• Title/Summary/Keyword: Edoxaban

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Optimal Dose of Edoxaban for Very Elderly Atrial Fibrillation Patients at High Risk of Bleeding: The LEDIOS Registry

  • Ju Youn Kim;Juwon Kim;Seung-Jung Park;Kyoung-Min Park;Sang-Jin Han;Dae Kyeong Kim;Yae Min Park;Sung Ho Lee;Jong Sung Park;Young Keun On
    • Korean Circulation Journal
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    • v.54 no.7
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    • pp.398-406
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    • 2024
  • Background and Objectives: Optimal anticoagulation in very elderly patients is challenging due to the high risk of anticoagulant-induced bleeding. The aim of this study was to assess outcomes of on-label reduced-dose edoxaban (30 mg) in very elderly patients who had additional risk factors for bleeding. Methods: This was a multi-center, prospective, non-interventional observational study to evaluate the efficacy and safety of on-label reduced-dose edoxaban in atrial fibrillation (AF) patients 80 years of age or older and who had more than 1 risk factor for bleeding. Results: A total of 2448 patients (mean age 75.0±8.3 years, 801 [32.7%] males) was included in the present study, and 586 (23.9%) were 80 years of age or older with additional risk factors for bleeding. Major bleeding events occurred frequently among very elderly AF patients who had additional bleeding risk factors compared to other patients (unadjusted hazard ratio [HR], 2.16; 95% confidence interval [CI], 1.16-4.02); however, there were no significant differences in stroke incidence (HR, 1.86; 95% CI, 0.98-3.55). There were no significant differences for either factor after adjusting for age and sex (adjusted HR, 1.65; 95% CI, 0.75-3.62 for major bleeding; adjusted HR, 1.13; 95% CI, 0.51-2.50 for stroke). Conclusions: In very elderly AF patients with comorbidities associated with greater risk of bleeding, the incidence of major bleeding events was significantly increased. In addition, risk of stroke showed tendency to increase in same population. Effective anticoagulation therapy might be important in these high-risk population, and close observation of bleeding events might also be required.

Risk Factors of Gastrointestinal Bleeding in Patients Receiving New Oral Anticoagulants (New Oral Anticoagulants를 복용하는 환자들에서 위장관 출혈의 위험인자)

  • Lee, Ju Yup
    • The Korean journal of helicobacter and upper gastrointestinal research
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    • v.18 no.4
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    • pp.219-224
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    • 2018
  • New oral anticoagulants (NOACs) are now widely used for the prevention and treatment of venous thrombosis, and for the prevention of stroke and systemic embolism in patients with atrial fibrillation. As compared with warfarin, NOACs have the advantage of rapid onset of action and less drug interaction. However, they carry a higher risk of gastrointestinal (GI) bleeding than warfarin. The risk of GI bleeding in patients using NOACs varies according to the type and dose of the drug. By contrast, apixaban and edoxaban are reported to carry similar risks as warfarin, and the risks with dabigatran and rivaroxaban are higher than that with warfarin. In patients using NOACs, old age, impaired renal function, impaired liver function, concurrent use of antiplatelet agents, and nonsteroidal anti-inflammatory drugs are considered major risk factors of GI bleeding, and gastroprotective agents such as histamine-2 receptor antagonist and proton pump inhibitor have preventive effects. To prevent GI bleeding associated with NOACs, the characteristics of each NOAC and the risk factors of bleeding should be recognized.

