Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions

Antonio Colombo, Janusz Drzewiecki, Adrian Banning, Eberhard Grube, Karl Hauptmann, Sigmund Silber, Dariusz Dudek, Stephen Fort, Francois Schiele, Krysztof Zmudka, Giulio Guagliumi, Mary E. Russell

Research output: Contribution to journalArticlepeer-review

Abstract

Background - Early clinical studies demonstrated the feasibility of local paclitaxel delivery in reducing restenosis after treatment of de novo coronary lesions in small patient populations. Methods and Results - We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23. 2% and 20.5%; P

Original languageEnglish
Pages (from-to)788-794
Number of pages7
JournalCirculation
Volume108
Issue number7
DOIs
Publication statusPublished - Aug 19 2003

Keywords

  • Coronary disease
  • Drugs
  • Restenosis
  • Stents

ASJC Scopus subject areas

  • Physiology
  • Cardiology and Cardiovascular Medicine

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