| 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. | |
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MedLine Citation:
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PMID: 18420096 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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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:
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Created Date: 2008-04-18 Completed Date: 2008-05-15 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 1543-52 Citation Subset: AIM; IM |
Affiliation:
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Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27705, USA. kruco001@mc.duke.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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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