Five-Year Outcomes Published for Medtronic's CoreValve TAVR System in High-Risk Patients
November 26, 2018—The 5-year outcomes from the randomized United States pivotal high-risk trial of the CoreValve transcatheter aortic valve replacement (TAVR) system (Medtronic) were published by Thomas G. Gleason, MD, et al in Journal of the American College of Cardiology (JACC; 2018;72:2687–2696).
The investigators reported midterm 5-year outcomes of safety, performance, and durability for TAVR compared with surgical aortic valve replacement (SAVR). At 1 year, the trial had demonstrated superior 1-year mortality of TAVR versus SAVR among patients at high operative mortality risk.
In the study, surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding CoreValve bioprosthesis or SAVR. Valve Academic Research Consortium I definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥ 40 mm Hg or a change in gradient ≥ 20 mm Hg or new severe aortic regurgitation.
As summarized in JACC, a total of 797 patients were randomized at 45 centers in the United States, with 750 patients undergoing an attempted implant (TAVR, 391; SAVR, 359). The overall mean age was 83 years, and the Society of Thoracic Surgeons score was 7.4%.
The investigators reported the following at 5 years for TAVR versus SAVR, respectively:
- All-cause mortality rate, 55.3% vs 55.4%
- Subgroup analysis showed no differences in mortality
- Major stroke rate, 12.3% vs 13.2%
- Mean aortic valve gradients, 7.1 ± 3.6 vs 10.9 ± 5.7 mm Hg
- No clinically significant valve thrombosis was observed
- Freedom from severe structural valve deterioration, 99.2% vs 98.3% (P = .32)
- Freedom from valve reintervention, 97% vs 98.9% (P = .04)
- Patients implanted with a permanent pacemaker, 33% vs 19.8%
This study shows similar midterm survival and stroke rates in high-risk patients following TAVR or SAVR; additionally, severe structural valve deterioration and valve reinterventions were uncommon, concluded the investigators in JACC.