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Three-Year Outcomes After Bifurcation Stenting With Zotarolimus-Eluting Stents: Final Results From the RESOLUTE ONYX Postapproval Study. | LitMetric

AI Article Synopsis

  • * A total of 205 patients participated, with a 1-year target-vessel failure (TVF) rate of 7.4%, significantly below the performance goal set at 24.5%, and a 3-year TVF rate of 12.1%.
  • * The findings indicate that using a provisional stenting approach for bifurcation lesions with the Resolute Onyx ZES led to positive clinical outcomes, suggesting it

Article Abstract

Background: Bifurcation represents a challenging lesion subset for percutaneous coronary intervention.

Methods: In this prospective study of the Resolute Onyx zotarolimus-eluting stent (ZES), patients with a single bifurcation target lesion who underwent planned treatment using a provisional stenting technique were enrolled at 25 centers in the United States and Europe. The primary end point was target-vessel failure (TVF) at 1 year, and follow-up was performed through 3 years.

Results: A total of 205 patients were enrolled. Mean age was 66.6 ± 10.7 years, 21.5% of patients were female, and diabetes mellitus was present in 30.2%. A provisional approach with a single stent was performed in 96.6% of patients. The rate of TVF at 1 year was 7.4%, fulfilling the prespecified performance criterion (upper 1-sided 95% CI of 11.1%, compared with the performance goal of 24.5%). At 3-year follow-up, the rate of TVF was 12.1%, the rate of clinically driven target-lesion revascularization was 6.0%, and there were no episodes of stent thrombosis related to the target lesion. Event rates were consistent among the cohort of patients with angiographic core laboratory-confirmed bifurcation lesions.

Conclusions: In this prospective, multicenter study, bifurcation lesion treatment with Resolute Onyx ZES using a planned provisional stent approach was associated with favorable clinical outcomes through 3 years. These results support the longer-term safety and effectiveness of Resolute Onyx ZES to treat bifurcation lesions that are amenable to a planned provisional stenting technique.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11308709PMC
http://dx.doi.org/10.1016/j.jscai.2023.101116DOI Listing

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