LRT Trial Evaluates TAVR in Low-Risk Patients at 1 Year
May 20, 2019—The 1-year results of transcatheter aortic valve replacement (TAVR) in the Low-Risk TAVR (LRT) trial were published by Ron Waksman, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2019;12:901–907). The study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after TAVR in low-risk patients.
The investigators concluded that TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. They noted that hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.
As summarized in JACC: Cardiovascular Interventions, the LRT trial was an investigator-initiated, prospective, multicenter study and was the first FDA-approved investigational device exemption trial to evaluate the feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.
The LRT trial enrolled 200 low-risk patients with symptomatic severe aortic stenosis to undergo TAVR at 11 centers. The mean patient age was 73.6 years, and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and a low permanent pacemaker implantation rate (5.0%).
At 1-year follow-up, mortality was 3.0%, the stroke rate was 2.1%, and the permanent pacemaker implantation rate was 7.3%. Two (1.0%) patients underwent surgical reintervention for endocarditis. Of the 14% of TAVR patients who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs 1.9%; P = .53), reported the investigators in JACC: Cardiovascular Interventions.