Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials

Fadi J. Sawaya, Marie Claude Morice, Marco Spaziano, Roxana Mehran, Romain Didier, Andrew Roy, Marco Valgimigli, Hyo Soo Kim, Kyung Woo Park, Myeong Ki Hong, Byeong Keuk Kim, Yangsoo Jang, Fausto Feres, Alexandre Abizaid, Ricardo A. Costa, Antonio Colombo, Alaide Chieffo, Gennaro Giustino, Gregg W. Stone, Deepak L. BhattTullio Palmerini, Martine Gilard

Research output: Contribution to journalArticle

Abstract

Background: Whether the efficacy and safety of dual antiplatelet therapy (DAPT) are uniform between sexes is unclear. We sought to compare clinical outcomes between short- (≤6 months) versus long-term (≥1 year) DAPT after drug-eluting stent (DES) placement in women and men. Methods and Results: We pooled individual patient data from 6 randomized trials of DAPT (EXCELLENT, OPTIMIZE, PRODIGY, RESET, SECURITY, ITALIC PLUS). The primary outcome was 1-year risk of major adverse cardiac events (MACE). The main secondary outcome was 1-year risk of any bleeding. Out of the 11,473 randomized patients included in the pooled dataset, 3,454 (30%) were females. At 1-year follow-up, women had higher risk of MACE (3.6% vs. 2.8%; P=0.01) but similar risk of bleeding (1.9% vs. 1.6%; P=0.16) as compared with men. Compared with long-term DAPT, short-term DAPT was associated with similar rates of MACE in both women (HR 0.88; 95% CI 0.62-1.25) and men (HR 1.25; 95% CI 0.95-1.6; P interaction=0.08)]. At 1-year follow-up, short-term DAPT was associated with lower rates of bleeding as compared with long-term DAPT in both women (HR 0.84; 95% CI 0.51-1.37) and men (HR 0.58; 95% CI 0.40-0.84; P-interaction=0.25). The presence of MVD was associated with higher MACE rates in the short-term DAPT group in women (HR: 1.16; CI 0.60-2.23) and men (HR: 2.29; CI 1.22-4.29; P interaction=0.25). Conclusions: Short-term DAPT is associated with similar rates of MACE but lower risk of bleeding when as compared with prolonged DAPT. There was no significant difference between sexes in the population studied.

Original languageEnglish
JournalCatheterization and Cardiovascular Interventions
DOIs
Publication statusAccepted/In press - 2016

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Keywords

  • Drug-eluting stents
  • Dual antiplatelet therapy duration
  • Major adverse cardiac events
  • Women

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Sawaya, F. J., Morice, M. C., Spaziano, M., Mehran, R., Didier, R., Roy, A., Valgimigli, M., Kim, H. S., Woo Park, K., Hong, M. K., Kim, B. K., Jang, Y., Feres, F., Abizaid, A., Costa, R. A., Colombo, A., Chieffo, A., Giustino, G., Stone, G. W., ... Gilard, M. (Accepted/In press). Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men: A sex-specific patient-level pooled-analysis of six randomized trials. Catheterization and Cardiovascular Interventions. https://doi.org/10.1002/ccd.26653