At one year, the rate of death from any cause was 4.6% among patients undergoing TAVR and 6.6% among those undergoing open-heart surgery, a difference that met the trial's pre-specified threshold for non-inferiority of TAVR. Rates of death from cardiovascular disease, stroke and a composite of those two outcomes were similar between the two groups.
Patients who received TAVR had a significantly higher rate of vascular complications, which occurred in 4.8% of TAVR patients and 1.3% of those receiving surgery. TAVR patients were also more likely to have a pacemaker implanted, which was necessary in 12.2% of TAVR patients and 6.6% of those receiving surgery. In addition, patients who underwent TAVR had a higher rate of aortic regurgitation (blood leaking through the valve), a finding that might, in some cases, adversely affect long-term outcomes. Mild aortic regurgitation occurred at one year in 38.3% of patients undergoing TAVR and 11.7% of patients undergoing surgery, while moderate regurgitation occurred in 2.3% of TAVR patients and 0.6% of surgery patients.
On the other hand, patients undergoing TAVR had a significantly lower rate of major bleeding complications, which occurred in 6.3% of TAVR patients and 17.1% of those undergoing surgery. TAVR was also associated with a shorter hospital stay, fewer days in intensive care, and better functional capacity and quality of life measures at six weeks after the procedure. Functional capacity and quality of life were similar between the two groups at one year, however.
Toff said that the results reflect only a relatively short follow-up period, and that longer-term outcomes could reveal important differences. The researchers plan to continue to track outcomes for a minimum of five years.
"I think it's important that we take a measured approach and individualize the decision-making for these patients, factoring in the patient's preference and attitude to risk," Toff said. "The results from our trial and others are encouraging, but patients need to be fully informed and know that the long-term durability of the TAVR valves and the long-term implications of the increased risk of aortic regurgitation are still uncertain."
This study was funded by the U.K. National Institute for Health Research (NIHR) Health Technology Assessment Programme.
ACC.20/WCC will take place March 28-30, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention.
The American College of Cardiology envisions a world where innovation and knowledge optimize cardiovascular care and outcomes. As the professional home for the entire cardiovascular care team, the mission of the College and its 54,000 members is to transform cardiovascular care and to improve heart health. The ACC bestows credentials upon cardiovascular professionals who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. The College also provides professional medical education, disseminates cardiovascular research through its world-renowned JACC Journals, operates national registries to measure and improve care and offers cardiovascular accreditation to hospitals and institutions.
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