scholarly journals Direct oral anticoagulants (DOAC) for prevention of recurrent arterial or venous thromboembolic events (ATE/VTE) in myeloproliferative neoplasms

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.

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.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4845-4845
Author(s):  
Christian F Christiansen ◽  
Karynsa Cetin ◽  
Merete Lund Mægbæk ◽  
Waleed Ghanima ◽  
Shahram Bahmanyar ◽  
...  

Abstract Background: ITP is a rare autoimmune disorder characterized by low platelet counts, resulting in an increased risk for bleeding. Paradoxically, patients with cITP may also have an increased incidence of thrombotic or thromboembolic events, but population-based data on this are limited. We estimated the incidence of these events in a prospective cohort study of incident cITP patients in three Nordic countries. Methods: Based on National Health Registry Systems (NHRSs) and medical records in Denmark, Norway, and Sweden, the study cohort included all adults diagnosed with cITP from January 1, 2008 to December 31, 2012 (n=1,821). Arterial thrombotic events (myocardial infarction [MI] and stroke) and venous thromboembolic events (pulmonary embolism and deep vein thrombosis) were identified in the NHRSs. Patients were followed from the latest of cITP diagnosis or April 1, 2009, until the earliest date of the first occurrence of the event of interest, death, emigration, or December 31, 2012. Incidence rates (events per 1,000 person-weeks [PW]) were computed for the entire cohort and stratified by gender, age, splenectomy status, and comorbidity burden. Results: Nearly 60% of the cITP cohort was >50 years in age, and 56% were female. Overall, the incidence of arterial thrombotic events was 0.31 per 1,000 PW (95% confidence interval [CI]: 0.25-0.39) and the incidence of venous thromboembolic events was 0.18 per 1,000 PW (95% CI: 0.13-0.24). For arterial thrombotic events, the risk was higher in males (compared with females), and the risk for both event types increased with increasing age and comorbid burden. Given the small number of patients who underwent splenectomy (n=101), it was difficult to detect any differences in the risk of thrombotic events by splenectomy status, but the incidence of venous thromboembolic events was higher in splenectomized versus non-splenectomized patients (0.27 per 1,000 PW [95% CI: 0.15-0.50] versus 0.16 [95% CI: 0.11-0.23]). Conclusions: Among patients with cITP, the risk of arterial thrombotic events is higher in males than females and increases with increasing age and level of comorbid burden. The risk of venous thromboembolic events is heightened in cITP patients who have undergone splenectomy. Abstract 4845. TableArterial thrombotic eventsVenous thromboembolic eventsN / PWIncidence rate per 1,000 PW (95% CI)N / PWIncidence rate per 1,000 PW (95% CI)Overall (n=1,821)68 / 218,3910.31 (0.25-0.39)39 / 220,8650.18 (0.13-0.24)GenderMale (n=794)39 / 90,5310.43 (0.31-0.59)17 / 92,4080.18 (0.11-0.30)Female (n=1,027)29 / 127,8600.23 (0.16-0.33)22 / 128,4570.17 (0.11-0.26)Age18-50 years (n=751)5 / 96,1190.05 (0.02-0.12)5 / 95,9630.05 (0.02-0.13)51-70 years (n=544)13 / 65,6520.20 (0.11-0.34)13 / 65,5560.20 (0.12-0.34)>70 years (n=526)50 / 56,6210.88 (0.67-1.17)21 / 59,3450.35 (0.23-0.54)Comorbid burdenLow (n=1,243)25 / 154,1810.16 (0.11-0.24)18 / 155,0580.12 (0.07-0.18)Moderate (n=435)29 / 48,3070.60 (0.42-0.86)14 / 49,6940.28 (0.17-0.48)High (n=143)14 / 15,9030.88 (0.52-1.49)7 / 16,1130.43 (0.21-0.91)Splenectomy statusSplenectomized (n=101)10 / 37,1210.27 (0.14-0.50)10 / 36,9570.27 (0.15-0.50)Non-splenectomized (n=1,720)58 / 181,2700.32 (0.25-0.41)29 / 183,9080.16 (0.11-0.23) Disclosures Cetin: Amgen: Employment. Ghanima:Roche: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; GlaxoSmithKline: Consultancy. Stryker:Amgen Inc.: Employment, Equity Ownership.


2019 ◽  
Vol 120 (01) ◽  
pp. 014-026 ◽  
Author(s):  
Marc Schindewolf ◽  
Jeffrey Ian Weitz

AbstractTraditionally, venous thromboembolism (VTE) resulting from major transient risk factors (e.g., surgery or trauma) or a major persistent risk factor such as cancer, has been defined as being provoked, whereas unprovoked VTE encompasses events without an identifiable cause. These categorizations influence anticoagulant treatment duration; unlike VTE provoked by major transient risk factors, extended anticoagulation beyond 3 months is advised for patients with cancer or unprovoked VTE due to risk persistence after treatment cessation. However, some patients with VTE provoked by minor transient or minor persistent risk factors may also be candidates for extended anticoagulation therapy due to the continuing risk of recurrence. In patients who require extended therapy, vitamin K antagonists (VKAs) are effective but are associated with an increased risk of bleeding and various treatment burdens (e.g., anticoagulation monitoring and dose adjustment). Evaluations of extended VTE treatment with the less-burdensome direct oral anticoagulants such as apixaban, dabigatran, edoxaban, and rivaroxaban show that they are at least as safe and effective as VKAs in a broad range of patients. In addition, apixaban and rivaroxaban offer more than one dosing option, allowing tailoring of treatment to the patient's specific risk factor profile. Analysis of more granular definitions for risk factor groupings has also yielded vital information on the most appropriate strategies for the treatment of patients with specific risk factors, highlighting that extended anticoagulation treatment may benefit those with minor transient and persistent environmental and nonenvironmental risk factors who commonly receive shorter-duration therapy.


