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Catheter Ablation in Combination With Left Atrial Appendage Closure for Atrial Fibrillation
Published on: February 26, 2013
Reduced Rivaroxaban Dose Versus Dual Antiplatelet Therapy After Left Atrial Appendage Closure: ADRIFT a Randomized
Guillaume Duthoit1, Johanne Silvain1, Eloi Marijon2
1Sorbonne Université, ACTION Study Group (Allies in Cardiovascular Trials, Initiatives and Organized Networks), INSERM UMRS1166, ICAN, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France (G.D., J.S., N.B., A.C., N.H., D.B., G.M.).
Insights
Reduced doses of rivaroxaban significantly lowered thrombin generation after left atrial appendage closure (LAAC) compared to dual antiplatelet therapy (DAPT). This suggests rivaroxaban as a potential alternative antithrombotic strategy post-LAAC.
Area of Science:
- Cardiology
- Pharmacology
- Medical Devices
Background:
- Percutaneous left atrial appendage closure (LAAC) carries a risk of device thrombosis, especially in atrial fibrillation patients contraindicated for full anticoagulation.
- Dual antiplatelet therapy (DAPT) is the current standard, but its efficacy and safety post-LAAC require further investigation.
- No randomized trials have assessed non-vitamin K antagonist oral anticoagulants (NOACs) following LAAC.
Purpose of the Study:
- To evaluate the efficacy and safety of reduced doses of rivaroxaban compared to DAPT after LAAC.
- To assess thrombin generation as a primary endpoint in patients treated with rivaroxaban or DAPT post-LAAC.
- To explore alternative antithrombotic strategies for patients undergoing LAAC.
Main Methods:
- A multicenter, phase IIb study randomized 105 patients post-LAAC into three groups: rivaroxaban 10 mg (R10), rivaroxaban 15 mg (R15), or DAPT (aspirin and clopidogrel).
- The primary endpoint was thrombin generation (prothrombin fragments 1+2) measured 2-4 hours post-drug intake at 10 days.
- Secondary endpoints included thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations, and clinical outcomes at 3 months.
Main Results:
- Both R10 and R15 significantly reduced thrombin generation compared to DAPT (P<0.0001).
- No significant difference in thrombin generation was observed between R10 and R15, although rivaroxaban concentrations were higher with R15.
- Thrombin-antithrombin complex and D-dimers were numerically lower with rivaroxaban, and no significant differences in clinical endpoints were noted. Device thrombosis occurred in 2 DAPT patients.
Conclusions:
- Reduced doses of rivaroxaban demonstrate lower thrombin generation post-LAAC compared to DAPT.
- These findings support rivaroxaban as a potential alternative antithrombotic regimen after LAAC.
- Larger studies are warranted to further evaluate the efficacy and safety of rivaroxaban in this patient population.
Background:
Percutaneous left atrial appendage closure (LAAC) exposes to the risk of device thrombosis in patients with atrial fibrillation who frequently have a contraindication to full anticoagulation. Thereby, dual antiplatelet therapy (DAPT) is usually preferred. No randomized study has evaluated nonvitamin K antagonist oral anticoagulant after LAAC, and we decided to evaluate the efficacy and safety of reduced doses of rivaroxaban after LAAC.
Methods:
ADRIFT (Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure) is a multicenter, phase IIb study, which randomized 105 patients after successful LAAC to either rivaroxaban 10 mg (R10, n=37), rivaroxaban 15 mg (R15, n=35), or DAPT with aspirin 75 mg and clopidogrel 75 mg (n=33). The primary end point was thrombin generation (prothrombin fragments 1+2) measured 2 to 4 hours after drug intake, 10 days after treatment initiation. Thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations were also measured at 10 days and 3 months. Clinical end points were evaluated at 3-month follow-up.
Results:
The primary end point was reduced with R10 (179 pmol/L [interquartile range (IQR), 129-273], P<0.0001) and R15 (163 pmol/L [IQR, 112-231], P<0.0001) as compared with DAPT (322 pmol/L [IQR, 218-528]). We observed no significant reduction of the primary end point between R10 and R15 while rivaroxaban concentrations increased significantly from 184 ng/mL (IQR, 127-290) with R10 to 274 ng/mL (IQR, 192-377) with R15, P<0.0001. Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT. These findings were all confirmed at 3 months. The clinical end points were not different between groups. A device thrombosis was noted in 2 patients assigned to DAPT.
Conclusions:
Thrombin generation measured after LAAC was lower in patients treated by reduced rivaroxaban doses than DAPT, supporting an alternative to the antithrombotic regimens currently used after LAAC and deserves further evaluation in larger studies. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03273322.
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