Transcatheter aortic valve implantation (TAVI) with the Evolut system (Medtronic) is as successful as surgical valve replacement in low-risk aortic stenosis patients. Data from the Evolut low risk trial were presented at the American College of Cardiology 68th Annual Scientific Session (ACC 19) and published simultaneously in the New England Journal of Medicine. It compared the minimally invasive Evolut transcatheter aortic valve implantation (TAVI) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients.
The Evolut Low Risk trial was a global, prospective, multicentre, randomised trial that evaluated three valve generations (CoreValve, Evolut R and Evolut PRO valves) across a variety of valve sizes in >1,400 low-risk severe aortic stenosis patients deemed to have a low mortality risk with surgery with a predicted risk of mortality of <3%. It met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3% vs. 6.7% posterior probability of non-inferiority >0.999). Additionally, the prespecified 30-day safety composite of all-cause mortality, disabling stroke, life-threatening bleeding, major vascular complications or acute kidney injury was significantly lower for valve implantation compared to open heart surgery (5.3% vs. 10.7%), as was the rate of the composite endpoint of all-cause mortality or disabling stroke at 30 days (0.8% vs. 2.6%). The pacemaker rate was greater in the transcatheter implantation treatment arm.
Transcatheter implantation also demonstrated excellent haemodynamic (blood flow) performance, with significantly lower mean aortic valve gradients (8.6mmHg vs. 11.2mmHg) and larger effective orifice areas than surgery (2.3 vs. 2.0) at 12 months. The implantation treatment arm also showed statistically lower rates of heart failure hospitalisations (3.2% vs. 6.5%) and disabling stroke (0.8% vs. 2.4%) compared to surgery at 12 months.
Michael Reardon (Houston Methodist DeBakey Heart and Vascular Center), principal investigator and senior author of the trial, says: “Low-risk aortic stenosis patients have unique characteristics due to their tendency to be younger and more active than their higher-risk counterparts. These data suggest that not only did TAVI match the gold standard of surgery, but it demonstrated statistical superiority across several key endpoints, including quality of life and haemodynamics—important considerations for severe aortic stenosis patients who may be more active.”
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