JACC Cardiovasc Interv. 2026 Nov 9;19(21):2876-2888. doi: 10.1016/j.jcin.2026.08.016.
ABSTRACT
BACKGROUND: The current American College of Cardiology/American Heart Association valvular heart disease guidelines were published before several recent trials that provide greater support for early intervention in patients with asymptomatic severe aortic stenosis (AS).
OBJECTIVES: This study sought to investigate the prevalence and clinical impact of American College of Cardiology/American Heart Association Class II recommendations for AVR in the EARLY TAVR trial.
METHODS: The EARLY TAVR trial randomized patients with asymptomatic severe AS to transfemoral transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve or clinical surveillance (CS) with conversion to TAVR based on development of ACC/AHA Class I indications. Patients in the intention-to-treat cohort were stratified by presence of a Class II indication for AVR at randomization. The primary endpoint of the present analysis was the composite of all-cause death, stroke, or heart failure hospitalization. Interaction tests were performed to assess whether the treatment effect differed by level of guideline recommendation. Timing of conversion to AVR in the CS group according to the presence/absence of Class II indications was also assessed.
RESULTS: Of the 901 patients randomized to TAVR (N = 445) and CS (N = 446), 636 (70.6%) patients had no guideline recommendation, and 265 (29.4%) had at least1 1 Class II recommendation for AVR at the time of randomization. At a median follow-up of 3.8 years, patients with a Class II indication for AVR experienced higher rates of the primary endpoint (Class II: 24.5% vs no recommendation: 14.5%; HR = 1.78; 95% CI: 1.30-2.44; P < 0.001) and were more likely to have acute valve syndrome at the time of conversion. Compared with CS, the relative benefit of early TAVR on the primary endpoint was similar regardless of the presence or absence of a Class II guideline recommendation (HR = 0.62; 95% CI: 0.37-1.02 vs 0.61; 95% CI: 0.40-0.92; Pinteraction = 0.96).
CONCLUSIONS: Among patients in the EARLY TAVR trial, Class II indications for AVR were present in almost one-third of patients at baseline. The benefit of early TAVR was consistent regardless of the presence or absence of Class II indications. These findings support the strategy of early TAVR over CS in asymptomatic patients with severe AS, independent of guideline indications.
CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT03042104; Unique Identifier: NCT03042104.
PMID:43003599 | DOI:10.1016/j.jcin.2026.08.016
