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Sex-Based Outcomes in Patients With High Bleeding Risk After PCI With 1-Month DAPT: Results From the Onyx ONE Clear
Roxana Mehran1, Birgit Vogel1, David E Kandzari2
1Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York.
Summary
This study found that women and men with high bleeding risk (HBR) treated with Resolute Onyx stents and short dual antiplatelet therapy (DAPT) had similar low rates of cardiac events and bleeding at two years.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Clinical Trials
Background:
- The Onyx ONE Clear study showed positive 1-year outcomes for Resolute Onyx zotarolimus-eluting stents (ZES) in high bleeding risk (HBR) patients on 1-month dual antiplatelet therapy (DAPT).
- Sex-based differences in outcomes after early DAPT discontinuation in HBR patients remain underexplored.
Purpose of the Study:
- To compare 2-year ischemic and bleeding outcomes by sex in HBR patients treated with Resolute Onyx ZES and abbreviated DAPT.
- To evaluate the safety and efficacy of early DAPT cessation in diverse patient populations.
Main Methods:
- A prespecified subgroup analysis of the Onyx ONE Clear study.
- Included patients with ≥1 HBR criterion treated with Resolute Onyx ZES, event-free at 30 days.
- Compared 2-year composite of cardiac death/myocardial infarction (CD/MI), all-cause mortality, other ischemic events, and Bleeding Academic Research Consortium (BARC) bleeding by sex.
Main Results:
- Among 1507 patients (32.2% women), women were older and more likely to have acute coronary syndrome.
- No significant sex differences in 2-year CD/MI (10.6% women vs. 12.6% men) or other ischemic events.
- Women had lower all-cause mortality (10.1% vs. 14.6%, P=.018), which was not significant after adjustment. Sex did not predict BARC 3-5 bleeding.
Conclusions:
- HBR patients treated with Resolute Onyx ZES and 1-month DAPT experienced low 2-year rates of CD/MI and bleeding, with no significant sex-based disparities.
- These findings support the use of abbreviated DAPT in both women and men with HBR undergoing ZES implantation.
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