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

doi:10.1016/j.jscai.2023.101116

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

J Soc Cardiovasc Angiogr Interv. 2023 Aug 5;2(6Part A):101116. doi: 10.1016/j.jscai.2023.101116. eCollection 2023 Nov-Dec.

Authors

Matthew J Price¹, Loukas Boutis², Ajay J Kirtane³, Stanley Chetcuti⁴, Petra Poliačiková⁵, Joseph Dens⁶, Michael Attubato⁷, Yale Wang⁸, Patrick Hu⁹, Douglas Spriggs¹⁰, Joshua Krasnow¹¹, Yiannis Chatzizisis¹², Adel Aminian¹³, Ronald Caputo¹⁴, Alpesh Shah¹⁵, Michelle Dauler¹⁶, Sherif Ibrahim¹⁶, Te-Hsin Lung¹⁶, Roxana Mehran¹⁷

Affiliations

¹ Scripps Clinic, La Jolla, California.
² North Shore University Hospital, Manhasset, New York.
³ Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, New York, New York.
⁴ University of Michigan Health System, Ann Arbor, Michigan.
⁵ Stredoslovenský ústav srdcových a cievnych chorôb, Banská Bystrica, Slovakia.
⁶ Ziekenhuis Oost Limburg, Genk, Belgium.
⁷ NYU Langone Medical Center, New York, New York.
⁸ Abbott Northwestern, Minneapolis, Minnesota.
⁹ Riverside Community Hospital, Riverside, California.
¹⁰ Morton Plant Hospital, Clearwater, Florida.
¹¹ Huntsville Hospital, Huntsville, Alabama.
¹² Nebraska Medical Center, Omaha, Nebraska.
¹³ CHU Charleroi, Charleroi, Belgium.
¹⁴ St. Joseph's Hospital Health Center, Syracuse, New York.
¹⁵ Houston Methodist Hospital, Houston, Texas.
¹⁶ Medtronic, Santa Rosa, California.
¹⁷ The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.

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.

Keywords: bifurcation; drug-eluting stent; percutaneous coronary intervention; zotarolimus.