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.


2021 ◽  
Vol 11 (11) ◽  
Author(s):  
Joan How ◽  
Charlotte Story ◽  
Siyang Ren ◽  
Donna Neuberg ◽  
Rachel P. Rosovsky ◽  
...  

AbstractMyeloproliferative neoplasms (MPNs) are characterized by an increased risk of thrombosis and bleeding. Vitamin K antagonists (VKAs) are the historic anticoagulant recommended for use in MPNs. Direct oral anticoagulants (DOACs) are being increasingly used in general and cancer populations. However, DOAC safety and efficacy in MPN patients remains unclear. We characterized real-world practice patterns of DOAC use in MPN patients and evaluated thrombosis and bleeding risk. We conducted a retrospective cohort study of 133 MPN patients prescribed DOACs for venous thromboembolism (VTE), atrial fibrillation, or arterial thromboembolism (ATE). Practice patterns including duration of anticoagulation, dosing, and concomitant use of antiplatelet/cytoreductive agents, were heterogeneous among MPN patients. The 1-year cumulative incidence of thrombosis and bleeding on DOAC was 5.5% (1.5–9.5%) and 12.3% (6.4–18.2%) respectively. In comparison, reported bleeding rates in MPN patients on DOAC and VKAs are 1–3%. On multivariable analysis, prior history of thrombosis, use of dabigatran or edoxaban, and younger age were significantly associated with a higher risk of recurrent thrombosis, while leukocytosis was associated with a higher risk of bleeding on DOAC. The higher-than-expected bleeding rate found in our study indicates the continued need for rigorous evaluation of DOACs in this population.


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.


2021 ◽  
Vol 10 (15) ◽  
pp. 3212
Author(s):  
Fabiana Lucà ◽  
Simona Giubilato ◽  
Stefania Angela Di Fusco ◽  
Laura Piccioni ◽  
Carmelo Massimiliano Rao ◽  
...  

The therapeutic dilemma between rhythm and rate control in the management of atrial fibrillation (AF) is still unresolved and electrical or pharmacological cardioversion (CV) frequently represents a useful strategy. The most recent guidelines recommend anticoagulation according to individual thromboembolic risk. Vitamin K antagonists (VKAs) have been routinely used to prevent thromboembolic events. Non-vitamin K antagonist oral anticoagulants (NOACs) represent a significant advance due to their more predictable therapeutic effect and more favorable hemorrhagic risk profile. In hemodynamically unstable patients, an emergency electrical cardioversion (ECV) must be performed. In this situation, intravenous heparin or low molecular weight heparin (LMWH) should be administered before CV. In patients with AF occurring within less than 48 h, synchronized direct ECV should be the elective procedure, as it restores sinus rhythm quicker and more successfully than pharmacological cardioversion (PCV) and is associated with shorter length of hospitalization. Patients with acute onset AF were traditionally considered at lower risk of thromboembolic events due to the shorter time for atrial thrombus formation. In patients with hemodynamic stability and AF for more than 48 h, an ECV should be planned after at least 3 weeks of anticoagulation therapy. Alternatively, transesophageal echocardiography (TEE) to rule out left atrial appendage thrombus (LAAT) should be performed, followed by ECV and anticoagulation for at least 4 weeks. Theoretically, the standardized use of TEE before CV allows a better stratification of thromboembolic risk, although data available to date are not univocal.


2021 ◽  
Vol 5 (8) ◽  
pp. 2055-2062
Author(s):  
Soravis Osataphan ◽  
Rushad Patell ◽  
Thita Chiasakul ◽  
Alok A. Khorana ◽  
Jeffrey I. Zwicker

Abstract Hospitalized medically ill patients with cancer are at increased risk of both venous thromboembolism and bleeding. The safety and efficacy of extended thromboprophylaxis in patients with cancer are unclear. We conducted a systematic review and meta-analysis of the literature using of MEDLINE, EMBASE, and the Cochrane CENTRAL databases to identify cancer subgroups enrolled in randomized controlled trials evaluating extended thromboprophylaxis following hospitalization. The primary outcomes were symptomatic and incidental venous thromboembolic events and hemorrhage (major hemorrhage and clinically relevant nonmajor bleeding). Four randomized controlled trials reported the outcomes of extended thromboprophylaxis in 3655 medically ill patients with active or history of cancer. The rates of venous thromboembolic events were similar between the extended-duration and standard-duration groups (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.61-1.18; I2 = 0%). However, major and clinically relevant nonmajor bleeding occurred significantly more frequently in the extended-duration thromboprophylaxis group (OR, 2.10; 95% CI, 1.33-3.35; I2 = 8%). Extended thromboprophylaxis in hospitalized medically ill patients with cancer was not associated with a reduced rate of venous thromboembolic events but was associated with increased risk of hemorrhage. This study protocol was registered on PROSPERO as #CRD42020209333.


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. 


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