scholarly journals A prospective multicenter observational study evaluating the risk of periendoscopic events in patients using anticoagulants: the Osaka GIANT Study

2019 ◽  
Vol 07 (02) ◽  
pp. E104-E114 ◽  
Author(s):  
Takuya Inoue ◽  
Hideki Iijima ◽  
Takuya Yamada ◽  
Yuji Okuyama ◽  
Kanae Takahashi ◽  
...  

Abstract Background and study aims An increasing number of patients have been using anticoagulants including anti-vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs); however, in patients using anticoagulants, limited data are available with regard to the risks of gastrointestinal bleeding and thromboembolic events during the peri-endoscopic period. We aimed to evaluate the peri-endoscopic bleeding and thrombotic risks in patients administered VKAs or DOACs. Patients and methods Consecutive patients using anticoagulants who underwent endoscopic biopsy, mucosal resection, or submucosal dissection were prospectively enrolled across 11 hospitals. The primary outcome assessed was difference in incidence of post-procedural gastrointestinal bleeding in patients using VKAs and DOACs. Duration of hospitalization and peri-procedural thromboembolic events were also compared. Results We enrolled 174 patients using VKAs and 37 using DOACs. In total, 16 patients using VKA were excluded from the analysis because of cancellation of endoscopic procedures and contraindications to the use of DOACs; 128 (81 %) patients using VKAs and 17 (46 %) using DOACs received heparin-bridging therapy (HB). The rate of post-procedural gastrointestinal bleeding in DOAC users was similar to that in VKA users (16.2 % vs. 16.4 %, P = 1.000). Duration of hospitalization was significantly longer in patients using VKAs than in those using DOACs (median 15 vs. 7 days, P < 0.0001). Myocardial infarction occurred during pre-endoscopic HB in one patient using VKAs. Conclusion DOAC administration showed similar post-procedural gastrointestinal bleeding risk to VKA administration in patients undergoing endoscopic procedures, but it shortened the hospital stay.

Author(s):  
Karlo Huenerbein ◽  
Parvis Sadjadian ◽  
Tatjana Becker ◽  
Vera Kolatzki ◽  
Eva Deventer ◽  
...  

AbstractIn patients with BCR-ABL-negative myeloproliferative neoplasms (MPN), arterial or venous thromboembolic events (ATE/VTE) are a major burden. In order to control these complications, vitamin K antagonists (VKA) are widely used. There is no robust evidence supporting the use of direct oral anticoagulants (DOAC) in MPN patients. We therefore compared the efficacy and safety of both anticoagulants in 71 cases from a cohort of 782 MPN patients. Seventy-one of 782 MPN patients (9.1%) had ATE/VTE with nine ATE (12.7%) and 62 VTE (87.3%). Forty-five of 71 ATE/VTE (63.4%) were treated with VKA and 26 (36.6%) with DOAC. The duration of anticoagulation therapy (p = 0.984), the number of patients receiving additional aspirin (p = 1.0), and the proportion of patients receiving cytoreductive therapy (p = 0.807) did not differ significantly between the VKA and DOAC groups. During anticoagulation therapy, significantly more relapses occurred under VKA (n = 16) compared to DOAC treatment (n = 0, p = 0.0003). However, during the entire observation period of median 3.2 years (0.1–20.4), ATE/VTE relapse-free survival (p = 0.2) did not differ significantly between the two anticoagulants. For all bleeding events (p = 0.516) or major bleeding (p = 1.0), no significant differences were observed between VKA and DOAC. In our experience, the use of DOAC was as effective and safe as VKA, possibly even potentially beneficial with a lower number of recurrences and no increased risk for bleedings. However, further and larger studies are required before DOAC can be routinely used in MPN patients.


2018 ◽  
Vol 159 (20) ◽  
pp. 798-802
Author(s):  
László Márk

Abstract: Atrial fibrillation is the most common clinically relevant arrhythmia frequently causing systemic thromboembolic events. Traditionally vitamin K antagonists had been used for decades to prevent these events. The emerging of the new direct anticoagulants has revolutionized this treatment and a gradual growth and extensive spread of usage is expected. The latest one approved in Hungary, edoxaban, is a factor Xa inhibitor. Once-daily administration and favourable safety profile are major benefits of this drug. In a large clinical study with a high number of patients it proved to be at least as effective as warfarin in the prevention of stroke and systemic embolization while causing significantly less major bleedings. As the incidence of atrial fibrillation increases with age, the observation that, compared with the other direct oral anticoagulants, the administration of edoxaban in the elderly has a favourable net clinical benefit (in the rate of prevented thromboembolic events and the number of caused bleedings) may have a great importance. Orv Hetil. 2018; 159(20): 798–802.


