Premium
Three‐year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry
Author(s) -
Lhermusier Thibault,
Carrie Didier,
Cayla Guillaume,
Fajadet Jean,
Sainsous Joel,
Elhadad Simon,
Tarragano Francois,
Chevalier Bernard,
Ranc Sylvain,
Curinier Corentin,
Le Breton Herve,
Koning Rene
Publication year - 2021
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.29369
Subject(s) - medicine , clinical endpoint , mace , percutaneous coronary intervention , myocardial infarction , population , thrombosis , surgery , revascularization , target lesion , clinical trial , cardiology , environmental health
Objectives The aim of this study was to determine the 3‐year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation. Background Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1‐year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long‐term follow‐up of patients treated with BVS are scarce. Methods All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3‐year scaffold thrombosis and target vessel revascularization (TVR). Results Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3‐year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS. Conclusions Although 3‐year mortality was low in this ACS population, device‐related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long‐term follow‐up.