Prevalence and Consequences of Guideline-Directed Indications for Aortic Valve Replacement in the EARLY TAVR Trial.

In 30 seconds

This analysis of the multicenter randomized EARLY TAVR trial examined how often patients with asymptomatic severe aortic stenosis had ACC/AHA Class II indications for aortic valve replacement (AVR), and whether these indications modified outcomes. Among 901 participants, 29.4% had at least one Class II indication at randomization. At median follow-up of 3.8 years, the primary composite of death, stroke, or heart failure hospitalization occurred more often in patients with a Class II indication than in those without a guideline recommendation (24.5% vs 14.5%; HR = 1.78; 95% CI: 1.30-2.44; P < 0.001). Early TAVR’s relative benefit was similar across groups.

Key findings

• Of 901 participants, 265 (29.4%) had at least one Class II AVR indication at randomization.
• The primary endpoint occurred in 24.5% with a Class II indication versus 14.5% with no recommendation (HR = 1.78; 95% CI: 1.30-2.44; P < 0.001).
• Early TAVR’s relative effect was similar with and without a Class II indication (HR = 0.62; 95% CI: 0.37-1.02 vs 0.61; 95% CI: 0.40-0.92; P interaction = 0.96).
• Patients with a Class II indication were more likely to have acute valve syndrome when converting from surveillance to AVR.

Why it matters

Class II indications identified a substantial subgroup with higher observed rates of death, stroke, or heart failure hospitalization, but did not appear to distinguish who benefited relatively from early TAVR. This helps contextualize guideline-based risk stratification in asymptomatic severe aortic stenosis and suggests that, within this trial population, the treatment effect was not confined to patients meeting Class II criteria.

What to keep in mind

This is a subgroup analysis within a randomized trial; the abstract does not report the precision of the treatment-effect estimates beyond the stated confidence intervals.