EARLY TAVR Trial Results Presented

October 28, 2024—The EARLY TAVR randomized trial demonstrated that early intervention with transcatheter aortic valve replacement (TAVR) in patients with asymptomatic, severe aortic stenosis (AS) was a safe and effective alternative to clinical surveillance (CS).

The EARLY TAVR findings were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC, and published by Philippe Généreux, MD, et al online in The New England Journal of Medicine.

The TCT press release noted that current guidelines recommend CS every 6 to 12 months for patients with asymptomatic, severe AS and preserved left ventricular ejection fraction. The study sought to help determine whether the strategy of early TAVR confers benefits over guideline-indicated CS.

As summarized by TCT, the study included 1,578 patients who consented for screening at 75 centers in the United States and Canada from March 2017 through December 2021. Of these, a total of 901 patients were randomized to either transfemoral TAVR (n = 455) or CS (n = 446).

According to the TCT press release, patient characteristics included the following: mean age of 76 years; 69% male; mean Society of Thoracic Surgeons risk score of 1.8%; and 84% patients considered low surgical risk per local heart team evaluation. Additionally, asymptomatic status was confirmed in > 90% of patients with a negative treadmill stress test, and mean Kansas City Cardiomyopathy Questionnaire score at baseline was 92.7 (excellent status). Baseline echo characteristics were similar between both groups.

The primary endpoint—the composite of death, stroke, or unplanned cardiovascular hospitalization—was evaluated for superiority in the intent-to-treat population after a minimum follow-up of 2 years.

TCT outlined the EARLY TAVR results as follows:

• There was significant reduction in the primary endpoint at 2 years (median follow-up, 3.8 years), occurring in 35.1% in the TAVR group versus 51.2% in the surveillance group (hazard ratio, 0.5; 95% CI, 0.4-0.63; P < .001).
• The secondary endpoint (favorable health status outcome) occurred more frequently in the early TAVR group compared with the surveillance group, with 86.6% versus 68% (absolute Δ, 18.5% [12.6%-24.3%]; P < .001).
• Left ventricular and left atrial health at 2 years was also better for patients who underwent early TAVR (48.1% vs 35.9%; absolute Δ, 12.2% [4.4%-19.4%]; P = .001).
• Change in left ventricular ejection fraction from baseline to 2 years, new onset atrial fibrillation, and death or disabling stroke were similar between the two groups.

The investigators further found that by 2 years, > 70% of the patients in the CS group underwent aortic valve replacement, with the vast majority becoming symptomatic. The median time to conversion was 11.1 months, with 26% requiring aortic valve replacement at 6 months and 47% requiring aortic valve replacement at 1 year.

Additionally, approximately 40% of patients from the CS group presented with acute and advanced signs and symptoms, such as New York Heart Association III to IV heart failure, pulmonary edema, or syncope.

“Given the benefits observed and the lack of harm, early TAVR may be preferred to CS in patients with asymptomatic severe AS, especially when combined with the challenges of timely symptom recognition and prompt treatment in real-world settings,” commented Dr. Généreux in the TCT press release. “Not only is early intervention safe and effective, but it also prevents a decline in quality of life for those who later receive TAVR and could prevent the development of cardiac damage.”

Dr. Généreux is Director of the Structural Heart Program at the Gagnon Cardiovascular Institute at Morristown Medical Center in Morristown, New Jersey.

The EARLY TAVR study was funded by Edwards Lifesciences, noted TCT.