Women treated with second-generation zotarolimus-eluting resolute stents and everolimus-eluting xience V stents: insights from the gender-stratified, randomized, controlled TWENTE trial
Kenneth Tandjung, Mounir W Z Basalus, Hanim Sen, Martin G Stoel, K Gert van Houwelingen, J Hans W Louwerenburg, Frits H A F de Man, Gerard C M Linssen, Salah A M Saïd, Miep A W J Kleijne, Job van der Palen, Clemens von Birgelen, Kenneth Tandjung, Mounir W Z Basalus, Hanim Sen, Martin G Stoel, K Gert van Houwelingen, J Hans W Louwerenburg, Frits H A F de Man, Gerard C M Linssen, Salah A M Saïd, Miep A W J Kleijne, Job van der Palen, Clemens von Birgelen
Abstract
Background: Women are underrepresented in clinical research, and few data are available from randomized head-to-head comparisons of second-generation drug-eluting stents (DES) in female patients. Aim of this study was to assess safety and efficacy of two second-generation DES in women. In TWENTE-a prospective, randomized, comparative DES trial-"real-world" patients were stratified for gender before randomization for Resolute or Xience V stents.
Methods: Target vessel failure (TVF; cardiac death, target vessel-related myocardial infarction, and clinically indicated target vessel revascularization) after 1 year was the predefined endpoint.
Results: Among 1,391 patients, 382 (27.5%) women were randomized to Resolute (n = 192) and Xience V (n = 190). Baseline and procedural characteristics were similar for females in both study arms, except for smaller vessel and stent diameters in Resolute-treated lesions. After 1 year, TVF (8.9 vs. 8.4%; adjusted odds ratio [OR]: 0.95, 95% confidence interval [CI]: 0.41-2.20, P = 0.91) and a patient-oriented composite endpoint (13.0 vs. 12.1%, P = 0.79) did not differ significantly between women in both arms. Women were older than men (P < 0.01) and had more often diabetes mellitus (26.4 vs. 19.8%, P = 0.01) and hypertension (63.6 vs. 52.5%, P < 0.01), but there was no significant gender difference in TVF (adjusted OR: 1.18, 95% CI: 0.73-1.92, P = 0.50).
Conclusions: This gender-stratified TWENTE trial analysis resulted in no significant difference in safety and efficacy outcomes between Resolute- and Xience V-treated females.
Trial registration: ClinicalTrials.gov NCT01066650.
Keywords: Resolute; Xience V; drug-eluting stent(s); gender; percutaneous coronary intervention; women.
Copyright © 2013 Wiley Periodicals, Inc.
Source: PubMed