WASHINGTON, DC - Early transcatheter aortic valve replacement (TAVR) is superior to clinical surveillance (CS) in patients with asymptomatic severe aortic stenosis (AS), results from the EARLY TAVR trial show. Philippe Généreux, MD, of the Morristown Medical Center, New Jersey, presented these results at a late-breaking trial session Monday at Transcatheter Cardiovascular Therapeutics (TCT) 2024 in Washington, DC. “Given the benefits observed and the lack of harm, early TAVR may be preferred to clinical surveillance in patients with asymptomatic severe AS, especially when combined with the challenges of timely symptom recognition and prompt treatment in real-world settings,” said Dr. Généreux at a press release on Monday. According to the current American College of Cardiology/American Heart Association guidelines, patients with asymptomatic severe AS and preserved left ventricular ejection fraction (LVEF) (≥50%) should be under CS with routine 6 to 12-month follow-ups. Two small, randomized trials demonstrated potential benefits of early surgical AVR compared with CS, but early TAVR had yet to be investigated in this patient population. The investigators in the prospective, multicenter, randomized EARLY TAVR trial sought to determine the safety and effectiveness of early TAVR in patients with asymptomatic severe AS. A total of 75 clinical sites across the U.S. and Canada were included in the study. The primary endpoint of this study was the composite of all-cause death, stroke or unplanned cardiovascular hospitalization at a follow-up of at least 2-years. A total of 901 patients ≥ 65 years old were included in the study (455 to TAVR, 446 to CS; total mean age=75.8 years), and 83.6% of patients had low surgical risk. Patients who underwent TAVR received the SAPIEN 3 (Edwards Lifsciences) or SAPIEN 3 Ultra transcatheter heart valve. In the TAVR group, 122 patients experienced a primary endpoint event, while the primary endpoint occurred in 202 patients in the CS group (hazard ratio [HR]=0.50, 95% confidence interval [CI]=0.40-0.63, p<0.001). Specifically, death occurred in 8.4% of TAVR patients and 9.2% of CS patients, stroke occurred in 4.2% of TAVR patients and 6.7% of CS patients and unplanned CV hospitalization was experienced by 20.9% of TAVR patients and 41.7% of CS patients. The median follow-up was 3.8 years, and 87.0% of patients in the CS group had aortic valve replacement. No procedure-related adverse events were reported between groups for those who underwent aortic valve replacement. Overall, patients with asymptomatic severe AS who underwent TAVR had significantly lower rates of the primary endpoint of this study, and did not have excess mortality or stroke, compared with patients who underwent standard CS. Image Caption: Philippe Généreux, MD, speaks during a news conference Monday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org