TCT 24: The TAVR UNLOAD Trial
TCT Conference 2024 - TAVR for Moderate AS in Patients with HFrEF on OHFT was Safe, But Did Not Affect the Primary Endpoint at 2Y.
Dr Nicolas M Van Mieghem (Erasmus University Medical Center, Rotterdam, NL) joins us onsite at TCT Conference to discuss the findings from TAVR UNLOAD (NCT02661451).
TAVR UNLOAD is an international, multicenter, open-label clinical trial, where patients with heart failure (HF) and moderate aortic stenosis were randomised 1:1 to receive either TAVR (Edwards SAPIEN 3 Transcatheter Heart Valve) in addition to OHFT or OHFT alone. 600 patients were enrolled in the trial and were followed-up at 1, 6, and 12 months, as well as 2 years after randomisation. The primary outcome measures were the hierarchical occurrence of all-cause death, disabling stroke, hospitalisations related to HF, symptomatic aortic valve disease or nondisabling stroke, and change in the Kansas City Cardiomyopathy Questionnaire at one year.
Results showed that TAVR in this patient group was safe, but did not affect the primary hierarchical composite endpoint at a median follow up of 23 months. TAVR resulted in more wins in the primary endpoint at one year follow up, driven by clinically meaningful improvement in quality of life compared to clinical aortic stenosis surveillance.
Interview Questions:
1. What is the reasoning behind the trial?
2. Could you tell us about the patient population and study design for TAVR UNLOAD?
3. What were the key findings?
4. How should these findings impact clinical practice?
5. What further research is needed?
Recorded on-site at TCT Conference in Washington, 2024.
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