Stents (Bare-metal, Drug-eluting)
Two-Year Outcomes After PCI in High Bleeding Risk Asian Patients: The Onyx ONE Clear Study
Hyo-Soo Kim1, Jeehoon Kang1, Abd Kahar Abd Ghapar2, Kamaraj Selvaraj2, Seung-Ho Hur3, Frankie CC Tam4, Yangsoo Jang5, In-Ho Chae6, David E. Kandzari7, Ajay J. Kirtane8, Azeem Latib9, Elvin Kedhi10, Te-Hsin Lung11, So-Jeong You12, Stephan Windecker13, Gregg W. Stone14
Seoul National University Hospital, Korea (Republic of)1, Hospital Serdang, Malaysia2, Keimyung University Dongsan Medical Center, Korea (Republic of)3, Queen Mary Hospital, Hong Kong, China4, CHA Bundang Medical Center, Korea (Republic of)5, Seoul National University Bundang Hospital, Korea (Republic of)6, Piedmont Heart Institute, USA7, Columbia University Medical Center, USA8, Montefiore Medical Center, Italy9, Isala Zwolle, Netherlands10, Medtronic, USA11, Medtronic, Korea (Republic of)12, University Hospital of Bern, Switzerland13, Mount Sinai, Cardiovascular Research Foundation, USA14
Percutaneous coronary intervention (PCI) with the Resolute OnyxTM zotarolimus-eluting stents (ZES) with 1-month dual antiplatelet therapy (DAPT) has been demonstrated to be safe and effective in high bleeding risk (HBR) patients. Due to the unique ischemia/bleeding risk profile in Asians, the clinical outcomes in Asian patients with HBR after PCI and 1-month DAPT should be evaluated.
Onyx ONE Clear was a prospective, multicenter study that enrolled HBR patients receiving PCI with the Resolute Onyx ZES. Event-free patients after 1-month DAPT were transitioned to SAPT with either aspirin or clopidogrel at operator discretion. Clinical outcomes between 1 month and 2 years were compared between patients from Asia-Pacific countries (excluding Australia and New Zealand) and non-Asian countries after 1:1 propensity score matching to account for baseline differences.
Patients from Asian countries represented 18.1% (N=273) of the Onyx ONE Clear study group (N=1507). Asian patients were more likely to have anemia, renal failure, and greater lesion complexity compared to non-Asians (N=1234). Non-Asian patients had greater clinical complexity, with more co-morbidities, such as old age, hypertension, stroke, atrial fibrillation (AF) and a history of coronary artery disease. After 1:1 propensity score matching, differences between groups were reduced, although non-Asians still had a higher rate of AF. There were no significant differences in ischemic outcomes in the propensity matched patient cohorts between 1 month and 2 years post-PCI, including the primary composite endpoint of cardiac death or myocardial infarction (9.9% vs 10.4%, p=0.89). There were significantly fewer BARC 3-5 bleeding events in the Asian vs. non-Asian cohort (3.4% vs. 8.8%, p=0.011), despite similar high bleeding risk criteria after matching.
After propensity score matching to account for baseline differences, HBR patients from Asian countries receiving the Resolute Onyx ZES during 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.