Consistent benefit of early TAVR in asymptomatic severe aortic stenosis, irrespective of NT-proBNP or hs-cTnT
ACC.25 – In the biomarker analysis from EARLY TAVR, the benefit of an early TAVR strategy on clinical outcomes was consistent regardless of baseline NT-proBNP and hs-cTnT levels in patients with asymptomatic, severe aortic stenosis.
This summary is based on the presentation of Brian Lindman, MD (Nashville, TN, USA) at the ACC.25 Scientific Session - Cardiac Biomarkers In Patients With Asymptomatic Severe Aortic Stenosis: Primary Biomarker Analysis From The EARLY TAVR Trial.
Introduction and methods
The EARLY TAVR trial demonstrated that a strategy of early transcatheter aortic valve replacement (TAVR ) is superior to clinical surveillance in patients with asymptomatic, severe aortic stenosis (AS). It remains unknown whether patients with elevated biomarkers benefit the most from early TAVR compared to those with lower biomarker levels.
EARLY TAVR was a prospective, multicenter RCT in which patients with asymptomatic severe AS (aged ≥65 years) with an STS score ≤10% and LVEF ≥50% were randomized to transfemoral-TAVR (n=414) or clinical surveillance (n=384). In the biomarker analysis of EARLY TAVR, 798 patients with NT-proBNP and hs-cTnT measurements were included. The median follow-up period was 3.8 years.
The primary outcome was a composite of death, stroke or unplanned CV hospitalization. Key secondary outcomes were (1) a composite of death, stroke or HF hospitalization; (2) a composite of death, stroke, unplanned CV hospitalization or intervention with advanced signs or symptoms; and (3) HF hospitalization.
Main results
NT-proBNP and hs-cTnT tertiles
- Higher NT-proBNP levels were associated with a higher incidence of the primary and secondary outcomes. Similar findings were observed for hs-cTnT.
- The treatment effect of early TAVR versus CS on clinical outcomes was consisted across NT-proBNP tertiles and hs-cTNT tertiles (all P for interaction>0.05).
Elevated versus normal biomarkers
- There was no interaction of elevated versus normal NT-proBNP across all clinical outcomes (all P for interaction>0.05).
- The treatment effect of early TAVR on HF hospitalizations was modified by hs-cTnT (HR: 0.11; 95%CI: 0.03–0.38 for normal hs-cTnT; and HR:0.55; 95%CI: 0.26–1.19 for elevated hs-cTnT; P for interaction=0.03).
- When comparing ≤3-fold versus >3-fold elevated NT-proBNP, there was no interaction on the treatment effect of early TAVR compared with CS (all P for interaction>0.05).
Conclusion
This analysis of EARLY TAVR showed that higher biomarker levels at baseline were associated with higher event rates in patients with asymptomatic, severe AS. The benefit of early TAVR on clinical outcomes was consistent, regardless of baseline NT-proBNP and hs-cTnT levels. “Collectively, these findings suggest limited value for single measurements of NT-proBNP and hs-cTnT to guide the timing of TAVR in asymptomatic severe aortic stenosis patients,” said Brian Lindman.
- Our reporting is based on the information provided at the ACC.25 Scientific Session -