The REPRISE III trial was a multi-center, randomized controlled trial that compared a mechanically expanded Lotus (Boston Scientific) vs. self-expanding CoreValve (Medtronic) TAVR valve for the treatment of symptomatic severe aortic stenosis in high-risk surgical patients. This was the first large scale randomized controlled trial comparing two different TAVR valve platforms. A total of 912 patients were randomized in a 2:1 manner to Lotus or CoreValve at 55 centers in North America, Europe, and Australia. All-cause mortality and all-cause mortality or disabling stroke at 2-years were evaluated. The mean STS risk score was 6.8%. At 2-years, the all-cause mortality was not-significant with Lotus (21.3%) vs. CoreValve (22.5%). All-cause mortality or disabling stroke was similarly not significant 22.8% vs. 27.0%. Important differences in secondary end points included a permanent pacemaker implantation rate of 41.7% in Lotus vs. 26.1% for CoreValve (p<0.01) and a rate of moderate or greater peri-valvular leak of 0.3% with Lotus vs. 3.8% with CoreValve (p<0.01). Following publication of REPRISE III the Lotus valve received FDA approval for use in symptomatic severe aortic stenosis patients at high-surgical risk, brining a third TAVR valve platform to the US market for the first time.
REPRISE IV is an on-going nonrandomized trial evaluating the newest iteration of the Boston Scientific TAVR valve, Lotus Edge, for use in intermediate surgical risk patients with severe symptomatic aortic stenosis. Inclusion criteria includes an estimated operative mortality risk of ≥3% and <8% by determined by the STS risk score and heart-team assessment. An important sub-study of this trial will randomize patients with bicuspid aortic valve disease, the first randomized controlled TAVR trial to do so. Target enrollment is 896 patients which is estimated to be completed by June 2022.