Document Detail


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.
MedLine Citation:
PMID:  18420096     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 bioresorbable polymer loaded to elute 10 microg 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.
Authors:
Mitchell W Krucoff; Dean J Kereiakes; John L Petersen; Roxana Mehran; Vic Hasselblad; Alexandra J Lansky; Peter J Fitzgerald; Jyotsna Garg; Mark A Turco; Charles A Simonton; Stefan Verheye; Christophe L Dubois; Roger Gammon; Wayne B Batchelor; Charles D O'Shaughnessy; James B Hermiller; Joachim Schofer; Maurice Buchbinder; William Wijns;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  51     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2008 Apr 
Date Detail:
Created Date:  2008-04-18     Completed Date:  2008-05-15     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1543-52     Citation Subset:  AIM; IM    
Affiliation:
Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27705, USA. kruco001@mc.duke.edu
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MeSH Terms
Descriptor/Qualifier:
Absorbable Implants*
Angioplasty, Transluminal, Percutaneous Coronary
Antineoplastic Agents, Phytogenic / administration & dosage*,  therapeutic use
Chromium Alloys*
Coronary Angiography
Coronary Artery Disease / drug therapy*,  mortality,  physiopathology
Coronary Restenosis / drug therapy*,  mortality,  physiopathology
Diabetes Mellitus
Female
Humans
Male
Middle Aged
Paclitaxel / administration & dosage*,  therapeutic use
Platelet Aggregation Inhibitors / administration & dosage
Polymers*
Risk
Thromboembolism / prevention & control
Ticlopidine / administration & dosage,  analogs & derivatives
Time Factors
Chemical
Reg. No./Substance:
0/Antineoplastic Agents, Phytogenic; 0/Chromium Alloys; 0/Platelet Aggregation Inhibitors; 0/Polymers; 33069-62-4/Paclitaxel; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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