Gender and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients: The TROPICAL-ACS gender substudy

Lisa Gross, Danny Kupka, Dietmar Trenk, Tobias Geisler, Martin Hadamitzky, Anja Löw, Martin Orban, Kurt Huber, R. Kiss, B. Merkely, Zenon Huczek, Bo Eric Beuthner, Ralph Hein-Rothweiler, Monika Baylacher, Konstantinos Rizas, Steffen Massberg, Daniel Aradi, Dirk Sibbing, Claudius Jacobshagen

Research output: Contribution to journalArticle

Abstract

Objectives This prespecified analysis of the TROPICAL-ACS trial aimed to assess the impact of gender on clinical outcomes and platelet reactivity (PR) following guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients. Background Guided de-escalation of DAPT was recently identified as an effective alternative treatment strategy in ACS. Methods We used Cox proportional hazards models and linear regression analysis to assess the interaction of gender with clinical endpoints and PR. Results In both male (n = 2,052) and female (n = 558) patients, the 1-year incidence of the primary endpoint did not differ in guided de-escalation versus control group patients (male: 7.0% vs. 9.0%; hazard ratio [HR], 0.78, 95% confidence interval [CI], 0.57-1.06, p = 0.11; female: 8.4% vs. 9.2%; HR, 0.92, 95% CI, 0.53-1.62, p = 0.76, p int = 0.60). The 1-year incidence of combined ischemic events (male: 2.5% vs. 3.3%; HR, 0.76, 95% CI, 0.46-1.26, p = 0.29; female: 2.2% vs. 2.8%; HR, 0.78,95% CI, 0.27-2.25, p = 0.65, p int = 0.96) as well as Bleeding Academic Research Consortium ≥ 2 bleeding (male: 4.6% vs. 6.0%; HR, 0.77, 95% CI, 0.52-1.12, p = 0.17; female: 6.2% vs. 6.4%; HR, 0.99, 95% CI, 0.51-1.92, p = 0.97, p int = 0.51) was similar in the guided de-escalation versus control group for both male and female patients. Interaction testing revealed no significant impact of gender on PR levels (prasugrel or clopidogrel) across treatment groups (p int = 0.72). Conclusion Guided de-escalation of DAPT appears to be equally safe and effective in women and men. Especially in patients with increased bleeding risk and independent from gender, a guided DAPT de-escalation strategy may be used as an alternative treatment strategy.

Original languageEnglish
Pages (from-to)1527-1538
Number of pages12
JournalThrombosis and Haemostasis
Volume119
Issue number9
DOIs
Publication statusPublished - Jan 1 2019

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Acute Coronary Syndrome
Confidence Intervals
Blood Platelets
clopidogrel
Hemorrhage
Therapeutics
Control Groups
Incidence
Proportional Hazards Models
Linear Models
Regression Analysis
Research

Keywords

  • acute coronary syndrome
  • bleeding
  • gender
  • platelets
  • thrombosis

ASJC Scopus subject areas

  • Hematology

Cite this

Gender and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients : The TROPICAL-ACS gender substudy. / Gross, Lisa; Kupka, Danny; Trenk, Dietmar; Geisler, Tobias; Hadamitzky, Martin; Löw, Anja; Orban, Martin; Huber, Kurt; Kiss, R.; Merkely, B.; Huczek, Zenon; Beuthner, Bo Eric; Hein-Rothweiler, Ralph; Baylacher, Monika; Rizas, Konstantinos; Massberg, Steffen; Aradi, Daniel; Sibbing, Dirk; Jacobshagen, Claudius.

In: Thrombosis and Haemostasis, Vol. 119, No. 9, 01.01.2019, p. 1527-1538.

Research output: Contribution to journalArticle

Gross, L, Kupka, D, Trenk, D, Geisler, T, Hadamitzky, M, Löw, A, Orban, M, Huber, K, Kiss, R, Merkely, B, Huczek, Z, Beuthner, BE, Hein-Rothweiler, R, Baylacher, M, Rizas, K, Massberg, S, Aradi, D, Sibbing, D & Jacobshagen, C 2019, 'Gender and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients: The TROPICAL-ACS gender substudy', Thrombosis and Haemostasis, vol. 119, no. 9, pp. 1527-1538. https://doi.org/10.1055/s-0039-1692441
Gross, Lisa ; Kupka, Danny ; Trenk, Dietmar ; Geisler, Tobias ; Hadamitzky, Martin ; Löw, Anja ; Orban, Martin ; Huber, Kurt ; Kiss, R. ; Merkely, B. ; Huczek, Zenon ; Beuthner, Bo Eric ; Hein-Rothweiler, Ralph ; Baylacher, Monika ; Rizas, Konstantinos ; Massberg, Steffen ; Aradi, Daniel ; Sibbing, Dirk ; Jacobshagen, Claudius. / Gender and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients : The TROPICAL-ACS gender substudy. In: Thrombosis and Haemostasis. 2019 ; Vol. 119, No. 9. pp. 1527-1538.
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abstract = "Objectives This prespecified analysis of the TROPICAL-ACS trial aimed to assess the impact of gender on clinical outcomes and platelet reactivity (PR) following guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients. Background Guided de-escalation of DAPT was recently identified as an effective alternative treatment strategy in ACS. Methods We used Cox proportional hazards models and linear regression analysis to assess the interaction of gender with clinical endpoints and PR. Results In both male (n = 2,052) and female (n = 558) patients, the 1-year incidence of the primary endpoint did not differ in guided de-escalation versus control group patients (male: 7.0{\%} vs. 9.0{\%}; hazard ratio [HR], 0.78, 95{\%} confidence interval [CI], 0.57-1.06, p = 0.11; female: 8.4{\%} vs. 9.2{\%}; HR, 0.92, 95{\%} CI, 0.53-1.62, p = 0.76, p int = 0.60). The 1-year incidence of combined ischemic events (male: 2.5{\%} vs. 3.3{\%}; HR, 0.76, 95{\%} CI, 0.46-1.26, p = 0.29; female: 2.2{\%} vs. 2.8{\%}; HR, 0.78,95{\%} CI, 0.27-2.25, p = 0.65, p int = 0.96) as well as Bleeding Academic Research Consortium ≥ 2 bleeding (male: 4.6{\%} vs. 6.0{\%}; HR, 0.77, 95{\%} CI, 0.52-1.12, p = 0.17; female: 6.2{\%} vs. 6.4{\%}; HR, 0.99, 95{\%} CI, 0.51-1.92, p = 0.97, p int = 0.51) was similar in the guided de-escalation versus control group for both male and female patients. Interaction testing revealed no significant impact of gender on PR levels (prasugrel or clopidogrel) across treatment groups (p int = 0.72). Conclusion Guided de-escalation of DAPT appears to be equally safe and effective in women and men. Especially in patients with increased bleeding risk and independent from gender, a guided DAPT de-escalation strategy may be used as an alternative treatment strategy.",
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TY - JOUR