2019 ◽  
Vol 15 (1) ◽  
pp. 49-53
Author(s):  
V. I. Petrov ◽  
O. V. Shatalova ◽  
A. S. Gerasimenko ◽  
V. S. Gorbatenko

Aim. To study the frequency of prescribing antithrombotic agents in patients with non-valvular atrial fibrillation (AF) who were hospitalized in the cardiology department of a multidisciplinary hospital.Material and methods. A retrospective one-time study of medical records of 765 patients with non-valvular AF treated in the cardiology department of a multidisciplinary hospital in 2012 and 2016 was performed.Results. All patients were stratified in three groups depending on the CHA2DS2-VASc score. The frequency of prescribing antithrombotic agents was evaluated in each group. A low risk of thromboembolic complications was found in 1% (n=3) of patients in 2012 and 0.6% (n=3) in 2016. All these patients received antithrombotic agents. CHA2DS2-VASc=1 was found in 6% (n=15) of patients with AF in 2012 and in 3.4% (n=17) in 2016. A significant number of patients in this group received anticoagulant therapy with vitamin K antagonists (warfarin) or with direct oral anticoagulants. A high risk of thromboembolic complications (CHA2DS2-VASc≥2) was found in 93% of patient (n=245) in 2012 and in 96% (n=482) in 2016. Anticoagulant therapy was prescribed in 70.2% (n=172) patients with high risk in 2012 and 80% (n=387) in 2016. However, some patients with high risk of thromboembolic complications did not have the necessary therapy.Conclusion. Positive changes in the structure and frequency of prescribing anticoagulant drugs in patients with AF and a high risk of thromboembolic complications were found during the years studied. 


RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001678
Author(s):  
Nazariy Koval ◽  
Mariana Alves ◽  
Rui Plácido ◽  
Ana G Almeida ◽  
João Eurico Fonseca ◽  
...  

BackgroundDespite vitamin K antagonists (VKA) being the gold standard in the prevention of thromboembolic events in antiphospholipid syndrome (APS), non-vitamin K antagonists oral anticoagulants/direct oral anticoagulants (DOACs) have been used off-label.ObjectiveWe aimed to perform a systematic review comparing DOACs to VKA regarding prevention of thromboembolic events, occurrence of bleeding events and mortality in patients with APS.MethodsAn electronic database search was performed through MEDLINE, CENTRAL and Web of Science. After data extraction, we pooled the results using risk ratio (RR) and 95% CI. Heterogeneity was assessed using the I². The outcomes considered were all thromboembolic events as primary, and major bleeding, all bleeding events and mortality as secondary. Evidence confidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology.ResultsWe included 7 studies and a total of 835 patients for analyses. Thromboembolic events were significantly increased in DOACs arm, compared with VKA—RR 1.69, 95% CI 1.09 to 2.62, I²—24%, n=719, 6 studies. In studies using exclusively rivaroxaban, which was the most representative drug in all included studies, the thromboembolic risk was increased threefold (RR 3.36, 95% CI 1.53 to 7.37). The risks of major bleeding, all bleeding events and mortality were not significantly different from control arm. The grade of certainty of our results is very low.ConclusionsCurrent evidence suggests DOACs use, particularly rivaroxaban, among patients with APS, is less effective than VKA since it is associated with 69% increased risk of thromboembolic events.Trial registration numberCRD42020216178.


2019 ◽  
Vol 15 (4) ◽  
pp. 593-603
Author(s):  
A. I. Kochetkov ◽  
O. D. Ostroumova

In recent years, there has been a persistent trend towards the more frequent prescription of direct oral anticoagulants (DOACs) compared with vitamin K antagonists due to the extensive body of evidence showing their high safety and efficacy, which in some cases exceed those of warfarin, and also by reason of there is no necessity for regular monitoring of international normalized ratio. However, the question of the reasonable and rational prescription of DOACs becomes relevant, including issues of their dosing, especially as a result of increasing in the number of patients with a complex cardiovascular risk profile and multimorbidity. In these terms, apixaban stands high among the DOAC class, and its high efficacy and safety both in full dose and reasonably reduced dosage has been proved, including older patients, patients with chronic kidney disease, coronary artery disease, with history of acute coronary syndrome and individuals undergoing percutaneous coronary intervention. This DOAC has strict indications to reduce the dose, they are specified in the drug label, and in such cases a reduced dose should be prescribed, in these clinical conditions the effectiveness and safety of apixaban is also proven. The favorable apixaban pharmacokinetic properties, consisting in low renal clearance, lack of clinically relevant interaction with food and the linear smooth effect on the blood coagulation components without episodes of hypo- and hypercoagulation, are the most important components of high efficacy and safety of this DOAC. The optimal efficacy and safety coupling of apixaban is reflected in the exclusively high patients’ adherence to the treatment confirmed by evidence-based medicine data, and therefore there is no necessity for additional procedures to maintain adherence. All the aforementioned facts allow us to recommend apixaban for widespread use in patients requiring anticoagulant therapy for optimal prevention of systemic thromboembolism and minimizing the associated risk of bleeding.


