Multicentric Randomized Evaluation of Tricuspid Valve Percutaneous Repair System (Clip for the Tricuspid Valve) in the Treatment of Severe Secondary Tricuspid Disorders - TRI.Fr

Aug 31, 2024
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
French Ministry for Health (PHRC-N)
Date Presented:
08/31/2024
Date Published:
08/31/2024
Original Posted Date:
08/31/2024
References

Contribution To Literature:

The TRI.Fr trial showed that among patients with ≥ severe symptomatic TR, T-TEER with TriClip + GDMT was superior to GDMT alone in improving patient symptoms, KCCQ score, and the severity of TR.

Description:

The goal of the trial was to assess the efficacy and safety of tricuspid transcatheter edge-to-edge repair (T-TEER) + guideline-directed medical therapy (GDMT) compared with GDMT alone among patients with symptomatic ≥ severe tricuspid regurgitation (TR).

Study Design

Patients with ≥ severe TR who were already on GDMT were randomized to receive T-TEER + GDMT (n = 152) versus GDMT (n = 148) alone. T-TEER was pursued with Abbott’s TriClip device.

  • Total number of enrollees: 300
  • Duration of follow-up: 1 year
  • Mean patient age: 78 years
  • Percentage female: 54%

Inclusion criteria:

  • Age ≥18 years
  • Symptomatic secondary (at least) severe TR (Carpentier Type IIIB [restrictive] and/or I [tricuspid annulus dilation]) stable for ≥30 days
  • New York Heart Association (NYHA) functional class II-IV heart failure without cirrhosis and/or ascites
  • Signs of heart failure in the previous 12 months with or without having been hospitalized
  • Stable optimized medical and/or interventional treatment
  • Ineligible for corrective action on the valve by surgical approach after a specialized multidisciplinary consultation (“heart team”) including at least a cardiothoracic surgeon, an interventional cardiologist, an imaging cardiologist, and an anesthesiologist
  • Central core laboratory analysis: TR characterized before implantation by at least one of the following criteria:
    • Regurgitation volume >45 mL/beat
    • Surface of the regurgitant orifice >40 mm²
    • Vena contracta >7 mm
    • Gap between leaflets ≤10 mm (at the presumed location of the clip)

Exclusion criteria:

  • Patient treated with MitraClip or other percutaneous approach on the mitral valve in the past 3 months
  • Any prior tricuspid valve procedure that would interfere with placement of the TriClip device
  • Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, or sufficient reduction in TR
  • Myocardial infarction or coronary bypass surgery in the past 3 months
  • Left ventricular ejection fraction ≤35%
  • Cardiac resynchronization therapy for <3 months and having a TR that is clearly related to the right ventricular lead positioning
  • Cardioversion for <6 weeks
  • Life expectancy irrespective of the valvular heart disease <1 year (due to comorbidities)
  • Other scheduled cardiac surgery (including registration in cardiac transplant list)
  • Coronary angioplasty in the preceding month
  • Current infection requiring prescription of antibiotics
  • End-stage renal failure (dialysis patient)
  • Severe hepatic insufficiency (disruption of liver metabolism associated with coagulation disorders (factor V <50%)
  • Stroke in the previous 3 months
  • Uncontrolled pre-capillary pulmonary hypertension (right catheterization required) (systolic pulmonary pressure >60 mm Hg)
  • Tricuspid prosthetic valve
  • Pacemaker lead or ICD lead that would prevent appropriate placement of the TriClips

Principal Findings:

The primary outcome, improvement in Milton Packer clinical composite score at 1 year (classifies each patient into 1 of 3 categories [improved, worsened, unchanged], and is determined aggregating evaluation functional using NYHA class, quality-of-life score using patient global assessment, and number of major cardiovascular events) for TriClip + GDMT vs. GDMT, was 74.1% vs. 40.6% (effect estimate: 0.67, 95% confidence interval [CI] 0.61-0.72; p < 0.0001).

Secondary outcomes at 1 year for TriClip + GDMT vs. GDMT:

  • TR grade <4+: 93.2% vs. 46.5% (p < 0.001)
  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline: 70.4 vs. 55.0 (p < 0.0001)
  • Patient global assessment improved: 74.6% vs. 39.5% (p < 0.0001)
  • Hierarchical composite endpoint of time to death or tricuspid valve surgery, or heart failure hospitalizations, and improvement of ≥15 points in KCCQ score at 1 year: hazard ratio 2.06, 95% CI 1.38-3.08 (p = 0.0004)
  • All-cause mortality: 15.6% vs. 20% (p = 0.38)

Interpretation:

Among patients with ≥ severe symptomatic TR, T-TEER with TriClip + GDMT was superior to GDMT alone in improving patient symptoms, KCCQ score, and the severity of TR. Patients were deemed to be high risk or inoperable by the heart team. These are important results, and overall fairly similar to those noted in the TRILUMINATE pivotal trial. Unlike that trial, the current trial was not sponsored by industry. No clear improvement in hard endpoints was noted with T-TEER. The exact role of T-TEER among patients with ≥ severe TR, the right patient population, appropriate timing, cost-effectiveness, and comparison with transcatheter tricuspid valve replacement are some of the issues that will need to be assessed in future studies.

References:

Presented by Dr. Erwan Donal at the European Society of Cardiology Congress, London, UK, August 31, 2024.

Clinical Topics: Heart Failure and Cardiomyopathies, Valvular Heart Disease, Acute Heart Failure

Keywords: Heart Failure, Heart Valve Diseases, Tricuspid Valve Insufficiency, ESC Congress, ESC24


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