Respiratory Review of 2014: Pulmonary Thromboembolism

  • Lee, Jae Seung
    • Tuberculosis and Respiratory Diseases
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    • v.77 no.3
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    • pp.105-110
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    • 2014
  • Venous thromboembolism (VTE), which includes pulmonary embolism and deep vein thrombosis, is an important cause of morbidity and mortality. The aim of this review is to summarize the findings from clinically important publications over the last year in the area of VTE. In this review, we discuss 11 randomized controlled trials published from March 2013 to April 2014. The COAG and the EU-PACT trials indicate that pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or marginal usefulness in the Caucasian population. Recent clinical trials with novel oral anticoagulants (NOACs) have demonstrated that the efficacy and safety of rivaroxaban, apixaban, edoxaban, and dabigatran are not inferior to those of conventional anticoagulants for the treatment of VTE. The PEITHO and ULTIMA trials suggested that rescue thrombolysis or catheter-directed thrombolysis may maximize the clinical benefits and minimize the bleeding risk. Lastly, riociguat has a proven efficacy in treating chronic thromboembolic pulmonary hypertension. In the future, NOACs, riociguat, and catheter-directed thrombolysis have the potential to revolutionize the management of patients with VTE.

Comparison of Early Complications of Oral Anticoagulants after Totally Thoracoscopic Ablation: Warfarin versus Non-vitamin K Antagonist Oral Anticoagulants

  • MuHyung Heo;Dong Seop Jeong;Suryeun Chung;Kyoung Min Park;Seung Jung Park;Young Keun On
    • Journal of Chest Surgery
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    • v.56 no.2
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    • pp.90-98
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    • 2023
  • Background: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Totally thoracoscopic ablation (TTA) is a surgical treatment showing a high success rate as a hybrid procedure with radiofrequency catheter ablation to control AF. This study compared the early complications of warfarin and non-vitamin K antagonist oral anticoagulants (NOACs) in patients who underwent TTA. Methods: This single-center retrospective cohort study enrolled patients who underwent planned TTA for AF from February 2012 to October 2020. All patients received postoperative anticoagulation, either with warfarin or a NOAC (apixaban, rivaroxaban, dabigatran, or edoxaban). Propensity score matching was performed for both groups. Early complications were assessed at 12 weeks after TTA and were divided into efficacy and safety outcomes. Both efficacy and safety outcomes were compared in the propensity score-matched groups. Results: Early complications involving efficacy outcomes, such as stroke and transient ischemic attack, were seen in 5 patients in the warfarin group and none in the NOAC group. Although the 2 groups differed in the incidence of efficacy outcomes, it was not statistically significant. In safety outcomes, 11 patients in the warfarin group and 24 patients in the NOAC group had complications, but likewise, the between-group difference was not statistically significant. Conclusion: Among patients who underwent TTA, those who received NOACs had a lower incidence of thromboembolic complications than those who received warfarin; however, both groups showed a similar bleeding complication rate. Using a NOAC after TTA does not reduce efficacy and safety when compared to warfarin.

Therapeutic Endoscopy-related Gastrointestinal Bleeding and Thromboembolic Events in Patients Using Warfarin or Direct Oral Anticoagulant (와파린 및 새로운 경구용 항응고제를 복용하는 환자에서의 치료 내시경과 관련된 위장관 출혈 및 혈전색전증의 위험)

