Randomized, Multicenter, Event-Driven Trial of TAVI Versus SAVR in Patients With Symptomatic Severe Aortic-Valve Stenosis - DEDICATE-DZHK6

Apr 08, 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:
German Center for Cardiovascular Research and the German Heart Foundation
Date Presented:
04/08/2024
Date Published:
04/08/2024
Original Posted Date:
04/08/2024
References

Contribution To Literature:

The DEDICATE-DZHK6 trial showed that among low to intermediate risk patients, TAVI is noninferior to SAVR regarding all-cause mortality and stroke.

Description:

The goal of the trial was to evaluate transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis and low to intermediate surgical risk.

Study Design

  • Randomized
  • Parallel
  • Blinded

Patients with symptomatic severe aortic stenosis were randomized to TAVI (n = 701) vs. placebo SAVR (n = 713).

  • Total number of enrollees: 1,414
  • Duration of follow-up: 12 months
  • Mean patient age: 74 years
  • Percentage female: 44%
  • Percentage with diabetes: 34%

Inclusion criteria:

  • Symptomatic severe aortic stenosis
  • 65-85 years of age
  • Low to intermediate surgical risk

Exclusion criteria:

  • Bicuspid aortic valve
  • Noncalcified aortic valve
  • Endocarditis
  • Cardiac reoperation
  • Severe coronary disease or percutaneous coronary intervention within the last month
  • Severe mitral or tricuspid valve disease
  • Left ventricular ejection fraction <20%
  • Stroke within the last month

Other salient features/characteristics:

  • Balloon-expandable transcatheter heart valve in 61%
  • Cerebral embolic protection in 5.1%
  • Median Society of Thoracic Surgeons risk score: 1.8%

Principal Findings:

The primary outcome (all-cause death or stroke) at 1 year was 5.4% in the TAVI group vs. 10.0% in the SAVR group (p for noninferiority < 0.001).

Secondary outcomes:

  • All-cause mortality: 2.6% in the TAVI group vs. 6.2% in the SAVR group
  • Disabling stroke: 1.3% in the TAVI group vs. 3.1% in the SAVR group
  • Atrial fibrillation: 12.4% in the TAVI group vs. 30.8% in the SAVR group
  • Major or life-threatening bleeding: 4.3% in the TAVI group vs. 17.2% in the SAVR group
  • At least moderate aortic regurgitation: 2.8% in the TAVI group vs. 1.0% in the SAVR group

Interpretation:

Among low to intermediate risk patients with symptomatic severe aortic stenosis, TAVI was noninferior to SAVR. TAVI was associated with a lower incidence of all-cause mortality or stroke at 12 months compared with SAVR. The incidence of stroke was low in the TAVI group (1.3%) despite infrequent use of cerebral embolic protection. Atrial fibrillation and major or life-threatening bleeding was more frequent in the SAVR group. In the TAVI group, approximately two-thirds of participants were treated with a balloon-expandable valve. This is an important non–industry-sponsored trial, which adds to a growing body of evidence supporting the expanding role of TAVI for treatment of aortic valve disease; however, results do not apply to patients with bicuspid aortic valve disease.

References:

Blankenberg S, Seiffert M, Vonthein R, et al., on behalf of the DEDICATE-DZHK6 Investigators. Transcatheter or Surgical Treatment of Aortic-Valve Stenosis. N Engl J Med 2024;Apr 8:[Epub ahead of print].

Editorial: Shah PB. Another Early Win for TAVI in Low-Risk Patients. N Engl J Med 2024;Apr 8:[Epub ahead of print].

Presented by Dr. Moritz Seiffert at the American College of Cardiology Annual Scientific Session (ACC.24), Atlanta, GA, April 8, 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: ACC24, ACC Annual Scientific Session, Aortic Valve Stenosis, Cardiac Surgical Procedures, Transcatheter Aortic Valve Replacement


< Back to Listings