scholarly journals Different Risk Profiles of European Patients Using Direct Oral Anticoagulants or Vitamin K Antagonists: a Rapid Review

2020 ◽  
Vol 7 (4) ◽  
pp. 290-299
Author(s):  
Katrin Krueger ◽  
Kathrin Jobski ◽  
Annemarie Voss ◽  
Ulrike Haug

Abstract Purpose of Review We investigated the risk profiles of patients using direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA) in European cohort studies to estimate the importance of potential (measured or unmeasured) confounding factors in analyses comparing these drugs. We searched MEDLINE and EMBASE (2008–2018) for relevant studies and extracted information on age, sex, comorbidity, Charlson comorbidity index, HAS-BLED score (assessing risk of bleeding) and CHA2DS2-VASc score (assessing risk of stroke). Recent Findings Overall, 66 studies with 2,808,757 patients were included. Most patients were from France (37%), Denmark (24%) and Germany (23%). In 56 studies (85%), the focus was on patients with atrial fibrillation. Of the 43 studies comparing DOAC with VKA users, 33% reported a higher and 16% a lower age of DOAC compared with VKA users. The mean age varied by about 1 year in most of these studies. Rivaroxaban was used in the widest age range. Patients with DOAC more often had a history of stroke or bleedings, and patients with VKA more often had a history of diabetes, renal failure, cancer, heart failure or other heart diseases. Most studies did not observe differences regarding the HAS-BLED score or the CHA2DS2-VASc score between groups. Summary Our review suggests that there are relevant differences in the risk profiles of DOAC versus VKA users and between users of individual DOACs. Reported HAS-BLED or CHA2DS2-VASc scores did not reflect these differences. These patterns require careful consideration in the interpretation of observational studies comparing the effectiveness and the risks of these drugs, also when comparing the results of studies conducted in different countries.

Author(s):  
Na He ◽  
Sophie Dell'Aniello ◽  
Suodi Zhai ◽  
Samy Suissa ◽  
Christel Renoux

Abstract Aims To determine the risk of fracture associated with direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF), accounting for cumulative duration of use. Methods and results Using Quebec administrative healthcare databases, we formed a cohort of all patients aged 40 years or older newly diagnosed with NVAF, who filled a first prescription for DOACs or VKAs between 2011 and 2014. Exposure was modelled as a time-varying variable whereby patients were considered unexposed up to 180 days of cumulative duration of use (to account for a biologically meaningful exposure) and exposed thereafter. The final cohort included 10 306 new users of DOACs and 15 357 new users of VKAs. After propensity score-based fine stratification and weighting, use of DOACs for 180 days or greater was associated with a 35% decreased risk of fracture [crude incidence rates 7.5 vs. 15.3 per 1000 person-years; adjusted hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.46–0.91] compared to VKA duration ≥180 days. Direct oral anticoagulants use was also associated with a lower risk of hip fracture (HR 0.51, 95% CI 0.31–0.86) compared with VKAs. There was no difference in the rate of fracture for shorter duration of use (HR 1.10; 95% CI 0.79–1.53). The risk was not modified by age, sex, chronic kidney disease, osteoporosis, history of fracture or falls. Conclusion Prolonged use of DOACs is associated with a lower risk of fracture compared with VKAs. These findings support the first-line recommendation for DOACs in patients with NVAF.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Whitlock ◽  
E.P Belley-Cote ◽  
J Healey ◽  
P.J Devereaux ◽  
J Eikelboom ◽  
...  

Abstract Background About 10% of patients undergoing cardiac surgery have a history of atrial fibrillation (AF). Among these patients, uncertainty exists regarding the safest and most effective oral anticoagulant (OAC) during the postoperative period. Purpose To evaluate practice patterns regarding OAC early after cardiac surgery in patients with a preoperative history of AF and to compare the safety and effectiveness of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods We conducted a nested cohort study within the Left Atrial Appendage Occlusion Study (LAAOS) III (NCT01561651). LAAOS III included patients with AF undergoing cardiac surgery with a CHA2DS2-VASC ≥2. In this substudy, we examined patients without end-stage renal dysfunction (eGFR >30 mL/min/1.73m2) who were discharged on OAC. We evaluated bleeding and thromboembolism within 90 days postoperatively using logistic regression adjusting for CHA2DS2-VASC score. Results Recruitment started in 2012 and completed in 2018 in 113 centres in 31 countries. Of the 4811 patients enrolled in LAAOS III, 3725 (77%) were included in this substudy. Preoperatively, 58% of patients received OAC: 56% DOACs and 44% VKAs. At hospital discharge 23% received DOACs and 77% VKAs; 55% of patients on a DOAC at baseline were switched to a VKA while 5% of patients on a VKA were switched to a DOAC. Patients discharged on a DOAC were older, had a higher CHA2DS2-VASC, and were more likely to be male. Patients having undergone an isolated coronary bypass procedure were more likely prescribed DOACs than VKAs (41% vs 23%, p<0.001) whereas isolated non-mechanical valve patients were more likely to be prescribed VKAs (43% vs 28%, p<0.001). Switching from a DOAC to a VKA postoperatively occurred in 42% of patients In Australia/New Zealand, 49% in Europe, and 63% in North America. Major bleeding between 48 hours postoperatively and 30 days occurred in 1.5% in the DOAC group and 1.3% in the VKA group (aOR 1.14, 95% CI 0.60–2.15, p=0.69) while between 48 hours and 90 days, it occurred in 1.8% of patients in both groups (aOR 0.97, 95% CI, 0.54–1.17, p=0.91). Cardiac tamponade, the composite of stroke and systemic arterial embolism, and the composite of stroke, systemic arterial embolism and death did not differ significantly at 30 and 90 days between the DOAC and VKA groups. Conclusions VKAs was the dominant OAC used early after cardiac surgery, but postoperative OAC practices varied by region. After adjustment for CHA2DS2-VASC score, the early postoperative incidence of major bleeding and of the composite of stroke and systemic arterial embolism did not differ significantly when DOACs were compared with VKAs. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): CIHR, Heart and Stroke Foundation


