B-16 | The RESOLUTE ONYX Bifurcation Study: 3-Year Outcomes in Patients With Coronary Bifurcation Lesions

Abstract

Coronary bifurcation lesions are challenging to treat, with higher risk of procedural complications and adverse events than non-bifurcation lesions. In this study, we evaluated the 3-year clinical outcomes in patients with bifurcation lesions treated with the Resolute Onyx zotarolimus-eluting stent (ZES). Patients with a single bifurcation target lesion undergoing planned treatment using the provisional stenting technique were enrolled at 25 centers in the United States and Europe. Inclusion criteria included main branch reference vessel diameter (RVD) 2.25-5.0 mm, lesion length ≤35 mm, stenosis ≥50%, side branch ≥2.0 mm, and TIMI flow ≥2. The primary endpoint was target vessel failure (TVF) at 1-year. Follow-up was for 3 years. Between Apr 2017 to Dec 2019, 205 patients with 209 bifurcation lesions (of 267 total) were enrolled. Patients were 66.6 ± 10.7yrs, 21.5% female, 26.3% type II diabetic, 35.1% had previous PCI. Core lab analysis showed that 32.5% of lesions were true bifurcation lesions per Medina classification (1.1.1, 1.0.1, 0.1.1). Target vessel RVD was 2.65 ± 0.47 mm and lesion length was 17.03 ± 9.64 mm. 12.1% of patients had TVF through 3 years. There were no instances of stent thrombosis (Figure). Patients with coronary bifurcation lesions treated with the Resolute Onyx ZES had favorable long-term clinical outcomes at 3 years, with only 6% of target lesion revascularization and no cases of stent thrombosis. These results support the use of Resolute Onyx ZES to treat complex coronary bifurcation lesions using a planned provisional stenting technique, safely and effectively.