Serious adverse events in clinical trials with TAVR and SAVR

Abstract

The expansion of the transcatheter aortic valve replacement (TAVR) indication towards patients with intermediate surgical risk (Ref. Society of Thoracic Surgeons, STS, score) was analyzed. The aim was to investigate if the complication rates particularly with respect to TAVR and surgical aortic valve replacement (SAVR) concerning patients with intermediate risk are comparable. An analysis of serious adverse events (SAEs) and complication rates in clinical trials with TAVR and SAVR of these patients in comparison with high surgical risk patients was performed with the scientific literature and in the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) database (2012-2017). In several studies for intermediate-risk TAVR patients the published data showed that some complication rates (e. g. mortality) are comparable or better than for intermediate-risk SAVR patients. The analysis of the BfArM database in study1 (TAVR) resulted in alower all-cause mortality for intermediate-risk patients (0.9% at 30days and 7.3% at 1year post-procedure) than concerning high-risk patients (5.2% at 30days and 15.7% at 1year post-procedure). In study1 the cardiovascular mortality was altogether 11.5% at 4years post-procedure (9.2% for intermediate and 13.4% for high-risk patients), in study2 (patients with high-risk) at 4years it was 15.5% in the TAVR group with slightly lower cardiovascular mortality for SAVR patients with 14.8%. In the analysis TAVR interventions have favorable incidences concerning mortality (all-cause and cardiovascular) for intermediate-risk patients. Recently, atranscatheter aortic heart valve with this expanded risk indication received a CE label for the first time in Europe; however, the results of larger clinical studies are relevant for the evaluation (e. g. long-term function over more than 5years) of TAVR valves for intermediate-risk patients.