Thromb Haemost 2019; 119(09): 1527-1538
DOI: 10.1055/s-0039-1692441
Atherosclerosis and Ischaemic Disease
Georg Thieme Verlag KG Stuttgart · New York

Gender and Outcomes following Guided De-Escalation of Antiplatelet Treatment in Acute Coronary Syndrome Patients: The TROPICAL-ACS Gender Substudy

Lisa Gross*
1  Department of Cardiology, LMU München, Munich, Germany
,
Danny Kupka*
1  Department of Cardiology, LMU München, Munich, Germany
,
Dietmar Trenk
2  University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany
,
Tobias Geisler
3  Department of Cardiology, University Hospital of Tuebingen, Tübingen, Germany
,
Martin Hadamitzky
4  Department of Radiology, German Heart Center of Munich, Munich, Germany
,
Anja Löw
1  Department of Cardiology, LMU München, Munich, Germany
,
Martin Orban
1  Department of Cardiology, LMU München, Munich, Germany
,
Kurt Huber
5  Wilhelminen Hospital, 3rd Medical Department for Cardiology and Emergency Medicine, and Sigmund Freud University, Medical School, Vienna, Austria
,
Robert Gabor Kiss
6  Department of Cardiology, Military Hospital, Budapest, Hungary
,
Bela Merkely
7  Heart and Vascular Centre, Semmelweis University, Budapest, Hungary
,
Zenon Huczek
8  1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland
,
Bo Eric Beuthner
9  Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany
,
Ralph Hein-Rothweiler
1  Department of Cardiology, LMU München, Munich, Germany
,
Monika Baylacher
1  Department of Cardiology, LMU München, Munich, Germany
,
Konstantinos Rizas
1  Department of Cardiology, LMU München, Munich, Germany
,
Steffen Massberg
1  Department of Cardiology, LMU München, Munich, Germany
10  DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
,
Daniel Aradi
11  Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University, Budapest, Hungary
,
Dirk Sibbing*
1  Department of Cardiology, LMU München, Munich, Germany
10  DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
,
Claudius Jacobshagen*
9  Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany
› Author Affiliations
Funding TROPICAL-ACS is an independent, investigator-initiated trial with an academic sponsor (Klinikum der Universität München). The trial was financially supported by a research grant from Roche Diagnostics (Rotkreuz, Switzerland) and a research grant from the German Centre for Cardiovascular Research (DZHK). Prasugrel purchase, drug delivery, and related logistics were kindly supported by Eli Lilly and Company and Daiichi Sankyo Company. Funders of this study had no role in study design, collection of data and data analysis, or writing of the manuscript.
Further Information

Publication History

03 March 2019

21 April 2019

Publication Date:
21 June 2019 (eFirst)

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.

Clinical Trial Registration URL: https//www.clinicaltrials.gov. Unique Identifier: NCT: 01959451.

* Both first authors and both senior authors contributed equally to this work.