Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial
Philipp Lurz, Rebecca T. Hahn, Susheel Kodali, Raj Makkar, Rahul Sharma, Charles J. Davidson, Brian O’Neill, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram F. Eleid, Molly Szerlip, Robert L Smith, Brian Whisenant, Santiago Garcia, Tobias Kister, Robert Kipperman, Scott Lim, John Saxon, Samir Kapadia, James Hermiller, Jacob M. Mishell, Andrew N. Rassi, Howard C Herrmann, Wilson Y. Szeto, Jörg Hausleiter, Vasilis Babaliaros, Colin M. Barker, Brian R. Lindman, Azeem Latib, Kamran I. Muhammad, Ralph Stephan von Bardeleben, Matthew Summers, Stanley Chetcuti, Gorav Ailawadi, Mark Russo, Michael Rinaldi, Bassem Chehab, Georg Nickenig, Curtiss Stinis, Ignacio Inglessis‐Azuaje, Abhijeet Dhoble, Adnan K. Chhatriwalla, George Petrossian, Pinak Shah, Cezar Staniloae, Mathew Williams, Marcos Nores, James M. McCabe, Gagan D. Singh, Stephan Baldus, Volker Rudolph, Ilie Barb, C.T. Klodell, William A. Gray, Justin A Strote, Anna Sannino, Paul Grayburn, Michael J. Mack, Martin B. Leon, Vinod H. Thourani
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 vs 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 randomized 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) hospitalization 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% confidence interval (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 hospitalization 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.