5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis

The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at two years. In this new publication, the authors report the five-year outcomes of the Evolut Low Risk trial. In this trial, low-risk patients with severe aortic stenosis were randomly assigned to TAVR or surgery. The primary endpoint was a composite of all-cause mortality or disabling stroke. Secondary endpoints included clinical, echocardiographic, and quality-of-life outcomes through five years.  A total of 1,414 patients underwent attempted valve implantation (n = 730 for TAVR, n = 684 for surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35 percent of the patients. At five years, the Kaplan-Meier estimate for the primary endpoint of all-cause mortality or disabling stroke was 15.5 percent for the TAVR group and 16.4 percent for the surgery group (P = 0.47). The Kaplan-Meier estimates in the TAVR and surgery groups for all-cause mortality were 13.5 percent and 14.9 percent (P = 0.39) and for disabling stroke were 3.6 percent and 4.0 percent (P = 0.57). Cardiovascular mortality was 7.2 percent in the TAVR group and 9.3 percent in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8 percent and 6.2 percent in the surgery group (P = 0.73). A site-level vital status sweep was performed for patients who were lost to follow-up or withdrew from the study. With the addition of these patients, the all-cause mortality rate at five years for patients undergoing TAVR was 14.7 percent, and for surgery, it was 15.2 percent (P = 0.74). Over five years, the valve reintervention rate was 3.3 percent for TAVR and 2.5 percent for surgery (P = 0.44). A sustained improvement in quality of life was observed in both treatment arms, with a mean Kansas City Cardiomyopathy Questionnaire summary score of 88.3 plus or minus 15.8 in TAVR and 88.5 plus or minus 15.8 in surgery.