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

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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.

Original languageEnglish
Pages (from-to)396-405
JournalCatheterization and cardiovascular interventions
Volume82
Issue number3
DOIs
Publication statusPublished - 2013

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Keywords

  • METIS-297399
  • IR-87080
  • Drug-eluting stent(s)
  • Gender
  • Xience V
  • Resolute
  • Women
  • Percutaneous Coronary Intervention (PCI)

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