Objective: To investigate the timing of pericardial drainage catheter removal and restart of the anticoagulation in patients with atrial fibrillation (AF) suffered from perioperative pericardial tamponade during atrial fibrillation catheter ablation and uninterrupted dabigatran. Methods: A total of 20 patients with pericardial tamponade, who underwent AF catheter ablation with uninterrupted dabigatran in Beijing Anzhen Hospital from January 2019 to August 2021, were included in this retrospective analysis. The clinical characteristics of enrolled patients, information of catheter ablation procedures, pericardial tamponade management, perioperative complications, the timing of pericardial drainage catheter removal and restart of anticoagulation were analyzed. Results: All patients underwent pericardiocentesis and pericardial effusion drainage was successful in all patients. The average drainage volume was (427.8±527.4) ml. Seven cases were treated with idarucizumab, of which 1 patient received surgical repair. The average timing of pericardial drainage catheter removal and restart of anticoagulation in 19 patients without surgical repair was (1.4±0.7) and (0.8±0.4) days, respectively. No new bleeding, embolism and death were reported during hospitalization and within 30 days following hospital discharge. Time of removal of pericardial drainage catheter, restart of anticoagulation and hospital stay were similar between patients treated with idarucizumab or not. Conclusion: It is safe and reasonable to remove pericardial drainage catheter and restart anticoagulation as soon as possible during catheter ablation of atrial fibrillation with uninterrupted dabigatran independent of the idarucizumab use or not in case of confirmed hemostasis.
Humans ; Atrial Fibrillation/drug therapy* ; Dabigatran/therapeutic use* ; Cardiac Tamponade/complications* ; Anticoagulants/therapeutic use* ; Retrospective Studies ; Treatment Outcome ; Drainage/adverse effects* ; Catheter Ablation ; Catheters/adverse effects*

Abdominal Injuries ; Antithrombins/adverse effects* ; Atrial Fibrillation ; Dabigatran/adverse effects* ; Humans ; Thoracic Injuries

Oral anticoagulants play an important role in the prevention and treatment of thromboembolic diseases.Warfarin,a traditional oral anticoagulant,is limited in clinical use due to its limitations such as narrow therapeutic window and requirements on frequent monitoring and dose adjustment.Direct oral anticoagulants(DOACs)such as dabigatran,rivaroxaban,apixaban,and edoxaban are increasingly used to prevent and treat venous thrombosis or thrombus formation.However,recent studies have documented inter-individual variability in plasma drug levels of DOACs.This article summarizes the recent advances in the pharmacogenomics of DOACs.
Administration, Oral ; Anticoagulants ; therapeutic use ; Atrial Fibrillation ; drug therapy ; Dabigatran ; Pharmacogenetics ; Rivaroxaban

Objective: To compare the predictive value of HAS-BLED, HEMORR₂HAGES, ATRIA and ORBIT scores on the bleeding risk in nonvalvular atrial fibrillation (NVAF) patients treated with dabigatran. Methods: Data of 942 NVAF patients participating a non-interventional prospective study of anticoagulant therapy with dabigatran, which was conducted in 12 centers from February 2015 to December 2017 in China, were analyzed. Complete HAS-BLED HEMORR₂HAGES, ATRIA and ORBIT bleeding risk scores data and follow-up data were available in the enrolled patients. The endpoint of the study was bleeding events occurred during a 6 months follow-up. Cox proportional hazards models were constructed to analyze the associations between HAS-BLED, HEMORR₂HAGES, ATRIA and ORBIT scores and risk of bleeding, and the area under the curve (AUC) of receiver operating characteristics curves (ROC) of each score was used to set the predictive value for bleeding risk. Results: Among the 942 patients, the mean age was (65.3±11.2) years old, 542 (57.5%) were males. A total of 93 (9.9%) bleeding events occurred during follow up, 89 (9.4%) events were minor bleeding, and 4 (0.4%) events were major bleeding. Patients with a high-risk HAS-BLED score had a 1.87-fold increased risk of bleeding compared with low-risk patients (HR = 2.87, 95% CI:1.26-6.51, P = 0.012). There was no statistically significant difference between low-medium-high-risk grading in other scoring systems and bleeding risk (all P>0.05). The AUC (95%CI) of HAS-BLED, HEMORR₂HAGES, ATRIA and ORBIT bleeding risk scores were 0.558 (0.525-0.590), 0.520 (0.487-0.553), 0.513(0.480-0.545), 0.523(0.490-0.555), respectively. The AUC of all bleeding score systems were of ≤ 0.700. Conclusion: Among the NVAF patients taking dabigatran in China, the HAS-BLED bleeding risk score is superior to other 3 bleeding risk score on predicting the bleeding risk in these patients, but its predictive value is still relatively low.
Aged ; Anticoagulants ; Atrial Fibrillation ; China ; Dabigatran ; Humans ; Male ; Middle Aged ; Prospective Studies ; Risk Assessment ; Risk Factors ; Stroke

