More than a year’s worth of real world data in more than 6,000 patients showed that all-cause mortality rates and stroke at 30 days with Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system were comparable with findings in the pivotal trial that led to the device’s approval.
Medtronic announced the results on Oct. 12 and presented the findings at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.
The FDA approved the CoreValve TAVR system in 2014 for aortic stenosis patients at high or extreme risk for surgery. From then until March 2015, 6,160 patients in the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) registry were implanted with the CoreValve TAVR system.
The rates of all-cause mortality (5.2 percent) and strokes (2.6 percent) at 30 days in the registry were similar to the rates (6.9 percent for all-cause mortality and 5 percent for stroke) in the pivotal trial.
“The rollout of this showed we can do this with the same great results that we did at [investigational device exemption] trials at expert centers,” Michael Reardon, MD, of the Houston Methodist DeBakey Heart & Vascular Center, told Cardiovascular Business.
Reardon presented two-year results of the CoreValve TAVR system at the American College of Cardiology scientific session in March. The study showed that the system was superior to standard surgery in terms of all-cause mortality and stroke.
At the TCT conference, the analysis of the registry data also found 98 percent of implants were successful, 89.3 percent of patients were treated via transfemoral access, 1.1 percent had major vascular complications and 1.5 percent required valve related readmissions. The rates in the trial were 96.8 percent, 77.3 percent, 7.5 percent and 5.9 percent, respectively.
Of the patients in the registry who received the CoreValve TAVR system, 39.3 percent were considered extreme risk, 55.5 percent were considered high risk, 3.5 percent were considered intermediate risk and 0.6 percent were considered low risk.
The researchers defined extreme risk as inoperable, comorbid and debilated patients; high risk as a predicted 30-day mortality risk of 8 percent or higher; intermediate risk as a predicted 30-day mortality risk of 4 percent to 7 percent; and low risk as a predicted 30-day mortality risk of less than 4 percent.
The data presented at TCT did not include information on the second generation CoreValve Evolut R device, which the FDA approved on June 23. Reardon, who has used the CoreValve more than 500 times, said the Evolut R device will be used more often than the first generation device.
“One of the nice things about the Evolut R is being recapturable, redeployable and repositionable, it gives you a level of confidence, particularly for the new implanters,” he said. “If you miss, it’s not a disaster because you don’t have to let go until you’re happy.”