Medtronic has reported late-breaking data from the randomised Evolut Low Risk Trial’s five-year outcomes of the Evolut transcatheter aortic valve replacement (TAVR) system in low-risk aortic stenosis individuals.
According to the company, the system exhibited “durable” clinical results and “strong” valve performance during the study.
The multi-centre, international trial was designed to evaluate the efficacy and safety of the system against surgery in subjects with a low predicted risk of death within 30 days as per the local heart team evaluation.
A total of 1,414 subjects were randomised, with 730 given the TAVR with either the Evolut R, PRO, or CoreValve and 684 undergoing surgical intervention.
Subjects with severe aortic stenosis who underwent treatment with either the Evolut TAVR or surgery exhibited “comparable” rates of all-cause death or disabling stroke over five years, with 15.5% in the Evolut TAVR group and 16.4% in the surgery group.
The study also found a “numerically” lower cardiovascular death rate in the TAVR group with 7.2% against 9.3% in surgery, as well as “larger” effective orifice areas (EOA) and lower mean gradients in the TAVR group versus the surgical arm.
Medtronic cardiovascular portfolio’s structural heart chief medical officer and vice-president Kendra Grubb said: “These results reinforce the recently reported Evolut evidence from the SMART trial, which emphasised superior haemodynamics and lower rates of valve dysfunction.
“The Evolut Low Risk data presented today will help clinicians make personalised treatment decisions for younger, lower-risk patients by considering each patient’s unique needs, now acknowledging that data supports TAVR with Evolut as a safe and durable alternative to surgery.”
According to the company, the CoreValve and Evolut systems are TAVR devices that offer a “less” invasive alternative to traditional open-heart surgery.
These two devices have been assessed in over 12 clinical trials.
Last month, the company reported two-year outcomes from the Small Annuli Randomized To Evolut or SAPIEN (SMART) trial of Evolut transfemoral TAVR for aortic stenosis and small aortic annulus.
