WASHINGTON (dpa-AFX) - Medtronic plc (MDT) announced data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes.
The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. The patients had a predicted 30-day mortality risk less than 3%, as assessed by a local heart team. 1,414 patients were randomized, with 730 receiving TAVR with either a Medtronic Evolut R, PRO, or CoreValve and 684 undergoing surgery.
Patients with severe aortic stenosis who were treated with either Evolut TAVR or surgery showed comparable rates of all-cause mortality or disabling stroke at 5 years (Evolut TAVR [15.5%] and surgery [16.4%]; p=0.47).
Additional findings at five years include Numerically lower rate of cardiovascular mortality (7.2% Evolut TAVR vs. 9.3% surgery); significantly larger effective orifice areas and lower mean gradients in the TAVR vs. surgical arms.
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