Real-world low-risk patients undergoing TAVR have a greater risk of adverse events at one year, particularly mortality, when compared with published clinical trial data, according to a study published April 3 in Circulation.

Analyzing a total of 383,030 patients undergoing TAVR for severe aortic stenosis from January 2020 to March 2024 in the STS/ACC TVT Registry, Andrew M. Vekstein, MD, found 108,407 were deemed low risk by their care team and 68,194 met other study inclusion or exclusion criteria. Of these patients, 42,093 (38%) would have been considered eligible for low-risk trials. They examined 30-day and one-year outcomes, including mortality, stroke, new pacemaker and "alive and well," defined as alive at one year with a Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥60 and ≤10-point decrease from baseline.

In patients determined low risk by their care team, 0.8% died, 1.5% experienced a stroke and 8.4% required a new pacemaker at 30 days. At one year, 4.6% died, 2.6% experienced a stroke and 90% of patients were considered alive and well. Meanwhile, among patients identified as trial-eligible, 0.6% died, 1.4% experienced a stroke and 8% required a new pacemaker at 30 days, and by one year post procedure, 3.1% died, 2.4% experienced a stroke and 92% met the alive and well criteria.

The authors note that the mortality rate at one-year for trial-eligible patients (3.1%) was numerically higher than rates from the PARTNER 3 (1%) or Evolut Low Risk (1%) trials. "The greater divergence between real-world and trial data in terms of one-year mortality rates suggests that real-world trial-eligible patients were potentially sicker than trial low-risk patients despite identical STS Predicted Risk of Mortality scores," write the authors.

They highlight that in the real-world low-risk population they studied, patients had higher rates of atrial fibrillation and lower baseline KCCQ scores than the trial participants, which were both identified as predictors of one-year mortality. According to the authors, increased rates of adverse outcomes in the real-world trial-eligible group are "likely attributable to greater comorbidity…and previously identified factors, such as care fragmentation."