Women treated with second-generation zotarolimus-eluting resolute stents and everolimus-eluting xience V stents: insights from the gender-stratified, randomized, controlled TWENTE trial

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 pr...

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Published in:Catheterization and cardiovascular interventions 2013-09, Vol.82 (3), p.396-405
Main Authors: Tandjung, Kenneth, Basalus, Mounir W.Z., Sen, Hanim, Stoel, Martin G., van Houwelingen, K. Gert, Louwerenburg, J. (Hans) W., de Man, Frits H.A.F., Linssen, Gerard C.M., Saïd, Salah A.M., Kleijne, Miep A.W.J., van der Palen, Job, von Birgelen, Clemens
Format: Article
Language:English
Subjects:
Age Factors
Aged
Cardiovascular Agents - administration & dosage
Chi-Square Distribution
Comorbidity
Coronary Angiography
Coronary Artery Disease - diagnosis
Coronary Artery Disease - mortality
Coronary Artery Disease - therapy
drug-eluting stent(s)
Drug-Eluting Stents
Everolimus
Female
gender
Humans
Kaplan-Meier Estimate
Logistic Models
Male
Middle Aged
Myocardial Infarction - mortality
Netherlands
Odds Ratio
percutaneous coronary intervention
Percutaneous Coronary Intervention - adverse effects
Percutaneous Coronary Intervention - instrumentation
Percutaneous Coronary Intervention - mortality
Prospective Studies
Prosthesis Design
Resolute
Risk Factors
Sex Factors
Sirolimus - administration & dosage
Sirolimus - analogs & derivatives
Time Factors
Treatment Outcome
women
Xience V
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Summary: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 
ISSN:1522-1946
1522-726X
DOI:10.1002/ccd.24848