Transcatheter or Surgical Aortic-Valve Replacement in Low-Risk Patients at 7 Years.

Background

Five-year data from the PARTNER 3 trial showed that among low-risk patients with severe, symptomatic aortic stenosis, outcomes were similar among patients who had undergone transcatheter aortic-valve replacement (TAVR) and those who had undergone surgical aortic-valve replacement. Longer-term assessments of clinical outcomes and valve durability are needed.

Methods

Patients were randomly assigned in a 1:1 ratio to undergo transfemoral TAVR or surgery. The first primary end point was a nonhierarchical composite of death, stroke, or rehospitalization related to the procedure, the valve, or heart failure. The second primary end point was a hierarchical composite of death, disabling stroke, nondisabling stroke, and the number of rehospitalization days related to the procedure, the valve, or heart failure, analyzed with the use of a win ratio analysis. Clinical, echocardiographic, valve-durability, and health-status end points were assessed through 7 years.

Results

A total of 1000 patients underwent randomization. In the analysis of the first primary end point, the Kaplan-Meier estimate of the incidence of an end-point event was 34.6% with TAVR and 37.2% with surgery (difference, -2.6 percentage points; 95% confidence interval [CI], -9.0 to 3.7). The win ratio for the second primary end point was 1.04 (95% CI, 0.84 to 1.30). In the TAVR and surgery groups, respectively, the Kaplan-Meier estimates for the incidence of components of the first primary end point were as follows: death, 19.5% and 16.8%; stroke, 8.5% and 8.1%; and rehospitalization, 20.6% and 23.5%. The mean (±SD) aortic-valve gradients assessed by echocardiography at 7 years were 13.1±8.5 mm Hg after TAVR and 12.1±6.3 mm Hg after surgery. The percentage of bioprosthetic valves that failed was 6.9% in the TAVR group and 7.5% in the surgery group. Patient-reported outcomes were similar in the two groups.

Conclusions

Among low-risk patients with severe, symptomatic aortic stenosis, no significant differences with respect to two primary composite end points involving death, stroke, and rehospitalization were observed at 7 years between those who had undergone TAVR and those who had undergone surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).