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  • TRILUMINATE Trial Details Qualify-of-Life Improvements in Severe TR Treated with TriClip vs. Medical Therapy

    A deeper look into the TRILUMINATE pivotal trial results shows that transcatheter edge-to-edge repair (TEER) for patients with symptomatic, severe tricuspid regurgitation resulted in meaningfully improved quality of life in patients with mostly concomitant, but treated, left-sided valve disease.

    Paul Sorajja, MD, of the Allina Health Minneapolis Heart Institute, reported these findings during a late-breaking trial session Wednesday at EuroPCR 2023 in Paris.

    The TRILUMINATE pivotal trial randomized 350 patients with symptomatic, severe TR at intermediate or greater surgical risk to undergo TEER with the TriClip device, manufactured by Abbott, the trial sponsor, or medical therapy alone.

    Top-line results released in March, presented by Sorajja at the American College of Cardiology Scientific Sessions 2023 in New Orleans, showed that use of the TriClip was associated with a reduction in TR severity and improved quality of life, but no survival benefit, compared to medical therapy alone and that the device was safe.

    On Wednesday, Sorajja presented a “deeper dive” into the characteristics of the trial’s patients.

    The patients’ mean age was 78 ± 7 years, 55% were female, most (90%) had atrial fibrillation, and 71% of the patients had massive or torrential TR. About 37% of the patients had undergone prior aortic (15%) or mitral (25%) interventions. The most common previous aortic intervention was surgical valve replacement (11%) and the most common mitral procedural was transcatheter edge-to-edge repair (11%).

    Nearly 1 in 5 (19%) patients had prior coronary artery bypass grafting, 14% had prior percutaneous coronary intervention, 15% had a prior pacemaker, and 25% had been hospitalized for heart failure within the previous year.

    Sorajja pointed out the trial patients were “significantly impaired,” with 55% in New York Heart Association (NYHA) heart failure class III (another 2% were in class IV).

    The baseline average Kansas City Cardiomyopathy Questionnaire (KCCQ) score was 55 points. About 44% had significant impairment, with scores below 50, but 25% were in the “good to very good” range of KCCQ scores (75-100 points).

    Most patients (89%) had enlarged right ventricles, and about 61% had normal left ventricles but dilated right ventricles. The mean right ventricular end-diastolic diameter was 5.1 ± 0.8 cm.

    An “overwhelming majority” of patients (87%) had normal left ventricular function, with a mean left ventricular ejection fraction of 59% ± 10%, but there was evidence of mild right ventricular dysfunction in a majority of patients (54%), with a mean tricuspid annular plane systolic excursion of 1.6 ± 0.4 cm.

    All TRILUMINATE patients were required to undergo invasive heart catheterization. Their mean pulmonary capillary wedge pressure was 14.9 ± 4.4 mmHg, which shows that these patients’ left-sided heart disease was well-managed, Sorajja said, adding that patients with a wedge pressure >20 mmHg were excluded for further heart failure optimization.

    The patients’ mean pulmonary artery pressure was 25.5 ± 6.1 mmHg, which indicates mild to moderate pulmonary hypertension, and the mean right atrial pressure was 11.0 ± 5.0 mmHg, indicating moderate levels of congestion. Most patients (86%) had a pulmonary artery systolic pressure <50 mmHg.

    N-terminal pro b-type natriuretic peptide (NT PRO-BNP) was elevated in nearly all patients, and 40% had NT PRO-BNP values of more than 2,000 pg/mL, which Sorajja termed “quite significant.” About 55% of patients had kidney dysfunction, and 48% had moderate or severe dysfunction. Two-thirds (67%) of patients had elevated gamma-glutamyl transferase levels, indicating liver congestion.

    The main TRILUMINATE results showed a similar mortality rate between patients who received the TriClip and those on medical therapy alone. Sorajja showed a graph depicting the mortality rates from both arms of the TRILUMINATE trial (device 8.6%, control 7.4%), along with mortality rates from other studies of patients with treated left-sided valve disease or isolated TR, which ranged from 7% to 14%. By comparison, mortality rates of patients with severe TR with untreated left-sided valve disease ranged from 22% to 50%.

    Sorajja showed another slide that displayed TRILUMINATE in the middle of other studies showing quality-of-life change, ranging from PARADIGM-HF (2.99-point drop from baseline KCCQ of 73) to PAL-HF (26.3-point increase from baseline KCCQ of 36). TRILUMINATE patients saw their KCCQ score improve by 15.2 points from a baseline of 56.

    In response to a question during a press conference, Sorajja said the TRILUMINATE investigators plan to conduct an analysis stratified by baseline KCCQ score to determine whether there was a survival benefit for TriClip in sicker patients.

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