October 5, 2015New England Journal of Medicine1,036 citationsOpen Access
View Full PaperPossible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves
Key Result
Therapeutic anticoagulation with warfarin, compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced aortic-valve leaflet motion (0% vs 55%, P=0.01).
Study Design
Type
Observational (n=187)
Multicenter
Yes
Structured PICO
Does therapeutic anticoagulation with warfarin prevent or resolve reduced aortic-valve leaflet motion in patients with bioprosthetic aortic valves compared to dual antiplatelet therapy?
P
Population
187 patients undergoing transcatheter or surgical aortic-valve bioprosthesis implantation evaluated for reduced leaflet motion using CT.
E
Exposure
Therapeutic anticoagulation with warfarin
C
Comparator
Dual antiplatelet therapy or no anticoagulation
O
Outcome
Reduced aortic-valve leaflet motion detected on four-dimensional, volume-rendered CT scanssurrogate
Therapeutic anticoagulation with warfarin effectively resolves subclinical leaflet thrombosis (reduced leaflet motion) in bioprosthetic aortic valves, a condition that may be associated with an increased risk of stroke or TIA.
Main Result
Absolute Event Rate: 0% vs 55%
p-value: p=0.01
Limitations
- The effect of this finding on clinical outcomes including stroke needs further investigation.
Abstract
BACKGROUND: A finding of reduced aortic-valve leaflet motion was noted on computed tomography (CT) in a patient who had a stroke after transcatheter aortic-valve replacement (TAVR) during an ongoing clinical trial. This finding raised a concern about possible subclinical leaflet thrombosis and prompted further investigation. METHODS: We analyzed data obtained from 55 patients in a clinical trial of TAVR and from two single-center registries that included 132 patients who were undergoing either TAVR or surgical aortic-valve bioprosthesis implantation. We obtained four-dimensional, volume-rendered CT scans along with data on anticoagulation and clinical outcomes (including strokes and transient ischemic attacks TIAs). RESULTS: Reduced leaflet motion was noted on CT in 22 of 55 patients (40%) in the clinical trial and in 17 of 132 patients (13%) in the two registries. Reduced leaflet motion was detected among patients with multiple bioprosthesis types, including transcatheter and surgical bioprostheses. Therapeutic anticoagulation with warfarin, as compared with dual antiplatelet therapy, was associated with a decreased incidence of reduced leaflet motion (0% and 55%, respectively, P=0.01 in the clinical trial; and 0% and 29%, respectively, P=0.04 in the pooled registries). In patients who were reevaluated with follow-up CT, restoration of leaflet motion was noted in all 11 patients who were receiving anticoagulation and in 1 of 10 patients who were not receiving anticoagulation (P<0.001). There was no significant difference in the incidence of stroke or TIA between patients with reduced leaflet motion and those with normal leaflet motion in the clinical trial (2 of 22 patients and 0 of 33 patients, respectively; P=0.16), although in the pooled registries, a significant difference was detected (3 of 17 patients and 1 of 115 patients, respectively; P=0.007). CONCLUSIONS: Reduced aortic-valve leaflet motion was shown in patients with bioprosthetic aortic valves. The condition resolved with therapeutic anticoagulation. The effect of this finding on clinical outcomes including stroke needs further investigation. (Funded by St. Jude Medical and Cedars-Sinai Heart Institute; Portico-IDE ClinicalTrials.gov number, NCT02000115; SAVORY registry, NCT02426307; and RESOLVE registry, NCT02318342.).