Key Points:
- In this sub analysis of the EARLY TAVR trial, the authors aim to evaluate outcomes among all patients who underwent transcatheter aortic valve replacement (TAVR), regardless of whether they were randomized to receive early TAVR versus clinical surveillance.
- Patients who underwent delayed AVR had higher rates of periprocedural stroke (1.8% vs. 0.9%) and permanent pacemaker implantation (8.4% vs. 5.7%).
- There were significant differences in the rates of the primary outcome (death, stroke, and unplanned hospitalizations for cardiovascular causes) between the delayed AVR with acute valve syndrome vs. delayed TAVR with progressive valve syndrome vs. early TAVR group with a rate of 14.9% vs. 8.2% vs. 6.8% respectively (log rank: p=0.008).
Published in 2024, the EARLY TAVR trial was designed to evaluate whether there was a benefit for early intervention with transcatheter aortic valve replacement (TAVR) in patients with asymptomatic severe aortic stenosis and preserved left ventricular systolic function. In the trial, 901 patients across 75 centers in the United States and Canada were randomized to receive early TAVR versus ongoing clinical assessment. The authors found a reduction in the primary endpoint, the composite of death, stroke, and unplanned hospitalizations for cardiovascular causes, in the early TAVR group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; P<0.001). One limitation of the trial was in the high percentage of patients in the clinical surveillance group who ultimately underwent delayed TAVR. For this reason, in this sub analysis, the authors aimed to evaluate outcomes between patients undergoing early TAVR and those randomized to clinical surveillance who ultimately underwent delayed AVR.
Within the overall sample, 97.6% of patients (444/455) who were randomized to early TAVR underwent TAVR and 87.0% (388/446) of patients in the clinical surveillance group underwent delayed TAVR within five years. The median time to conversion to aortic valve replacement was 11.1 months. Compared to patients who were randomized to early TAVR, those that underwent delayed TAVR were younger (75.4 vs 76 years old) and had a worse 6-minute walk test (373.0 vs. 377 meters) and KCCQ score (92.5 vs. 92.9) with a higher NT-proBNP (299 vs. 273 pg/mL).
In terms of outcomes, patients who underwent delayed TAVR had higher rates of periprocedural stroke (1.8% vs. 0.9%) and permanent pacemaker implantation (8.4% vs. 5.7%). However, there was no significant difference in the primary outcome, the composite of death, stroke, and unplanned hospitalizations for cardiovascular causes, in the delayed TAVR group compared to the early TAVR group (hazard ratio: 0.65 [0.40, 1.05]; p = 0.08). After further dividing the delayed AVR group into those with an acute valve syndrome vs. those with a progressive valve syndrome, there was a significant difference between the three groups (early TAVR vs. delayed AVR with acute valve syndrome vs. delayed AVR with progressive valve syndrome) with the highest rate of the primary outcome in the delayed AVR with acute valve syndrome group (14.9%). This difference was driven by a higher rate of stroke in the patients with delayed AVR with an acute valve syndrome. Although this adds valuable context to the findings of the EARLY TAVR trial, since the groups no longer represent the randomized intention-to-treat sample, there is a potential for there to be confounding driving the observed differences. Future studies are necessary to further determine which patients will most benefit from early TAVR.