PARTNER 3

Clinical Trial Details

The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

The purpose of this trial is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).

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.

PARTNER 3 Trial

Martin Leon, MD and Michael Mack, MD provide an overview of the results of PARTNER 3 which were presented at ACC 2019 in New Orleans.


Swipe table left to see full data

PARTNER 3
 TAVRSurgeryP
Composite:
all-cause mortality, stroke, rehospitalization
8.5%15.1%0.001
Stroke0.6%2.4%0.02
Death or stroke1%3.3%0.01


Purpose: To compare the safety and efficacy of transcatheter heart valve replacement to surgical valve replacement in low surgical risk patients who require aortic valve replacement because of severe calcific aortic stenosis.

Trial Design: Safety and efficacy, controlled, multi-center, prospective trial; 1,000 patients with severe symptomatic aortic stenosis and low risk for surgical aortic valve replacement, randomized 1:1 to transcatheter heart valve replacement (TAVR) (Edwards SAPIEN 3) or aortic valve replacement with a surgical bioprosthetic valve. Follow up at discharge, 30 days, 6 months, and annually for 10 years.

Primary Endpoints: All-cause mortality, stroke, re-hospitalization at 1 year.

Results: 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.

Background

The PARTNER 3 trial compares the safety and efficacy of transcatheter aortic heart valve replacement to surgical valve replacement in low surgical risk patients who require aortic valve replacement because of severe, symptomatic aortic stenosis.

Trial design: safety and efficacy, controlled, multi-center, prospective trial; patients at low risk for surgical aortic valve replacement, randomized1:1 to transcatheter heart valve replacement (TAVR) (Edwards SAPIEN 3) or aortic valve replacement with a surgical bioprosthetic valve. Follow up at discharge, 30 days, 6 months and annually for 10 years.

Trial population: 1000 patients with severe, symptomatic calcific aortic stenosis at low operative risk for surgical aortic valve replacement (AVR). Average age 73.4 years; 67.5% men; 32.5% women.

Primary endpoints: at 1 year, composite of all-cause mortality, stroke, re-hospitalization

Secondary endpoints:

  • Length of hospitalization for procedure
  • QOL
  • Death or stroke by 30 days

Results:

  • Primary endpoints:
    1 year Kaplan–Meier estimate of the rate of the composite of all-cause mortality, stroke, re-hospitalization: TAVR: 8.5%, Surgery: 15.1%; HR 0.54 (46% reduction); p= 0.001.
     
  • Secondary endpoints: at 30 days
    Stroke: TAVR: 0.6% vs surgery: 2.4%; p=0.02
    Death or stroke: TAVR: 1% vs surgery 3.3%; p=0.01
     
  • Other Endpoints:
    • Post-op/new-onset AF @ 30 days: 5% in TAVR patients; 39.5% in surgical patients; p < 0.001
    • Index hospitalization: TAVR: 3 days vs surgery: 7 days; p< 0.001

Principal Investigators:

  • Martin B Leon, MD, Columbia University Medical Center, New York Presbyterian Hospital, NY
  • Michael J Mack MD, The Heart Hospital Baylor, Plano, TX

Sponsors: Edwards Lifesciences

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

See more AHA coverage of science presented at ACC.19