EuroPCR 2017: REPRISE III – No space for surgery in extreme risk aortic stenosis patients
Reported from EuroPCR 2017, Paris
The REPRISE III trial is the first head-to-head TAVR/TAVI trial comparing the Lotus Valve System (Boston Scientific) against the CoreValve first-generation and Evolut R valves (Medtronic) in extreme surgical risk aortic stenosis patients. REPRISE III was a global, randomised, prospective noninferiority trial with dual primary study endpoints of safety and effectiveness.
In a trial presentation rich in data, a number of important findings emerged. Firstly, the Lotus Valve system successfully met noninferiority against the competitor valve in terms of patient safety at 30 days and 1 year. Secondly, the Lotus Valve performed similarly well in terms of primary effectiveness, with a significantly lower rate of disabling stroke and paravalvular leak observed with the Lotus versus CoreValve system. However, these impressive findings were tempered somewhat by an almost twofold increased need for pacemaker implantation with the Lotus system. Furthermore, the inclusion of paravalvular leak as a component of the primary efficacy endpoint and the unexpectedly high stroke rate with the CoreValve system mark idiosyncrasies of the REPRISE III trial.
In summary, the treatment of choice for extreme surgical risk aortic stenosis patients is simple - TAVR / TAVIleads the way. However, the choice between Lotus and CoreValve systems appears less clear, with an apparent balance to be struck between rates of stroke, pacemaker implantation and paravalvular leak.