EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2018
One-year clinical outcomes after unrestricted implantation of the Absorb bioresorbable scaffold (RAI registry).
СтатьяНазвание и аннотация: Перевод пока не подготовлен
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Ielasi Alfonso, Cortese Bernardo, Moscarella Elisabetta, Loi Bruno, Tarantini Giuseppe, Varricchio Attilio, Pisano Francesco, Durante Alessandro, Pasquetto Giampaolo, Colombo Alessandro, Tumminello Gabriele, Moretti Luciano, Calabrò Paolo, Mazzarotto Pietro, Tespili Maurizio, Orrego Pedro Silva, Corrado Donatella, Steffenino Giuseppe
Аннотация
AIMS: The aim of this study was to assess outcomes following Absorb bioresorbable scaffold (BVS) implantation in an unrestricted clinical practice according to an "on-label" versus "off-label" indication.
METHODS AND RESULTS: RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR.
CONCLUSIONS: Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.
METHODS AND RESULTS: RAI is a prospective registry, investigating BVS performance in different lesion subsets. No specific exclusion criteria were applied. Co-primary endpoints were target lesion revascularisation (TLR) and definite/probable scaffold thrombosis (ScT) at one year. A total of 1,505 patients (1,969 lesions) were enrolled. In 58% of patients, BVS was implanted in at least one off-label subset according to the manufacturer's instructions for use. Predilatation was performed in 98.5% of the cases, and post-dilatation in 96.8%. At one-year follow-up, TLR and ScT rates were 3.3% and 1.3%, respectively. TLR was significantly higher in the off-label group (4.0% vs. 2.2%, HR 1.8, 95% CI: 1.0-3.4; p=0.05) while a trend towards a higher ScT rate was observed in the off-label group (1.7% vs. 0.6%, HR 2.7, 95% CI: 0.9-8.2; p=0.06). At multivariate analysis, treatment of in-stent restenosis, chronic total occlusion and BVS diameter were independent predictors of TLR.
CONCLUSIONS: Our data from a real-world population suggest that BVS could be associated with acceptable one-year clinical outcomes when meticulously implanted. However, a higher rate of adverse events was observed when this device was used in off-label lesions.