Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients.

MedStar author(s):
Citation: Circulation: Cardiovascular Interventions. 14(1):e009983, 2021 01.PMID: 33423540Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Heart Valve Prosthesis | *Transcatheter Aortic Valve Replacement | Aortic Valve Stenosis/dg [Diagnostic Imaging] | Aortic Valve Stenosis/su [Surgery] | Aortic Valve/dg [Diagnostic Imaging] | Aortic Valve/su [Surgery] | Aspirin/ae [Adverse Effects] | Humans | Risk Factors | Transcatheter Aortic Valve Replacement/ae [Adverse Effects] | Treatment Outcome | United States | Warfarin/ae [Adverse Effects]Year: 2021Local holdings: Available online from MWHC library: 2008 - presentISSN:
  • 1941-7640
Name of journal: Circulation. Cardiovascular interventionsAbstract: BACKGROUND: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.CONCLUSIONS: In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.METHODS: In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient >=20 mm Hg, effective orifice area <=1.0 cm2, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.RESULTS: Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (P=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (P=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (P=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).All authors: Asch FM, Ben-Dor I, Bilfinger T, Brizzio ME, Buchbinder M, Cocke T, Comas G, Craig P, Garcia-Garcia HM, Hahn C, Hanna N, Levitt R, Mahoney P, Moreno R, Newton J, Parikh P, Rogers T, Satler LF, Shea C, Shults C, Torguson R, Waksman R, Weissman G, Zhang COriginally published: Circulation: Cardiovascular Interventions. 14(1):e009983, 2021 Jan.Fiscal year: FY2021Digital Object Identifier: Date added to catalog: 2021-02-17
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 33423540 Available 33423540

Available online from MWHC library: 2008 - present

BACKGROUND: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear.

CONCLUSIONS: In low-risk transcatheter aortic valve replacement patients, anticoagulation with warfarin may prevent transcatheter heart valve dysfunction in the short term without excess bleeding. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03557242.

METHODS: In this randomized open-label study, low-risk patients undergoing transfemoral transcatheter aortic valve replacement at 7 centers in the United States were randomized 1:1 to low-dose aspirin or warfarin plus low-dose aspirin for 30 days. Patients who could not be randomized were enrolled in a separate registry. Computed tomography or transesophageal echocardiography was performed at 30 days. The primary effectiveness end point was a composite of the following at 30 days: hypoattenuated leaflet thickening, at least moderately reduced leaflet motion, hemodynamic dysfunction (mean aortic valve gradient >=20 mm Hg, effective orifice area <=1.0 cm2, dimensionless valve index <0.35, or moderate or severe aortic regurgitation), stroke, or transient ischemic attack.

RESULTS: Between July 2018 and October 2019, 94 patients were randomly assigned, 50 to aspirin and 44 to warfarin plus aspirin, and 30 were enrolled into the registry. In the intention-to-treat analysis of the randomized cohort, the composite primary effectiveness end point was met in 26.5% for aspirin versus 7.0% for warfarin plus aspirin (P=0.014; odds ratio, 4.8 [95% CI, 1.3-18.3]). The rate of hypoattenuated leaflet thickening was 16.3% for aspirin versus 4.7% for warfarin plus aspirin (P=0.07; odds ratio, 4.0 [95% CI, 0.8-20.0]). There was no excess bleeding at 30 days with anticoagulation. In the as-treated analysis of pooled randomized and registry cohorts, the rate of hypoattenuated leaflet thickening was 16.7% for aspirin versus 3.1% for warfarin plus aspirin (P=0.011; odds ratio, 6.3 [95% CI, 1.3-30.6]).

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