2021 ◽  
Vol 8 ◽  
Author(s):  
Aleix Cases ◽  
Pablo Gomez ◽  
Jose Jesus Broseta ◽  
Elisa Perez Bernat ◽  
Juan de Dios Arjona Barrionuevo ◽  
...  

Atrial fibrillation (AF) is the most common arrhythmia in chronic kidney disease (CKD), with a close bidirectional relationship between the two entities. The presence of CKD in AF increases the risk of thromboembolic events, mortality and bleeding. Vitamin K antagonists (VKA) have been the mainstay of treatment for the prevention of thromboembolic events in AF until recently, with confirmed benefits in AF patients with stage 3 CKD. However, the risk-benefit profile of VKA in patients with AF and stages 4–5 CKD is controversial due to the lack of evidence from randomized controlled trials. Treatment with VKA in CKD patients has been associated with conditions such as poorer anticoagulation quality, increased risk of bleeding, faster progression of vascular/valvular calcification and higher risk of calciphylaxis. Direct oral anticoagulants (DOACs) have shown equal or greater efficacy in stroke/systemic embolism prevention, and a better safety profile than VKA in post-hoc analysis of the pivotal randomized controlled trials in patients with non-valvular AF and stage 3 CKD, yet evidence of its risk-benefit profile in more advanced stages of CKD is scarce. Observational studies associate DOACs with a good safety/effectiveness profile compared to VKA in non-dialysis CKD patients. Further, DOACs have been associated with a lower risk of acute kidney injury and CKD development/progression than VKA. This narrative review summarizes the evidence of the efficacy and safety of warfarin and DOACs in patients with AF at different CKD stages, as well as their effects on renal function, vascular/valvular calcification and bone health.


2017 ◽  
Vol 10 (6) ◽  
pp. 495-505 ◽  
Author(s):  
David Deutsch ◽  
Christian Boustière ◽  
Emile Ferrari ◽  
Pierre Albaladejo ◽  
Pierre-Emmanuel Morange ◽  
...  

The use of direct oral anticoagulants (DOACs) was an important step forward in the management of atrial fibrillation and venous thromboembolism (VTE). The DOACs, anti-IIa for dabigatran and anti-Xa for rivaroxaban, apixaban and edoxaban, all have a rapid onset of action and a short half life. There is no need for routine hemostasis testing for treatment monitoring of a DOAC. Compared with vitamin K antagonists (VKAs), DOACs may increase the risk of gastrointestinal bleeding (relative risk 1.25). Withholding the DOAC treatment, evaluating the time of the last intake and estimating the patient’s renal function are the first steps in the management of gastrointestinal bleeding. For patients without impaired renal function, achieving low coagulation takes around 24 h after the last intake of a DOAC. The use of DOAC antagonists will be helpful in controlling bleeding in the most severe and urgent situations. Idarucizumab is available for clinical use for dabigatran and andexanet is currently being reviewed by drug agencies for rivaroxaban, apixaban and edoxaban. It is important to assess the bleeding risk associated with the planned procedure, and the patient’s renal function before withholding DOAC therapy for a scheduled intervention. It is mandatory to strengthen the local hemostasis strategies in DOAC-treated patients undergoing a therapeutic endoscopic procedure. Resuming or not resuming anticoagulation with a DOAC after bleeding or a risky procedure depends on the thrombotic and bleeding risk as well as the procedure involved. This discussion should always involve the cardiologist and decisions should be taken by a pluridisciplinary team.


2020 ◽  
Vol 10 (11) ◽  
pp. 842
Author(s):  
Nicolas Eibinger ◽  
Sascha Halvachizadeh ◽  
Barbara Hallmann ◽  
Franz Josef Seibert ◽  
Paul Puchwein ◽  
...  

The purpose of this study was to assess anticoagulant medication as an independent factor influencing the occurrence of a severe traumatic brain injury in geriatric patients. Data were collected from the TraumaRegister DGU® between January 2015 and December 2018. We included patients with an age of ≥65 years with a blunt TBI; an AISHead ≥2 but no other relevant injuries. Patients were divided into five subgroups: no anticoagulant medication, anti-platelet drugs, vitamin K antagonists, direct-oral-anticoagulants, and heparinoids. Separation between moderate TBI (AISHead 2–3) and severe TBI (AISHead ≥ 4) and multivariable regression analysis were performed. The average age of 10,559 included patients was 78.8 years with a mean ISS of 16.8 points and a mortality of 22.9%. The most common cause of injury was a low fall of <3 m with 72.8%. With increasing age, the number of patients without any anticoagulant therapy decreased from 65.9% to 29.9%. The intake of coagulation medication increased mortality significantly. Severe TBI was observed in 51% of patients without medication and ranged from 61 to 67% with anticoagulant drugs. After adjusting for confounding variables, the intake of VKA or DOACs was significantly associated with an increased risk of severe TBI. The use of anticoagulant medication is an independent factor and is associated with an increased severity of TBI depending on the type of medication used.


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