- Medtronic Plc MDT has announced the complete two-year outcomes from a low-risk trial comparing the Evolut transcatheter aortic valve replacement (TAVR) system to open-heart surgery in characteristically younger, healthier aortic stenosis patients.
- Data were presented at the EuroPCR 2021 e-Course.
- The results showed the Evolut TAVR platform was non-inferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at two years (4.3% for TAVR versus 6.3% for surgery).
- At two years, the study showed that improved safety shown early on for TAVR was sustained over time.
- Better hemodynamic (blood flow) performance for TAVR with statistically significantly lower mean aortic valve gradient (9.0 mm Hg versus 11.7 mm Hg) was seen.
- A larger effective orifice area than surgery (2.2 cm2 versus 2.0 cm2) at two years was observed.
- Numerically lower rates of death in the TAVR arm (3.5% versus 4.4%), heart failure hospitalizations (5.3% versus 7.1%), and disabling stroke (1.5% versus 2.7%) compared to surgery at two years were reported.
- The prosthesis-patient mismatch was lower for TAVR than surgery at two years, with a difference of 2.1% versus 4.9% in the severe category.
- Valve thrombosis rates showed no signs of increase and remained low at two years.
- Price Action: MDT shares are up 0.76% at $126.49 during the market session on the last check Tuesday.
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