Edwards trial supports earlier valve replacement in moderate aortic stenosis

Edwards Lifesciences announced on November 2 that its PROGRESS trial found transcatheter aortic valve replacement, or TAVR, superior to clinical surveillance in moderate aortic stenosis patients with at-risk features. The primary measure combined deaths and heart-failure events over two years; success on that combined measure does not establish that each outcome improved separately.^[1]

Aortic stenosis is a narrowing of the valve through which blood leaves the heart for the body's main artery. TAVR delivers a replacement valve through a catheter, while clinical surveillance means monitoring the condition over time. The company-reported result supports earlier intervention in this patient group, but the supplied announcement excerpt gives no size of benefit or safety data.^[1]

If physicians use this evidence to offer valve replacement to more patients matching the trial population, hospitals would buy more valves and perform more implantations, supporting device and procedure revenue.^[1] Wider adoption would still depend on physicians' assessment of benefits and risks, applicable regulatory approvals and reimbursement; the excerpt is insufficient to estimate additional patients or sales.^[1]

Impact