Dive Brief:
- Edwards Lifesciences’ Early TAVR trial results showed asymptomatic patients with severe aortic stenosis had better outcomes after transcatheter aortic valve replacement than under routine clinical surveillance.
- Analysts said the positive data could help Edwards reaccelerate growth in its TAVR business, where sales have slowed in recent quarters. The data were presented Monday at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium and published simultaneously in The New England Journal of Medicine.
- The study is the first randomized, controlled trial to look at early intervention with TAVR as a strategy in patients with asymptomatic severe aortic stenosis, according to Edwards. The study was funded by Edwards.
Dive Insight:
For people with severe aortic stenosis but no symptoms, guidelines from the American College of Cardiology and the American Heart Association recommend clinical surveillance, also known as watchful waiting.
The disease causes a narrowing of the aortic valve, forcing the heart to work harder to pump blood. In a TAVR procedure, a replacement valve is threaded through the arteries to the heart via a catheter.
The Edwards study sought to reassess the standard approach to managing patients with asymptomatic severe aortic stenosis. Investigators evaluated 901 patients with an average age of 76 years, across 75 sites in the U.S. and Canada.
Edwards set the study’s primary endpoint as the rate of death, stroke or unplanned cardiovascular hospitalization. Nearly 27% of the 455 patients who received early TAVR experienced a primary endpoint event, compared to about 45% of the 446 patients in the clinical surveillance group, at the median follow-up of 3.8 years.
Study author Philippe Genereux said the trial showed asymptomatic patients without intervention experienced unpredictable and rapid decline, with numerous adverse outcomes.
“These results shatter 60 years of ingrained belief on the treatment for severe aortic stenosis, with guidelines that currently recommend ‘watchful waiting’ for intervention until symptoms develop,” Genereux, director of the structural heart program at Morristown Medical Center’s Gagnon Cardiovascular Institute in New Jersey, said in Edwards’ statement. “With no demonstrated clinical penalty for TAVR, these trial results strongly support a change to the practice and current guidelines for the treatment of aortic stenosis patients.” Genereux is a consultant for Edwards.
Truist Securities analyst Richard Newitter predicted the study could boost TAVR volumes by 5% to 10% over a year or two.
“The bar had been high for EARLY TAVR to be incrementally positive, and non-controversial, and for the most part we think results clear both hurdles,” Newitter wrote in a Monday report to investors.
Newitter said the data did not show a statistically significant benefit in reducing mortality, as some investors were looking for. However, the analyst downplayed the statistic as an issue, especially given the superiority of the consolidated primary endpoint.
Death from any cause occurred in 8.4% of TAVR patients and 9.2% of clinical surveillance patients, according to the study.
J.P. Morgan analyst Robbie Marcus also viewed the data as positive for the long-term TAVR outlook.
“While some investors were looking for a mortality-driven endpoint, we think the lack of mortality benefit was more a testament to the highly effective clinical surveillance today for these patients,” Marcus said in a note to clients.
William Blair analyst Margaret Kaczor Andrew said in an investor note that a standing-room-only audience at the conference applauded after the primary endpoint was displayed.
“As we await potential guideline changes and reimbursement updates, we believe these results should both expedite the symptomatic patient funnel and eventually, lead to a broader acceptance of earlier intervention in asymptomatic patients,” wrote Kaczor Andrew.