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One-Month Dual Antiplatelet Therapy in High Bleeding Risk Asian Patients Undergoing Percutaneous Coronary
Jeehoon Kang1, Abdul Kahar Abdul Ghapar2, Kamaraj Selvaraj2
1Seoul National University Hospital Seoul Republic of Korea.
Insights
One-month dual antiplatelet therapy (DAPT) in high bleeding risk patients undergoing percutaneous coronary intervention (PCI) showed similar ischemic outcomes for Asian and non-Asian individuals. Asian patients experienced significantly fewer bleeding events after PCI with Resolute Onyx stents.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Dual antiplatelet therapy (DAPT) duration is critical for patients undergoing percutaneous coronary intervention (PCI).
- High bleeding risk (HBR) patients require careful management of antiplatelet therapy.
- Asian populations may have distinct ischemia and bleeding risk profiles.
Purpose of the Study:
- To compare clinical outcomes between Asian and non-Asian patients receiving 1-month DAPT after PCI with Resolute Onyx zotarolimus-eluting stents (ZES).
- To evaluate the safety and efficacy of a shortened DAPT strategy in diverse ethnic groups.
Main Methods:
- Prospective, multicenter Onyx ONE Clear study (NCT03647475) included HBR patients treated with Resolute Onyx ZES.
- 1,507 patients received 1-month DAPT, transitioning to single antiplatelet therapy if event-free.
- 1:1 propensity score matching compared outcomes between Asian (18%) and non-Asian patients from 1 month to 2 years.
Main Results:
- No significant differences in ischemic outcomes (cardiac death or myocardial infarction) between matched Asian and non-Asian cohorts (12% vs. 12%; P>0.99).
- Significantly fewer Bleeding Academic Research Consortium types 3-5 bleeding events observed in Asian patients compared to non-Asian patients (4% vs. 9%; P=0.007).
- Baseline clinical complexity differences between groups were minimized after propensity score matching.
Conclusions:
- One-month DAPT is safe and effective for HBR patients undergoing PCI with Resolute Onyx ZES, irrespective of ethnicity.
- Asian patients experienced similar ischemic event rates but lower bleeding rates compared to non-Asian patients.
- These findings support individualized DAPT strategies considering ethnic risk profiles.
Background:
One-month dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with the Resolute OnyxTM zotarolimus-eluting stents (ZES) is safe and effective. Asian patients have a unique ischemia/bleeding risk profile. Here, we compare the outcomes between Asian and non-Asian patients after PCI and 1-month DAPT.
Methods And Results:
Onyx ONE Clear was a prospective, multicenter study enrolling HBR patients undergoing PCI with the Resolute Onyx ZES (ClinicalTrials.gov identifier NCT03647475). Event-free patients after 1-month DAPT transitioned to single antiplatelet therapy. Clinical outcomes between 1 month and 2 years were compared between patients from Asian and non-Asian countries after 1 : 1 propensity score matching accounting for baseline differences. Patients from Asian countries represented 18% (n=273) of the study group (n=1,507). Non-Asian patients had greater clinical complexity; however, these differences were minimal after matching. There were no significant differences in ischemic outcomes between matched cohorts from 1 month to 2 years, including the primary composite endpoint of cardiac death or myocardial infarction (12% vs. 12%; P>0.99). However, there were significantly fewer Bleeding Academic Research Consortium types 3-5 bleeding events in the Asian vs. non-Asian cohort (4% vs. 9%; P=0.007), despite similar bleeding risk profiles after matching.
Conclusions:
After propensity score matching, HBR patients from Asian countries undergoing PCI treated with 1-month DAPT had similar ischemic outcomes but fewer bleeding events between 1 month and 2 years compared with patients from non-Asian countries.
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