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Published on: February 28, 2012
Efficacy of 15 mg Edoxaban on Long-Term Outcome after Percutaneous Coronary Intervention in Patients with Atrial
Takao Sato1, Yoshifusa Aizawa2, Toshihiro Miyamoto1
1Department of Cardiology, International University of Health and Welfare Narita Hospital.
Insights
For older patients with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), low-dose edoxaban (15 mg) did not show superiority over the standard dose (30 mg) for preventing thrombotic or bleeding events. Further research is needed to clarify optimal dosing strategies.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Dual antiplatelet therapy (DAPT) plus oral anticoagulants increase bleeding risk in atrial fibrillation (AF) patients undergoing percutaneous coronary intervention (PCI).
- Low-dose edoxaban (15 mg) is established for high-risk AF patients, but its efficacy post-PCI compared to the standard 30 mg dose is not well-defined.
Purpose of the Study:
- To compare the safety and efficacy of 15 mg versus 30 mg edoxaban in patients with AF following PCI.
Main Methods:
- Retrospective analysis of AF patients undergoing PCI for acute coronary syndrome, treated with either 15 mg (n=49) or 30 mg (n=99) edoxaban.
- Assessment of bleeding and thrombotic events over two years, alongside clinical risk scores (CHADS2, HAS-BLED, CREDO-Kyoto).
- Weighted Cox regression analysis was used to compare outcomes between the two dosage groups.
Main Results:
- Patients on 15 mg edoxaban were older, had lower hemoglobin and BMI, and higher CHADS2, HAS-BLED, and CREDO-Kyoto scores.
- Major bleeding events were numerically lower in the 15 mg group (6.8%) compared to the 30 mg group (19.7%), but this difference was not statistically significant (P=0.08).
- Thrombotic events were comparable between the groups (3.0% vs 7.4%, P=0.35).
Conclusions:
- In older, high bleeding-risk AF patients post-PCI, 15 mg edoxaban did not demonstrate statistically significant superiority over 30 mg edoxaban in reducing thrombotic or bleeding events.
- The study suggests that while numerically lower, the 15 mg dose may not offer a significant advantage in this specific high-risk population.
- Further prospective studies are warranted to establish optimal edoxaban dosing in AF patients undergoing PCI.
Abstract:
In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) plus oral anticoagulants increase bleeding risk. Low-dose edoxaban (15 mg) is safe for high-risk older patients with AF; however, its role after PCI compared with the standard 30 mg dose remains unclear. We aimed to compare outcomes of 15 mg and 30 mg edoxaban after PCI.We retrospectively analyzed data from patients with AF undergoing PCI for acute coronary syndrome who received edoxaban 30 mg (n = 99) or 15 mg (n = 49). During admission, DAPT was transitioned to P2Y12 inhibitor monotherapy. Bleeding and thrombotic events were assessed over 2 years, alongside CHADS2, HAS-BLED, and CREDO-Kyoto scores.Compared with 30 mg edoxaban, patients on 15 mg edoxaban were older (86 ± 2 versus 80 ± 6 years, P< 0.01) and had lower hemoglobin levels and body mass index (19.4 ± 3.1 versus 22.7 ± 2.7, P < 0.01) but higher CHADS2 (3.3 ± 0.9 versus 2.8 ± 0.9, P < 0.01), HAS-BLED (3.2 ± 0.9 versus 2.6 ± 0.6, P < 0.01), and CREDO-Kyoto thrombotic and bleeding (5.0 ± 1.1 versus 4.0 ± 1.8, P < 0.01; and 4.1 ± 1.7 versus 2.7 ± 1.2, P < 0.01, respectively) scores. Major bleeding, including clinically relevant non-major bleeding, was more frequent in the 30 mg group (19.7% versus 6.8%, P = 0.08); thrombotic events were comparable (7.4% versus 3.0%, P = 0.35).In weighted Cox analysis, 15 mg edoxaban showed numerically lower hazard ratios for thrombotic (HR: 0.12, 95% CI: 0.01-1.17; P = 0.09) and bleeding (HR: 0.24, 95% CI: 0.06-1.29; P = 0.07) events compared with 30 mg, although these differences did not reach statistical significance.Among older high bleeding-risk patients with AF undergoing PCI, 15 mg edoxaban did not demonstrate superiority over 30 mg with respect to thrombotic or bleeding outcomes.
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