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

6 Citations (Scopus)

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
Pages (from-to)178-189
Number of pages12
JournalCatheterization and Cardiovascular Interventions
Volume89
Issue number2
DOIs
StatePublished - 1 Feb 2017

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Drug-Eluting Stents
Hemorrhage
Therapeutics
Group Psychotherapy
Sex Characteristics
Safety

Keywords

  • drug-eluting stents
  • dual antiplatelet therapy duration
  • major adverse cardiac events
  • women

Cite this

Sawaya, Fadi J. ; Morice, Marie Claude ; Spaziano, Marco ; Mehran, Roxana ; Didier, Romain ; Roy, Andrew ; Valgimigli, Marco ; Kim, Hyo Soo ; Woo Park, Kyung ; Hong, Myeong Ki ; Kim, Byeong Keuk ; Jang, Yangsoo ; Feres, Fausto ; Abizaid, Alexandre ; Costa, Ricardo A. ; Colombo, Antonio ; Chieffo, Alaide ; Giustino, Gennaro ; Stone, Gregg W. ; Bhatt, Deepak L. ; Palmerini, Tullio ; Gilard, Martine. / 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. In: Catheterization and Cardiovascular Interventions. 2017 ; Vol. 89, No. 2. pp. 178-189.
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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.",
keywords = "drug-eluting stents, dual antiplatelet therapy duration, major adverse cardiac events, women",
author = "Sawaya, {Fadi J.} and Morice, {Marie Claude} and Marco Spaziano and Roxana Mehran and Romain Didier and Andrew Roy and Marco Valgimigli and Kim, {Hyo Soo} and {Woo Park}, Kyung and Hong, {Myeong Ki} and Kim, {Byeong Keuk} and Yangsoo Jang and Fausto Feres and Alexandre Abizaid and Costa, {Ricardo A.} and Antonio Colombo and Alaide Chieffo and Gennaro Giustino and Stone, {Gregg W.} and Bhatt, {Deepak L.} and Tullio Palmerini and Martine Gilard",
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language = "English",
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Sawaya, FJ, Morice, MC, Spaziano, M, Mehran, R, Didier, R, Roy, A, Valgimigli, M, Kim, HS, Woo Park, K, Hong, MK, Kim, BK, Jang, Y, Feres, F, Abizaid, A, Costa, RA, Colombo, A, Chieffo, A, Giustino, G, Stone, GW, Bhatt, DL, Palmerini, T & Gilard, M 2017, '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, vol. 89, no. 2, pp. 178-189. https://doi.org/10.1002/ccd.26653

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

In: Catheterization and Cardiovascular Interventions, Vol. 89, No. 2, 01.02.2017, p. 178-189.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Short-versus long-term Dual Antiplatelet therapy after drug-eluting stent implantation in women versus men

T2 - A sex-specific patient-level pooled-analysis of six randomized trials

AU - Sawaya, Fadi J.

AU - Morice, Marie Claude

AU - Spaziano, Marco

AU - Mehran, Roxana

AU - Didier, Romain

AU - Roy, Andrew

AU - Valgimigli, Marco

AU - Kim, Hyo Soo

AU - Woo Park, Kyung

AU - Hong, Myeong Ki

AU - Kim, Byeong Keuk

AU - Jang, Yangsoo

AU - Feres, Fausto

AU - Abizaid, Alexandre

AU - Costa, Ricardo A.

AU - Colombo, Antonio

AU - Chieffo, Alaide

AU - Giustino, Gennaro

AU - Stone, Gregg W.

AU - Bhatt, Deepak L.

AU - Palmerini, Tullio

AU - Gilard, Martine

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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.

AB - 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.

KW - drug-eluting stents

KW - dual antiplatelet therapy duration

KW - major adverse cardiac events

KW - women

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DO - 10.1002/ccd.26653

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