Evolut Low Risk Trial

1. EVOLUT LOW RISK TRIAL

2. EVOLUT LOW RISK TRIAL
Acronym: EVOLUT LOW RISK TRIAL
Description: EVOLUT Surgical Replacement and
Transcatheter Aortic Valve Implantation in Low Risk
Patients

3. Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1816885
Presenters: Jeffrey J. Popma, M.D., G. Michael Deeb, M.D., Steven J.
Yakubov, M.D., Mubashir Mumtaz, M.D., Hemal Gada, M.D., Daniel O’Hair,
M.D., Tanvir Bajwa, M.D., John C. Heiser, M.D., William Merhi, D.O., Neal S.
Kleiman, M.D., Judah Askew, M.D., Paul Sorajja, M.D.,
Trial objective: To assess the safety and efficacy of transcatheter aortic
valve replacement (TAVR) with the self-expanding CoreValve compared with
surgical aortic valve replacement (SAVR) in low-risk patients.
EVOLUT LOW RISK TRIAL

4. Trial design: Multinational, randomized, noninferiority clinical trial
Sample size: 1,403 individuals (TAVR: n = 725 and SAVR: n = 678)
Inclusion criteria:
•Severe symptomatic aortic stenosis
•Anatomy suitable for TAVR or SAVR
•Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score ≤3%
Exclusion criteria:
•Contraindication for placement of a bioprosthetic valve
•Bicuspid valve
•A known hypersensitivity or contraindication to all anticoagulation/antiplatelet
regimens
EVOLUT LOW RISK TRIAL

5. Methodology:
 Patients were randomly assigned in a 1:1 ratio to undergo either
TAVR (n = 725) or SAVR (n = 678). TAVR was performed with the self-
expanding CoreValve Evolut in most cases; 22.3% received the third-
generation Evolut PRO.
 Individuals are followed up after 24 months
 Mean patient age is 74 years
 Percentage female is 35%
EVOLUT LOW RISK TRIAL

6. Results:
Primary outcome:
• The primary endpoint of all-cause mortality or disabling stroke for TAVR vs.
SAVR at 24 months, was 5.3% vs. 6.7% (p < 0.05 for noninferiority, p > 0.05
for superiority).
• Also at 2 years, all-cause mortality was 4.5% for TAVR vs. 4.5% for SAVR (p >
0.05). Disabling stroke was 1.1% for TAVR vs. 3.5% for SAVR (p < 0.05).
Secondary Outcome:
•All-cause mortality or disabling stroke at 30 days: 0.8% vs. 2.6% (p < 0.05)
•All-cause mortality at 30 days: 0.5% vs. 1.3% (p > 0.05)
•All strokes at 30 days: 3.4% vs. 3.4% (p = 1.0)
•Death, disabling stroke, life-threatening bleeding, major vascular complications,
stage 2/3 kidney injury: 5.3% vs. 10.7% (p < 0.05)
Continued….
EVOLUT LOW RISK TRIAL

7. Secondary Outcome:
•All strokes at 30 days: 3.4% vs. 5.6% (p < 0.05)
•Major vascular complication at 30 days: 3.8% vs. 3.2% (p > 0.05)
•Life-threatening or disabling bleeding at 30 days: 2.4% vs. 7.5% (p < 0.05)
•New permanent pacemaker at 30 days: 17.4% vs. 6.1% (p < 0.05)
•Moderate to severe paravalvular leak: 3.5% vs. 0.5% (p < 0.05)
•Atrial fibrillation at 30 days: 7.7% vs. 35.4% (p < 0.05)
•Primary endpoint at 1 year: 2.9% for TAVR vs. 4.6% for SAVR (p > 0.05)
•Mean aortic gradient at 1 year: 8.6 mm Hg for TAVR vs. 11.2 mm Hg for
SAVR (p < 0.05)
•Mean effective orifice area at 1 year: 2.3 for TAVR vs. 2.0 for SAVR (p < 0.05)
•Mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change from
baseline at 30 days: 20.0 for TAVR vs. 9.1 for SAVR (p < 0.05)
EVOLUT LOW RISK TRIAL

8. Conclusion:
 In patients with severe aortic stenosis who were at low surgical
risk, TAVR with a self-expanding supra annular bio-prosthesis was
noninferior to surgery with respect to the composite end point of
death or disabling stroke at 24 months.
 Need for permanent pacemaker and moderate to severe
paravalvular leak were higher with TAVR at 30 days, while new-
onset atrial fibrillation, acute kidney injury, and severe bleeding
were higher in the SAVR arm.
 Valve performance at 2 years was similar between the two
strategies, with lower mean gradients and higher effective orifice
areas with TAVR.
EVOLUT LOW RISK TRIAL