Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation - SCOPE 2

Oct 15, 2020
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
CERIC Sàrl and Symetis SA
Date Presented:
10/15/2020
Date Published:
10/15/2020
Original Posted Date:
10/15/2020
References

Contribution To Literature:

In the SCOPE 2 trial, TAVR with the Acurate neo valve did not meet criteria for noninferiority compared with CoreValve Evolut valve for treatment of symptomatic severe aortic stenosis in mostly intermediate-risk patients.

Description:

The goal of the trial was to compare the safety and efficacy of TAVR with two self-expanding supra-annular valves, Acurate neo vs. CoreValve Evolut, among patients with severe aortic stenosis undergoing transfemoral TAVR.

Study Design

Eligible patients were randomized in a 1:1 fashion to transfemoral TAVR with either Boston Scientific’s Acurate neo (n = 398) or Medtronic’s CoreValve Evolut (n = 398).

  • Total number of enrollees: 796
  • Duration of follow-up: 1 year
  • Mean patient age: 83 years
  • Percentage female: 68%

Inclusion criteria:

  • Age ≥75 years
  • Severe symptomatic aortic stenosis
  • High risk for surgical AVR (SAVR) based on risk scores and/or heart team recommendation
  • Aortic annulus dimensions and peripheral access suitable for either device

Exclusion criteria:

  • Congenital or noncalcific anomaly of aortic valve, or unicuspid or bicuspid valve
  • Severe left ventricular dysfunction
  • Left-sided prosthetic valve
  • Active infection
  • Severe eccentric calcification
  • Severe coagulation disorder

Other salient features/characteristics:

  • Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) score: 4.6%
  • Annulus perimeter: 73.5 mm, aortic annulus area: 425 mm2
  • General anesthesia: 13%
  • Predilation: 79% (Acurate neo) vs. 41% (CoreValve Evolut)

Principal Findings:

The primary endpoint, death or stroke at 1 year, for Acurate neo vs. CoreValve Evolut, was 15.8% vs. 13.9% (p = 0.055 for noninferiority).

  • All-cause mortality: 13% vs. 9% (p = 0.13)
  • Stroke: 5% vs. 6% (p = 0.33)

Secondary outcomes for Acurate neo vs. CoreValve Evolut:

  • New pacemaker implantation: 11% vs. 18% (p = 0.004)
  • Cardiac death: 8% vs. 4% (p = 0.01)
  • Access site complication: 9% vs. 6% (p = 0.22)
  • ≥ Mild paravalvular leak at 30 days: 72.8% vs. 55.1% (p < 0.0001)

Interpretation:

The results of this trial indicate that TAVR with the Acurate neo valve did not meet criteria for noninferiority compared with CoreValve Evolut valve for treatment of symptomatic severe aortic stenosis in mostly intermediate-risk patients. Both are self-expanding, supra-annular valves with porcine pericardial leaflets. Cardiac death and paravalvular leak were higher with Acurate neo, while pacemaker rates were lower.

These data represent one of the few head-to-head comparisons between TAVR valves, and are important for the field. In the SCOPE-1 trial, Acurate neo was inferior to Sapien S3 for the primary endpoint. Although widely used outside the United States, the Acurate neo valve is not currently Food and Drug Administration (FDA) approved in the United States.

References:

Capodanno D, Tamburino C, Bleiziffer S, et al. Comparison of self-expanding bioprostheses for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: the SCOPE 2 randomized clinical trial. Circulation 2020;Oct 15:[Epub ahead of print].

Presented by Dr. Corrado Tamburino at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 15, 2020.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Stroke, Transcatheter Aortic Valve Replacement, TCT20, Transcatheter Cardiovascular Therapeutics


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