Non-Vitamin K antagonist oral anticoagulants (NOACs) have been extensively investigated in medical conditions at high risk of venous or arterial thrombosis other than atrial fibrillation (AF), including hip or knee arthroplasty, acute venous thromboembolism (VTE), cancer-associated VTE, acute coronary syndrome (ACS), stable atherosclerotic vascular disease, chronic heart failure, and embolic stroke of undetermined source (ESUS). Two large ESUS trials failed to show the benefit of rivaroxaban or dabigatran, and large randomized controlled trial (RCT) data of NOACs are lacking for another potential candidates of patent foramen ovale-related stroke, acute ischemic stroke, and cerebral venous thrombosis. On the other hand, high quality evidences of NOACs have been compiled for VTE prophylaxis after hip or knee arthroplasty, acute VTE, cancer-associated VTE, and concomitant ACS and AF, which have been reflected in clinical practice guidelines. In addition, RCTs showed the benefit of very low dose rivaroxaban in combination with antiplatelet therapy in patients with ACS and in those with stable cardiovascular disease. This article summarizes the accumulated evidences of NOACs in cardiovascular diseases beyond AF, and aims to inform healthcare providers of optimal regimens tailored to individual medical conditions and help investigators design future clinical trials.
Acute Coronary Syndrome ; Anticoagulants ; Arthroplasty, Replacement, Knee ; Atrial Fibrillation ; Cardiovascular Diseases ; Dabigatran ; Hand ; Health Personnel ; Heart Failure ; Hip ; Humans ; Research Personnel ; Rivaroxaban ; Stroke ; Thromboembolism ; Thrombosis ; Vascular Diseases ; Venous Thromboembolism ; Venous Thrombosis

BACKGROUND: To evaluate oral anticoagulant (OAC) utilization in patients with atrial fibrillation after the changes in the health insurance coverage policy in July 2015. METHODS: We used the Health Insurance Review and Assessment Service-National Patient Samples (HIRA-NPS) between 2014 and 2016. The HIRA-NPS, including approximately 1.4 million individuals, is a stratified random sample of 3% of the entire Korean population using 16 age groups and 2 sex groups. The HIRA-NPS comprises personal and medical information such as surgical or medical treatment provided, diagnoses, age, sex, region of medical institution, and clinician characteristics. The studied drugs included non-vitamin K antagonist OACs (NOACs) such as apixaban, dabigatran, edoxaban, and rivaroxaban, and were compared with warfarin. We analyzed drug utilization pattern under three aspects: person, time, and place. RESULTS: The number of patients with atrial fibrillation who were prescribed OACs was 3,114, 3,954, and 4,828; and the proportions of prescribed NOACs to total OACs were 5.1%, 36.2%, and 60.8% in 2014, 2015, and 2016, respectively. The growth rate of OACs prescription increased from 61.4 patients/quarter before June 2015 to 147.7 patients/quarter thereafter. These changes were predominantly in elderly individuals aged more than 70 years. The proportion of NOACs to OACs showed significant regional difference. CONCLUSION: The change of health insurance coverage policy substantially influenced OACs prescription pattern in whole Korean region. But the impact has been significantly different among regions and age groups, which provides the evidence for developing standard clinical practice guideline on OACs use.
Aged ; Anticoagulants ; Atrial Fibrillation* ; Dabigatran ; Drug Utilization ; Drug Utilization Review ; Humans ; Insurance, Health* ; Korea* ; Prescriptions* ; Rivaroxaban ; Warfarin

