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

被引:7
作者
Tandjung, Kenneth [1 ]
Basalus, Mounir W. Z. [1 ]
Sen, Hanim [1 ]
Stoel, Martin G. [1 ]
van Houwelingen, K. Gert [1 ]
Louwerenburg, J. W. [1 ]
de Man, Frits H. A. F. [1 ]
Linssen, Gerard C. M. [2 ]
Said, Salah A. M. [3 ]
Kleijne, Miep A. W. J. [4 ]
van der Palen, Job [5 ,6 ]
von Birgelen, Clemens [1 ,7 ]
机构
[1] Thoraxctr Twente, Dept Cardiol, Med Spectrum Twente, NL-7513 ER Enschede, Netherlands
[2] Ziekenhuisgrp Twente, Dept Cardiol, Almelo, Netherlands
[3] Ziekenhuisgrp Twente, Dept Cardiol, Hengelo, Netherlands
[4] Streekziekenhuis Koningin Beatrix, Dept Cardiol, Winterswijk, Netherlands
[5] Med Spectrum Twente, Dept Epidemiol, Enschede, Netherlands
[6] Univ Twente, Dept Res Methodol Measurement & Data Anal, NL-7500 AE Enschede, Netherlands
[7] Univ Twente, MIRA, Dept Hlth Technol & Serv Res, NL-7500 AE Enschede, Netherlands
关键词
drug-eluting stent(s); gender; Xience V; Resolute; women; percutaneous coronary intervention; PERCUTANEOUS CORONARY INTERVENTION; ARTERY-DISEASE; CARDIOVASCULAR-DISEASE; CLINICAL-TRIALS; NATIONAL-HEART; TERM OUTCOMES; SPIRIT III; BARE-METAL; PACLITAXEL; SEX;
D O I
10.1002/ccd.24848
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 TWENTEa prospective, randomized, comparative DES trialreal-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. (c) 2013 Wiley Periodicals, Inc.
引用
收藏
页码:396 / 405
页数:10
相关论文
共 37 条
[21]   Comparison of Everolimus- and Paclitaxel-Eluting Stents in Patients With Acute and Stable Coronary Syndromes Pooled Results From the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials [J].
Planer, David ;
Smits, Pieter C. ;
Kereiakes, Dean J. ;
Kedhi, Elvin ;
Fahy, Martin ;
Xu, Ke ;
Serruys, Patrick W. ;
Stone, Gregg W. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (10) :1104-1115
[22]   Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR) [J].
Kim, Yongcheol ;
Oh, Sung Sik ;
Jeong, Myung Ho ;
Ahn, Youngkeun ;
Kim, Ju Han ;
Hong, Young Joon ;
Sim, Doo Sun ;
Kim, Min Chul ;
Kim, Hyo-Soo ;
Yun, Kyeong Ho ;
Oh, Seok Kyu ;
Kim, Chong Jin ;
Cho, Myeong Chan .
CARDIOLOGY JOURNAL, 2019, 26 (05) :469-476
[23]   Gender-Based Evaluation of the XIENCE V™ Everolimus-Eluting Coronary Stent System: Clinical and Angiographic Results from the SPIRIT III Randomized Trial [J].
Lansky, Alexandra J. ;
Ng, Vivian G. ;
Mutlu, Halil ;
Cristea, Ecaterina ;
Guiran, Julian Benetato ;
Midei, Mark ;
Newman, William ;
Sanz, Mark ;
Sood, Poornima ;
Doostzadeh, Julie ;
Su, Xiaolu ;
White, Roseann ;
Cao, Sherry ;
Sudhir, Krishnankutty ;
Stone, Gregg W. .
CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2009, 74 (05) :719-727
[24]   Clinical Impact of Second-Generation Everolimus-Eluting Stent Compared With First-Generation Drug-Eluting Stents in Diabetes Mellitus Patients Insights From a Nationwide Coronary Intervention Register [J].
