Medtronic plc MDT recently presented the initial clinical outcome of its Evolut Low Risk Trial at the 68th Annual Scientific Session of the American College of Cardiology. This data was also published in the New England Journal of Medicine.
The clinical program was aimed at comparing the minimally invasive Evolut transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in younger, healthier aortic stenosis patients.
Per Medtronic, these low-risk aortic stenosis patients have special characteristics on account of their tendency to be younger and active as compared to their higher-risk counterparts. The study itself is significant and timely considering the fact that there are 165,000 low-risk patients suffering severe aortic stenosis per year in the United States, Western Europe and Japan. If left untreated, the ailment can cause heart failure within a span of two years.
Data at a Glance
In the second year, the findings of this randomized Evolut Low Risk study claim to meet its primary non-inferiority endpoint of all-cause mortality or disabling stroke as compared to surgery. More specifically, all-cause mortality or disabling stroke incident was 5.3% with the Evolut TAVR as compared to 6.7% incident with traditional surgery.
This apart, the pre-specified 30-day safety composite of all-cause mortality, disabling stroke, life-threatening bleeding, major vascular complications or acute kidney injury was significantly lower for TAVR in comparison to open heart surgery.
Medtronic’s success from this favorable study outcome has too some extent disappeared following its rival in this field — Edwards’ Lifesciences EW — releasing a Phase 3 clinical trial outcome of its PARTNER 3 study on SAPIEN 3 mitral valve in patients with severe symptomatic aortic stenosis. Edwards’ data showed a 1% incident for all-cause mortality or disabling stroke in these patients.
Other major peers of Medtronic in this field are Boston Scientific Corporation BSX and Abbott Laboratories ABT who are also presenting their study results at the latest session of the Americal College of Cardiology.
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