Stents liberadores de rapamicina sin polímero frente a stents liberadores de paclitaxel con polímero: un análisis de datos de pacientes procedentes de ensayos aleatorizados

Translated title of the contribution: Polymer-free sirolimus-eluting versus polymer-based paclitaxel-eluting stents: An individual patient data analysis of randomized trials

Salvatore Cassese, Steffen Desch, Adnan Kastrati, Robert A. Byrne, Lamin King, Tomohisa Tada, Bernward Lauer, Albert Schömig, Holger Thiele, Jürgen Pache

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Introduction and objectives The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents. Methods Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction. Results A total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0,53 [0,59] mm vs 0,46 [0,57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,72-1.89; P=.50), target lesion revascularization (relative risk=0,98; 95% confidence interval, 0,65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0,85-3.76; P=.12). Conclusions In this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.

Translated title of the contributionPolymer-free sirolimus-eluting versus polymer-based paclitaxel-eluting stents: An individual patient data analysis of randomized trials
Original languageSpanish
Pages (from-to)435-442
Number of pages8
JournalRevista Espanola de Cardiologia
Volume66
Issue number6
DOIs
StatePublished - Jun 2013

Keywords

  • Late lumen loss
  • Paclitaxel-eluting stent
  • Polymer
  • Sirolimus-eluting stent

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