TOPLINE:
Female patients at high bleeding risk (HBR) who undergo a stent implantation and receive abbreviated dual antiplatelet therapy (DAPT) don't have a higher risk for bleeding or ischemic events than male patients, despite more high-risk characteristics at baseline, results of a new study suggested.
METHODOLOGY:
- The study was a subgroup analysis of the 4579 patients enrolled in the multicenter open-label Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial; 69.3% were male with a mean age of 76 years.
- Patients randomized to abbreviated treatment discontinued DAPT (aspirin and a platelet ADP P2Y12 receptor inhibitor) at 1 month and continued on single antiplatelet therapy (SAPT) for ≥ 6 months, except those receiving oral anticoagulation (OAC) therapy; those randomized to standard treatment continued DAPT for ≥ 2 months (except those receiving OAC) and then continued to receive SAPT for 11 months.
- Outcomes included net adverse clinical events (NACEs), a composite of death due to any cause, myocardial infarction (MI), stroke, or major bleeding; major adverse cardiac or cerebral events (MACCEs), the composite of death due to any cause, MI, or stroke; and major or clinically relevant nonmajor bleeding (MCB), a composite of Bleeding Academic Research Consortium type 2, 3, or 5. Researchers assessed outcomes separately for male and female patients.
TAKEAWAY:
- Women were older; had higher prevalence of arterial hypertension, chronic kidney disease, and hematological or coagulation disorders; and were more likely treated with corticosteroids or nonsteroidal anti-inflammatory drugs than men.
- At 12 months, NACEs (unadjusted hazard ratio [HR], 1.02; 95% CI, 0.82-1.28; P = .83), MACCEs (unadjusted HR, 0.96; 95% CI, 0.75-1.25; P = .78), and MCB (unadjusted HR, 0.98; 95% CI, 0.78-1.23; P = .86) did not differ significantly between men and women.
- After multivariable adjustment for baseline confounders, risk for NACEs, MACCEs, and MCB remained similar between the sexes.
- There was no evidence of heterogeneity for NACEs and MCB across sexes, while abbreviated DAPT was associated with a nominal 1% increase in MACCE rates in men and more than 2% decrease in MACCE rates in women, although this should be interpreted with caution, said the authors.
IN PRACTICE:
"Our findings suggest for the first time that abbreviated DAPT should be considered for women with HBR in particular because they derive not only bleeding benefit, similarly to men, but also no discernible incremental ischemic risk compared with standard DAPT," the authors wrote.
SOURCE:
The study was conducted by Antonio Landi, MD, Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland, and colleagues. It was published online on November 22, 2023, in JAMA Cardiology.
LIMITATIONS:
Results are not generalizable to patients with a complicated 30-day course after percutaneous coronary intervention (PCI). That the study had a smaller proportion of women suggests a cautious interpretation of results is needed. Given the lack of correction for multiplicity, results remain exploratory and hypothesis generating. The type of SAPT varied in the abbreviated DAPT group, with a higher use of ticagrelor monotherapy in women than in men. Results may not apply to patients who receive other stent types.
DISCLOSURES:
The MASTER DAPT study was sponsored by the European Cardiovascular Research Institute, a nonprofit organization, and received grant support from Terumo Corporation; this sub-study did not receive funding. Landi has no relevant conflicts of interest; see paper for disclosures of other authors.
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