Oral anticoagulation after low-risk TAVR safely reduces leaflet thrombosis
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Low-risk patients who underwent transcatheter aortic valve replacement and took oral anticoagulation for 30 days had lower incidence of leaflet thrombosis without increased bleeding compared with those who took aspirin after the procedure, according to data from the Low-Risk TAVR trial presented at Cardiovascular Research Technologies.
Another late-breaking trial session at this meeting included findings from the Low-Risk TAVR trial. As Healio previously reported, TAVR was safe in low-risk patients with bicuspid aortic stenosis, as shown through short hospital stays, zero disabling stroke and zero deaths at 30 days.
In this study, Toby Rogers, MD, PhD, interventional cardiologist and scientific lead for the structural heart disease program at MedStar Heart and Vascular Institute in Washington, D.C., and colleagues evaluated data from 124 low-risk patients with symptomatic severe aortic stenosis who underwent TAVR. Patients were assigned oral anticoagulation with warfarin (n = 44; mean age, 74 years; 66% men) or aspirin (n = 50; mean age, 73 years; 74% men). Data from a pooled cohort (n = 124) were also assessed, with patients taking oral anticoagulation (n = 68; mean age, 74 years; 68% men) or aspirin (n = 56; mean age, 73 years; 75% men).
The primary safety endpoint was all stroke, all-cause mortality, major vascular complications, life-threatening or major bleeding and hospitalizations for worsening HF or valve-related symptoms at 30 days. The primary efficacy endpoint was defined as hemodynamic dysfunction, hypoattenuated leaflet thickening at 30 days and at least moderately restricted leaflet motion at 30 days.
No mortality was observed at 30 days.
In the randomized cohort, there were no statistically significant differences in the anticoagulation and aspirin groups regarding in-hospital outcomes, which included life-threatening or major bleeding. For the pooled cohort, more patients taking aspirin had Valve Academic Research Consortium (VARC)-2 major vascular complications compared with those taking oral anticoagulation (7.1% vs. 0%; P = .02).
At 30 days, outcomes were similar in both groups for the randomized cohort. The rate of VARC-2 major vascular complications remained the same at 30 days for the pooled cohort.
The incidence of leaflet thrombosis was lower in patients assigned oral anticoagulation compared with aspirin in both the randomized (4.7% vs. 16.3%; P = .07) and the pooled cohort (3.1% vs. 16.4%; P = .01).
“In low-risk patients, oral anticoagulation for 30 days after TAVR is associated with lower incidence of leaflet thrombosis but does not appear to be associated with increased bleeding,” Rogers said during the presentation. – by Darlene Dobkowski
Reference:
Rogers T. Late-Breaking Trials: Session III. Presented at: Cardiovascular Research Technologies; Feb. 22-25, 2020; National Harbor, Md.
Disclosure: Rogers reports he is a consultant and proctor for Edwards Lifesciences and Medtronic.