Clinical Efficacy of Polymer-Based Paclitaxel-Eluting Stents in the Treatment of Complex, Long Coronary Artery Lesions From a Multicenter, Randomized Trial
- 22 November 2005
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Circulation
- Vol. 112 (21), 3306-3313
- https://doi.org/10.1161/circulationaha.105.552190
Abstract
Background— Intracoronary polymer-based stent delivery of paclitaxel has been shown to be effective in reducing restenosis in simple coronary lesions, but the evidence base for contemporary use in longer, more complex coronary stenoses is lacking. Methods and Results— TAXUS VI is a prospective, multicenter, double-blind, randomized trial assessing clinical and angiographic outcomes of the TAXUS Moderate Release paclitaxel-eluting stent in the treatment of long, complex coronary artery lesions. Four hundred forty-eight patients at 44 sites were randomized (1:1) between a drug-eluting TAXUS Express 2 and an uncoated Express 2 control stent. Per protocol, the 9-month follow-up included an angiographic reevaluation in all patients. The primary end point was the rate of target-vessel revascularization 9 months after the study procedure; secondary end points included the rate of target-lesion revascularization and binary restenosis at follow-up. Mean lesion length in the study was 20.6 mm, with a mean stent-covered length of 33.4 mm. Of all lesions, 55.6% were classified as complex lesions (type C of the AHA/ACC classification). At 9 months, target-vessel revascularization was 9.1% in the TAXUS group and 19.4% in the control group ( P =0.0027; relative reduction, 53%). Target-lesion revascularization was reduced from 18.9% to 6.8%, respectively ( P =0.0001). The incidence of major adverse cardiac events was similar in the 2 groups, 16.4% and 22.5% in TAXUS and control, respectively ( P =0.12), including comparable rates for acute myocardial infarction. Binary restenosis in the stented area was reduced from 32.9% in the control group to 9.1% in the TAXUS patients ( P Conclusions— The finding that the TAXUS Moderate Release stent system is safe and effective in the treatment of long, complex coronary artery lesions provides the evidence base for the more widespread use of drug-eluting stents in contemporary clinical practice.Keywords
This publication has 12 references indexed in Scilit:
- One-Year Clinical Results With the Slow-Release, Polymer-Based, Paclitaxel-Eluting TAXUS StentCirculation, 2004
- Inhibition of Restenosis With a Paclitaxel-Eluting, Polymer-Free Coronary StentCirculation, 2004
- A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery DiseaseNew England Journal of Medicine, 2004
- Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary ArteryNew England Journal of Medicine, 2003
- Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS)The Lancet, 2003
- Randomized Study to Assess the Effectiveness of Slow- and Moderate-Release Polymer-Based Paclitaxel-Eluting Stents for Coronary Artery LesionsCirculation, 2003
- A Paclitaxel-Eluting Stent for the Prevention of Coronary RestenosisNew England Journal of Medicine, 2003
- TAXUS ICirculation, 2003
- Randomized comparison of success and adverse event rates and cost effectiveness of one long versus two short stents for treatment of long coronary narrowingsThe American Journal of Cardiology, 2002
- A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary RevascularizationNew England Journal of Medicine, 2002