Antithrombotic drugs for acute coronary syndromes in women: sex-adjusted treatment and female representation in randomised clinical trials. A clinical consensus statement of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the ESC Working Group on Thrombosis

Abstract

Thrombotic and bleeding risks differ between sexes, partly in relation to distinct biology and hormonal status, but also due to differences in age, comorbidities, and body size at presentation. Women experience frequent fluctuations of prothrombotic and bleeding status related to menstrual cycle, use of oral contraceptives, hormone replacement therapy, or menopause. Although clinical studies tend to underrepresent women, available data consistently support sex-specific differences in the baseline thrombotic and haemorrhagic risks. Compared with men, women feature an increased risk of in-hospital bleeding related to invasive procedures, as well as long-term out-of-hospital bleeding events. In addition, the inappropriate dosing of antithrombotic drugs, which is not adapted to body weight or renal function, is more frequently associated with an increased risk of bleeding in women compared to men. While acute coronary syndrome (ACS) studies support similar antithrombotic drug efficacy, irrespective of sex, women may receive delayed treatment due to bias in their referral, diagnosis, and invasive treatment decisions. The current clinical consensus statement highlights the need for an increased awareness of sex-specific risks and biases in ACS management, with a focus on sex-specific bleeding mitigation strategies, antithrombotic management in special conditions (e.g., myocardial infarction with non-obstructive coronary arteries), and barriers to female representation in cardiovascular trials. This manuscript aims to provide expert opinion, based on the best available evidence, and consensus statements on optimising antithrombotic therapy according to sex, which is critical to improve sex-based disparities in outcome.

Keywords: antithrombotic therapies; bleeding; coagulation; gender; haemostasis; platelets; sex; thrombosis.