Author + information
- Received December 15, 2008
- Accepted December 21, 2008
- Published online March 1, 2009.
- 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‡‡ and
- Alexandra J. Lansky, MD§§
- ↵⁎Reprint requests and correspondence:
Dr. Stefan Verheye, Antwerp Cardiovascular Institute Middelheim, Ziekenhuis Netwerk Antwerpen, Lindendreef 1, 2020 Antwerp, Belgium
The results of this trial were presented at the 2008 Society for Cardiovascular Angiography and Interventions/American College of Cardiology Innovations in Interventions (SCAI/ACCi2) Conference Proceedings (Late Breaking Clinical Trial session), held in Chicago (March 29 to April 1, 2008).
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)
This work received funding from Conor Medsystems.
Dr. Dawkins is currently an employee of Boston Scientific Corporation. Dr. Cohen is an employee of Cordis-Johnson & Johnson.
- Received December 15, 2008.
- Accepted December 21, 2008.
- American College of Cardiology Foundation