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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

A Novel Bioresorbable Polymer Paclitaxel-Eluting Stent for the Treatment of Single and Multivessel Coronary Disease

Primary Results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II Study

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 for the COSTAR II Investigators Group

^_* Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
Christ Hospital Heart and Vascular Center/Lindner Center, Cincinnati, Ohio
Columbia University Medical Center, New York, New York
Cardiovascular Research Foundation, New York, New York
^|| Stanford University Medical Center, Stanford, California
^¶ Washington Hospital Center, Washington, DC
^# Sanger Clinic, Carolinas HealthCare System, Charlotte, North Carolina
^_** Antwerp Cardiovascular Institute Middelheim, Antwerp, Belgium
University Hospital Gasthuisberg, Leuven, Belgium
Austin Heart, Austin, Texas
Heart and Vascular Institute, Tallahassee Memorial Healthcare, Tallahassee, Florida
^|||| North Ohio Heart Center, Elyria, Ohio
^¶¶ St. Vincent's Hospital, Indianapolis, Indiana
^## Center for Cardiology and Vascular Intervention, Hamburg, Germany
^_*** Foundation for Cardiovascular Medicine, La Jolla, California
Cardiovascular Center, Aalst, Belgium.

Manuscript received August 27, 2007; revised manuscript received January 10, 2008, accepted January 15, 2008.

^_* 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. (Email: kruco001{at}mc.duke.edu).

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.

Abbreviations and Acronyms   CEC = clinical events committee   DES = drug-eluting stent(s)   ECG = electrocardiography/electrocardiogram   FDA = Food and Drug Administration   IVUS = intravascular ultrasound   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PLGA = poly–lactic-co-glycolic acid   QCA = quantitative coronary angiography   TVR = target vessel revascularization

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