Five-year angiographic, OCT and clinical outcomes of a randomized comparison of everolimus and biolimus-eluting coronary stents with everolimus-eluting bioresorbable vascular scaffolds.

Abstract

AimsTo compare 5‐year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug‐eluting stents (DES).MethodsThe EverBio‐2 trial (Comparison of Everolimus‐ and Biolimus‐Eluting Coronary Stents with Everolimus‐Eluting Bioresorbable Vascular Scaffold) was a single‐center, assessor‐blinded, randomized controlled trial in which 240 patients were randomly allocated (1:1:1) to BVS, everolimus‐eluting (EES) or biolimus‐eluting (BES) DES. Clinical follow‐up was scheduled up to 5 years. All patients, alive and who did not have repeat revascularization of the target lesion during follow‐up were asked to return for angiographic follow‐up at 5 years.ResultsFive‐year angiographic follow‐up was completed in 122 patients (51%) and OCT analysis was performed in 86 (36%) patients. In‐stent late lumen loss was similar in both groups with 0.50 ± 0.38 mm in BVS versus 0.58 ± 0.36 mm in EES/BES, p = 0.20. Clinical follow‐up was complete in 232 patients (97%) at 5 years. The rate of the device‐oriented endpoint was 22% in the BVS and 18% in the EES/BES group (p = 0.49). The patient‐oriented composite endpoint occurred in 40% of BVS‐ and 43% of EES/BES‐treated patients (p = 0.72) at 5 years. No acute coronary syndrome due to stent thrombosis was detected after 2 years. Complete BVS strut resorption was observed at 5 years in the OCT subgroup.ConclusionFive‐year clinical outcomes were similar between BVS and DES patients as well as angiographic outcomes in a selected subgroup. However, a definitive conclusion cannot be drawn because the EverBio‐2 trial was not powered for clinical and angiographic endpoints at 5 years of follow‐up.