TY - JOUR
T1 - Women treated with second-generation zotarolimus-eluting resolute stents and everolimus-eluting xience V stents
T2 - insights from the gender-stratified, randomized, controlled TWENTE trial
AU - Tandjung, Kenneth
AU - Basalus, Mounir W.Z.
AU - Sen, Hanim
AU - Stoel, Martin G.
AU - van Houwelingen, K. Gert
AU - Louwerenburg, J. (Hans) W.
AU - de Man, Frits H.A.F.
AU - Linssen, Gerard C.M.
AU - Saïd, Salah A.M.
AU - Kleijne, Miep A.W.J.
AU - van der Palen, Job
AU - von Birgelen, Clemens
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
KW - METIS-297399
KW - IR-87080
KW - Drug-eluting stent(s)
KW - Gender
KW - Xience V
KW - Resolute
KW - Women
KW - Percutaneous Coronary Intervention (PCI)
U2 - 10.1002/ccd.24848
DO - 10.1002/ccd.24848
M3 - Article
VL - 82
SP - 396
EP - 405
JO - Catheterization and cardiovascular interventions
JF - Catheterization and cardiovascular interventions
SN - 1522-1946
IS - 3
ER -