Author(s):  
Martin Müller ◽  
Ioannis Chanias ◽  
Michael Nagler ◽  
Aristomenis K. Exadaktylos ◽  
Thomas C. Sauter

Abstract Background Falls from standing are common in the elderly and are associated with a significant risk of bleeding. We have compared the proportional incidence of bleeding complications in patients on either direct oral anticoagulants (DOAC) or vitamin K antagonists (VKA). Methods Our retrospective cohort study compared elderly patients (≥65 years) on DOAC or VKA oral anticoagulation who presented at the study site – a Swiss university emergency department (ED) – between 01.06.2012 and 01.07.2017 after a fall. The outcomes were the proportional incidence of any bleeding complication and its components (e.g. intracranial haemorrhage), as well as procedural and clinical parameters (length of hospital stay, admission to intensive care unit, in-hospital-mortality). Uni- and multivariable analyses were used to compare the studied outcomes. Results In total, 1447 anticoagulated patients were included – on either VKA (n = 1021) or DOAC (n = 426). There were relatively more bleeding complications in the VKA group (n = 237, 23.2%) than in the DOAC group (n = 69, 16.2%, p = 0.003). The difference persisted in multivariable analysis with 0.7-fold (95% CI: 0.5–0.9, p = 0.014) lower odds for patients under DOAC than under VKA for presenting with any bleeding complications, and 0.6-fold (95% 0.4–0.9, p = 0.013) lower odds for presenting with intracranial haemorrhage. There were no significant differences in the other studied outcomes. Conclusions Among elderly, anticoagulated patients who had fallen from standing, those under DOACs had a lower proportional incidence of bleeding complications in general and an even lower incidence of intracranial haemorrhage than in patients under VKAs.


2020 ◽  
Vol 25 (4) ◽  
pp. 316-323
Author(s):  
Martín Ruiz Ortiz ◽  
Javier Muñiz ◽  
María Asunción Esteve-Pastor ◽  
Francisco Marín ◽  
Inmaculada Roldán ◽  
...  

Objective: To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs). Methods: A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received. Results: Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, P = .01), cancer history (4.9% vs 10.9%, P = .046), renal failure (21.1% vs 32.2%, P = .02), and left ventricular dysfunction (2.4% vs 8.0%, P = .03); and higher frequency of previous stroke (26.0% vs 16.6%, P = .02) and previous major bleeding (8.1% vs 3.6%, P = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( P = .15), 3.45 vs 4.41 ( P = .48), and 8.2 vs 11.0 ( P = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, P = .19; HR: 0.88, 95% CI: 0.44-1.76, P = .72 and HR: 0.84, 95% CI: 0.53-1.33, P = .46, respectively). Conclusion: In this “real-world” registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.


2015 ◽  
Vol 4 (1) ◽  
pp. 44 ◽  
Author(s):  
Philipp Bushoven ◽  
Sven Linzbach ◽  
Mate Vamos ◽  
Stefan H Hohnloser ◽  
◽  
...  

For many patients with symptomatic atrial fibrillation, cardioversion is performed to restore sinus rhythm and relieve symptoms. Cardioversion carries a distinct risk for thromboembolism which has been described to be in the order of magnitude of 1 to 3 %. For almost five decades, vitamin K antagonist therapy has been the mainstay of therapy to prevent thromboembolism around the time of cardioversion although not a single prospective trial has formally established its efficacy and safety. Currently, three new direct oral anticoagulants are approved for stroke prevention in patients with non-valvular atrial fibrillation. For all three, there are data regarding its usefulness during the time of electrical or pharmacological cardioversion. Due to the ease of handling, their efficacy regarding stroke prevention, and their safety with respect to bleeding complications, the new direct oral anticoagulants are endorsed as the preferred therapy over vitamin K antagonists for stroke prevention in non-valvular atrial fibrillation including the clinical setting of elective cardioversion.


2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Kyle M. Ware ◽  
Douglas L. Feinstein ◽  
Israel Rubinstein ◽  
Prudhvi Battula ◽  
Jose Otero ◽  
...  

Background and Purpose. Anticoagulant therapy is broadly used to prevent thromboembolic events. Intracranial hemorrhages are serious complications of anticoagulation, especially with warfarin. Direct oral anticoagulants reduce but do not eliminate the risk of intracranial hemorrhages. The aim of this study is to determine the degree of intracranial hemorrhage after application of anticoagulants without additional triggers. Methods. Rats were treated with different anticoagulant classes (vitamin K antagonists, heparin, direct thrombin inhibitor, and factor Xa inhibitor). Brain hemorrhages were assessed by the free hemoglobin concentration in the brain parenchyma. Results. Vitamin K antagonists (warfarin and brodifacoum) significantly increased free hemoglobin in the brain. Among direct oral anticoagulants, thrombin inhibitor dabigatran also significantly increased free hemoglobin in the brain, whereas treatment with factor Xa inhibitor rivaroxaban did not have significant effect on the free hemoglobin concentration. Conclusions. Our data indicates that the severity of brain hemorrhages depends on the anticoagulant class and it is more pronounced with vitamin K antagonists.


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