October 8, 2026Heart
Baseline invasive haemodynamics and treatment response to transcatheter tricuspid edge-to-edge repair: an exploratory analysis of the TRI-FR randomised trial
Key result
Baseline invasive hemodynamics modify clinical response to T-TEER in tricuspid regurgitation.
- n=300
Why the study?
Clinical response to transcatheter tricuspid edge-to-edge repair varies considerably among patients with severe tricuspid regurgitation, and the association with baseline invasive haemodynamics is unclear.
Does transcatheter tricuspid edge-to-edge repair added to guideline-directed medical therapy improve clinical outcomes in patients with severe tricuspid regurgitation compared to medical therapy alone?
Key Points
- To determine whether baseline invasive haemodynamic variables modify clinical treatment response to transcatheter tricuspid edge-to-edge repair in patients with severe tricuspid regurgitation.
- Conducted a prespecified exploratory post hoc analysis of the randomized TRI-FR trial (NCT04646811) comprising 300 patients.
- Assigned participants to transcatheter tricuspid edge-to-edge repair (T-TEER) plus guideline-directed medical therapy (GDMT) or GDMT alone.
- Evaluated treatment-effect modification at 1 year across haemodynamic markers for a hierarchical composite of functional class, global assessment, cardiovascular death, and heart failure hospitalisation.
- T-TEER improved the primary composite endpoint, showing significant treatment-effect modification by right atrial mean pressure (p=0.035), pulmonary capillary wedge pressure (p=0.013), and pulmonary artery pulsatility index (p=0.040).
- Descriptive tertile analyses showed larger between-group treatment benefits in patients with lower filling pressures (RAP ≤6 mm Hg or PCWP ≤11 mm Hg) and higher pulsatility indices (PAPi ≥3.22).
- Cardiac output and the ratio of tricuspid annular plane systolic excursion to systolic pulmonary artery pressure showed no significant interaction with treatment effect.
Study Design
Type
RCT (n=300)
Structured PICO
Does transcatheter tricuspid edge-to-edge repair added to guideline-directed medical therapy improve clinical outcomes in patients with severe tricuspid regurgitation compared to medical therapy alone?
P
Population
300 patients with severe tricuspid regurgitation randomized to T-TEER plus GDMT or GDMT alone, evaluated at 1 year for a clinical composite.
I
Intervention
Transcatheter tricuspid edge-to-edge repair (T-TEER) plus guideline-directed medical therapy (GDMT)
C
Comparator
Guideline-directed medical therapy (GDMT) alone
O
Outcome
1-year hierarchical clinical composite integrating New York Heart Association class, patient global assessment, cardiovascular death and heart failure hospitalisationcomposite
Limitations
- Analyses describe heterogeneity in average treatment response and do not establish individual-benefit thresholds
- Findings are exploratory and warrant prospective validation
- Exploratory post hoc analysis
- Does not establish individual-benefit thresholds
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
GWGregg W. StoneInterventional cardiologist, Icahn School of Medicine at Mount Sinai
“Although it is certainly conceivable that the major benefit of reducing severe TR is symptomatic improvement only (especially in patients without right ventricular dysfunction), the lack of even a signal toward reduced mortality or HFH after T-TEER is quite striking given the marked 13.5-point between-group improvement in mean KCCQ score at 1 year.”
“TRI.Fr is a positive prospective study, confirming a clear benefit for patients suffering from severe tricuspid regurgitation. It is important to note that medical treatment and strict monitoring of these patients, who are often in advanced heart failure, are equally crucial. What seems to be confirmed is that tricuspid regurgitation treatment with clips effectively complements medical therapy and is a therapeutic option that must be recognised, as overlooking tricuspid regurgitation in our patients should be avoided at all costs.”
Implication
Baseline invasive hemodynamics, particularly right atrial pressure, pulmonary capillary wedge pressure, and pulmonary artery pulsatility index, appear to modify the clinical benefit of transcatheter tricuspid edge-to-edge repair in patients with severe tricuspid regurgitation.
Abstract
Background Clinical response to transcatheter tricuspid edge-to-edge repair (T-TEER) varies considerably among patients with severe tricuspid regurgitation (TR). We explored whether baseline invasive haemodynamics were associated with variation in treatment response. Methods This prespecified exploratory post hoc analysis of the TRI-FR randomised trial included 300 patients assigned to T-TEER plus guideline-directed medical therapy (GDMT) or GDMT alone. The primary endpoint was a 1-year hierarchical clinical composite integrating New York Heart Association class, patient global assessment, cardiovascular death and heart failure hospitalisation. Treatment-effect modification was assessed for right atrial mean pressure (RAP), pulmonary capillary wedge pressure (PCWP), Pulmonary Artery Pulsatility Index (PAPi), tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure and cardiac output. Secondary exploratory endpoints included Kansas City Cardiomyopathy Questionnaire overall summary score and 6-minute walk distance. Results T-TEER improved the primary endpoint. Exploratory interaction analyses suggested treatment-effect modification by RAP (p=0.035), PCWP (p=0.013) and PAPi (p=0.040), whereas TAPSE/systolic pulmonary artery pressure and cardiac output did not. In descriptive tertile analyses, lower filling pressures (RAP ≤6 mm Hg or PCWP ≤11 mm Hg) and higher PAPi (≥3.22) were associated with larger between-group differences. PCWP and RAP showed exploratory interactions for quality of life and exercise capacity. These analyses describe heterogeneity in average treatment response and do not establish individual-benefit thresholds. Conclusions Baseline filling pressures and pulmonary artery pulsatility were associated with variation in clinical response to T-TEER. These exploratory findings suggest that haemodynamic disease stage may influence treatment response and warrant prospective validation. Trial registration number NCT04646811.
Discussion
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Cite This Study
Donal et al. (2026) conducted an RCT in Severe tricuspid regurgitation (n=300). Transcatheter tricuspid edge-to-edge repair (T-TEER) plus guideline-directed medical therapy (GDMT) vs. Guideline-directed medical therapy (GDMT) alone was evaluated on 1-year hierarchical clinical composite integrating New York Heart Association class, patient global assessment, cardiovascular death and heart failure hospitalisation. Treatment response to T-TEER was modified by baseline right atrial mean pressure (p=0.035), pulmonary capillary wedge pressure (p=0.013), and pulmonary artery pulsatility index (p=0.040).