Key result
Bioresorbable scaffold implantation performed since 2015 was associated with a lower 24-month MACE rate (10.52% vs 12.67%) compared to earlier procedures, suggesting a learning curve effect.
Why the study?
The study investigated predictors of scaffold failure and the potential impact of an optimized implantation technique via a learning curve on long-term clinical outcomes after bioresorbable scaffold implantation.
Does an optimized scaffold implantation technique and operator experience improve clinical outcomes and reduce scaffold failure in patients undergoing bioresorbable scaffold implantation?
Observational (n=3,326)
Yes
Does an optimized scaffold implantation technique and operator experience improve clinical outcomes and reduce scaffold failure in patients undergoing bioresorbable scaffold implantation?
Optimized implantation techniques and increased operator experience over time are associated with lower rates of scaffold thrombosis and target lesion revascularization following bioresorbable scaffold implantation.
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.
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Boeder et al. (2021) conducted an observational in Patients undergoing bioresorbable scaffold implantation (n=3,326). Bioresorbable scaffold implantation since 2015 vs. Bioresorbable scaffold implantation before 2015 was evaluated on Major adverse cardiac events (composite of death, target vessel revascularization, and myocardial infarction). Bioresorbable scaffold implantation performed since 2015 was associated with a lower 24-month MACE rate (10.52% vs 12.67%) compared to earlier procedures, suggesting a learning curve effect.
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