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; Robert Gabor Kiss; Bela Merkely; Zenon Huczek; Bo Eric Beuthner; Ralph Hein-Rothweiler; Monika Baylacher; Konstantinos Rizas; Steffen Massberg; Daniel Aradi; Dirk Sibbing; Claudius Jacobshagen

doi:10.1055/s-0039-1692441

Thrombosis and Haemostasis, Table of Contents

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‡^*

¹Department of Cardiology, LMU München, Munich, Germany

,

Danny Kupka‡^*

¹Department of Cardiology, LMU München, Munich, Germany

,

Dietmar Trenk

²University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany

,

Tobias Geisler

³Department of Cardiology, University Hospital of Tuebingen, Tübingen, Germany

,

Martin Hadamitzky

⁴Department of Radiology, German Heart Center of Munich, Munich, Germany

,

Anja Löw

¹Department of Cardiology, LMU München, Munich, Germany

,

Martin Orban

¹Department of Cardiology, LMU München, Munich, Germany

,

Kurt Huber

⁵Wilhelminen Hospital, 3rd Medical Department for Cardiology and Emergency Medicine, and Sigmund Freud University, Medical School, Vienna, Austria

,

Robert Gabor Kiss

⁶Department of Cardiology, Military Hospital, Budapest, Hungary

,

Bela Merkely

⁷Heart and Vascular Centre, Semmelweis University, Budapest, Hungary

,

Zenon Huczek

⁸1st Department of Cardiology, Medical University of Warsaw, Warsaw, Poland

,

Bo Eric Beuthner

⁹Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany

,

Ralph Hein-Rothweiler

¹Department of Cardiology, LMU München, Munich, Germany

,

Monika Baylacher

¹Department of Cardiology, LMU München, Munich, Germany

,

Konstantinos Rizas

¹Department of Cardiology, LMU München, Munich, Germany

,

Steffen Massberg

¹Department of Cardiology, LMU München, Munich, Germany

¹⁰DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany

,

Daniel Aradi

¹¹Heart Centre Balatonfüred and Heart and Vascular Centre, Semmelweis University, Budapest, Hungary

,

Dirk Sibbing^*

¹Department of Cardiology, LMU München, Munich, Germany

¹⁰DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany

,

Claudius Jacobshagen^*

⁹Department of Cardiology and Pneumology, University Medical Center Göttingen (UMG), Göttingen, Germany

› Author Affiliations

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.

Keywords

acute coronary syndrome - gender - platelets - thrombosis - bleeding

Full Text

References

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