Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: The Intracoronary stenting and angiographic results: Test efficacy of sirolimus- and probucol-eluting versus zotarolimus-eluting stents (ISAR-TEST 5) Trial

Steffen Massberg, Robert A. Byrne, Adnan Kastrati, Stefanie Schulz, Jürgen Pache, Jörg Hausleiter, Tareq Ibrahim, Massimiliano Fusaro, Ilka Ott, Albert Schömig, Karl Ludwig Laugwitz, Julinda Mehilli

Publikation: Beitrag in FachzeitschriftArtikelBegutachtung

115 Zitate (Scopus)

Abstract

Background-Durable polymer coatings have been implicated in mid- and long-term adverse events after drug-eluting stent implantation. A polymer-free dual-drug sirolimus- and probucol-eluting stent and a new generation permanent polymer zotarolimus-eluting stent are recently developed technologies demonstrating encouraging results. Methods and Results-In a clinical trial with minimal exclusion criteria, we randomly assigned 3002 patients to treatment with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The trial was designed to demonstrate noninferiority of the sirolimus- and probucol-eluting stents. The primary end point was the combined incidence of cardiac death, target-vessel-related myocardial infarction, or target-lesion revascularization at 1-year follow-up. Follow-up angiography was scheduled at 6 to 8 months. The sirolimus- and probucol-eluting stent was noninferior to the zotarolimus-eluting stent in terms of occurrence of the primary end point (13.1% versus 13.5%, respectively, P noninferiority=0.006; hazard ratio=0.97, 95% confidence interval, 0.78 to 1.19; P superiority=0.74) . The incidence of definite/probable stent thrombosis was low in both groups (1.1% versus 1.2%, respectively; hazard ratio=0.91 [95% confidence interval, 0.45 to 1.84], P=0.80). With regard to angiographic efficacy, there were no differences between the sirolimus- and probucol-eluting stent and the zotarolimus-eluting stent in terms of either in-segment binary angiographic restenosis (13.3% versus 13.4% respectively; P=0.95) or in-stent late luminal loss (0.31±0.58 mm versus 0.29±0.56 mm, respectively; P=0.46). Conclusion-In this large-scale study powered for clinical end points, a polymer-free sirolimus- and probucol-eluting stent was noninferior to a new generation durable polymer-based zotarolimus-eluting stent out to 12 months. Clinical Trial Registration-http://www.clinicaltrials.gov. Unique identifier NCT 00598533.

OriginalspracheEnglisch
Seiten (von - bis)624-632
Seitenumfang9
FachzeitschriftCirculation
Jahrgang124
Ausgabenummer5
DOIs
PublikationsstatusVeröffentlicht - 2 Aug. 2011

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