title: Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.
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.
  
  
  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<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
  
  
  CONCLUSIONS
  Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
authors.affiliation: Ospedale San Raffaele, Milano, Italy. colombo@emocolumbus.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Janusz
authors.initials: J
authors.lastname: Drzewiecki
authors.forename: Adrian
authors.initials: A
authors.lastname: Banning
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Karl
authors.initials: K
authors.lastname: Hauptmann
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Stephen
authors.initials: S
authors.lastname: Fort
authors.forename: Francois
authors.initials: F
authors.lastname: Schiele
authors.forename: Krysztof
authors.initials: K
authors.lastname: Zmudka
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Mary E
authors.initials: ME
authors.lastname: Russell
mesh_terms: D020099:Coated Materials, Biocompatible / Q000008:administration & dosage*; D015331:Cohort Studies; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000601:surgery*; D003692:Delayed-Action Preparations / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004343:Drug Implants / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D015607:Stents / Q000009:adverse effects / Q000592:standards; D013927:Thrombosis / Q000209:etiology; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D020099:Coated Materials, Biocompatible; D003692:Delayed-Action Preparations; D004343:Drug Implants