TY - JOUR
T1 - Safety and Efficacy of the cobalt chromium PRO-Kinetik coronary stent system
T2 - Results of the MULTIBENE study
AU - Vermeersch, Paul
AU - Appelman, Yolande
AU - Horstkotte, Dieter
AU - Richardt, Gert
AU - Boland, Jean
AU - Lalmand, Jacques
AU - Coussement, Patrick
AU - Castadot, Marc
AU - Janssens, Luc
AU - Agostoni, Pierfrancesco
AU - Buysschaert, Ian
AU - Suttorp, Maarten J.
N1 - Funding Information: This work was supported by a clinical trial grant from Biotronik AG, Buelach, Switzerland .
PY - 2012/11
Y1 - 2012/11
N2 - 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 ± 0.61. mm 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.
AB - 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 ± 0.61. mm 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.
KW - Bare metal stent
KW - Cobalt-chromium
KW - Coronary artery disease
KW - Silicon carbide
UR - http://www.scopus.com/inward/record.url?scp=84869409483&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.carrev.2012.09.006
DO - https://doi.org/10.1016/j.carrev.2012.09.006
M3 - Article
C2 - 23164477
SN - 1553-8389
VL - 13
SP - 316
EP - 320
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
IS - 6
ER -