REPRISE III Trial Compares Mechanical- Versus Self-Expanding TAVR Devices
March 5, 2019—Two-year outcomes from the REPRISE III randomized clinical trial were published online by Michael J. Reardon, MD, et al in Journal of the American Medical Association (JAMA): Cardiology.
The large, randomized REPRISE III trial compares the mechanically expanded Lotus transcatheter aortic valve replacement (TAVR) platform (Boston Scientific Corporation) and self-expanding CoreValve TAVR system (Medtronic).
The 2-year findings demonstrated that all-cause mortality rates and mortality or disabling stroke were similar between Lotus and CoreValve. Disabling stroke, functional class, valve migration, and paravalvular leaks (PVLs) favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm, concluded the investigators.
The investigators reported in JAMA: Cardiology, a total of 912 patients with high/extreme-risk and severe, symptomatic aortic stenosis were enrolled in the trial between September 22, 2014, and December 24, 2015. The mean (standard deviation [SD]) age was 82.8 (7.3) years, 465 (51%) were women, and the mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 6.8% (4%).
The patients were randomized 2:1 to receive Lotus (607 [66.6%]) or CoreValve (305 [33.4%]) at 55 centers in North America, Europe, and Australia.
The first 2-year visit occurred in October 2016 and the last was conducted in April 2018. Clinical and echocardiographic assessments are complete through 2 years and will continue annually through 5 years.
Investigators reported main outcomes were all-cause mortality and all-cause mortality or disabling stroke at 2 years. Other clinical factors evaluated were overall stroke, disabling stroke, repeated procedures, rehospitalization, valve thrombosis, and pacemaker implantation. The echocardiographic analyses included effective orifice area, mean gradient, and PVLs.
As summarized in JAMA: Cardiology, the 2-years results for Lotus versus CoreValve, respectively, include the following:
- All-cause death, 21.3% versus 22.5% (hazard ratio [HR], 0.94; 95% confidence interval [CI], 0.69–1.26; P = .67)
- All-cause mortality or disabling stroke, 22.8% versus 27% (HR, 0.81; 95% CI, 0.61–1.07; P = .14)
- Overall stroke, 8.4% versus 11.4% (HR, 0.75; 95% CI, 0.48–1.17; P = .21)
- Disabling stroke, 4.7% versus 8.6% (HR, 0.53; 95% CI, 0.31–0.93; P = .02)
- Received new permanent pacemaker, 41.7% versus 26.1% (HR, 1.87; 95% CI, 1.41–2.49; P < .01)
- Valve thrombosis, 3% vs 0.0% (P < .01)
- Received repeat procedure, 0.6% vs 2.9% (HR, 0.19; 95% CI, 0.05–0.70; P < .01)
- Valve migration, 0.0% vs 0.7% (P = .05)
- Embolization, 0.0% vs 2.0% (P < .01)
Valve areas remained significantly larger and the mean gradient was lower with CoreValve than Lotus (valve area, mean [SD]: Lotus, 1.53 [0.49] cm2 vs CoreValve, 1.76 [0.51] cm2; P < .01; valve gradient, mean [SD]: Lotus, 13 [6.7] mm Hg vs CoreValve, 8.1 [3.7] mm Hg; P < .01); moderate or greater PVL, 0.3% versus 3.8% (P < .01).
Finally, larger improvements in New York Heart Association (NYHA) functional class were observed with Lotus compared with CoreValve:
- ≥ 1 NYHA classes: 338 (84.1%) of 402 vs 143 (75.7%) of 189; P = .01
- ≥ 2 NYHA classes: 122 (37.3%) of 402 vs 65 (21.3%) of 305