Medtronic plc (NYSE:MDT) today announced first-ever clinical data from the landmark Evolut Low Risk Trial comparing the minimally invasive Evolut(TM) transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. The randomized trial, which met its primary non-inferiority endpoint of all-cause mortality or disabling stroke at two years compared to surgery (5.3 percent versus 6.7 percent; posterior probability of non-inferiority >0.999), was presented today at the American College of Cardiology 68th Annual Scientific Session (ACC.19) and published simultaneously in The New England Journal of Medicine (NEJM)(1).
Key Data Highlights:
* 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 TAVR as compared to open heart surgery (5.3 percent versus 10.7 percent), as was the rate of the composite endpoint of all-cause mortality or disabling stroke at 30 days (0.8 percent versus 2.6 percent). The pacemaker rate was greater in the TAVR treatment arm.
* TAVR demonstrated excellent hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients (8.6 mm Hg versus 11.2 mm Hg) and larger EOAs (effective orifice area) than surgery (2.3 vs. 2.0) at 12 months.
* The TAVR treatment arm also showed statistically lower rates of heart failure hospitalizations (3.2 percent versus 6.5 percent) and disabling stroke (0.8 percent versus 2.4 percent) compared to surgery at 12 months.
* 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 TAVR as compared to open heart surgery (5.3 percent versus 10.7 percent), as was the rate of the composite endpoint of all-cause mortality or disabling stroke at 30 days (0.8 percent versus 2.6 percent). The pacemaker rate was greater in the TAVR treatment arm.
* TAVR demonstrated excellent hemodynamic (blood flow) performance with significantly lower mean aortic valve gradients (8.6 mm Hg versus 11.2 mm Hg) and larger EOAs (effective orifice area) than surgery (2.3 vs. 2.0) at 12 months.
* The TAVR treatment arm also showed statistically lower rates of heart failure hospitalizations (3.2 percent versus 6.5 percent) and disabling stroke (0.8 percent versus 2.4 percent) compared to surgery at 12 months.
Analyst and Investor Briefing
Medtronic will host a webcast to highlight its Cardiac and Vascular Group from 2:30-3:30 p.m. CDT, Sunday, March 17. The webcast will feature remarks from Medtronic management, including comments on Medtronic’s clinical data and product pipelines. The live audio webcast can be accessed by clicking on the Investor Events link at http://investorrelations.medtronic.com on March 17.
Within 24 hours of the webcast, a replay will be available on the same webpage. This event is not part of the official ACC Scientific Sessions.
Within 24 hours of the webcast, a replay will be available on the same webpage. This event is not part of the official ACC Scientific Sessions.
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