bRIGHT Study Spotlights Favorable 1-Year Outcomes for TriClip

The bRIGHT study offers a valuable glimpse into the real-world performance of the Abbott TriClip device, a transcatheter edge-to-edge repair (TEER) system for severe tricuspid regurgitation (TR). The growing burden of TR is increasingly recognized as a culprit for poor quality of life (QOL), end-organ dysfunction, worsening heart failure, and mortality. The TriClip device received commercial approval from the US Food and Drug Administration in April 2024 based on results from the TRILUMINATE Pivotal trial (NCT03904147). The bRIGHT registry provides a robust observational dataset that extends beyond the controlled environments of clinical trials, reflecting the device’s safety and efficacy in a more varied and representative patient population.

Background and Methods

Severe TR is a challenging condition, often associated with poor outcomes when left untreated. Surgery for isolated TR is rarely performed and generally has poor outcomes, leading to a significant unmet need for this growing patient population. The TriClip device, designed specifically for TEER, has emerged as a promising intervention. The bRIGHT study, a prospective, single-arm, open-label, multicenter registry, aimed to assess the safety and efficacy of the TriClip device in a real-world setting. Conducted at 26 sites across Europe, the study enrolled 511 consecutive patients, with data collected over a 1-year period. Key metrics included reduction in TR severity, changes in New York Heart Association (NYHA) functional class, and overall survival. Data quality was bolstered by echocardiographic core lab assessment of TR severity, as well as independent outcomes adjudication.

Results

The study population was characterized by advanced age (mean age, 79 years; 56% female) and a high burden of comorbidities, with 88% of patients presenting with massive or torrential TR. Compared with the TRILUMINATE Pivotal trial, patients treated as part of the bRIGHT registry were overall sicker and more symptomatic, with more severe baseline TR, worse NYHA functional class, and lower baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score. Interestingly, about a fifth of bRIGHT registry procedures were performed at sites with <15 cases, indicating applicability to real-world practice in relatively inexperienced groups.

Despite these challenges, the TriClip procedure in the bRIGHT population demonstrated a substantial reduction in TR severity, with 81% of patients achieving moderate or less TR at 1 year. Notably, TR reduction achieved at 30 days was sustained at the 1-year follow-up, and results were comparable at sites with <15 cases and those with more experience. This reduction was associated with significant clinical improvements: 75% of patients were in NYHA class I/II at 1 year compared with 21% at baseline, and there was an average 19-point (±26 points) increase in KCCQ score. The study also showed a favorable safety profile, with a 30-day mortality of 1.0%, a major bleeding rate of 7.0%, and a single leaflet device attachment rate of 3.5% with no device embolizations.

Mortality at 1 year was significantly lower among patients who achieved moderate or less TR at 30 days (P<.0001), underscoring the importance of early procedural success. Interestingly, baseline TR severity was not predictive of mortality, a finding that contrasts with previous studies. Instead, other factors, such as baseline serum creatinine levels and right ventricular function (as measured by tricuspid annular plane systolic excursion, or TAPSE) were more closely associated with outcomes. Mortality was not associated with central volume.

Clinical Relevance

The bRIGHT study’s findings are particularly noteworthy when compared with the TRILUMINATE Pivotal trial, the first randomized, controlled trial in this field. While TRILUMINATE demonstrated high rates of TR reduction and QOL improvement, it did not show a significant survival benefit at 1 year. The bRIGHT study, by contrast, suggests that effective TR reduction with the TriClip device was associated with survival benefits in a real-world setting, particularly among patients with advanced disease. Barring limitations of observational data, extended 5-year follow-up of bRIGHT study participants will continue to provide valuable insights.

This study highlights the potential of the TriClip device as a transformative therapy for severe TR, particularly in patients who are not candidates for surgery. The association between TR reduction and survival, as well as the device’s performance across a broad range of centers, underscores its clinical utility. However, the study also raises important questions about patient selection and the optimal timing of intervention, particularly given the variability in outcomes related to residual TR and baseline comorbidities.

In conclusion, the bRIGHT study represents a significant step forward in our understanding of how TEER with the TriClip device can be integrated into the broader management strategy for TR. As the field continues to evolve, further studies, particularly those that can refine patient selection criteria and device selection, will be crucial to maximize the benefits of this promising therapy.

Reference

Lurz P, Rommel KP, Schmitz T, et al. Real-world 1-year results of tricuspid edge-to-edge repair from the bRIGHT study. JACC. 2024. doi:10.1016/j.jacc.2024.05.006