This marks the first FDA approval for transcatheter aortic valve replacement (TAVR) in asymptomatic AS patients. Approval came on the back of data from the EARLY TAVR trial. EARLY TAVR demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance (watchful waiting).
Edwards says EARLY TAVR marked the first randomized, controlled trial designed to evaluate TAVR compared to watchful waiting in asymptomatic severe AS. It had a median follow-up of 3.8 years. Investigators reported that 26.8% of the 455 patients in the TAVR arm experienced death, stroke or unplanned cardiovascular hospitalization. That compared to 45.3% of the 466 patients in the clinical surveillance arm.
Dr. Philippe Genereux serves as director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center in New Jersey. Genereux called the need to change practice and TAVR guidelines for AS “urgent.” Additionally, Genereux said EARLY TAVR underscored the importance of early evaluation to benefit patient outcomes and the healthcare system.
Sapien, meanwhile, has become the most studied valve platform since its introduction more than 20 years ago, Edwards says.
“This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” said Larry Wood, Edwards’ corporate VP and group president, Transcatheter Aortic Valve Replacement and Surgical. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”
