Key result
Different study types, including RCTs, registries, and real-world surveillance, are needed to strengthen evidence for TAVI in treating symptomatic severe aortic valve stenosis.
Why the study?
Randomised controlled trials have driven the shift from SAVR to TAVI for symptomatic severe AS, but other study types are needed to strengthen evidence and provide insights.
This review discusses the complementary roles of RCTs, registries, and real-world surveillance studies in building the evidence base for TAVI.
During the past decade, several important clinical trials have provided evidence supporting a paradigm shift from surgical aortic valve replacement (SAVR) towards transcatheter aortic valve implantation (TAVI) for the treatment of patients with symptomatic severe aortic valve stenosis (AS). Randomised controlled trials (RCTs) are the cornerstone of evidence-based medicine and have been the major driver of this paradigm shift. However, other study types such as international multicentre registries (both prospective and retrospective), post-market real-world surveillance studies, and head-to-head comparisons of different types of transcatheter heart valve (THV) are also needed in order to strengthen this evidence and provide insights ...
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Backer et al. (2020) conducted a review in symptomatic severe aortic valve stenosis. Transcatheter aortic valve implantation (TAVI) vs. Surgical aortic valve replacement (SAVR) was evaluated. Different study types, including RCTs, registries, and real-world surveillance, are needed to strengthen evidence for TAVI in treating symptomatic severe aortic valve stenosis.
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