EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device - TRISCEND II

Oct 30, 2024
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Edwards Lifesciences
Date Presented:
10/30/2024
Date Published:
10/30/2024
Original Posted Date:
10/30/2024
References

Contribution To Literature:

The TRISCEND II trial showed that among patients with severe symptomatic TR, orthotopic TTVR using the Evoque valve along with medical therapy is superior to medical therapy alone in improving cardiovascular outcomes, primarily through improvements in symptoms and measures of QoL with no differences in mortality or HF hospitalization.

Description:

The goal of the trial was to assess the safety and efficacy of Evoque transcatheter tricuspid valve replacement (TTVR) among patients with symptomatic severe tricuspid regurgitation (TR).

Study Design

Patients on appropriate guideline-directed medical therapy were randomized in a 2:1 fashion to orthotopic TTVR using Evoque (n = 267) vs. control (n = 133). This had an open-label design.

Evoque was available in four sizes in the trial: 44, 48, 52, and 56 mm.

  • Total number of enrollees: 400
  • Duration of follow-up: 1 year
  • Mean patient age: 79 years
  • Percentage female: 76%

Inclusion criteria:

  • At least severe functional and/or degenerative TR
  • Signs or symptoms of TR despite optimal medical therapy (stable oral diuretic medications, unless the patient has a documented history of intolerance) or previous heart failure (HF) hospitalization for TR
  • Anatomy suitable for Evoque valve

Exclusion criteria:

  • Left ventricular ejection fraction (LVEF) <25%
  • Severe right ventricular (RV) dysfunction
  • Pacemaker dependency without alternative pacing option
  • Previous tricuspid surgery or intervention
  • Prior heart transplantation
  • Estimated glomerular filtration rate (eGFR) ≤25 mL/min/1.73 m2 or required chronic renal replacement therapy
  • Anatomy precluding proper device delivery, deployment, and/or function

Other salient features/characteristics:

  • Mean Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) for mitral valve repair/replacement: 7/10
  • New York Heart Association (NYHA) class III/IV: 71%
  • Prior cardiac implantable electronic device: 39%
  • eGFR: 53 mL/min/1.73 m2, chronic kidney disease stage II-V: 57%
  • LVEF: 54%
  • Etiology of TR: secondary/mixed: 82%
  • Mean pulmonary artery pressure: 38 mm Hg

Principal Findings:

The primary, hierarchical composite endpoint (all-cause mortality, RV assist device [RVAD] implantation or transplant, surgical or percutaneous tricuspid valve intervention, HF hospitalization, Kansas City Cardiomyopathy Questionnaire-overall summary score [KCCQ-OS] >10 points, NYHA >1 class, 6-minute walk distance [6MWD] >30 m) for Evoque vs. control, was: win ratio 2.02, 95% confidence interval (CI) 1.56-2.62, p < 0.0001.

Secondary outcomes for Evoque vs. control at 1 year:

  • All-cause mortality: 12.6% vs. 15.2%, p > 0.05
  • HF hospitalization: 20.9% vs. 26.1%, p > 0.05
  • All-cause mortality or HF hospitalization: 28.4% vs. 33.3%, p > 0.05
  • TR, none/trace: 72.6% vs. 0%; mild: 22.6% vs. 2.3%, moderate: 3.8% vs. 13.8%, ≥ severe: 0.9% vs. 83.9%
  • 1-year severe bleeding: 15.4% vs. 5.3%, p = 0.003
  • New permanent pacemaker: 17.4% vs. 2.3%, p < 0.001

Quality of life (QoL):

  • KCCQ-OS at 1 year: 72.4 vs. 54.7, between-group difference: 17.8, 95% CI 13.0-22.5, p < 0.001
  • KCCQ-total symptoms at 1 year: 75.5 vs. 58.7, between-group difference: 16.8, 95% CI 11.7-21.8, p < 0.001
  • At 1 year, patients alive with a large improvement in KCCQ-OS ≥20 points: 39.5% vs. 19.5%, p < 0.001; number needed to treat = 5.0)
  • Medical outcomes study (MOS) Short Form (SF)-36 physical component: 40.4 vs. 36.2, between-group difference: 4.3, 95% CI 2.3-6.2, p < 0.001
  • 6MWD change ≥30 meters: 47.6% vs. 31.8%, p < 0.05
  • Greater improvements in KCCQ-OS were noted among patients with greater baseline TR (p for interaction = 0.049), RV fractional area shortening ≥35% (p for interaction = 0.013), and greater functional capacity at baseline (6MWD ≥238.5 m, p for interaction = 0.016).

Interpretation:

The results of this trial indicate that among patients with severe symptomatic TR, orthotopic TTVR using the Evoque valve along with medical therapy is superior to medical therapy alone in improving cardiovascular outcomes, primarily through improvements in symptoms and measures of QoL with no differences in mortality or HF hospitalization. Dramatic improvements in TR were noted, with <5% having residual ≥ moderate TR at 1 year. Bleeding risk and need for permanent pacemaker were higher with Evoque. The largest QoL benefit appeared to be among those with massive/torrential TR, greater functional capacity, and better RV function at baseline.

Results from TRILUMINATE for T-TEER and TRISCEND II for TTVR are concordant and suggest that the benefit is primarily in QoL, with no differences in mortality or HF hospitalization. TR reduction is greater with TTVR; head-to-head comparisons will be important going forward.

References:

Hahn RT, Makkar R, Thourani VH, et al., for the TRISCEND II Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med 2024;Oct 30:[Epub ahead of print].

Editorial: O’Gara PT. Early-Stage Results With Transcatheter Tricuspid-Valve Replacement. N Engl J Med 2024;Oct 30:[Epub ahead of print].

Arnold SV, Hahn RT, Thourani VH, et al., for the TRISCEND II Pivotal Trial Investigators. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol 2024;Oct 30:[Epub ahead of print].

Presented by Drs. Susheel K. Kodali and Suzanne V. Arnold at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 30, 2024.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Quality of Life, TCT24, Transcatheter Cardiovascular Therapeutics, Tricuspid Valve


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