scholarly journals Direct oral anticoagulants increase bleeding risk after endoscopic sphincterotomy: a retrospective study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sakue Masuda ◽  
Kazuya Koizumi ◽  
Takashi Nishino ◽  
Tomohiko Tazawa ◽  
Karen Kimura ◽  
...  
Keyword(s):  
Risk Factors ◽  
Endoscopic Sphincterotomy ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Serious Adverse Event ◽  
Antithrombotic Drug ◽  
Number Of Patients ◽  
Low Platelet Count ◽  
Attending Physician

Abstract Background Bleeding can be a serious adverse event of endoscopic sphincterotomy (EST). However, the risk of EST bleeding between direct oral anticoagulant (DOAC) users and those who received no antithrombotic agents has not been clarified. This study analyzed the risk factors for bleeding after EST in patients on DOAC and evaluated the Japan Gastroenterological Endoscopy Society (JGES) guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment. Methods We retrospectively analyzed 524 patients treated with EST who received DOAC or no antithrombotic drug from May 2016 to August 2019. We investigated the risk factors for bleeding. DOAC was typically discontinued for ≤ 1-day based on the JGES guideline. Although DOAC therapy recommenced the next morning after EST in principle, the duration of DOAC cessation and heparin replacement were determined by the attending physician based on each patient’s status. Results The number of patients on DOAC (DOAC group) and those not on antithrombotic drug (no-drug group) was 42 (8.0%) and 482 (92.0%), respectively. DOAC was discontinued for ≤ 1-day in 17 (40.0%) patients and for > 1-day in 25 (60.0%). Of the 524 patients, 21 (4.0%) had EST bleeding. The bleeding rate was higher in the DOAC group (14.0%) (p = 0.004). Multivariate analysis showed that bleeding occurred more frequently in patients on DOAC (odds ratio [OR] 3.95, 95% confidence interval [CI] 1.37–11.4, p = 0.011), patients with low platelet counts (< 100,000/µl) (OR 6.74, 95% CI 2.1–21.6, p = 0.001), and elderly patients (> 80 years old) (OR 3.36, 95%CI 1.17–9.65, p = 0.024). Conclusions DOAC treatment, low platelet count, and old age (> 80 years old) are risk factors for EST bleeding. Although the bleeding incidence increased in patients on DOAC who received antithrombotic therapy according to the JGES guidelines, successful hemostasis was achieved with endoscopy in all cases, and no thrombotic events occurred after cessation of DOAC. Thus, the JGES guidelines are acceptable.

scholarly journals Direct Oral Anticoagulants Increase Bleeding Risk After Endoscopic Sphincterotomy: A Retrospective Study

2020 ◽  
Author(s):  
Sakue Masuda ◽  
Kazuya Koizumi ◽  
Takashi Nishino ◽  
Tomohiko Tazawa ◽  
Karen Kimura ◽  
...  
Keyword(s):  
Risk Factors ◽  
Endoscopic Sphincterotomy ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Significant Risk ◽  
Bleeding Risk ◽  
Antithrombotic Drug ◽  
Number Of Patients ◽  
Low Platelet Count ◽  
Attending Physician

Abstract Background: Bleeding is a serious adverse event of endoscopic sphincterotomy (EST). However, the risk of EST bleeding between direct oral anticoagulant (DOAC) users and those who received no antithrombotic agents has not been clarified. This study analyzed the risk factors for bleeding after EST in patients on DOAC and evaluated the Japan Gastroenterological Endoscopy Society (JGES) guidelines for gastroenterological endoscopy in patients undergoing antithrombotic treatment.Methods: We retrospectively analyzed 524 patients treated with EST who received DOAC or no antithrombotic drug from May 2016 to August 2019. We investigated the risk factors for bleeding. Cessation and resumption of DOAC treatment were determined according to the JGES guidelines, although DOAC cessation or heparin replacement was determined by the attending physician. Results: The number of patients on DOAC (DOAC group) and those without antithrombotic drug (no-drug group) were 42 (8.0%) and 482 (92.0%), respectively. DOAC was discontinued for <2 days in 24 (57.2%) patients and for ≥2 days in 18 (42.8%) patients. Of the 524 patients, 21 (4.0%) had EST bleeding. The bleeding rate was significantly higher in the DOAC group (14.3%, 6/42). Multivariate analysis showed that bleeding occurs more frequently in patients on DOAC, patients with low platelet counts (<100,000/µl), and elderly patients (>80 years old).Conclusions: DOAC treatment, low platelet count, and old age (>80 years old) are significant risk factors for EST bleeding. Although the bleeding incidence increased in patients on DOAC, which was discontinued according to the JGES guidelines, successful hemostasis was achieved with endoscopy in all cases with bleeding, and no thrombotic events occurred after cessation of DOAC. Thus, the JGES guidelines are acceptable.

