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Two-Year Clinical Outcomes in Patients With Coronary Bifurcation Lesions: Results From the Onyx ONE Clear Study
Christopher Garnett1, David E Kandzari2, Azeem Latib3
1Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
Insights
High bleeding risk patients with bifurcation lesions can safely undergo abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI). This study found similar ischemic and bleeding events compared to those without bifurcation lesions.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Optimal dual antiplatelet therapy (DAPT) duration for high bleeding risk (HBR) patients post-percutaneous coronary intervention (PCI) is debated.
- Bifurcation lesions increase ischemic event risk, raising questions about abbreviated DAPT safety in HBR patients with these lesions.
Purpose of the Study:
- To evaluate ischemic and bleeding outcomes in HBR patients with and without bifurcation lesions undergoing PCI.
- To determine if abbreviated DAPT (1 month) is safe for HBR patients with bifurcation lesions.
Main Methods:
- Analysis of data from the Onyx ONE Clear study, including HBR patients treated with Resolute Onyx zotarolimus-eluting stents.
- Comparison of outcomes between HBR patients with and without bifurcation lesions, all receiving 1 month of DAPT post-event-free 1 month.
Main Results:
- 14.3% of 1507 HBR patients had bifurcation lesions, mostly treated with a provisional approach.
- No significant differences in composite cardiac death/myocardial infarction rates (12.2% vs 11.6%) between bifurcation and non-bifurcation lesion groups.
- Similar rates of BARC 3-5 bleeding events and other clinical/angiographic outcomes across both groups.
Conclusions:
- HBR patients with bifurcation lesions treated with Resolute Onyx stents and 1-month DAPT experienced comparable ischemic event rates to those without bifurcation lesions.
- Abbreviated DAPT appears safe in HBR patients with bifurcation lesions, even with increased lesion and procedural complexity.
Background:
The optimal duration of dual antiplatelet therapy (DAPT) for high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) can vary based on individual clinical and lesion characteristics. As bifurcation lesions are associated with a greater risk of ischemic events, it is unknown whether HBR patients with bifurcation lesions can be safely treated with abbreviated DAPT.
Methods:
We examined ischemic and bleeding outcomes in patients with and without bifurcation lesions who underwent PCI with the Resolute Onyx zotarolimus-eluting stent (Medtronic) from the Onyx ONE Clear study. HBR patients free of events through 1 month were prescribed 1 month of DAPT. Outcomes from 1 month to 2 years were analyzed among patients with HBR who underwent successful PCI for at least 1 bifurcation lesion followed by 1-month DAPT.
Results:
Of 1507 total HBR patients, 215 (14.3%) underwent PCI of a bifurcation lesion, with 86.6% treated with a provisional approach. Included patients had an average of 1.6 HBR criteria. Patients with bifurcation lesions treated had more stents implanted and longer total length of stents implanted. The composite of cardiac death or myocardial infarction was similar for patients with vs without bifurcation lesions (12.2% vs 11.6%, P = .92). There were no differences in any clinical or angiographic outcomes between groups, including BARC 3 to 5 bleeding events.
Conclusions:
In the Onyx ONE Clear study, HBR patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent and 1-month DAPT had comparable ischemic event rates at 2 years compared with patients without bifurcation lesions, despite greater lesion and procedural complexity.
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