Predictors of scaffold failure and impact of optimized scaffold implantation technique on outcome: Results from the German-Austrian ABSORB RegIstRy

Aims: We aimed to investigate predictors of scaffold failure and the potential impact of an optimized scaffold implantation technique by means of a learning curve on long-term clinical outcome after bioresorbable scaffold (BRS) implantation and to evaluate predictors of scaffold failure.

Methods and results: A total of 3326 patients were included in this prospective, observational, multi-center study (ClinicalTrials.gov NCT02066623) of consecutive patients undergoing BRS implantation between November 2013 and January 2016. The 3144 patients completed follow-up after 24 months, 3265 patients were eligible for time-to-event-analysis. Clinical endpoints were major adverse cardiac events-a composite endpoint of death, target vessel revascularization and myocardial infarction, and scaffold thrombosis (ScT). Patients were grouped according to treatment before or since 2015. During follow-up MACE rate improved from 2.52% after 30 days, 5.45% after 6 months and 12.67% after 24 months to 1.52%, 3.44%, and 10.52%, respectively. A total of 75 ScT occurred. In multiple regression analysis, treatment of bifurcations, long lesions, and procedures performed earlier than 2014 were identified as predictors for the occurrence of ScT.

Conclusion: Treatment of bifurcation lesions is the strongest predictor of ScT following BRS implantation. A significantly lower incidence of ScT and 24-month target lesion revascularization in patients recruited after 2014 into our observational registry suggests the influence of a learning curve.