scholarly journals Current Recommendations for the Management of Cancer-Associated Venous Thromboembolism

2021 ◽  
Vol 7 (2) ◽  
pp. 27-38
Author(s):  
Katalin Makó
Keyword(s):  
Risk Factors ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Term Treatment ◽  
Long Term Treatment ◽  
High Bleeding Risk ◽  
Cancer Associated Thrombosis

Abstract Cancer-associated thrombosis (CAT) is a major cause of death in oncological patients. The mechanisms of thrombogenesis in cancer patients are not fully established, and it seems to be multifactorial in origin. Also, several risk factors for venous thromboembolism (VTE) are present in these patients such as tumor site, stage, histology of cancer, chemotherapy, surgery, and immobilization. Anticoagulant treatment in CAT is challenging because of high bleeding risk during treatment and recurrence of VTE. Current major guidelines recommend low molecular weight heparins (LMWHs) for early and long-term treatment of VTE in cancer patients. In the past years, direct oral anticoagulants (DOACs) are recommended as potential treatment option for VTE and have recently been proposed as a new option for treating CAT. This manuscript will give a short overview of risk factors involved in the development of CAT and a summary on the recent recommendations and guidelines for treatment of VTE in patients with malignancies, discussing also some special clinical situations (e.g. renal impairment, catheter-related thrombosis, and thrombocytopenia).

Abstract 15237: Predictors of Intracranial and Gastrointestinal Bleeding in Cirrhosis With Use of Direct Oral Anticoagulants: A Large Population Based Study

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Muhammad U Butt ◽  
Aun R Shah ◽  
Osama Hamid ◽  
Sara Ghoneim ◽  
Maham Malik
Keyword(s):  
Risk Factors ◽  
Gastrointestinal Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Large Population ◽  
Bleeding Risk ◽  
Population Based ◽  
Snomed Ct ◽  
Risk Of Bleeding ◽  
Cirrhotic Patients

Introduction: Use of Direct Oral Anticoagulants (DOACs) in patients with cirrhosis remains controversial, as the studies demonstrating safety of DOACs excluded these patients. Hypothesis: To determine the predictors of Intracranial and Gastrointestinal bleeding in cirrhosis with use of DOACs. Methods: We reviewed data from a large commercial database (Explorys IBM) that aggregates electronic health records from 26 large nationwide healthcare systems. Using systemized nomenclature of clinical medical terms (SNOMED CT), we identified adults with liver cirrhosis, intracranial and gastrointestinal bleeding. Risk factors known to be associated with bleeding such as alcohol abuse, NSAIDs, CKD and advanced age were collected. Bleeding risk with DOAC use was compared with coumadin. Univariable and multivariable logistic regression analyses were performed to investigate strongest predictors Results: Out of 61.4 million active adult patients in the database, 468,580 patients (0.61%) had documented cirrhosis. 9.14 % and 3.14 % of the cirrhotic patients were on DOACs and coumadin, respectively. In cirrhotic patients, there was higher composite risk of ICH or GIB if they were on DOACs (35.47% vs 21.24 % OR 2.04 [2.01-2.07]), used NSAIDs (31.15% vs 23.63% OR 1.46 [1.44-1.48]), had CKD (32.61% vs 25.04 %, OR 1.45 [1.42-1.47]), or abused alcohol (36.22% vs 23.57%, OR 1.84 [1.81- 1.87]). Risk of bleeding was higher with DOACs as compared to coumadin (35.47% vs 22.81%: p< 0.001). In Multivariable model CKD modified composite bleeding risk of ICH or GIB after adjustment for other risk factors. A cirrhotic patient on DOAC had higher risk of bleeding with CKD (OR 2.29 [(2.22-2.37)]) than without CKD (OR 1.66 [(1.63-1.69)]). This interaction was found to be statistically significant. Similar trend was noticed with use of coumadin. Conclusions: Major bleeding risk in cirrhosis was significantly higher with use of DOACs as compared to warfarin. This risk was highest in patients with CKD.

