Toby Rogers1,2, Christian Shults3, Rebecca Torguson1, Corey Shea1, Puja Parikh4, Thomas Bilfinger5, Thomas Cocke6, Mariano E Brizzio7, Robert Levitt8, Chiwon Hahn9, Nicholas Hanna10, George Comas11, Paul Mahoney12, Joseph Newton13, Maurice Buchbinder14, Ricardo Moreno15, Cheng Zhang1, Paige Craig1, Federico M Asch, Gaby Weissman16, Hector M Garcia-Garcia16, Itsik Ben-Dor1, Lowell F Satler1, Ron Waksman1. 1. Section of Interventional Cardiology (T.R., R.T., C. Shea, C.Z., P.C., I.B.-D., L.F.S., R.W.), MedStar Washington Hospital Center, WA. 2. Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (T.R.). 3. Department of Cardiac Surgery (C. Shults), MedStar Health Research Institute (F.M.A.), MedStar Washington Hospital Center, WA. 4. Department of Cardiology (P.P.), Stony Brook University Hospital, NY. 5. Department of Cardiothoracic Surgery (T.B.), Stony Brook University Hospital, NY. 6. Department of Cardiology (T.C.), The Valley Hospital, Ridgewood, NJ. 7. Department of Cardiothoracic Surgery (M.E.B.), The Valley Hospital, Ridgewood, NJ. 8. Henrico Cardiology Associates (R.L.), HCA Virginia Health System. 9. Cardiothoracic Surgical Associates - Richmond (C.H.), HCA Virginia Health System. 10. Department of Cardiology (N.H.), St. John Health System, Tulsa, OK. 11. Department of Cardiothoracic Surgery (G.C.), St. John Health System, Tulsa, OK. 12. Department of Cardiology (P.M.), Sentara Norfolk General Hospital, VA. 13. Department of Cardiothoracic Surgery (J.N.), Sentara Norfolk General Hospital, VA. 14. Department of Cardiology (M.B.), Foundation for Cardiovascular Medicine, San Diego, CA. 15. Department of Cardiothoracic Surgery (R.M.), Foundation for Cardiovascular Medicine, San Diego, CA. 16. Department of Cardiology (G.W., H.M.G.-G.), MedStar Washington Hospital Center, WA.
Abstract
BACKGROUND: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear. 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 toaspirin 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]). 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.
RCT Entities:
BACKGROUND: The optimal antithrombotic regimen after transcatheter aortic valve replacement remains unclear. 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]). 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.