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.

 

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Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing comprehensive coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. Cardiac Interventions Today premiered in March 2007 and each edition contains a variety of topics in a flexible format, including articles covering various perspectives on current clinical topics, in-depth interviews with expert physicians, overviews of available technologies, industry news, and insights into the issues affecting today's interventional cardiology practices.