A review of the PARTNER 3 Low-Risk Trial with Michael Mack, M.D., chairman, cardiovascular service line, Baylor Scott and White Health, Dallas Texas, chairman of the board of the BSW Health Research institute, Dallas, and co-principal investigator of the trial. The PARTNER 3 Low-Risk Trial two-year data were presented as a late-breaking study at the virtual American College of Cardiology (ACC) 2020 annual meeting. The trial offers additional evidence that TAVR performs as well as surgery in select low-risk patients.
Mack said the trial included patients over the age of 65, and there is still a question about long-term durability of the Sapien 3 TAVR valve used in trial before it is used in younger patients. He said patients in this trial will be tracked out to 10 years, which will offer a lot of information on durability of the current iteration of this valve. In the video, he also elaborates on TAVR issues involved with bicuspid aortic valves and other patient selection issues.
PARTNER 3 enrolled 1,000 patients with severe aortic stenosis and a Society of Thoracic Surgeons (STS) risk score of less than 4 percent. All patients had a tricuspid aortic valve. Half of the participants were randomly assigned to undergo TAVR and half underwent surgery. At two years, 11.5 percent of patients receiving TAVR and 17.4 percent of those receiving surgery died, suffered a stroke or were rehospitalized for cardiovascular problems, a difference in the composite primary endpoint that researchers reported as showing non-inferiority, meaning neither treatment was superior to the other.
In a secondary analysis, rates of death and stroke were found to be not significantly different between the two groups. Death occurred in 2.4 percent of those receiving TAVR and 3.2 percent of those receiving surgery, while stroke occurred in 2.4 percent of those receiving TAVR and 3.6 percent of those receiving surgery. Rehospitalization rates showed a significant difference in favor of TAVR; 8.5 percent of those receiving TAVR and 12.5 percent of those receiving surgery were rehospitalized for cardiovascular reasons during the study period.