Clinical and angiographic analysis with a cobalt alloy coronary stent (driver) in stable and unstable angina pectoris.
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.
Legrand
Victor
V
Centre Hospitalier Universitaire Sart Tilman, Liege, Belgium. vlegrand@chu.ulg.ac.be
Kelbaek
Henning
H
Hauptmann
Karl Eugen
KE
Glogar
Dietmar
D
Rutsch
Wolfgang
W
Grollier
Gilles
G
Vermeersch
Paul
P
Elias
Joseph
J
De Cock
Cornelis Carolus
CC
D000368:Aged; D000787:Angina Pectoris / Q000000981:diagnostic imaging / Q000628:therapy*; D001672:Biocompatible Materials / Q000627:therapeutic use*; D002858:Chromium Alloys / Q000627:therapeutic use*; D017023:Coronary Angiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
D001672:Biocompatible Materials; D002858:Chromium Alloys