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Gender Data Forum: Safety and Efficacy of Drug-Eluting Stents in Women: An Individual Patient-Level Pooled Analysis of 26 Randomized Trials Including 11,557 Women

Presenter abstract
Discussant report
All the Scientific resources on ESC Congress 365


By Roxana Mehran
Other authors: Usman Baber USA; Giulio Stefanini Italy; Samantha Sartori USA; Gregg W. Stone USA; Martin B. Leon USA ; Giora Weisz USA; William Wijns Germany; Edoardo Camenzind Switzerland; Gabriel Philippe Steg France; Peter Smits The Netherlands; Clemens Von Birgelen The Netherlands; David Kandzari USA; Soren Galatius Denmark; Takeshi Kimura Japan; Ghada Mikhail UK; Hyo-Soo Kim Korea; Marco Valgimigli Italy; Adnan Kastrati Germany; Patrick Serruys The Netherlands; Marie-Claude Morice France; Dipti Itchhaporia USA; Rebecca Ortega USA; Laxmi Mehta USA; Alaide Chieffo Italy ; Stephan Windecker Germany

Drug-eluting stents (DES) have been shown effective and safe in patients with coronary artery disease in numerous randomized trials. However, data on women remains sparse as they comprise less than 30% of recruited patients. In response to the FDA guidance on sex difference evaluation in medical device clinical trials, we aimed to study the safety and efficacy of DES in women.

Individual patient-level data in female participants from 26 randomized DES trials (RAVEL, SIRIUS, E- and C-SIRIUS, TAXUS I II IV and V, SIRTAX, ENDEAVOR II III and IV, SPIRIT II III and IV, BASKET-PROVE, COMPARE I and II, EXCELLENT, RESET, RESOLUTE AC, TWENTE, LEADERS, ISAR-TEST 4, PRODIGY, and PROTECT) were pooled. Baseline characteristics and long-term clinical outcomes were evaluated and stratified according to stent type (i.e. bare-metal stents [BMS], early-generation [eDES], newer-generation [nDES]). Prespecified safety endpoints were all-cause death, myocardial infarction (MI), and definite or probable stent thrombosis (ST). The prespecified efficacy endpoint was target-lesion revascularization (TLR).

Of 43,904 patients recruited in 26 trials, 11,557 were women (26.3%) included in this analysis (mean age 67.1 ± 10.6 years). Diabetes was present in 31.2% of women, hypertension in 75.6%, hypercholesterolemia in 67.4%, and smoking in 26.6%. Clinical indication for revascularization was an acute coronary syndrome in 34.7% women, and multivessel disease was present in 28.8% women. 1,108 women (9.6%) received a BMS, 4,171 (36.1%) received an eDES, and 6,278 (54.3%) nDES. Mean follow-up was 2.9 ± 1.4 years. By 3 years, all-cause death occurred in 5.6%, MI in 3.9%, ST in 1.3%, and TLR in 7.7% of women. Rates of all-cause death, MI or ST among women receiving BMS, eDES, and nDES were 10.7%, 8.5% and 7.6%, respectively (P<0.001, Figure 1). A marked reduction in TLR rates (BMS 18.5%, eDES 7.6%, nDES 6.0%, P<0.001) was associated with eDES and nDES use.
Women comprise less than 30% of patients recruited in randomized trials examining the role of DES in patients with CAD. This largest patient-based pooled analysis shows that the use of DES in women is safe and effective as compared to BMS during long-term follow-up. Among women, nDES use was associated with improved safety outcomes as compared to eDES.

Discussant Report

Stuart J. Pocock
This comprehensive meta-analysis of individual patient data from 26 RCTs provides important evidence on the relative merits for women of bare-metal stents and both early- and newer-generation drug-eluting stents (DES). 
Such evidence specific for women is unique and robust, and leads to key findings: the increased risk of stent thrombosis with early DES no longer exists for newer DES.  Also the benefits of DES over BMS in reducing risks of TLR and also MI are significantly enhanced with newer-generation DES.

I wish to raise three key issues:

  1. to what extent do these conclusions apply to each specific newer DES versus each specific early DES?  That is, are we sure the conclusions are generic, or might there be important differences between newer DES’s in their efficacy and safety?
  2. are these findings in women any different from what happens in men?  It would be helpful if such gender comparisons were made available, rather than an exclusive focus on one gender.
  3. for each comparison (eg early vs newer DES) the methods used in this meta-analysis combine direct evidence from within each RCT along with more indirect evidence (eg via BMS comparisons) in the spirit of a network meta-analysis.  It would be helpful if the more reliable direct evidence were documented separately to see if it supports the overall findings.

In conclusion this study provides clear evidence that in women the use of newer-generation DES carries important benefits for both safety and efficacy.




Gender Data Forum: Safety and Efficacy of Drug-Eluting Stents in Women: An Individual Patient-Level Pooled Analysis of 26 Randomized Trials Including 11,557 Women

The content of this article reflects the personal opinion of the author/s and is not necessarily the official position of the European Society of Cardiology.