scholarly journals Management of risk factors for gastrointestinal bleeding in patients receiving anticoagulant therapy

2021 ◽  
Vol 26 (8) ◽  
pp. 4635
Author(s):  
N. V. Bakulina ◽  
S. V. Tikhonov ◽  
N. B. Lishchuk ◽  
A. B. Karaya
Keyword(s):  
Risk Factors ◽  
Gastrointestinal Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Gastrointestinal Diseases ◽  
Thromboembolic Events ◽  
Antiinflammatory Drugs ◽  
Patient Profile ◽  
Increased Risk

Direct oral anticoagulants (DOACs) are used to prevent and treat thrombosis and thromboembolic events in patients with various diseases. Despite its high efficacy and safety, DOAC therapy is accompanied by increased risk of hemorrhage, including gastrointestinal bleeding. Bleeding risk depends on individual patient profile and their risk factors. An increased risk of bleeding is associated with manifesting effect of DOACs on existing mucosal defects, active Helicobacter pylori infection. To reduce the risk of gastrointestinal bleeding in clinical practice, changing of following modifiable risk factors is required: H. pylori eradication; dose-adjusted DOAC therapy; prophylactic proton pump inhibitors (PPIs) administration to patients with HAS-BLED score ≥3, receiving dual or triple antithrombotic therapy, taking DOACs in combination with non-steroidal antiinflammatory drugs, to those with upper gastrointestinal diseases. In addition to PPIs, patients may be prescribed with rebamipide, bismuth tripotassium dicitrate, ursodeoxycholic acid. DOAC rivaroxaban (Xarelto®) has pharmacokinetic and pharmacodynamic advantages, a convenient single dosing regimen and a favorable safety profile, which provides effective protection against thrombosis and thromboembolic events in combination with low risk of gastrointestinal bleeding.

Bleeding risk in anticoagulated patients with atrial fibrillation

ESC CardioMed ◽  
2018 ◽  
pp. 2195-2198
Author(s):  
Margaret C. Fang
Keyword(s):  
Risk Factors ◽  
Atrial Fibrillation ◽  
Intracranial Haemorrhage ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Clinical Risk Factors ◽  
Anticoagulation Management ◽  
Clinical Risk

Bleeding is the primary complication associated with chronic anticoagulant treatment of atrial fibrillation and can range from minor, clinically insignificant bleeds to life-threatening events. Anticoagulants increase an individual’s bleeding risk by approximately 2–2.5-fold. The absolute rates of bleeding vary depending on the presence or absence of specific clinical risk factors, as well as the type of anticoagulant and the quality of anticoagulation management. There are many clinical risk factors for bleeding including older age, hypertension, prior bleeding, anaemia, and kidney impairment. Concomitant use of other medications, in particular other antithrombotic/antiplatelet drugs, also significantly raises bleeding risk. Intracranial haemorrhage, a relatively uncommon but widely feared complication of anticoagulants, results in a 30-day mortality of about 40%. Risk factors for intracranial haemorrhage include advanced age, elevated blood pressure, a history of cerebrovascular disease, and cerebral amyloid angiopathy. A number of risk stratification schemes have been developed in order to better estimate the risk of anticoagulant-related bleeding. Most of the risk schemes were developed and validated in patients taking vitamin K antagonists, but have increasingly been applied to populations taking the newer direct oral anticoagulants. Although bleeding risk tools can be useful to assist in counselling patients about their bleeding risk, in general, these risk schemes are only moderately predictive and are probably best applied to patients who are considered reasonable candidates for anticoagulation and who are on the lower end of ischaemic stroke risk.

