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Updated: Nov 22, 2025
Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
Published on: August 8, 2025
Randomized Trial of Aspirin Versus Warfarin After Transcatheter Aortic Valve Replacement in Low-Risk Patients
Toby Rogers1,2, Christian Shults3, Rebecca Torguson1
1Section 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.
Insights
Warfarin plus aspirin may prevent transcatheter heart valve dysfunction after transcatheter aortic valve replacement in low-risk patients. This regimen showed improved outcomes without increasing bleeding risk in a 30-day study.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Science
Background:
- The optimal antithrombotic strategy following transcatheter aortic valve replacement (TAVR) is not well-established.
- Ensuring the long-term function of bioprosthetic valves is crucial for patient outcomes.
Purpose of the Study:
- To compare the effectiveness of aspirin versus warfarin plus aspirin for antithrombotic therapy after TAVR in low-risk patients.
- To evaluate the incidence of TAVR dysfunction and bleeding events.
Main Methods:
- A randomized open-label study involving low-risk patients undergoing transfemoral TAVR.
- Patients were randomized to receive either low-dose aspirin or warfarin plus low-dose aspirin for 30 days.
- Primary endpoint included hypoattenuated leaflet thickening, reduced leaflet motion, hemodynamic dysfunction, stroke, or transient ischemic attack.
Main Results:
- The composite primary effectiveness endpoint occurred in 26.5% of the aspirin group versus 7.0% in the warfarin plus aspirin group (P=0.014).
- Hypattenuated leaflet thickening was observed in 16.3% of the aspirin group versus 4.7% in the warfarin plus aspirin group (P=0.07).
- No excess bleeding was noted in the anticoagulation arm at 30 days.
Conclusions:
- In low-risk TAVR patients, short-term anticoagulation with warfarin may prevent transcatheter heart valve dysfunction.
- This approach appears safe, with no increase in bleeding complications observed within the study period.
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.
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