Safety and efficacy of the cobalt chromium PRO-Kinetik coronary stent system: results of the MULTIBENE study.

BACKGROUND

The aim of this MULTIBENE study was to evaluate the safety and efficacy of the silicon carbide coated cobalt chromium PRO-Kinetik coronary stent system in patients with single de novo coronary lesions.

METHODS AND MATERIALS: This prospective international multicenter study included 202 patients at 10 European sites. Analysis was performed on the per protocol population of 197 patients. Patients were followed until 12 months, a subset of patients (n=72) underwent additional coronary angiography at 6 months. Primary endpoint was 6-months rate of target vessel failure (TVF), defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR).

RESULTS

At 6 months, rate of TVF was 10.9% and rate of major adverse cardiac events, a composite of cardiac death, MI, target lesion revascularization (TLR) and coronary artery bypass graft, was 11.4%, both being mainly attributed to TVR respective TLR. No cardiac death or stent thrombosis occurred. In-segment late lumen loss was 0.66±0.61mm and binary restenosis was 20.8%, as determined by core laboratory in the angiographic subgroup.

CONCLUSION

Based on these data, the PRO-Kinetik coronary stent system was found to be safe and effective.