scholarly journals Novel bleeding risk score for patients with atrial fibrillation on oral anticoagulants, including direct oral anticoagulants

2021 ◽  
Author(s):  
Luise Adam ◽  
Martin Feller ◽  
Lamprini Syrogiannouli ◽  
Cinzia Del‐Giovane ◽  
Jacques Donzé ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Score ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk

Contemporary Clinical Use of Aspirin: Mechanisms of Action, Current Concepts, Unresolved Questions, and Future Perspectives

2021 ◽  
Author(s):  
Mikael Christiansen ◽  
Erik Lerkevang Grove ◽  
Anne-Mette Hvas
Keyword(s):  
Cardiovascular Disease ◽  
Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Clinical Use ◽  
Action Current ◽  
Potential Clinical Benefit ◽  
Treatment Indications ◽  
Prevention Of Cardiovascular Disease

AbstractThe ability of aspirin to inhibit platelet aggregation has positioned this agent within the most frequently used drugs worldwide. The aim of this article is to review the contemporary clinical use of aspirin and also to discuss unresolved issues not yet translated into clinical practice. Results from several clinical trials have led to strong guideline recommendations for aspirin use in the acute management and secondary prevention of cardiovascular disease. On the contrary, guidelines regarding aspirin use as primary prevention of cardiovascular disease are almost conservative, supported by recent trials reporting that the bleeding risk outweighs the potential benefits in most patients. In pregnancy, aspirin has proved efficient in preventing preeclampsia and small-for-gestational-age births in women at high risk, and is hence widely recommended in clinical guidelines. Despite the vast amount of clinical data on aspirin, several unresolved questions remain. Randomized trials have reported that aspirin reduces the risk of recurrent venous thromboembolism, but the clinical relevance remains limited, because direct oral anticoagulants are more effective. Laboratory studies suggest that a twice-daily dosing regimen or evening intake may lead to more efficient platelet inhibition, and the potential clinical benefit of such strategies is currently being explored in ongoing clinical trials. Enteric-coated formulations of aspirin are frequently used, but it remains unclear if they are safer and as efficient as plain aspirin. In the future, aspirin use after percutaneous coronary interventions might not be mandatory in patients who also need anticoagulant therapy, as several trials support shorter aspirin duration strategies. On the other hand, new treatment indications for aspirin will likely arise, as there is growing evidence that aspirin may reduce the risk of colorectal cancer and other types of cancer.

scholarly journals Bleeding Risk in Non-Valvular Atrial Fibrillation Patients Receiving Direct Oral Anticoagulants and Warfarin: A Systematic Review and Meta-Analysis of Observational Studies

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3672-3672 ◽  
Author(s):  
Yimin Pearl Wang ◽  
Rohan Kehar ◽  
Alla Iansavitchene ◽  
Alejandro Lazo-Langner
Keyword(s):  
Major Bleeding ◽  
Lower Risk ◽  
Observational Studies ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Bleeding Risk ◽  
Risk Of Bleeding ◽  
Significant Difference

