A milestone for Medtronic: Low-risk TAVR patients treated with Evolut ‘doing exceptionally well’ after 2 years
After two years, low-risk patients treated with Medtronic’s Evolut transcatheter aortic valve repair (TAVR) system continue to experience outcomes similar to those who underwent surgery, according to new data presented virtually at EuroPCR 2021.
In fact, researchers behind the Evolut Low Risk Trial shared, the two-year rates of all-cause mortality or disabling stroke were 4.3% for TAVR patients and 6.3% for surgical aortic valve repair (SAVR) patients.
These latest findings represent a significant update for Medtronic. After one year, the rates of all-cause mortality or disabling stroke were 2.5% for TAVR patients and 4.3% for SAVR patients. With the numbers still being so close after another full year, TAVR continues to look like a safe, effective treatment option for low-risk patients with severe aortic stenosis.
“Heart teams can be confident that low-risk patients who undergo TAVR are doing exceptionally well at two years,” John Forrest, MD, director of interventional cardiology at Yale School of Medicine and principal investigator of the Evolut Low Risk Trial, said in a prepared statement. “There are some clear differences in secondary outcomes, and the long-term impact in areas such as hemodynamics, pacemakers, and prosthesis-patient mismatch will be important to follow.”
Other key two-year findings included:
- Mortality (3.5% vs. 4.4%), heart failure hospitalizations (5.3% vs.7.1%) and disabling stroke (1.5% vs. 2.7%) were all lower after TAVR than SAVR
- Prosthesis-patient mismatch was less common for the TAVR group
- Valve thrombosis rates are almost identical—0.3% for the TAVR group and 0.2% for SAVR
- Pacemaker implantation was more common after TAVR than SAVR
“Longer-term follow-up is needed to evaluate the differences demonstrated in the impact on patient outcomes,” according to a separate statement PCR published about the results. “Of note, patients will be followed for 10 years and so such data will be forthcoming.”