Author + information
- Received August 27, 2007
- Revision received January 10, 2008
- Accepted January 15, 2008
- Published online April 22, 2008.
- Mitchell W. Krucoff, MD, FACC⁎,⁎ (, )
- Dean J. Kereiakes, MD, FACC†,
- John L. Petersen, MD⁎,
- Roxana Mehran, MD‡,
- Vic Hasselblad, PhD⁎,
- Alexandra J. Lansky, MD§,
- Peter J. Fitzgerald, MD, PhD, FACC∥,
- Jyotsna Garg, MS⁎,
- Mark A. Turco, MD¶,
- Charles A. Simonton III, MD, FACC#,
- Stefan Verheye, MD, PhD⁎⁎,
- Christophe L. Dubois, MD††,
- Roger Gammon, MD‡‡,
- Wayne B. Batchelor, MD, MHS§§,
- Charles D. O'Shaughnessy, MD∥∥,
- James B. Hermiller Jr, MD¶¶,
- Joachim Schofer, MD##,
- Maurice Buchbinder, MD, FACC⁎⁎⁎,
- William Wijns, MD, PhD†††,
- COSTAR II Investigators Group
- ↵⁎Reprint requests and correspondence:
Dr. Mitchell W. Krucoff, Professor of Medicine/Cardiology, Duke University Medical Center, 508 Fulton Street, Room A3006, Durham, North Carolina 27705.
Objectives The aim was to compare safety and effectiveness of the CoStar drug-eluting stent (DES) (Conor MedSystems, Menlo Park, California) with those of the Taxus DES (Boston Scientific, Maple Grove, Minnesota) in de novo single- and multivessel percutaneous coronary intervention (PCI).
Background Paclitaxel elution from a stent coated with biostable polymer (Taxus) reduces restenosis after PCI. The CoStar DES is a novel stent with laser-cut reservoirs containing bioresorable polymer loaded to elute 10 μg paclitaxel/30 days.
Methods Patients undergoing PCI for a single target lesion per vessel in up to 3 native epicardial vessels were randomly assigned 3:2 to CoStar or Taxus. Primary end point was 8-month major adverse cardiac events (MACE), defined as adjudicated death, myocardial infarction (MI), or clinically driven target vessel revascularization (TVR). Protocol-specified 9-month angiographic follow-up included 457 vessels in 286 patients.
Results Of the 1,700 patients enrolled, 1,675 (98.5%) were evaluable (CoStar = 989; Taxus = 686), including 1,330 (79%) single-vessel and 345 (21%) multivessel PCI. The MACE rate at 8 months was 11.0% for CoStar versus 6.9% for Taxus (p < 0.005), including adjudicated death (0.5% vs. 0.7%, respectively), MI (3.4% vs. 2.4%, respectively), and TVR (8.1% vs. 4.3%, respectively). Per-vessel 9-month in-segment late loss was 0.49 mm with CoStar and 0.18 mm with Taxus (p < 0.0001). Findings were consistent across pre-specified subgroups.
Conclusions The CoStar DES is not noninferior to the Taxus DES based on per-patient clinical and per-vessel angiographic analyses. The relative benefit of Taxus is primarily attributable to reduction in TVR. Follow-up to 9 months showed no apparent difference in death, MI, or stent thrombosis rates.
Supported by a research grant from Conor MedSystems. For full author disclosures, please see the end of this paper.
- Received August 27, 2007.
- Revision received January 10, 2008.
- Accepted January 15, 2008.
- American College of Cardiology Foundation