Outcomes of Early vs Delayed Aortic Valve Replacement Analysis of the EARLY TAVR Valve Implant Population

BACKGROUND: For patients with asymptomatic, severe aortic stenosis (AS), the EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) trial demonstrated that early transcatheter aortic valve replacement (TAVR) was superior to clinical surveillance (CS) with respect to the primary endpoint in the intention-to-treat population. OBJECTIVES: The aim of this study was to compare postprocedural outcomes in the valve implant population. METHODS: The valve implant population comprised patients randomized to early TAVR who underwent the procedure and those randomized to CS who underwent delayed aortic valve replacement (AVR). The impact of the clinical presentation at time of delayed AVR was also assessed as progressive valve syndrome (eg, NYHA functional class II) vs acute valve syndrome (AVS; eg, NYHA functional class III or IV, syncope). The primary outcome was the composite of death, stroke, or heart failure hospitalization 2 years postprocedure. RESULTS: Across 75 sites, 97.6% of early TAVR patients (444 of 455) underwent the index procedure, and 87.0% of CS patients (388 of 446) underwent delayed AVR through 5 years; 39.2% presented with AVS and 58.5% with progressive valve syndrome (median time to delayed AVR 11.1 months). Early TAVR demonstrated a benefit compared with delayed AVR for the primary composite (adjusted HR [aHR]: 0.61; 95% CI: 0.38-0.99; P = 0.045). When examined by clinical presentation, delayed AVR with AVS was significantly associated with worse outcomes compared with early TAVR (aHR: 2.12; 95% CI: 1.19-3.78; P = 0.01), driven largely by stroke (aHR: 2.92; 95% CI: 1.26-6.76; P = 0.01). CONCLUSIONS: Among patients with asymptomatic, severe AS, delayed AVR with AVS is associated with higher rates of death, stroke, or heart failure hospitalization compared with early TAVR, highlighting a benefit for early TAVR before symptoms develop given the unpredictability of AS progression. (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis [EARLY TAVR]; NCT03042104).