Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial
Saibal Kar, Raj Makkar, Brian Whisenant, Nadira Hamid, Hursh Naik, Peter Tadros, Matthew J. Price, Gagan D. Singh, Jonathan Schwartz, Samir Kapadia, Oluseun Alli, Samuel Horr, Puvi Seshiah, Wayne Batchelor, Brandon Jones, Mustafa Ahmed, Raymond L. Benza, Ulrich P. Jorde, Vinod H. Thourani, Andrew Ghobrial, Gilbert H.L. Tang, Phillip M. Trusty, Dina Huang, Rebecca T. Hahn, David Adams, Paul Sorajja, for the TRILUMINATE Pivotal Investigators
Abstract
BACKGROUND: One-year outcomes of TRILUMINATE Pivotal (Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal) found that transcatheter edge-to-edge repair (TEER) for the treatment of severe, symptomatic tricuspid regurgitation improved quality of life compared with medical therapy alone with similar rates of mortality and heart failure hospitalization. However, additional follow-up is necessary to determine the prolonged benefits of tricuspid TEER. METHODS: A total of 572 patients with severe, symptomatic tricuspid regurgitation were randomized to either tricuspid TEER+medical therapy (device group) or medical therapy alone (control). Two-year prespecified end points were recurrent heart failure hospitalization and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention after treatment visit, assessed in the intention-to-treat population. RESULTS: The annualized rate of recurrent heart failure hospitalizations through 2 years was significantly lower with tricuspid TEER compared with control (0.19 event per patient-year versus 0.26 event per patient-year; P =0.02; joint frailty model hazard ratio, 0.72; one-sided upper confidence limit, 0.93; P =0.02). Freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention through 2 years was significantly higher with tricuspid TEER compared with control (77.6% versus 29.3%; P <0.0001), driven by more tricuspid valve intervention in control patients who crossed over to device treatment (3.8% versus 61.5%). Rates of all-cause mortality (17.9% versus 17.1%) and tricuspid valve surgery (2.3% versus 4.3%) were similar between groups. Moderate or less tricuspid regurgitation was present in 84% at 2 years in the device group. CONCLUSIONS: At the 2-year follow-up, tricuspid TEER appeared safe, significantly reduced tricuspid regurgitation severity, and decreased rates of heart failure hospitalization compared with medical therapy alone. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03904147.