Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial - CLASP IID

Oct 26, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
Edwards Lifesciences
Date Presented:
10/26/2023
Date Published:
10/26/2023
Date Updated:
10/26/2023
Original Posted Date:
09/17/2022
References

Contribution To Literature:

Highlighted text has been updated as of October 26, 2023.

The CLASP IID trial showed that transcatheter mitral edge-to-edge repair with the PASCAL system is noninferior to MitraClip for major adverse events among patients with degenerative MR and prohibitive surgical risk.

Description:

The goal of the trial was to assess the safety and efficacy of the PASCAL system compared with the MitraClip among patients with degenerative mitral regurgitation (MR) who were at prohibitive surgical risk.

Study Design

Eligible patients were randomized in a 2:1 fashion to either PASCAL (n = 117) or MitraClip (n = 63). Patients had to be anatomically suitable for both devices. PASCAL was available in two sizes (original and narrow Ace). In the MitraClip arm, about 39% received third-generation devices (NT, NTR, XTR) and the rest received fourth-generation devices (NT, NTW, XT, XTW).

  • Total number of enrollees: 180
  • Duration of follow-up: 6 months
  • Mean patient age: 81 years
  • Percentage female: 33%

Inclusion criteria:

  • Age ≥18 years
  • 3+ or 4+ degenerative MR by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE) as assessed by the echocardiographic core laboratory
  • Mitral valve transcatheter edge-to-edge repair (M-TEER) candidate suitable for both the PASCAL system and the MitraClip system
  • Deemed prohibitive surgical risk by the local heart team including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease     

Exclusion criteria:

  • Contraindication for TEE or unsuccessful screening TEE
  • Mitral valve anatomy which may preclude proper access, use, and/or deployment of either device

Other salient features/characteristics:

  • Median Society of Thoracic Surgeons–Predicted Risk of Mortality (STS PROM) for replacement: 5.4%
  • Atrial fibrillation: 58%
  • Heart failure hospitalization within 1 year: 37%
  • MR 4+: 77%
  • Effective regurgitant orifice area: 0.5 cm2, left ventricular (LV) end-systolic dimension: 39 mm, LV end-diastolic dimension: 57 mm, tricuspid regurgitation ≥3+: 3.5%; LV ejection fraction: 59%
  • Mean number of implanted devices: 1.5

Principal Findings:

The primary safety endpoint, major adverse events (cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and nonelective mitral valve re-intervention [either percutaneous or surgical]) for 30 days, for PASCAL vs. MitraClip, was: 3.4% vs. 4.8% (p for noninferiority < 0.05). Cardiovascular mortality was: 0.9% vs. 1.6%.

Secondary outcomes for PASCAL vs. MitraClip:

  • Major adverse events at 6 months: 6.1% vs. 11.1%
  • All-cause mortality or heart failure hospitalization at 12 months: 6.9% vs. 7.9% (p = 0.78)
  • MR ≤2+ at 6 months: 97.7% vs. 98.1%; MR ≤1 at 6 months: 83.7% vs. 71.2%
  • Mean mitral gradient: 3.7 mm Hg vs. 3.4 mm Hg (p > 0.05)
  • New York Heart Association (NYHA) class I/II at 6 months: 86.1% vs. 94.6%
  • Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OS) at 6 months: 74 vs. 79 (p = 0.16)

One-year outcomes for PASCAL vs. MitraClip:

  • Follow-up available for 91.5% vs. 94.3%
  • Echocardiogram available for 82.5% vs. 93.2%
  • MR ≤2+ at 6 months: 97.9% vs. 95.7% (p > 0.05)
  • MR ≤2+ at 12 months: 95.8% vs. 93.8% (p > 0.05)
  • MR ≤1+ at 12 months: 77.1% vs. 71.3% (p > 0.05)
  • Freedom from major adverse events at 1 year: 84.7% vs. 88.3% (p = 0.47)
  • Heart failure hospitalization at 1 year: 8.1% vs. 3.3% (p = 0.15)
  • All-cause mortality: 8.8% vs. 8.4% (p = 0.95)
  • NYHA class I/II at 12 months: 88.3% vs. 86.8% (p = 0.83)

Interpretation:

The results of this trial indicate that transcatheter mitral edge-to-edge repair with the PASCAL system is noninferior to MitraClip for major adverse events among patients with degenerative MR and prohibitive surgical risk. Echocardiographic results at 6 months seemed similar as well. Results appear durable at 1 year, within the limitation of somewhat greater attrition in follow-up rates for PASCAL vs. MitraClip. These are important results and led to Food and Drug Administration approval for use of the PASCAL device in the United States for this indication. Long-term results and cost differences, if any, are awaited. Data among functional MR patients are also awaited.

References:

Zahr F, Smith RJ, Gillam LD, et al., on behalf of the CLASP IID Pivotal Trial Investigators. One-Year Outcomes From the CLASP IID Randomized Trial for Degenerative Mitral Regurgitation. JACC Cardiovasc Interv 2023;Oct 26:[Epublished].

Editorial Comment: Rogers JH. Head-to-Head Transcatheter Mitral Edge-to-Edge Repair. JACC Cardiovasc Interv 2023;Oct 26:[Epublished].

Presented by Dr. Firas Zahr at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2023), San Francisco, CA, October 26, 2023.

Lim DS, Smith RL, Gillam LD, et al., on behalf of the CLASP IID Pivotal Trial Investigators. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv 2022;15:2523-36.

Presented by Dr. Konstantinos P. Koulogiannis at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 17, 2022.

Clinical Topics: Valvular Heart Disease, Invasive Cardiovascular Angiography and Intervention

Keywords: Heart Valve Diseases, Structural Intervention, TCT23, Transcatheter Cardiovascular Therapeutics


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