Medtronic, Edwards’ TAVR devices match surgery in long-term studies

TAVR devices equal surgery in long-term trials | Pharmtales

At the Transcatheter Cardiovascular Therapeutics conference in San Francisco, both Medtronic and Edwards Lifesciences unveiled the latest results from ongoing long-term studies of their transcatheter aortic valve replacement (TAVR) systems. These studies focus on patients with severely narrowed aortic valves categorized as low-risk for traditional open-heart surgery. Edwards presented five-year findings from its Sapien 3 implant, originating from the PARTNER 3 study. Medtronic shared four-year follow-up data from its Evolut valve in the Evolut Low Risk Trial. Both of these trials were pivotal in securing FDA approval in 2019 for extending TAVR use to low-risk patients, expanding beyond older, higher-risk individuals.

Edwards’ PARTNER 3 trial demonstrated, after one year, superior performance of the Sapien valve in TAVR compared to surgery in terms of patient death, strokes, or rehospitalizations. Now, after five years, the latest data indicates that these differences have converged, with no statistically significant distinctions observed. The reported rates of death, strokes, and rehospitalizations between TAVR and surgery groups showed little disparity. Valve failures occurred in a similar percentage 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.” 

– Martin Leon, professor of medicine at Columbia University Irving Medical Center

“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.”

– Larry Wood, Edwards’ group president for TAVR and surgical structural heart implants

However, Medtronic’s Evolut TAVR has continued to widen the gaps between TAVR and surgery outcomes over time. The four-year data reported a 26% relative risk reduction in death or disabling stroke for patients undergoing TAVR compared to surgery. The difference in event rates expanded over the years, emphasizing the potential benefits of TAVR for low-risk patients with symptomatic severe aortic stenosis.

These study results are instrumental in guiding treatment decisions for low-risk patients and illustrate the ongoing competitive dynamics between the two leading TAVR systems in long-term performance and outcomes.

“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.

– Michael Reardon, Allison Family Distinguished Chair of Cardiovascular Research at the Houston Methodist Hospital.

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