Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients

Abstract

BACKGROUNDPrevious trials have shown that among high-risk patients with aortic stenosis, survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical aorticvalve replacement. We evaluated the two procedures in a randomized trial involving intermediate-risk patients. METHODSWe randomly assigned 2032 intermediate-risk patients with severe aortic stenosis, at 57 centers, to undergo either TAVR or surgical replacement. The primary end point was death from any cause or disabling stroke at 2 years. The primary hypothesis was that TAVR would not be inferior to surgical replacement. Before randomization, patients were entered into one of two cohorts on the basis of clinical and imaging findings; 76.3% of the patients were included in the transfemoral-access cohort and 23.7% in the transthoracic-access cohort. RESULTSThe rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group (P = 0.001 for noninferiority). At 2 years, the Kaplan-Meier event rates were 19.3% in the TAVR group and 21.1% in the surgery group (hazard ratio in the TAVR group, 0.89; 95% confidence interval [CI], 0.73 to 1.09; P = 0.25). In the transfemoralaccess cohort, TAVR resulted in a lower rate of death or disabling stroke than surgery (hazard ratio, 0.79; 95% CI, 0.62 to 1.00; P = 0.05), whereas in the transthoracic-access cohort, outcomes were similar in the two groups. TAVR resulted in larger aortic-valve areas than did surgery and also resulted in lower rates of acute kidney injury, severe bleeding, and new-onset atrial fibrillation; surgery resulted in fewer major vascular complications and less paravalvular aortic regurgitation. CONCLUSIONSIn intermediate-risk patients, TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313.) a bs tr ac t

Diagnosis and Management of Cardiovascular Disease in Advanced and End‐Stage Renal Disease

“…TAVR should be used as an alternative to SAVR in patients at high or intermediate risk for surgery 117, 118. The decision to proceed with TAVR or SAVR should be made in consultation with a cardiac surgeon and an interventional cardiologist (Figure 3).…”

Incidence of Long‐Term Structural Valve Dysfunction and Bioprosthetic Valve Failure After Transcatheter Aortic Valve Replacement

“…On the basis of the favorable outcomes of recent randomized clinical trials conducted in intermediate‐risk populations,2, 3 TAVR is progressively being offered to younger and lower‐risk patients. In this particular subset, life expectancy is expected to exceed that of initial candidates to TAVR (ie, elderly and very elderly patients at high or prohibitive surgical risk), which makes the question of long‐term prosthesis durability of crucial importance.…”

Predictors of Mortality and Symptomatic Outcome of Patients With Low‐Flow Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

“…LV ejection fraction (LV‐EF) has affected survival after surgical aortic valve replacement2, 3, 4 and has consequently been incorporated in statistical models for assessment of operative risk 5. Conversely, in transcatheter aortic valve replacement (TAVR), which has been a safe and effective treatment for patients at intermediate6 and high surgical risk,7 the relationship is less clear 8, 9, 10, 11, 12…”