Kedhi, Elvin ;
Gomes, Marc E. ;
Lagerqvist, Bo ;
Smith, J. Gustav ;
Omerovic, Elmir ;
James, Stefan ;
Harnek, Jan ;
Olivecrona, Goran K. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2012, 5 (11) :1141-1149
[25]   Stent Thrombosis and Dual Antiplatelet Therapy Interruption With Everolimus-Eluting Stents Insights From the Xience V Coronary Stent System Trials [J].
Genereux, Philippe ;
Rutledge, David R. ;
Palmerini, Tullio ;
Caixeta, Adriano ;
Kedhi, Elvin ;
Hermiller, James B. ;
Wang, Jin ;
Krucoff, Mitchell W. ;
Jones-McMeans, Jennifer ;
Sudhir, Krishnankutty ;
Simonton, Charles A. ;
Serruys, Patrick W. ;
Stone, Gregg W. .
CIRCULATION-CARDIOVASCULAR INTERVENTIONS, 2015, 8 (05)
[26]   Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials [J].
Claessen, Bimmer E. ;
Smits, Pieter C. ;
Kereiakes, Dean J. ;
Parise, Helen ;
Fahy, Martin ;
Kedhi, Elvin ;
Serruys, Patrick W. ;
Lansky, Alexandra J. ;
Cristea, Ecaterina ;
Sudhir, Krishnankutty ;
Sood, Poornima ;
Simonton, Charles A. ;
Stone, Gregg W. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2011, 4 (11) :1209-1215
[27]   Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable -Polymer Everolimus-Eluting Stents for Coronary Revascularization 3-Year Outcomes From the Randomized BIOFLOW V Trial [J].
Kandzari, David E. ;
Koolen, Jacques J. ;
Doros, Gheorghe ;
Garcia-Garcia, Hector M. ;
Bennett, Johan ;
Roguin, Ariel ;
Gharib, Elie G. ;
Cutlip, Donald E. ;
Waksman, Ron .
JACC-CARDIOVASCULAR INTERVENTIONS, 2020, 13 (11) :1343-1353
[28]   Outcomes in Diabetic and Nondiabetic Patients Treated With Everolimus- or Paclitaxel-Eluting Stents Results From the SPIRIT IV Clinical Trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) [J].
Kereiakes, Dean J. ;
Cutlip, Donald E. ;
Applegate, Robert J. ;
Wang, John ;
Yaqub, Manejeh ;
Sood, Poornima ;
Su, Xiaolu ;
Su, Guoping ;
Farhat, Naim ;
Rizvi, Ali ;
Simonton, Charles A. ;
Sudhir, Krishnankutty ;
Stone, Gregg W. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2010, 56 (25) :2084-2089
[29]   Second-Generation Everolimus-Eluting Stents Versus First-Generation Sirolimus-Eluting Stents in Acute Myocardial Infarction 1-Year Results of the Randomized XAMI (XienceV Stent vs. Cypher Stent in Primary PCI for Acute Myocardial Infarction) Trial [J].
Hofma, Sjoerd H. ;
Brouwer, Jan ;
Velders, Matthijs A. ;
van't Hof, Arnoud W. J. ;
Smits, Pieter C. ;
Quere, Michel ;
de Vries, Cornelis Jan ;
van Boven, Adrianus J. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2012, 60 (05) :381-387
[30]   5-Year Results of a Randomized Comparison of XIENCE V Everolimus-Eluting and TAXUS Paclitaxel-Eluting Stents Final Results From the SPIRIT III Trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) [J].
Gada, Hemal ;
Kirtane, Ajay J. ;
Newman, William ;
Sanz, Mark ;
Hermiller, James B. ;
Mahaffey, Kenneth W. ;
Cutlip, Donald E. ;
Sudhir, Krishnankutty ;
Hou, Liming ;
Koo, Kai ;
Stone, Gregg W. .
JACC-CARDIOVASCULAR INTERVENTIONS, 2013, 6 (12) :1263-1266