Acurate neo vs. Sapien 3 Transcatheter Heart Valve System in Patients With Symptomatic Severe Aortic Stenosis - SCOPE I

Sep 17, 2022
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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:
Boston Scientific
Date Presented:
09/17/2022
Date Published:
09/27/2019
Date Updated:
09/17/2022
Original Posted Date:
09/27/2019
References

Contribution To Literature:

Highlighted text has been updated as of September 17, 2022.

The SCOPE I trial showed that TAVR with the self-expanding Acurate neo valve did not meet criteria for noninferiority at 30 days compared with the balloon-expandable Sapien 3 valve among patients undergoing transfemoral TAVR.

Description:

The goal of the trial was to compare the safety and efficacy of transcatheter aortic valve replacement (TAVR) with the balloon-expandable Sapien 3 to the self-expanding Acurate neo valves among intermediate to high surgical risk patients with severe aortic stenosis undergoing transfemoral TAVR.

Study Design

Eligible patients were randomized in a 1:1 fashion to transfemoral TAVR with either Acurate neo (n = 372) or Sapien 3 (n = 367).

  • Total number of enrollees: 739
  • Duration of follow-up: 30 days, 1 year
  • Mean patient age: 83 years
  • Percentage female: 57%

Inclusion criteria:

  • Age ≥75 years
  • Aortic valve area (AVA) <1 cm2
  • Clinical symptoms (> New York Heart Association [NYHA] class I, angina, syncope)
  • Inoperable or at increased risk for surgical AVR based on risk scores and/or heart team recommendation
  • Aortic annulus dimensions and peripheral access suitable for either device

Exclusion criteria:

  • Congenital anomaly of aortic valve
  • Emergency procedures
  • Left ventricular ejection fraction <20%
  • Left-sided prosthetic valve
  • Concomitant planned procedure (except for percutaneous coronary intervention)
  • Stroke or myocardial infarction (previous 30 days)
  • Planned noncardiac surgery (next 30 days)

Other salient features/characteristics:

  • Median Society of Thoracic Surgeons-Predicted Risk of Mortality (STS-PROM) score: 3.5%
  • Intermediate risk: 55%; high-risk: 8%

Principal Findings:

The primary endpoint of death/stroke/bleeding/vascular complications/coronary obstruction/acute kidney injury (AKI)/rehospitalization/repeat intervention/valve dysfunction, for Acurate neo vs. Sapien 3, was 23.7% vs. 16.5% (p = 0.42 for noninferiority, p = 0.016 for superiority).

  • All-cause mortality: 2.5% vs. 0.8% (p = 0.09)
  • Stroke: 1.9% vs. 3.0% (p = 0.33)
  • Major vascular complications: 7.9% vs. 5.5% (p = 0.21)
  • AKI: 3.0% vs. 0.8% (p = 0.03)
  • Valve-related dysfunction: 9.7% vs. 4.7% (p = 0.0084)

Secondary outcomes for Acurate neo vs. Sapien 3:

  • Contrast volume: 128 vs. 100 cc (p < 0.0001)
  • Need for multiple valves during implant: 3% vs. 1% (p = 0.012)
  • New pacemaker implantation: 11.5% vs. 10.3% (p = 0.68)
  • 30-day paravalvular leak ≥ moderate: 9.4% vs. 2.8% (p < 0.0001)
  • 30-day mean gradient: 7 vs. 11 mm Hg (p < 0.0001) 

One-year follow-up for Acurate neo vs. Sapien 3:

  • All-cause mortality or disabling stroke: 12% vs. 9.4% (p > 0.05)
  • All-cause mortality: 10.9% vs. 8.3% (p = 0.25)
  • Valve thrombosis: 0% vs. 0.9% (p > 0.05)
  • Mean gradients on echo: 7.2 vs. 11.5 mm Hg (p < 0.001)
  • Moderate/severe paravalvular leak: 8.9% vs. 3.6% (p = 0.006)

Three-year outcomes: All-cause mortality for Acurate neo vs. Sapien S3, was: 23.7% vs. 24.5% (p > 0.05).

  • CV death: 16.8% vs. 16.8% (p > 0.05)
  • Hospitalization for valve-related dysfunction or heart failure: 13.9% vs. 18.1% (hazard ratio 0.74, 95% confidence interval 0.51-1.07, p > 0.05)
  • NYHA class III or IV: 15.2% vs.16.4% (p > 0.05)
  • Echocardiography mean gradient: 8.0 vs. 12.1 mm Hg (p < 0.001)
  • AVA on echocardiography: 1.69 vs. 1.95 cm2 (p = 0.011)
  • Structural valve degeneration: 0.4% vs. 2.9%
  • Valve thrombosis: 0.3% vs. 1.8%

Interpretation:

The results of this trial indicate that TAVR with the self-expanding Acurate neo valve did not meet criteria for noninferiority compared with the balloon-expandable Sapien 3 valve among intermediate to high surgical risk patients undergoing transfemoral TAVR. In fact, TAVR with Sapien 3 was superior for the composite 30-day endpoint, driven primarily by lower rates of AKI, paravalvular regurgitation, and vascular complications. The Acurate neo valve had lower transvalvular gradients and a larger effective orifice area (EOA). These results were more or less sustained on 1-year follow-up. At 3 years, these short-term differences did not translate into a difference in clinical outcomes. Gradients remained lower with the Acurate neo valve at 3 years, although echocardiograms beyond 30 days were not core-lab adjudicated.

These data represent one of the few head-to-head comparisons between TAVR valves, and are important for the field. Longer-term outcomes are eagerly awaited. The Acurate neo valve is not currently Food and Drug Administration (FDA) approved in the United States.

References:

Presented by Dr. Jonas Lanz at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 17, 2022.

Presented by Dr. Thomas Walther at the Transcatheter Cardiovascular Therapeutics Virtual Meeting (TCT Connect), October 17, 2020.

Lanz J, Kim WK, Walther T, et al. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet 2019;394:1619-28.

Presented by Dr. Jonas Lanz at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2019), San Francisco, CA, September 27, 2019.

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

Keywords: Acute Kidney Injury, Aortic Valve Stenosis, Cardiac Surgical Procedures, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemorrhage, Stroke, Syncope, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics, TCT19, TCT20, TCT22, Vascular Diseases


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