The 1-year results of the Low-Risk TAVR (LRT) trial have been published in press by JACC: Cardiovascular Interventions and are available online.
LRT Trial Principal Investigator Ron Waksman, MD, FSCAI, presented the results as a late-breaking trial at Cardiovascular Research Technologies (CRT) 2019 in Washington, D.C., last week.
The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration-approved Investigational Device Exemption trial to evaluate the feasibility of transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis (AS) at low risk of surgical mortality.
The objective of the just-published study was to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis (AS) who were at low risk for surgical mortality.
The trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were male. The primary endpoint was all-cause mortality at 30 days.
As previously reported by Waksman and colleagues in a paper published in October 2018 in the Journal of the American College of Cardiology, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%) at 30 days.
Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year.
At 1-year follow-up, as Waksman and colleagues reported Tuesday in JACC: Cardiovascular Interventions, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two subjects (1.0%) underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening (HALT) at 30 days, there was no impact on valve hemodynamics at 1 year.
The study investigators concluded that TAVR in low-risk patients with symptomatic severe AS appears to be safe at 1 year and that HALT, observed in a minority of TAVR patients at 30 days, did not impact valve hemodynamics in the longer term.
The LRT trial results are seen as a possible preview of the two large randomized, commercially funded TAVR trials in low-risk patients that are scheduled for presentation on Sunday at the American College of Cardiology Scientific Sessions 2019 in New Orleans.