Death after 1 year more common for real-world low-risk TAVR patients than those treated in clinical trials
Low-risk patients undergoing transcatheter aortic valve replacement (TAVR) in a real-world setting face a higher risk of mortality than those treated as part of a clinical trial, according to a new analysis published in Circulation.[1] Real-world low-risk patients were still associated with “excellent” outcomes, researchers noted, but it is important for cardiologists and patients alike to know as much as possible about the odds of survival following treatment.
“Despite the widespread adoption of TAVR among low-risk populations, concern remains about the risk of permanent pacemaker requirement and late stroke with TAVR in the low-risk population after midterm data from the low-risk TAVR trials were released,” wrote first author Andrew M. Vekstein, MD, a researcher with the division of cardiovascular and thoracic surgery at Duke University Medical Center, and colleagues. “In addition, little is known about the quality of TAVR in low-risk patients, despite real-world outcomes assessment being a foundational aspect of the cycle of therapeutic development and quality.”
Vekstein et al. explored the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve (TVT) Registry, tracking more than 100,000 real-world TAVR patients treated from January 2020 to March 2024.
Many real-world patients would not have been eligible for clinical trials
Just 62% of the patients included in this analysis would have been eligible for inclusion in the PARTNER 3 or Evolut Low-Risk clinical trials.
Those common reasons that real-world patients would have been excluded from clinical trials included STS Predicted Risk of Mortality scores greater than 4% and a history of previous myocardial infarction or percutaneous coronary intervention within one month.
Comparing STS/ACC TVT Registry data to major low-risk trials
The mortality, stroke and permanent pacemaker rates after one year among real-world low-risk patients were 4.6%, 2.6% and 8.4%, respectively. Among patients who would have been eligible for the PARTNER 3 or Evolut Low-Risk trials, meanwhile, the mortality, stroke and permanent pacemaker rates after one year were 3.1%, 2.4% and 8%, respectively.
One-year mortality was 1% for the PARTNER 3 and Evolut Low-Risk trials. The one-year stroke rate for those trials was 1.2% for PARTNER 3 and 4.1% for Evolut-Low Risk. The permanent pacemaker rates for those trials was 6.6% for PARTNER 3 and 17.4% for Evolut Low-Risk.
Real-world patients also presented with higher rates of atrial fibrillation and lower Kansas City Cardiomyopathy Questionnaire (KCCQ) scores than low-risk trial participants, further highlighting the differences in these patient populations.
“Although one-year outcomes among the real-world trial-eligible patients were excellent, the adverse events rate was higher compared with published clinical trial data,” the authors concluded. “The increased incidence of adverse outcomes among the TVT Registry trial-eligible patients compared with published clinical trial data are likely attributable to greater comorbidity, such as atrial fibrillation, lower baseline KCCQ score, and previously identified factors, such as care fragmentation. These data can help inform expected outcomes and health status after low-risk TAVR.”
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.