Introduction: The standard oral anticoagulant therapy administered to non-valvular AF patients has typically been Vitamin K Antagonists (VKA) particularly warfarin. In recent years, Direct Oral Anticoagulants (DOACs) including Direct Thrombin Inhibitors (DTI) and Direct Factor Xa inhibitors (FXa inhibitors) have become an alternative to warfarin. Randomized trials comparing warfarin and DOACs showed comparable effectiveness without significant additional major bleeding risk. However, bleeding events in RCTs may differ from those in daily use due to the routine exclusion of patients with a higher risk of bleeding from many studies. We aimed to assess bleeding risk between DOACs and warfarin in AF patients in observational studies and we also sought to determine differences between patients that were experienced or naïve to oral anticoagulants. Methods: A systematic literature search was conducted in the OVID MEDLINE® and EMBASE® electronic databases. Observational studies and randomized control trials (RCT) from 1990 to January 2019 were retrieved and examined by two independent reviewers. A pooled effect hazard ratio (HR) was calculated using a random effects model using the generic inverse variance method. Subgroup analyses according to previous exposure to anticoagulants, study type, funding type and DOAC type were conducted. The primary outcome was major bleeding risk. The secondary outcome was clinically relevant non-major bleeding. All studies must have used an established or validated definition of major bleeding. Results: The initial literature search identified 3359 potentially eligible citations. After primary screening, 150 articles were eligible for full text review and there were 35 studies including 2,356,201 patients that met the inclusion criteria. Overall, patients on DOACs were less likely to experience a bleeding event compared to warfarin (HR 0.78, 95%CI 0.71, 0.85, P&lt;0.001). The results were consistent when analyzing patients receiving DTIs or FXa inhibitors (DTI: HR 0.76, 95% CI 0.67,0.87; FXa inhibitors: HR 0.79, 95% CI 0.69,0.89). However, among patients receiving factor Xa inhibitors, there was a significant difference in the risk of bleeding according to individual drug. Among patients receiving rivaroxaban the risk of bleeding was similar to warfarin (HR 0.98, 95%CI 0.91,1.06, p=0.60) whereas in those receiving apixaban there was a 40% reduction in the risk of bleeding compared to warfarin (HR 0.60, 95%CI 0.50,0.71, p&lt;0.001) (Figure 1). Three studies reported information according to previous anticoagulant exposure. The overall pooled hazard ratio was 0.68 (95% CI 0.55, 0.82 p&lt;0.001) in favor of patients on DOACs. In the subgroup analysis of previous anticoagulant use, the risk of bleeding was lower for DOACs compared to warfarin in both the experienced population (HR 0.70, 95%CI 0.51, 0.96) and the naïve population (HR 0.64, 95% CI 0.47,0.87). However, heterogeneity was moderate to high among both subgroups. Conclusion: This review and meta-analysis of observational studies including over 2.3 million patients showed that overall DOACs have a lower risk of major bleeding and clinically relevant non-major bleeding compared to warfarin. Most importantly, although the pooled effect estimate did not differ between DTIs and FXa inhibitors, among patients receiving FXa inhibitors there was a significant difference between individual agents. Patients on apixaban had a significantly lower risk of bleeding compared to warfarin in contrast to patients on rivaroxaban who had a similar risk. Disclosures No relevant conflicts of interest to declare.

scholarly journals Direct Oral Anticoagulants in Asian Patients with Atrial Fibrillation: Consensus Recommendations by the Asian Pacific Society of Cardiology on Strategies for Thrombotic and Bleeding Risk Management

2021 ◽  
Vol 16 ◽  
Author(s):  
Daniel TT Chong ◽  
Felicita Andreotti ◽  
Peter Verhamme ◽  
Jamshed J Dalal ◽  
Noppacharn Uaprasert ◽  
...  
Keyword(s):  
Disease Burden ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Asia Pacific ◽  
Asian Populations ◽  
Asian Patients ◽  
Consensus Statements ◽  
Asian Pacific

The disease burden of AF is greater in Asia-Pacific than other areas of the world. Direct oral anticoagulants (DOACs) have emerged as effective alternatives to vitamin K antagonists (VKA) for preventing thromboembolic events in patients with AF. The Asian Pacific Society of Cardiology developed this consensus statement to guide physicians in the management of AF in Asian populations. Statements were developed by an expert consensus panel who reviewed the available data from patients in Asia-Pacific. Consensus statements were developed then put to an online vote. The resulting 17 statements provide guidance on the assessment of stroke risk of AF patients in the region, the appropriate use of DOACs in these patients, as well as the concomitant use of DOACs and antiplatelets, and the transition to DOACs from VKAs and vice versa. The periprocedural management of patients on DOAC therapy and the management of patients with bleeding while on DOACs are also discussed.

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