Edwards Lifesciences (NYSE:EW) today announced results from the EARLY TAVR Trial, the first randomized, controlled trial designed to study the best strategy for treating asymptomatic severe aortic stenosis (AS) and the benefits of early intervention with transcatheter aortic valve replacement (TAVR). The trial results demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared with guideline-recommended clinical surveillance. Trial investigators presented the data today during a late-breaking clinical trials session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation(CRF) and published simultaneously in The New England Journal of Medicine.

With a median follow up of 3.8 years, the data demonstrated superiority of early TAVR, with 26.8% of the 455 patients in the TAVR arm experiencing death, stroke or unplanned cardiovascular hospitalization compared to 45.3% of the 446 patients in the clinical surveillance arm. Additionally, the data showed that early intervention with TAVR:

• Prevented unpredictable and rapid progression of symptoms, which sometimes resulted in emergent intervention and/or hospitalization;
• Prevented clinically meaningful and rapid decline in quality of life; and
• Resulted in numerically lower rate of stroke for patients with early TAVR (4.2% vs. 6.7% at a median follow-up time of 3.8 years).