Oral anticoagulant-associated intracerebral hemorrhage (OAC-ICH) accounts for nearly 20% of all ICH. The number of patients with an indication for oral anticoagulant therapy (OAT) increases with increasing age. OAT became less complicate with the introduction of non-vitamin K oral anticoagulants (NOAC) OAT because of easier handling, favorable risk-benefit profile, reduced rates of ICH compared to vitamin K antagonists and no need for routine coagulation testing. Consequently, despite a better safety profile of NOAC the number of patients with OAC-ICH will increase. The mortality and complication rates of OAC-ICH are high and therefore they are the most feared complication of OAT. Immediate normalization of coagulation is the main goal and therefore knowledge of pharmacodynamics and coagulation status is essential. Laboratory measurements of anticoagulant activity in NOAC patients is challenging as specific tests are not widely available. More accessible tests such as the prothrombin time and activated partial thromboplastin time have important limitations. In dabigatran-associated ICH 5 g Idarucizumab should be administered. In rivaroxaban and apixaban-associated ICHs administration of andexanet alpha should be considered. Prothrombin complex concentrate may be considered if andexanet alpha is not available or in case of an ICH associated with edoxaban.
Anticoagulants* ; Antidotes* ; Avena ; Cerebral Hemorrhage ; Dabigatran ; Hemorrhage* ; Humans ; Mortality ; Partial Thromboplastin Time ; Prothrombin ; Prothrombin Time ; Rivaroxaban ; Vitamin K

An 88-year-old woman complained of right quadrant abdominal pain and severe edema in both legs. She had a history of pulmonary embolism one month ago. Abdomen CT showed a huge hepatic cyst compressing the intrahepatic portion of the inferior vena cava (IVC). The venogram CT showed multifocal thrombosis in the iliocaval and both lower extremity veins. Percutaneous hepatic cyst drainage was carried out. Fluid analysis presented leukocytosis, which suggested an infected hepatic cyst. To prevent secondary pulmonary thromboembolism, an IVC filter was inserted before catheter drainage for the hepatic cyst. One week later, abdominal pain was relieved. Then, sclerotherapy for the remnant hepatic cyst was performed by ethanol. Follow-up CT showed an increased amount of thrombosis in the iliocaval and left calf vein, but the IVC filter prevented another thromboembolic event successfully. The patient started dabigatran, a new oral anticoagulant, and compression stockings were applied to both legs. After one month, no visible thrombosis in the pelvis or either extremity was detected in abdominal CT. This case suggests that a huge hepatic cyst, especially with infection, should be considered as a possible cause of deep vein thrombosis if no other risk factors for thromboembolism exist.
Abdomen ; Abdominal Pain ; Aged, 80 and over ; Catheters ; Dabigatran ; Drainage* ; Edema ; Ethanol ; Extremities ; Female ; Follow-Up Studies ; Humans ; Leg ; Leukocytosis ; Liver ; Lower Extremity ; Pelvis ; Pulmonary Embolism ; Risk Factors ; Sclerotherapy ; Stockings, Compression ; Thromboembolism ; Thrombosis ; Tomography, X-Ray Computed ; Veins ; Vena Cava Filters* ; Vena Cava, Inferior* ; Venous Thrombosis*

Development of direct oral anticoagulants and their antidotes has led to the need to reconsider the eligibility of acute stroke patients who have been taking oral anticoagulants for intravenous thrombolysis. Officially authorized Japanese guidelines on this issue were revised twice at the time of approval for clinical use of direct oral anticoagulants and idarucizumab, a specific reversal agent for dabigatran. A unique recommendation in the latest Japanese clinical guides was that thrombolysis can be recommended if the time of the last dose of direct oral anticoagulants exceeds 4 hours and if commonly available anticoagulation markers are normal or subnormal, i.e., international normalized ratio of prothrombin time < 1.7 and activated partial thromboplastin time < 1.5 times the baseline value (≤40 seconds only as a guide). These criteria are partly supported by the findings of domestic multicenter and single-center surveys that symptomatic or asymptomatic intracranial hemorrhage following thrombolysis was rare under the conditions of the criteria. Even for dabigatran users, stroke thrombolysis can be considered without pretreatment by idarucizumab if patients meet the above criteria. If not, direct mechanical thrombectomy can be considered without pretreatment by idarucizumab or thrombolysis, and use of idarucizumab, followed immediately by thrombolysis, can be considered only when thrombectomy cannot be quickly performed. These clinical guides are practical and to some extent economical, but they have some limitations, including lack of corroborating information from sufficient numbers of relevant cases. The guides will be further modified based on the results of future research.
Anticoagulants ; Antidotes ; Asian Continental Ancestry Group ; Atrial Fibrillation ; Consensus* ; Dabigatran ; Humans ; International Normalized Ratio ; Intracranial Hemorrhages ; Japan* ; Partial Thromboplastin Time ; Prothrombin Time ; Stroke* ; Thrombectomy

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.
Anticoagulants* ; Atrial Fibrillation ; Dabigatran ; Drug Interactions ; Embolism ; Gastrointestinal Hemorrhage ; Hemorrhage* ; Humans ; Liver ; Platelet Aggregation Inhibitors ; Proton Pumps ; Risk Factors* ; Rivaroxaban ; Stroke ; Venous Thrombosis ; Warfarin