Self-expanding valve TAVR

Clinical Trial Details

Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

Key Findings

The composite of death, stroke, and rehospitalization was lower with transcatheter aortic valve replacement compared to surgery for low-risk patients with severe, symptomatic AS.

Purpose: To compare the safety and efficacy of self-expanding transcatheter aortic valve replacement (TAVR) to surgical valve replacement in patients with severe aortic stenosis (SAVR).

Trial Design: 1468 patients with severe aortic stenosis. Average age 74 years. Pre-market, international , multi-center (86), interventional trial. 1468 patients with severe aortic stenosis with surgical risk were randomized 1:1 to a TAVR self-expanding device (CoreValve, Evolut R or Evolut PRO) or to surgical aortic valve replacement using bioprostheic valves.

Primary Endpoint: All-cause mortality or disabling stroke.

Results: Self-expanding TAVR was non-inferior to surgical aortic valve replacement in low surgical risk patients with sever aortic stenosis.

Self-Expanding TAVR vs SAVR
 30 days1 year24 months
All-cause mortality or disabling strokeTAVR 0.8%
SAVR 2.6%
TAVR 2.9%
SAVR 4.6%
TAVR 5.3%
SAVR 6.7%
All-cause mortalityTAVR 0.5%
SAVR 1.3%
TAVR 2.4%
SAVR 3%
 
Disabling strokeTAVR 0.5%
SAVR 1.7%
TAVR 0.8%
SAVR 2.4%
TAVR 1.1%
SAVR 3.5%

Self-Expanding transcatherter or surgical AVR in severe AS patients at low surgical risk

Michael Reardon, MD, breaks down the results of this trial comparing TAVR with a self-expanding transcather with surgery in patients at low risk of mortality.

Background

This trial compares the safety and efficacy of self-expanding transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement in patients with severe aortic stenosis (SAVR).

Trial design: Pre-market, international, multi-center (86), interventional trial. 1468 patients with severe aortic stenosis with surgical risk were randomized 1:1 to a TAVR self-expanding device (CoreValve, Evolut R or Evolut PRO) or to surgical aortic valve replacement using bioprosthetic valves.

Trial population: 1468 patients with severe aortic stenosis. Average age 74 years.

Primary endpoints: all-cause mortality or disabling stroke.

Secondary endpoints:

  • Composite: death, disabling stroke, life-threatening bleed, major vascular complication, or AKI at 30 days
  • Patients with new permanent pacemaker at 30 days
  • Patients with prosthetic valve endocarditis at 30 days
  • Prosthetic valve thrombosis at 1 year
  • Stroke at 1 year
  • Life-threatening bleed at 1 year
  • Valve-related dysfunction requiring repeat procedure at 1 year
  • QOL at 30 days and 1 year
  • Repeat hospitalization for signs and symptoms of aortic valve disease

Results:

Primary endpoints:

  • 30 days:
    • Combined all-cause mortality or disabling stroke: TAVR 0.8%, SAVR 2.6%
    • All-cause death: TAVR 0.5%, SAVR 1.3%
    • Disabling stroke: TAVR 0.5%, SAVR 1.7%
     
  • 1 year:
    • All-cause mortality: TAVR 2.4%, SAVR 3%
     
  • 24 months (estimated):
    • All-cause mortality: TAVR 4.5%, SAVR 4.5%
    • Disabling stroke: TAVR 1.1%, SAVR 3.5%

Secondary endpoints:

  • 30 days:
    • Bleeding complications: TAVR 2.4%, SAVR 7.5%
    • AF: TAVR 7.7%, SAVR 35.4%
    • Acute kidney injury: TAVR 0.9%, SAVR 2.8%
    • Severe aortic regurgitation: TAVR 3.5%, SAVR 0.5%
    • Pacemaker implantation: TAVR 17.4%, SAVR 6.1%
       
  • 1 year:
    • Major stroke: TAVR 0.8%, SAVR 2.4%
    • HF hospitalization: TAVR 3.2%, SAVR 6.5%

Principal Investigators

  • Jeffrey Popma, MD, Beth Israel Deaconess Medical Center
  • Michael Reardon, MD, The Methodist Hospital System

Sponsors and collaborators: Medtronic Cardiovascular

References

Key Words
aortic stenosis, TAVR, Sapien 3, calcific aortic stenosis, heart disease, ventricular outflow obstruction, valve disease, transcatheter valve replacement

Related Clinical Topics
Surgery, intervention, general cardiology

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