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

Research output: Contribution to journalArticlepeer-review

115 Scopus citations

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.

Original languageEnglish
Pages (from-to)624-632
Number of pages9
JournalCirculation
Volume124
Issue number5
DOIs
StatePublished - 2 Aug 2011

Keywords

  • Drug-eluting stents
  • Probucol
  • Randomized clinical trial
  • Sirolimus
  • Zotarolimus

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