  • Na, Hee Kyong
    • The Korean Journal of Gastroenterology
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    • v.72 no.5
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    • pp.271-273
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    • 2018
  • 내시경 시술 전 일시적으로 항응고제를 중단하는 것은 위장관 출혈의 위험과 혈전색전증의 위험 사이에 적절한 균형을 잡기 어렵기 때문에 논란의 여지가 많다. 와파린은 새로운 경구용 항응고제(direct oral anticoagulant agent, DOAC)보다 임상의에게 더 친숙하고, 효과를 쉽고 빠르게 전환시킬 수 있다는 장점이 있지만 복잡한 약역동학 특징과 좁은 치료적 범위 때문에 관리가 어렵다. 반면, DOAC는 약물의 모니터링 및 용량 조절 없이 정해진 용량으로 처방이 가능하며, 빠르게 작용하고, 반감기가 짧아 관리가 쉽지만 해독제가 없다는 단점이 있다. 이전 연구들에서 DOAC를 복용한 환자들은 와파린을 복용한 환자들보다 시술과 관련되지 않은 위장관 출혈의 위험이 높았다고 보고한 바 있다. 하지만 시술과 관련된 위장관 출혈 위험에 대하여는 알려진 바가 없는 실정이다. 미국이나 유럽 내시경 가이드라인들에서는 저위험 내시경 시술을 받는 환자들에서는 와파린과 DOAC를 유지하도록 권고하고 있으며, 고위험 시술의 경우에는 와파린를 사용하는 환자들에서 헤파린 교량 요법(heparin bridging)을 시행하도록 권고하고 있다. 임상적으로 DOAC를 사용하는 환자들 또한 혈전색전증을 예방하기 위하여 헤파린 교량 요법을 시행해볼 수 있는데, 와파린 및 DOAC의 헤파린 교량 요법과 관련된 출혈 및 혈전색전증 위험의 차이 또한 명확하지 않다. 따라서 저자들은 1) 와파린과 DOAC 치료를 받는 환자들에서의 출혈, 혈전색전증 및 사망의 위험을 비교하고자 하였으며, 2) 13종류의 고위험 내시경 시술 중에서 시술별 위험을 비교하고, 3) 헤파린 교량 요법이 합병증의 발생을 증가시키지 않는지 확인하고자 본 연구를 진행하였다. 일본 대규모 국가 입원 환자 데이터베이스를 이용하여 2014년 4월부터 2015년 5월까지 시술 전 와파린 또는 DOAC(rivaroxaban, apixaban, dabigatran, edoxaban)를 복용하고, 13종류의 고위험 내시경 시술을 시행받은 20세 이상의 성인 환자 총 16,977명을 확인하였다. 고위험 시술은 용종 절제술, 내시경 점막절제술, 내시경 점막하박리술, 협착 부위의 풍선확장술, 내시경 지혈술, 내시경 정맥결찰술, 내시경 주사 경화요법, 내시경 괄약근절개술, 내시경 초음파 유도하 미세침 흡인 검사, 경피적 위루술을 포함하였다. 일대일 성향 점수 매칭 분석(propensity score matching, 나이, 성별, 체질량 지수, 기저 질환, 병원의 규모, 시술의 종류, 약물의 종류를 매칭)을 시행하여 와파린군과 DOAC군에서 시술 위장관 출혈 및 혈전색전증, 사망의 발생을 비교하였다. 또한 경구항혈전제와 헤파린 교량 치료 시행 유무에 따라, DOAC 단독군, 와파린 단독군, DOAC와 헤파린 교량 요법군, 와파린과 헤파린 교량요법군으로 나누어, 하위군(subgroup) 분석을 시행하였다. 5,046쌍이 성향 점수 매칭 분석에 포함되었으며, 와파린군에서 DOAC군보다 통계적으로 의미 있게 위장관 출혈의 비율이 높았다(12.0% vs. 9.9% p=0.02). 혈전색전증 발생률(5.4% vs. 4.7%)과 입원중 사망률(5.4% vs. 4.7%)은 양 군에서 의미 있는 차이는 없었다. DOAC 종류별로 나누어 하위군 분석을 시행하였을 때, 와파린군은 rivaroxaban군에 비하여 위장관 출혈의 비율이 높았으며, rivaroxaban군, dabigatran군에 비하여 혈전색전증의 비율이 높았고, 입원 중 사망률에서는 의미 있는 차이는 없었다. 내시경 시술의 종류로 보정하였을 때 위장관 출혈 및 혈전색전증, 사망률은 DOAC 단독으로 치료한 환자에서보다 와파린과 헤파린 교량 요법(bridging) 또는 DOAC과 헤파린 교량 요법을 시행한 환자에서 높았다. 시술 종류 중에서는 위루관 삽입술에 비하여 내시경 점막하박리술, 내시경 점막절제술 및 내시경 정맥류결찰술, 내시경 주사경화요법을 시행한 환자에서 위장관 출혈의 위험이 가장 높았으며, 하부 내시경 점막절제술, 하부 용종 절제술, 내시경적 유두괄약근절제술 또는 내시경 초음파 유도하 미세침 흡인 검사는 중등도 위험을 보였다.