Premium
Women treated with second‐generation zotarolimus‐eluting resolute stents and everolimus‐eluting xience V stents: insights from the gender‐stratified, randomized, controlled TWENTE trial
Author(s) -
Tandjung Kenneth,
Basalus Mounir W.Z.,
Sen Hanim,
Stoel Martin G.,
Houwelingen K. Gert,
Louwerenburg J. Hans W.,
Man Frits H.A.F.,
Linssen Gerard C.M.,
Saïd Salah A.M.,
Kleijne Miep A.W.J.,
Palen Job,
Birgelen Clemens
Publication year - 2013
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.24848
Subject(s) - medicine , clinical endpoint , confidence interval , randomized controlled trial , odds ratio , myocardial infarction , stent , randomization , zotarolimus , cardiology , surgery , drug eluting stent , percutaneous coronary intervention
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. © 2013 Wiley Periodicals, Inc.