This Article Figures Only Full Text Full Text (PDF) View Online Appendix Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (11) Citing Articles via Google Scholar Google Scholar Articles by Krucoff, M. W. Search for Related Content PubMed PubMed Citation Articles by Krucoff, M. W. Related Collections Related Article

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

Related Article

Inside This Issue of JACC
J. Am. Coll. Cardiol. 2008 51: A23-A24. [Full Text] [PDF]

This article has been cited by other articles:

				J. F. Granada, M. J. Price, P. A. French, S. R. Steinhubl, D. E. Cutlip, R. C. Becker, S. S. Smyth, and H. L. Dauerman Platelet-Mediated Thrombosis and Drug-Eluting Stents Circ Cardiovasc Interv, December 1, 2011; 4(6): 629 - 637. [Full Text] [PDF]

				D. J. Kereiakes, K. Sudhir, J. B. Hermiller, P. C. Gordon, J. Ferguson, M. Yaqub, P. Sood, X. Su, S. Yakubov, A. J. Lansky, et al. Comparison of Everolimus-Eluting and Paclitaxel-Eluting Coronary Stents in Patients Undergoing Multilesion and Multivessel Intervention: The SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) and SPIRIT IV (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) Randomized Trials J. Am. Coll. Cardiol. Intv., December 1, 2010; 3(12): 1229 - 1239. [Abstract] [Full Text] [PDF]

				S. Garg and P. W. Serruys Coronary Stents: Looking Forward J. Am. Coll. Cardiol., August 31, 2010; 56(10_Suppl_S): S43 - S78. [Abstract] [Full Text] [PDF]

				E. Grube, J. Schofer, K. E. Hauptmann, G. Nickenig, N. Curzen, D. J. Allocco, and K. D. Dawkins A Novel Paclitaxel-Eluting Stent With an Ultrathin Abluminal Biodegradable Polymer: 9-Month Outcomes With the JACTAX HD Stent J. Am. Coll. Cardiol. Intv., April 1, 2010; 3(4): 431 - 438. [Abstract] [Full Text] [PDF]

				S. Silber, A. Colombo, A. P. Banning, K. Hauptmann, J. Drzewiecki, E. Grube, D. Dudek, and D. S. Baim Final 5-Year Results of the TAXUS II Trial: A Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-Based Paclitaxel-Eluting Stents for De Novo Coronary Artery Lesions Circulation, October 13, 2009; 120(15): 1498 - 1504. [Abstract] [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., June 2, 2009; 53(22): 2080 - 2097. [Full Text] [PDF]

				S. Verheye, P. Agostoni, K. D. Dawkins, J. Dens, W. Rutsch, D. Carrie, J. Schofer, C. Lotan, C. L. Dubois, S. A. Cohen, et al. 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 J. Am. Coll. Cardiol. Intv., March 1, 2009; 2(3): 205 - 214. [Abstract] [Full Text] [PDF]

				K. O. Niemela Biodegradable coating for drug-eluting stents--more than a facelift? Eur. Heart J., August 2, 2008; 29(16): 1930 - 1931. [Full Text] [PDF]