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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.

View larger version (59K): [in this window] [in a new window] [Download PPT slide]   Figure 1 The CoStar Stent The CoStar stent reservoir technology at 7 days and at 6 months.

View larger version (18K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Patient Flow Diagram Of the 1,700 patients randomly assigned, 1,675 were evaluable and constituted the primary study population. IVUS = intravascular ultrasound.

View larger version (15K): [in this window] [in a new window] [Download PPT slide]   Figure 3 MACE (A) 240- to 270-day hierarchical MACE. (B) 240- to 270-day death and Q-wave MI. (C) 240- to 270-day clinically driven TVR. MACE = major adverse cardiac events; MI = myocardial infarction; TVR = target vessel revascularization.

View larger version (18K): [in this window] [in a new window] [Download PPT slide]   Figure 4 MACE in Subgroups Eight-month hierarchical MACE in pre-specified subgroups. D/C = discontinued; IDDM = insulin-dependent diabetes mellitus; LAD = left anterior descending artery; MACE = major adverse cardiac events; MVD = multivessel disease; NIDDM = noninsulin-dependent diabetes mellitus; RVD = reference vessel diameter; Rx = prescription; SVD = single-vessel disease.

View larger version (4K): [in this window] [in a new window] [Download PPT slide]   Figure 5 Relative Risk Relative risk of CoStar versus imputed placebo 8-month major adverse cardiac events.