Real-world TAVR outcomes highlight the accuracy of clinical trials
The benefits of transcatheter aortic valve replacement (TAVR) identified in clinical trials also appear to be present in a real-world setting, according to a new analysis published in JACC: Cardiovascular Interventions.
“Randomized controlled trials are the gold standard to understand the effectiveness of an intervention, but whether trial results based on highly selected populations apply to patients encountered in clinical practice is often unknown,” wrote lead author Neel M. Butala, MD, of Beth Israel Deaconess Medical Center in Boston, and colleagues.
Butala explored this question as it relates to TAVR outcomes, exploring data from more than 2,000 patients who underwent the procedure in a clinical trial and more than 135,000 additional patients who underwent TAVR from November 2011 to December 2017.
Trial patients and real-world patients were “mostly similar,” the authors noted. However, trial participants were more likely to have hypertension or coagulopathy, and real-world patients were more likely to present with congestive heart failure or frailty.
Also, the estimated real-world TAVR treatment effect “was similar to or greater” than the treatment effect seen in various trials.
Focusing on the real-world impact of TAVR, the group estimated that its overall treatment effect was an 11.4% absolute reduction in mortality or stroke and an 8.7% absolute reduction at one year compared to conventional treatment options such as surgical aortic valve replacement.
“Trial TAVR outcome rates and treatment effects were similar to reweighted trial TAVR outcome rates and estimated treatment effects, supporting the notion that the treatment effects in the original TAVR pivotal trials reflect treatment effects anticipated in the real-world population of patients receiving TAVR in the United States,” the authors wrote. “These results have implications not only for TAVR trial applicability but also for estimating trial effects in real-world populations more broadly.”
Click here for the full study in JACC: Cardiovascular Interventions.
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.