United Kingdom Transcatheter Aortic Valve Implantation - UK TAVI

Mar 29, 2020
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Presenter/Author:
William D. Toff, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Institute for Health Research Leicester Biomedical Research Centre
Date Presented:
03/29/2020
Date Published:
03/29/2020
Date Updated:
03/29/2020
Original Posted Date:
03/29/2020
References

Contribution To Literature:

The UK TAVI trial showed that TAVR was noninferior to SAVR with regard to all-cause mortality.

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) compared with surgical valve replacement (SAVR) among patients with symptomatic severe aortic stenosis.

Study Design

  • Randomized
  • Parallel
  • Stratification

Patients with symptomatic severe aortic stenosis were randomized to TAVR (n = 458) versus SAVR (n = 455).

  • Total number of enrollees: 913
  • Duration of follow-up: 12 months
  • Mean patient age: 81 years
  • Percentage female: 46%
  • Percentage with diabetes: 23%

Inclusion criteria:

  • Symptomatic severe aortic stenosis
  • Age ≥80 years or, age ≥70 years with intermediate or high estimated surgical risk

Exclusion criteria:

  • Life expectancy <1 year
  • Previous AVR or TAVR
  • Technically unsuitable for TAVR or SAVR
  • Coronary artery disease for which surgical revascularization was deemed preferential
  • Primary aortic regurgitation
  • Severe mitral regurgitation

Other salient features/characteristics:

  • Mean left ventricular ejection fraction: 57%
  • Transfemoral access: 92%
  • Conscious sedation during TAVR: 70%
  • Valve type: 45% for Sapien 3, 14% for Evolut/Evolut R, 10% for Lotus
  • Median length of stay: 3 days for TAVR vs. 8 days for SAVR

Principal Findings:

The primary outcome, all-cause mortality at 12 months, occurred in 4.6% of the TAVR group compared with 6.6% of the SAVR group (p = 0.23). This met the prespecified criteria for noninferiority.

Secondary outcomes at 12 months:

  • Cardiovascular death: 2.8% of the TAVR group compared with 3.3% of the SAVR group (p = 0.69)
  • Stroke: 5.0% of the TAVR group compared with 2.9% of the SAVR group (p = 0.13)
  • Major bleeding: 6.3% of the TAVR group compared with 17.1% of the SAVR group (p < 0.001)
  • Permanent pacemaker: 12.2% of the TAVR group compared with 6.6% of the SAVR group (p < 0.001)
  • Vascular complications: 4.8% of the TAVR group compared with 1.3% of the SAVR group (p < 0.001)
  • Moderate aortic insufficiency: 2.3% of the TAVR group compared with 0.6% of the SAVR group

Interpretation:

Among patients with symptomatic severe aortic stenosis, TAVR was noninferior compared with SAVR on all-cause mortality. TAVR was associated with less bleeding and shorter hospital stay, but more vascular complications, permanent pacemaker, and paravalvular aortic regurgitation. Stroke was similar between treatment groups. Long-term follow-up is needed to confirm sustained clinical benefit and valve durability.

References:

Presented by Dr. William D. Toff at the American College of Cardiology Virtual Annual Scientific Session Together With World Congress of Cardiology (ACC 2020/WCC), March 29, 2020.

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

Keywords: acc20, ACC Annual Scientific Session, Cardiac Surgical Procedures, Aortic Valve Insufficiency, Aortic Valve Stenosis, Conscious Sedation, Geriatrics, Heart Failure, Heart Valve Diseases, Hemorrhage, Pacemaker, Artificial, Stroke, Stroke Volume, Transcatheter Aortic Valve Replacement, Ventricular Function, Left, Vascular Diseases


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