At two years of follow-up, patients with compromised heart tricuspid valve function who received optimal medical therapy and a minimally invasive procedure using clips to repair the valve were significantly less likely to die, have a heart attack or stroke, and be 40% less likely to be hospitalized for heart failure compared to similar patients randomly assigned to optimal medical therapy alone. The study was presented at the American College of Cardiology’s Annual Scientific Sessions (ACC.26).
We showed that transcatheter tricuspid edge-to-edge repair (T-TEER) combined with standard-of-care medications significantly reduced the need for prolonged hospitalization for recurrent heart failure over 2 years compared with standard-of-care medications alone. ”
Erwan Donal, MD, PhD, Principal Investigator, Professor at Rennes University Hospital, France
“These findings were strengthened by the fact that, in contrast to previous randomized studies of T-TEER, patients assigned to the control group did not cross over to receive T-TEER during the follow-up period,” he said. “Without the confounding effects of crossover, it is clear that in patients with very severe tricuspid regurgitation, T-TEER improved not only quality of life but also long-term patient outcomes.”
The tricuspid valve, one of four valves in the heart, controls blood flow from the right atrium (the upper right chamber of the heart) to the right ventricle (lower right chamber). Tricuspid regurgitation, which is more common in women than men, occurs when the valve leaks and blood flows backwards into the right atrium. When this happens, the heart has to work harder to pump blood effectively. Patients with severe tricuspid regurgitation often have symptoms such as severe fatigue and shortness of breath, an enlarged liver, kidney failure, and fluid accumulation in the abdomen, legs, ankles, or feet.
Currently, the best medications available for tricuspid regurgitation are diuretics, which reduce fluid buildup in the body, but often do not directly treat the leakage of blood through the valve, Donal said. However, T-TEER is a minimally invasive procedure that uses a catheter (a long, flexible tube) to place one or more small clips on the tricuspid valve leaflets to prevent blood from flowing back into the right atrium. The TRI-FR trial was designed to compare outcomes in patients with severe symptomatic tricuspid regurgitation who were randomly assigned to receive either T-TEER plus standard-of-care medications (T-TEER group) or standard-of-care medications alone (control group).
The trial enrolled 300 patients (mean age 78 years, 63.7% female) at 24 sites in France and Belgium. Ninety-one percent of the patients had very severe tricuspid regurgitation, 91% had atrial fibrillation (rapid, irregular heartbeat), and about 70% had high blood pressure despite treatment with high doses of antihypertensive drugs. The patient also had shortness of breath and was unable to walk 400 meters on flat ground in less than 6 minutes. Forty percent had been hospitalized for heart failure in the year before entering the study.
The primary endpoint of this trial was a combination of changes in heart failure severity. Changes in patient self-reported health status. If a major adverse cardiovascular event (fatal or non-fatal heart attack or stroke, hospitalization due to worsening heart failure, or need for emergency treatment to restore blood flow to the heart) occurs within 1 year. Secondary outcomes included physician assessment of tricuspid regurgitation severity and quality of life improvement.
Unlike previous randomized trials of T-TEER, the design of the TRI-FR trial did not allow patients assigned to the control group to cross over to receive T-TEER during follow-up because the French national health insurance system did not reimburse the TriClip T-TEER device used in the trial. As a result, patients in both randomized groups continued to be followed prospectively as prespecified in the study protocol, allowing researchers to report long-term clinical outcomes beyond two years without crossover treatment, Donal said.
“These findings provide complementary evidence to clinical trials such as TRILUMINATE conducted in the United States where crossover is allowed,” he said. “Thus, to our knowledge, TRI-FR is the first randomized study of T-TEER to report clinical outcomes beyond 2 years without crossover between treatment groups.”
At 2 years of follow-up, 19.7% of patients in the T-TEER group experienced the primary endpoint event, compared with 34.5% of patients in the control group. In the T-TEER group, 13.8% of patients were hospitalized for worsening heart failure compared to 23% in the control group, a 40% reduction in risk.
As a next step, Donal and colleagues are analyzing whether treatment with T-TEER plus optimal drug therapy results in cost savings compared to optimal drug therapy alone. They also plan to follow patients for a total of five years to assess whether those treated with T-TEER live longer than those who do not.
A limitation of the study was that it was not blinded, meaning both patients and clinicians knew who received T-TEER and who did not, Donal said.
The study was funded by the French Ministry of Health, with an additional grant from Abbott Vascular, the manufacturer of the TriClip device.
Donal will present his study, “Two-Year Results After Transcatheter Tricuspid Valve Repair Without Crossover in a Randomized Tri.Fr Trial,” on Sunday, March 29th at 4:00 PM CT/4:00 PM Universal Time in the main tent of the Great Hall.
sauce:
American College of Cardiology
