Edwards Lifesciences | Groundbreaking Data Demonstrate Superiority of EARLY TAVR in Asymptomatic Severe Aortic Stenosis Patients

Edwards Lifesciences 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).

“What we learned in this trial is that without intervention, patients rigorously confirmed as asymptomatic experienced unpredictable and rapid decline with numerous adverse outcomes. These results shatter 60 years of ingrained belief on the treatment for severe aortic stenosis, with guidelines that currently recommend ‘watchful waiting’ for intervention until symptoms develop,” said Philippe Genereux, MD, director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. “With no demonstrated clinical penalty for TAVR, these trial results strongly support a change to the practice and current guidelines for the treatment of aortic stenosis patients.”

The EARLY TAVR Trial enrolled 901 patients – with an average age of 76 and average KCCQ-OS score of 92.7 – at 75 sites across the US and Canada. Patients were rigorously confirmed as asymptomatic through a protocol-mandated stress test – a first in TAVR trials – and medical history evaluation. Designed specifically to evaluate if early intervention is a better strategy than clinical surveillance, the EARLY TAVR Trial showed that within the first six months, a striking 26.2% of patients in the clinical surveillance arm converted to aortic valve replacement (AVR) with many presenting progressive or advanced symptoms. In the 12-month follow-up period after randomization, the rate of conversion to AVR was 47.2%.

“This is the first pivotal trial to generate evidence about the best strategy for disease management of severe aortic stenosis,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “EARLY TAVR challenges the current standard of care by definitively showing that patients who don’t have symptoms of severe aortic stenosis have a deadly disease that requires urgent treatment.”

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”
Exit mobile version