Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial
Recommended Citation
Lurz P, Hahn RT, Kodali S, Makkar R, Sharma RP, Davidson CJ, O'Neill BP, Yadav P, Zahr F, Chadderdon S, Eleid MF, Szerlip M, Smith R, Whisenant B, Garcia S, Kister T, Kipperman RM, Lim S, Saxon J, Kapadia S, Hermiller J, Mishell JM, Rassi A, Herrmann HC, Szeto W, Hausleiter J, Babaliaros V, Barker CM, Lindman BR, Latib A, Muhammad K, von Bardeleben RS, Summers M, Chetcuti S, Ailawadi G, Russo M, Rinaldi M, Chehab BM, Nickenig G, Stinis C, Inglessis-Azuaje I, Dhoble A, Chhatriwalla AK, Petrossian G, Shah P, Staniloae C, Williams M, Nores M, McCabe JM, Singh G, Baldus S, Rudolph V, Barb I, Klodell C, Gray W, Strote J, Sannino A, Grayburn P, Mack MJ, Leon MB, and Thourani VH. Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial. Eur Heart J 2025.
Document Type
Article
Publication Date
8-29-2025
Publication Title
European heart journal
Abstract
BACKGROUND AND AIMS: The TRISCEND II trial demonstrated superior clinical benefits for patients with ≥severe tricuspid regurgitation (TR) treated with the EVOQUE transcatheter tricuspid valve replacement (TTVR) system plus medical therapy versus medical therapy alone. This work reports 1-year and 18-month outcomes in patients stratified by baseline TR severity.
METHODS: The multicentre, prospective TRISCEND II trial enrolled 400 patients with symptomatic, ≥severe TR and randomised 2:1 to TTVR (n=267) or control (n=133). In a post-hoc analysis, patients were stratified into severe TR (n=172) and massive/torrential TR (n=220) cohorts. Clinical and quality-of-life outcomes were reported at 1 year, with Kaplan-Meier estimates for all-cause mortality and heart failure (HF) hospitalisation assessed at 18 months. Study oversight included an independent echocardiographic core laboratory, clinical events committee, and data safety monitoring board.
RESULTS: One year after TTVR, TR was ≤mild in 95.2% of severe TR and 95.3% of massive/torrential TR patients. The primary safety and effectiveness endpoint (win ratio) favoured TTVR over control regardless of baseline TR severity: severe (1.64 [95% CI: 1.11, 2.43]) and massive/torrential (2.20 [1.55, 3.14]). At 18 months, TTVR patients had similar mortality to controls (rate difference: severe 0.2% [-11.6, 11.9], massive/torrential -5.8% [-17.6, 6.0], whereas HF hospitalisation rates favoured TTVR in the massive/torrential cohort (vs. control, severe 9.8% [-3.0, 22.7], massive/torrential -15.2% [-28.9, -1.5]).
CONCLUSIONS: Patients with ≥severe TR benefit from TTVR, experiencing improvements in TR severity, functional capacity, and quality of life regardless of baseline TR severity, with a signal for greater benefit in patients with more advanced disease.
PubMed ID
40878717
ePublication
ePub ahead of print
