Low-risk transcatheter aortic valve replacement (TAVR) patients with aortic stenosis who receive the Evolut PRO continue to experience outcomes comparable to surgery, according to a late-breaking clinical science presentation at the TVT Connect 2020 virtual meeting.
In 2019, the Evolut Low Risk demonstrated similar outcomes for TAVR and surgical aortic valve replacement (SAVR) in low-risk patients with aortic stenosis, an outcome the FDA cited when it approved an expanded indication for several devices. The findings presented Saturday, June 20, at TVT Connect compared outcomes from the Evolut Low Risk trial with 432 patients from continued access study (CAS) and 543 real-world patients from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry.
Bruce Rutkin, MD, of Northwell Health in Manhasset, New York, presented the findings. Sunil Rao, MD, editor in chief of Circulation: Cardiovascular Interventions, chaired the session.
Overall, the outcomes between the three patient cohorts were similar. Pacemaker implantations did drop over time, a finding believed to show an increasing comfort among operators, and vascular complications saw a similar decline.
All-cause mortality at 30 days was 0.6% among the clinical trial patients, 0.7% among CAS patients and 1.3% among the real-world patients. Stroke and life-threatening or major bleeding complications were also down significantly from the time of the trial to the point when real-world patients were being treated throughout the United States.
In addition, Rutkin noted, the median time from procedure to discharge was “consistently low” for all patients.
“We always talk about what’s going to happen when these patients are enrolled in a real-world, commercial setting and if we are going to see differences compared to the stringently controlled randomized trial,” Rutkin said. “I think it’s reassuring that all three groups had similar outcomes, if not slightly improved for certain categories in the registry patients, albeit self-reported.”
Individuals who have signed up for TVT Connect 2020 can watch Rutkin and others discuss these findings here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.