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

AIMS: To compare 5‐year angiographic, optical coherence tomography (OCT), and clinical outcomes between patients treated with bioresorbable vascular scaffolds (BVS) and drug‐eluting stents (DES). METHODS: The 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. RESULTS: Five‐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. CONCLUSION: Five‐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.