ACURATE neo2 vs. Approved TAVR Devices in All-Risk Patients With Severe AS - ACURATE IDE

Oct 30, 2024
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Boston Scientific
Date Presented:
10/30/2024
Date Published:
10/30/2024
Original Posted Date:
10/30/2024
References

Contribution To Literature:

The ACURATE IDE trial failed to demonstrate that the Acurate neo2 valve was noninferior to a commercially available valve.

Description:

The goal of the trial was to evaluate the Acurate neo2 self-expanding valve compared with a commercially available valve (Sapien or Evolut) among patients with aortic stenosis across the risk spectrum.

The Acurate neo valve has a self-expanding platform with open cells for unrestricted coronary access, outer skirt to prevent paravalvular leak, and axial stabilization arches to stabilize valve position.

Study Design

  • Randomized
  • Parallel

Patients with severe aortic stenosis were randomized to the Acurate neo2 self-expanding valve (n = 752) vs. a commercially available valve (n = 748; Sapien in 504 and Evolut in 244).

  • Total number of enrollees: 1,500
  • Duration of follow-up: 12 months
  • Mean patient age: 78 years
  • Percentage female: 53%
  • Percentage with diabetes: 32%

Inclusion criteria:

  • Symptomatic severe aortic stenosis
  • Aortic annulus size 21-27 mm

Exclusion criteria:

  • Bicuspid valve
  • Pre-existing prosthetic aortic or mitral valve
  • Severe aortic, mitral, or tricuspid regurgitation
  • Severe left ventricular systolic dysfunction
  • Severe calcification of aortic annulus
  • Hypertrophic cardiomyopathy
  • Severe vascular disease
  • Acute myocardial infarction within the last month
  • Stroke or transient ischemic attack within the last 6 months
  • Renal insufficiency
  • Endocarditis within the last 6 months
  • Hemodynamic or respiratory instability
  • Untreated coronary artery disease

Other salient features/characteristics:

  • 72% of physicians implanted five or fewer cases over the course of the trial (only 10% of implanters performed >10 cases)
  • Embolic protection device, 32%

Principal Findings:

The primary outcome, death, stroke, or rehospitalization, was: 14.8% in the Acurate neo2 group vs. 9.1% in the conventional TAVR group (posterior median difference = 6.6%, noninferiority margin = 8.0%; therefore, noninferiority was not achieved).

Secondary outcomes:

  • Mortality: 5.0% in the Acurate neo2 group vs. 3.9% in the conventional TAVR group
  • Stroke: 5.7% in the Acurate neo2 group vs. 3.4% in the conventional TAVR group
  • Rehospitalization: 5.3% in the Acurate neo2 group vs. 3.5% in the conventional TAVR group
  • Echo-derived mean gradient: 8.0 mm Hg in the Acurate neo2 group vs. 11.6 mm Hg in the Sapien group vs. 7.0 mm Hg in the Evolut group
  • Mild paravalvular regurgitation at discharge: 23% in the Acurate neo2 group vs. 6.7% in the Sapien group vs. 28% in the Evolut group
  • Moderate paravalvular regurgitation at discharge: 1.0% in the Acurate neo2 group vs. 0% in the Sapien group vs. 0.8% in the Evolut group
  • Severe paravalvular regurgitation at discharge: 0.1% in the Acurate neo2 group vs. 0% in the Sapien group vs. 0% in the Evolut group
  • Valve under-expansion present in ~20% of Acurate neo2 group: among this group the primary outcome occurred in 18.8% of those with an under-expanded valve vs. 12.4% of those with a well-expanded valve (p = 0.05)

Interpretation:

Among patients with severe aortic stenosis, the Acurate neo2 valve failed to demonstrate noninferiority compared with a commercially available valve (Sapien or Evolut). Mortality, stroke, and rehospitalization tended to be higher in the Acurate neo2 group vs. the conventional TAVR group. Transvalvular gradients were relatively low with this platform (8.0%); however, there was a relatively high incidence of paravalvular regurgitation (mild 23%, moderate 1.0%, severe 0.1%). Part of the mechanism for the treatment difference may have been due to valve frame under-expansion, which was present in ~20% of the Acurate neo2 group.

References:

Presented by Dr. Michael J. Reardon at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 30, 2024.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, TCT24, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics


< Back to Listings