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

Matthew J. Price, Loukas Boutis, Ajay J. Kirtane, Stanley Chetcuti, Petra Poliačiková, Joseph Dens, Michael Attubato, Yale Wang, Patrick Hu, Douglas Spriggs, Joshua Krasnow, Yiannis Chatzizisis, Adel Aminian, Ronald Caputo, Alpesh Shah, Michelle Dauler, Sherif Ibrahim, Te Hsin Lung, Roxana Mehran

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Article number101116
JournalJournal of the Society for Cardiovascular Angiography and Interventions
Volume2
Issue number6
DOIs
StatePublished - 1 Nov 2023

Keywords

  • bifurcation
  • drug-eluting stent
  • percutaneous coronary intervention
  • zotarolimus

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