Ongoing long-term studies from the two major producers of transcatheter aortic valve replacements showed the minimally invasive route can continue to perform on par with open-heart surgery in a broader population of patients—but after four to five years, if there is to be a race between the dueling implants, it may still come down to a photo finish.
During the Transcatheter Cardiovascular Therapeutics conference in San Francisco, both Medtronic and Edwards Lifesciences presented clinical outcomes from landmark trials of their TAVR systems in patients with severely narrowed aortic valves who fell in the low-risk category for traditional surgery.
Edwards announced five-year findings from its Sapien 3 implant, taken from a study named PARTNER 3. Medtronic, meanwhile, presented four-year follow-up data gathered from its Evolut valve, from the appropriately named Evolut Low Risk Trial.
Both trials—now in the middle of their respective journeys, with longer follow-ups planned—had once been instrumental in securing a 2019 green light from the FDA that opened up the use of TAVR valves to low-risk patients. The minimally invasive approach had previously been reserved for the typically older and more frail patients who carried higher risks of complications from undergoing an open procedure.
After its first year, Edwards’ PARTNER 3 trial of 1,000 patients demonstrated that TAVR with a Sapien valve could outperform surgery, with a lower composite rate of patient deaths, strokes or rehospitalizations.
Now, after five years, those numbers have converged: The latest rates, while low, did not show a statistically significant difference—nor did measurements of overall health status or the number of cases of prosthetic valve failures.
The reported rates of death were 10.0% in the TAVR group and 8.2% in surgery, while stroke cases came to 5.8% and 6.4% and rehospitalizations to 13.7% and 17.4%, respectively. Valve failures occurred in 3.3% and 3.8% of patients.
“The five-year follow-up findings from the PARTNER 3 trial reaffirm the clinical outcome benefits and bioprosthetic valve durability of Sapien 3 TAVR as a meaningful alternative to surgical therapy for low-risk severe, symptomatic [aortic stenosis] patients,” co-principal investigator Martin Leon, professor of medicine at Columbia University Irving Medical Center, said in a statement. The trial’s results were simultaneously published in The New England Journal of Medicine.
Larry Wood, Edwards' group president for TAVR and surgical structural heart implants, said, “These data add to the robust body of clinical evidence that shows the versatility and durability of the Sapien 3 valve, highlighted by 10 approved indications and the real-world experience in the treatment of over one million patients worldwide, who have benefited from the design of a valve intended for true lifetime management.”
But for Medtronic’s Evolut, the gaps between TAVR and surgery have grown over time.
Evolut’s four-year data from 1,414 patients reported a 26% relative reduction in the risk of death or disabling stroke with TAVR, at a total rate of 10.7% compared to surgery’s 14.1%.
The difference in the absolute number of events expanded year after year. After 12 months, the two groups were separated by 1.8 percentage points; at two years, it grew to 2.0%; at three, 2.9%; and at four, 3.4%.
Meanwhile, overall composite measures of all-cause mortality, disabling stroke or rehospitalization came to 18.0% and 22.4%, respectively.
“As we see patients in the Evolut Low Risk trial continue to show positive outcomes and sustained valve performance compared to surgery out to four years, this helps us establish intermediate-term evidence for Evolut TAVR and helps define what this might look like in the long term,” said principal investigator Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research at the Houston Methodist Hospital.
“These results are not only encouraging but pivotal in shaping treatment decisions for low-risk patients with symptomatic severe aortic stenosis,” said Reardon. The study results were also printed in the Journal of the American College of Cardiology.