Men and women benefit equally from early aspirin withdrawal following PCI

A recent subgroup analysis of the TWILIGHT trial showed that while post-percutaneous coronary intervention (PCI) bleeding occurs more frequently in women; this is mostly attributable to baseline differences. Recurrent ischaemic events were similar between the sexes [1].

The TWILIGHT study (NCT02270242) was a double-blind, placebo-controlled study comparing the use of ticagrelor plus aspirin with the use of ticagrelor plus placebo (ticagrelor monotherapy) for 1 year in high-risk patients who had undergone PCI and had already completed 3 months of dual antiplatelet therapy. TWILIGHT demonstrated that ticagrelor monotherapy reduced the risk of bleeding compared with dual antiplatelet therapy.

Dr Birgit Vogel (Icahn School of Medicine, NY, USA) presented a pre-specified analysis that explored heterogeneity of outcomes between the sexes (23.9% women). The investigators stratified ischaemic and bleeding outcomes by sex among the 7,119 randomised participants. The 2 endpoints of this analysis were a primary bleeding event (defined as Bleeding Academic Research Consortium type 2, 3, or 5), and a primary ischaemic event (defined as a composite of death, myocardial infarction, or stroke) at 1 year after randomisation.

Women more frequently experienced the primary bleeding endpoint than men (6.8% vs 5.2%; HR 1.32; 95% CI 1.06–1.64; P=0.01). However, after multivariable adjustment, this increased risk was no longer significant (adjusted HR 1.20; 95% CI 0.95–1.52; P=0.12). The rate of ischaemic endpoints was similar between the sexes.

The clinical benefits of aspirin withdrawal following 3 months of dual antiplatelet therapy with ticagrelor were comparable between men and women. However, there was a hypothesis-generating trend for lower mortality with ticagrelor monotherapy in women, but not in men.

1. 
   
   1. Vogel B. Sex-Specific Outcomes in High-Risk Patients Receiving Ticagrelor with or without Aspirin After Percutaneous Coronary Intervention: Results from the TWILIGHT Study. ACC 2021 Scientific Session, 15–17 May.
   2. Vogel B, et al. JAMA Cardiol. 2021;May 15. DOI: 10.1001/jamacardio.2021.1720.

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Posted on 9 July, 202129 July, 2021