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Complete Two-Year Data Confirms That Medtronic's Evolut TAVR System Is Non-Inferior to Open Heart Surgery in Low Risk Patients
The New Data, Presented at EuroPCR, Confirms the Bayesian Analysis Presented at the ACC 2019 Scientific Sessions
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Medtronic's Evolut Transcatheter Aortic Valves
Medtronic's Evolut Transcatheter Aortic Valves
May 31, 2021 -- Confirming the preliminary data that was previously presented at the 2019 Scientific Session of the American College of Cardiology, and published in The New England Journal of Medicine, the complete data from over 1,400 patients enrolled in the Evolut Low Risk Trial was presented (virtually) at this year's EuroPCR meeting by John K Forrest, MD, FACC, FSCAI.

The result: the primary endpoint of all-cause mortality or disabling stroke at two years was 4.3% for TAVR versus 6.3% for surgery (p<0.0001 for non-inferiority). Interestingly, the 2019 estimate predicted that the two year outcomes would be 5.3% or TAVR versus 6.7% or surgery (SAVR), so the actual outcomes were very similar to the 2019 Bayesian statistical analysis and slightly more favorable to TAVR. This is important for two reasons: (1) the non-inferiority of TAVR to SAVR was confirmed; (2) the estimated outcomes of a trial, using complex Bayesian statistical analysis based on early results, was validated, meaning that important clinical trials of devices may not need to wait for two, three, or more years of study to gain approval.

To recap, low risk was defined at being less than 3% 30-day mortality risk from surgery. These tended to be younger and healthier patients. There were 730 patients randomized to TAVR and 684 to SAVR. The benefit seen at one year was sustained to two years.

Primary Outcome Evolut Low Risk Trial

The advantages of TAVR were better valve hemodynamics and lower patient-prosthesis mismatch (the size of the valve replacement was much more accurate in the TAVR arm). Heart failure/hospitalization was also better with TAVR. On the other hand, surgery showed lower incidence of the need for permanent pacemaker implantation (21.1% TAVR vs. 7.9% SAVR) and lower paravalvular leak (26.6% TAVR vs. 2.6% SAVR). As with all clinical trials that occur over months/years, the device being assessed changes and improves. The TAVR cases performed at the start of this trial were done with the 31mm CoreValve Classic; those at the end of the trial were done with the Evolut Pro; the majority were performed with the Evolut-R valve. Each iteration of the Medtronic TAVR system has shown significant improvements in both the need for permanent pacemaker implantation and paravalvular leakage.

The main caveat to this study is that little is known about differences in longer-term outcome, to which it's important to note that these patients will be followed up to ten years.

Summary of Evolut Low Risk Trial

This press release from Medtronic follows:

Medtronic Evolut™ TAVR System Shows Strong Performance at Two Years in Low Risk Trial
EuroPCR: Low Risk Study Demonstrates Hemodynamic Advantages of Evolut™ Transcatheter Aortic Valve Replacement (TAVR) System Over Open Heart Surgery Out to Two Years

May 18, 2021 -- Dublin -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the complete two-year outcomes from the landmark Evolut Low Risk Trial comparing the minimally invasive Evolut™ transcatheter aortic valve replacement (TAVR) system to the gold standard of open-heart surgery in characteristically younger, healthier aortic stenosis patients. Presented virtually today as a late-breaking clinical trial at the EuroPCR 2021 e-Course, 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; p<0.0001 for non-inferiority), and trended the same or lower on all critical events, confirming the earlier Bayesian statistical analysis presented at the American College of Cardiology (ACC) 68th Annual Scientific Session in 2019.

Dr. John K Forrest
Dr. John K Forrest

"We know that TAVR has an advantage over surgery in certain near-term outcomes; however, in these low-risk studies, longer term outcomes are more important than ever. The full two-year data from the randomized Evolut Low Risk Trial demonstrate that between years one and two, patients who have undergone TAVR continue to do exceptionally well with no convergence of the primary outcome curves," said John Forrest, M.D., director of interventional cardiology at the Yale School of Medicine in New Haven, Conn., and principal investigator in the Evolut Low Risk Trial. "Heart teams can be confident that low-risk patients who undergo TAVR are doing exceptionally well at two years. 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."

At two years, results from the study showed there was no convergence of the divergent Kaplan-Meier curves for death or disabling stroke between TAVR and surgery, demonstrating that improved safety shown early on for TAVR was sustained over time. In addition, results from the study showed:

  • Excellent hemodynamic (blood flow) performance for TAVR with statistically significantly lower mean aortic valve gradient (9.0 mm Hg versus 11.7 mm Hg) and larger effective orifice area than surgery (2.2 cm2 versus 2.0 cm2) at two years, (p<0.001 for both comparisons).
  • 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.
  • Prosthesis-patient mismatch was lower for TAVR compared to surgery at two years with a difference of 2.1% versus 4.9% in the severe category (p<0.001).
  • Valve thrombosis rates showed no signs of increase and remained low at two years (0.3% for TAVR versus 0.2% for SAVR).

The global randomized Evolut Low Risk Trial evaluated three valve generations (CoreValve™, Evolut™ R and Evolut™ PRO valves) across a variety of valve sizes in more than 700 patients with severe aortic stenosis deemed to have a low mortality risk with surgery with a predicted risk of mortality of less than 3%.

Dr. Jeffrey J. Popma
Dr. Jeffrey J. Popma

"Results from this landmark study reassure us that the positive outcomes presented using the Bayesian statistical analysis at ACC.19, before the full two-year outcomes were available, matched the actual two-year outcomes and thus was an extremely accurate and scientifically rigorous methodology that researchers can feel confident about moving forward," said Jeffrey J. Popma, M.D., vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic. "Furthermore, the Evolut TAVR platform continues to show it is a treatment option well-suited for lower-risk patients who are living longer and may be more active."

The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO and Evolut PRO+ TAVR Systems, is indicated for symptomatic patients with severe aortic stenosis across all surgical risk categories (extreme, high, intermediate and low) in the U.S. and countries that recognize CE Mark. It is estimated that 165,000 low-risk patients suffer from severe aortic stenosis per year in the U.S., Western Europe, and Japan. If left untreated, it can cause heart failure in as little as two years.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc (, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Reported by Burt Cohen, May 31, 2021