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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.

Publication ,  Journal Article
Krucoff, MW; Kereiakes, DJ; Petersen, JL; Mehran, R; Hasselblad, V; Lansky, AJ; Fitzgerald, PJ; Garg, J; Turco, MA; Simonton, CA; Verheye, S ...
Published in: J Am Coll Cardiol
April 22, 2008

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.

Duke Scholars

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

April 22, 2008

Volume

51

Issue

16

Start / End Page

1543 / 1552

Location

United States

Related Subject Headings

  • Time Factors
  • Ticlopidine
  • Thromboembolism
  • Risk
  • Polymers
  • Platelet Aggregation Inhibitors
  • Paclitaxel
  • Middle Aged
  • Male
  • Humans
 

Citation

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Krucoff, M. W., Kereiakes, D. J., Petersen, J. L., Mehran, R., Hasselblad, V., Lansky, A. J., … COSTAR II Investigators Group, . (2008). 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. J Am Coll Cardiol, 51(16), 1543–1552. https://doi.org/10.1016/j.jacc.2008.01.020
Krucoff, Mitchell W., Dean J. Kereiakes, John L. Petersen, Roxana Mehran, Vic Hasselblad, Alexandra J. Lansky, Peter J. Fitzgerald, et al. “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.J Am Coll Cardiol 51, no. 16 (April 22, 2008): 1543–52. https://doi.org/10.1016/j.jacc.2008.01.020.
Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA, Verheye S, Dubois CL, Gammon R, Batchelor WB, O’Shaughnessy CD, Hermiller JB, Schofer J, Buchbinder M, Wijns W, COSTAR II Investigators Group. 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. J Am Coll Cardiol. 2008 Apr 22;51(16):1543–1552.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

April 22, 2008

Volume

51

Issue

16

Start / End Page

1543 / 1552

Location

United States

Related Subject Headings

  • Time Factors
  • Ticlopidine
  • Thromboembolism
  • Risk
  • Polymers
  • Platelet Aggregation Inhibitors
  • Paclitaxel
  • Middle Aged
  • Male
  • Humans