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The GENESIS (Randomized, Multicenter Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries) Trial

Stefan Verheye, MD, PhD^_*,_*, Pierfrancesco Agostoni, MD^_*, Keith D. Dawkins, MD, Joseph Dens, MD, PhD, Wolfgang Rutsch, MD, Didier Carrie, MD^||, Joachim Schofer, MD^¶, Chaim Lotan, MD^#, Christophe L. Dubois, MD^_**, Sidney A. Cohen, MD, PhD, Peter J. Fitzgerald, MD, PhD, Alexandra J. Lansky, MD

^_* Antwerp Cardiovascular Institute Middelheim, Ziekenhuis Netwerk Antwerpen, Antwerp, Belgium
Southampton University Hospital, Southampton, United Kingdom
Oost-Limburg Hospital, Genk, Belgium
Charité Medical School, Humboldt-Universität, Berlin, Germany
^|| Rangueil Hospital, Toulouse, France
^¶ Medical Care Center, Hamburg University Cardiovascular Center, Hamburg, Germany
^# Hadassah-Hebrew University Medical Centre, Jerusalem, Israel
^_** University Hospital Gasthuisberg, Leuven, Belgium
Clinical Research Cordis Corporation, Warren, New Jersey
Stanford University Medical Center, Stanford, California
Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York

^_* Reprint requests and correspondence: Dr. Stefan Verheye, Antwerp Cardiovascular Institute Middelheim, Ziekenhuis Netwerk Antwerpen, Lindendreef 1, 2020 Antwerp, Belgium (Email: stefan.verheye{at}telenet.be).

Objectives: The aim of this study was to compare, in a randomized multicenter trial, paclitaxel-eluting stents (CoStar, Conor Medsystems, Menlo Park, California) versus pimecrolimus-eluting stents (Corio, Conor Medsystems) versus stents with dual elution of both drugs (SymBio, Conor Medsystems) in native coronary arteries.

Background: The CoStar cobalt-chromium reservoir-based stent platform, eluting paclitaxel in a controlled way via a bioresorbable polymer, reduces restenosis versus its respective bare-metal stent. The reservoir system allows the use of other drugs targeted to different mechanisms involved in the process of vascular restenosis and simultaneous loading of multiple, synergistic drugs.

Methods: Patients with single de novo lesions were asymmetrically randomized to 1 of the 3 types of stent (1:2:2). Six-month coronary angiography was planned in all. The primary analysis was a noninferiority test for the primary end point of 6-month angiographic in-stent late lumen loss of Corio versus CoStar and SymBio versus CoStar. Secondary end points included binary angiographic restenosis and major adverse clinical events (cardiac death, myocardial infarction, target vessel revascularization).

Results: The trial was prematurely suspended after 246 patients were enrolled (planned enrollment: 375 patients): 49 patients received CoStar, 97 received SymBio, and 100 received Corio. In-stent late loss was significantly reduced with CoStar versus either SymBio or Corio (0.58 ± 0.58 mm vs. 0.96 ± 0.73 mm and 0.58 ± 0.58 mm vs. 1.40 ± 0.67 mm, p < 0.001 for both comparisons). Binary in-stent restenosis rates were, 7.1%, 20%, and 40.9%, respectively (p < 0.001 for both comparisons); 6-month major adverse cardiac event rates were, 2.0%, 14.4%, and 39.0%, respectively (p < 0.001 for both comparisons).

Conclusions: Stents eluting pimecrolimus or the dual combination of pimecrolimus and paclitaxel failed to show angiographic noninferiority when compared with paclitaxel-eluting stents. (A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems; NCT00322569)

Key Words: coronary artery disease • paclitaxel-eluting stent • pimecrolimus-eluting stent • restenosis

Abbreviations and Acronyms   IVUS = intravascular ultrasound   MACE = major adverse cardiac event   MI = myocardial infarction   MLD = minimal luminal diameter   QCA = quantitative coronary angiography   PES = paclitaxel-eluting stent(s)   RVD = reference vessel diameter   TLR = target lesion revascularization   TVR = target vessel revascularization

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