98.3%. Cumulative incidence of major adverse cardiac events was 5.7% and target lesion revascularization was 3.4% at 180 days. In-stent late loss was 0.94 mm at 180 days, and no subacute stent thromboses were observed. This registry demonstrated the safety and efficacy of this novel coronary stent platform.