Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD

Neurohormonal modulation and afterload reduction are essential for treating heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), therapy with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT). In this study, the authors sought to determine whether TAVR for moderate AS provides clinical benefits to patients with HFrEF in addition to GDMT.  
Patients were randomized to either TAVR or clinical surveillance with aortic valve replacement upon progression to severe AS. The primary end point was the hierarchical occurrence of: 1) all-cause death, 2) disabling stroke, 3) disease-related hospitalizations and heart failure equivalents, and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio. A total of 178 patients were randomized to TAVR (n = 89) or clinical surveillance (n = 89). The mean age was 77 years, 20.8 percent were female, and 55.6 percent were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months).  
A total of 38 (43 percent) patients in the clinical surveillance group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months post randomization. TAVR was associated with wins in 47.6 percent of pairs, compared with 36.6 percent in the clinical surveillance group, resulting in a win ratio of 1.31 (95 percent CI: 0.91-1.88; P = 0.14). At one year, TAVR significantly improved the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the clinical surveillance group (12.8 ± 21.9 points versus 3.2 ± 22.8 points; P = 0.018). The authors concluded that TAVR was not superior to AS clinical surveillance for the primary hierarchical composite end point in patients with moderate AS and HFrEF on GDMT.