Transcatheter tricuspid edge-to-edge repair (T-TEER) in addition to standard-of-care medical therapy reduced the risk of death, myocardial infarction (MI), stroke and hospitalization for heart failure (HF) compared with standard-of-care alone in patients with severe symptomatic tricuspid regurgitation (TR), according to results from the TRI-FR study presented during a Late-Breaking Clinical Trials session at ACC.26 in New Orleans.

The multicenter, open-label trial randomized 300 patients at 24 centers across France and Belgium 1:1 to either T-TEER plus standard-of-care or standard-of-care alone. They were 78 years old on average and two-thirds were women; 91% had extremely severe TR. Also, 91% had atrial fibrillation, 70% had hypertension and 40% had been hospitalized for HF prior to enrollment.

Unlike previous T-TEER trials, no patients in the control group crossed over to receive T-TEER during follow-up. Thus, patients in both randomized groups continued to be followed prospectively, as prespecified in the study protocol, allowing the investigators to report long-term clinical outcomes beyond two years without treatment crossover.

The primary composite endpoint included change in HF severity, change in patient's self-reported health status and a major adverse cardiovascular event (fatal or nonfatal MI, stroke, hospitalization for worsening HF or need for emergency procedure to restore blood flow to the heart).

At two years, results showed that 20% of patients in the T-TEER group and 35% of patients in the standard care group experienced a primary endpoint. Furthermore 14% of T-TEER patients vs. 23% of standard care patients were hospitalized for worsening HF, representing a 40% reduction in risk.

"We have shown that [T-TEER] combined with standard-of-care medical therapy significantly reduces the long-term need for hospitalization for recurrent [HF] at two years, compared with standard-of-care medical therapy alone," said principal investigator Erwan Donal, MD, PhD. "Without the confounding effect of crossover, it is clear that, among patients with very severe tricuspid regurgitation, T-TEER improved not only quality of life but also patients' long-term outcomes."

The researchers plan to follow patients for a total of five years to evaluate whether patients who were treated with T-TEER live longer than those who did not. They will examine whether there is a potential cost savings with T-TEER compared with medical therapy alone. The lack of blinding was noted as a limitation of the study.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Hypertension

Keywords: ACC Annual Scientific Session, ACC26, New Orleans, Heart Valve Diseases, Tricuspid Valve Insufficiency, Myocardial Infarction, Quality of Life, Heart Failure, Atrial Fibrillation, Hospitalization, Hypertension, Stroke