The safety profile of bioresorbable scaffolds in comparison with drug-eluting stents in clinical trials

Background: Bioresorbable scaffolds (BRS) are a further option for the treatment of coronary stenosis apart from drug-eluting stents (DES). The primary expectation that BRS are able to reduce late stent thrombosis was not achieved by Absorb BRS. The study investigates the safety of BRS in comparison with DES in clinical trials. Methods: An analysis of the typical complication rates (TV-MI [“target vessel myocardial infarction”], TLF [“target lesion failure”], ST [“stent thrombosis”] etc.) of BRS and DES in clinical trials was performed by means of a search for the scientific literature (2010–18) and the Federal Institute for Drugs and Medical Devices (“Bundesinstitut für Arzneimittel und Medizinprodukte”, BfArM) database. Results: In some studies (e. g. Absorb II and III, AIDA) there were up to fourfold elevated incidences of ST concerning Absorb BRS compared with the Xience DES. The incidences of ST (e.g. DESolve NX, ST = 0% 5 years post-procedure) concerning other marketed BRS were more favorable. The evaluation of a BRS and DES study from the BfArM database showed lower TLR (“target lesion revascularization”) incidences (3.3% at 1 year and 4.8% at 5 years post-procedure) for study 1 (Non-Absorb study, study end 2017, only BRS) compared with patients implanted with DES (study 2, study end 2014, DES 1 TLR 3.9% at 1 year and 7.8% at 5 years post-procedure). In study 1 the TV-MI rate was 0.8% after 6 months, in comparison in study 2 the overall TV-MI rate was 3.9% 6 months post-procedure. Conclusion: The company Abbott Vascular ended the sale of Absorb and Absorb GT1 BRS in September 2017 in view of the elevated rates of side-effects (ST, TLF etc.) in the studies concerned. In ongoing Absorb studies the background of the elevated complication rates is being analyzed further. Other marketed BRS have proven favorable safety profiles in non-randomized clinical studies, although further long-term results of larger studies and registers for the assessment of new generation BRS remain to be seen. © 2018, Springer Medizin Verlag GmbH, ein Teil von Springer Nature.