T1 - Gender and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients

T2 - The TROPICAL-ACS gender substudy

AU - Gross, Lisa

AU - Kupka, Danny

AU - Trenk, Dietmar

AU - Geisler, Tobias

AU - Hadamitzky, Martin

AU - Löw, Anja

AU - Orban, Martin

AU - Huber, Kurt

AU - Kiss, R.

AU - Merkely, B.

AU - Huczek, Zenon

AU - Beuthner, Bo Eric

AU - Hein-Rothweiler, Ralph

AU - Baylacher, Monika

AU - Rizas, Konstantinos

AU - Massberg, Steffen

AU - Aradi, Daniel

AU - Sibbing, Dirk

AU - Jacobshagen, Claudius

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objectives This prespecified analysis of the TROPICAL-ACS trial aimed to assess the impact of gender on clinical outcomes and platelet reactivity (PR) following guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients. Background Guided de-escalation of DAPT was recently identified as an effective alternative treatment strategy in ACS. Methods We used Cox proportional hazards models and linear regression analysis to assess the interaction of gender with clinical endpoints and PR. Results In both male (n = 2,052) and female (n = 558) patients, the 1-year incidence of the primary endpoint did not differ in guided de-escalation versus control group patients (male: 7.0% vs. 9.0%; hazard ratio [HR], 0.78, 95% confidence interval [CI], 0.57-1.06, p = 0.11; female: 8.4% vs. 9.2%; HR, 0.92, 95% CI, 0.53-1.62, p = 0.76, p int = 0.60). The 1-year incidence of combined ischemic events (male: 2.5% vs. 3.3%; HR, 0.76, 95% CI, 0.46-1.26, p = 0.29; female: 2.2% vs. 2.8%; HR, 0.78,95% CI, 0.27-2.25, p = 0.65, p int = 0.96) as well as Bleeding Academic Research Consortium ≥ 2 bleeding (male: 4.6% vs. 6.0%; HR, 0.77, 95% CI, 0.52-1.12, p = 0.17; female: 6.2% vs. 6.4%; HR, 0.99, 95% CI, 0.51-1.92, p = 0.97, p int = 0.51) was similar in the guided de-escalation versus control group for both male and female patients. Interaction testing revealed no significant impact of gender on PR levels (prasugrel or clopidogrel) across treatment groups (p int = 0.72). Conclusion Guided de-escalation of DAPT appears to be equally safe and effective in women and men. Especially in patients with increased bleeding risk and independent from gender, a guided DAPT de-escalation strategy may be used as an alternative treatment strategy.

AB - Objectives This prespecified analysis of the TROPICAL-ACS trial aimed to assess the impact of gender on clinical outcomes and platelet reactivity (PR) following guided de-escalation of dual antiplatelet treatment (DAPT) in acute coronary syndrome (ACS) patients. Background Guided de-escalation of DAPT was recently identified as an effective alternative treatment strategy in ACS. Methods We used Cox proportional hazards models and linear regression analysis to assess the interaction of gender with clinical endpoints and PR. Results In both male (n = 2,052) and female (n = 558) patients, the 1-year incidence of the primary endpoint did not differ in guided de-escalation versus control group patients (male: 7.0% vs. 9.0%; hazard ratio [HR], 0.78, 95% confidence interval [CI], 0.57-1.06, p = 0.11; female: 8.4% vs. 9.2%; HR, 0.92, 95% CI, 0.53-1.62, p = 0.76, p int = 0.60). The 1-year incidence of combined ischemic events (male: 2.5% vs. 3.3%; HR, 0.76, 95% CI, 0.46-1.26, p = 0.29; female: 2.2% vs. 2.8%; HR, 0.78,95% CI, 0.27-2.25, p = 0.65, p int = 0.96) as well as Bleeding Academic Research Consortium ≥ 2 bleeding (male: 4.6% vs. 6.0%; HR, 0.77, 95% CI, 0.52-1.12, p = 0.17; female: 6.2% vs. 6.4%; HR, 0.99, 95% CI, 0.51-1.92, p = 0.97, p int = 0.51) was similar in the guided de-escalation versus control group for both male and female patients. Interaction testing revealed no significant impact of gender on PR levels (prasugrel or clopidogrel) across treatment groups (p int = 0.72). Conclusion Guided de-escalation of DAPT appears to be equally safe and effective in women and men. Especially in patients with increased bleeding risk and independent from gender, a guided DAPT de-escalation strategy may be used as an alternative treatment strategy.

KW - acute coronary syndrome

KW - bleeding

KW - gender

KW - platelets

KW - thrombosis

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