scholarly journals Detection of Direct Oral Anticoagulants in Patient Urine Samples by Prototype and Commercial Test Strips for DOACs – A Systematic Review and Meta-analysis

TH Open ◽  
2021 ◽  
Vol 05 (03) ◽  
pp. e438-e448
Author(s):  
Andrea Martini ◽  
Job Harenberg ◽  
Rupert Bauersachs ◽  
Jan Beyer-Westendorf ◽  
Mark Crowther ◽  
...  

AbstractThe DOAC Dipstick accurately detects the presence or absence of factor Xa (DXI) and thrombin inhibitor (DTI) classes of direct oral anticoagulants (DOACs) in patients' urine samples on DOAC treatment. The aim of the study was to systematically review the literature and compare the performance of prototype and commercial test strips with a meta-analysis.A systematic literature search of electronic databases PubMed (MEDLINE) and Cochrane Library was performed. Heterogeneity between studies was calculated using the Chi-squared test and the I2 index. A random effects model was used to pool data to compare the performance of prototype and commercial test strips.Using PRISMA reporting guidelines, four of 1,081 publications were eligible for inclusion in the meta-analysis: three reporting on prototype (DXI n = 658, DTI n = 586) and one on commercial test strips (DXI n = 451, DTI n = 429). Sensitivity and specificity of DXI and DTI detection did not differ significantly between the prototype and commercial test strips. Odds ratios were 0.718 and 0.365 for sensitivity and 1.211 and 1.072 for specificity of DXI and DTI (p-values between 0.3334 and 1.000), respectively. The pooled sensitivity and specificity values for DXI were 0.968 (p = 0.1290, I2 47.1%) and 0.979 (p = 0.1965, I2 35.9%), and for DTI 0.993 (p = 0.1870, I2 37.5%) and 0.993 (p = 0.7380, I2 0%), respectively.Prototype and commercial DOAC test strips did not differ in their ability to detect DXI and DTI in patient urine samples. This supports the confidence in use of the DOAC Dipstick test, although it needs to be validated in specific patient populations.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
R Sakurai

Abstract Background Direct oral anticoagulants have been demonstrated to have advantages in several patient populations compared with warfarin. However, the safety and efficacy are controversial between direct oral anticoagulants and warfarin in patients with chronic kidney disease, especially on dialysis, who have been excluded from randomised controlled trials. Purpose The purpose of this study was to investigate the safety and the efficacy of direct oral anticoagulants as compared to warfarin in patients on dialysis. Methods A meta-analysis was conducted on clinical studies in patients requiring oral anticoagulation and dialysis. PubMed, the Cochrane Library, and Web of Science were queried for the terms “dialysis”, “warfarin”, and “apixaban OR dabigatran OR rivaroxaban OR edoxaban”. The same terms or relevant studies were also queried on the website of the U.S. National Institute of Health and relevant reviews. The clinical endpoints were stroke/systemic embolism and major bleeding. Pooled estimates were calculated using a random-effects model. Results Six observational studies (18487 patients) were included in this study. The risk of major bleeding (odds ratio (OR) 0.45; 95% confidence interval (CI) 0.31–0.65; p<0.01) was lower in patients on direct oral anticoagulants compared to those on warfarin, whereas the risk of stroke/systemic embolism (OR0.63; 95% CI 0.30–1.33; p=0.23) was similar between the two types of anticoagulant. Conclusions Direct oral anticoagulants are associated with a lower risk of major bleeding and a similar risk of stroke/systemic embolism compared to warfarin in patients on dialysis. To validate these findings, randomised controlled trials are warranted. Funding Acknowledgement Type of funding source: None


2019 ◽  
Author(s):  
Mingxia Li ◽  
Hong Lin ◽  
Jiankuan Shi ◽  
Qianru Yang ◽  
Jianjun Li ◽  
...  

Abstract Background Anticoagulation and antiplatelet therapy were adopted respectively for the prevention ofcardio-embolic stroke or arterial origin stroke. while it’s difficult to make decisions for individual with Atrial fibrillation(AF)and arterial origin stroke as comorbidities, so we attempted to evaluate the efficacy and safety ofanticoagulants and antiplatelet forthe prevention of stroke in AF with arterial origin stroke and make an optimal treatment for these comorbidities. Methods Databases included PubMed, Cochrane Library and ClinicalTrials.gov were searched up to 31 Aug 2019. Eight RCTs with 77048 participants were enrolled. Results Direct oral anticoagulants(DOACs) reduced the relative risk of stroke and systemic embolism by 15% (95%CI 0.75-0.97, I2=65.6%) and the major bleeding by 23%(95%CI 0.63-0.95, I2=92.3%,). DOACs or warfarin plus aspirin compared with DOACs or warfarin alone did not show the benefit on stroke and systemic embolism prevent in AF patients, but increase the risk of major bleeding with RR 1.40 (95%CI 1.13-1.75,) and 1.33(95%CI 1.09-1.63)respectively. No differences in preventionof ischemic stroke were detected between OACs versus aspirin in arterial origin stroke. The major bleeding was significantly higher in the OACs group (RR,2.40,1.46-3.94, I2=62.2%). However, compared with aspirin, rivaroxabandid not increase the risk of major bleeding in Branch atheromatous stroke (RR,1.54,95%CI 0.26-9.12). Conclusions We speculatedthat DOACs alone may be enough to prevent stroke recurrence and not to increase the risk of bleeding in AF patients with arterial origin stroke. The well designed RCTs with the direct comparison would be needed in future.


2020 ◽  
Author(s):  
Tarun Dalia ◽  
Shubham Lahan ◽  
Sagar Ranka ◽  
Amandeep Goyal ◽  
Sara Zoubek ◽  
...  

Abstract Background: Left ventricular thrombus (LVT) is not uncommon and pose a risk of systemic embolism, which can be mitigated by adequate anticoagulation. Direct oral anticoagulants (DOACs) are increasingly being used as alternatives to warfarin for anticoagulation, but their efficacy and safety profile has been debated. We aim to compare the therapeutic efficacy and safety of DOACs versus warfarin for the treatment of LVT.Methodology: We systematically searched PubMed/Medline, Google Scholar, Cochrane library, and LILCAS databases from inception to 14th August 2020 to identify relevant studies comparing warfarin and DOACs for LVT treatment and used the pooled data extracted from retrieved studies to perform a meta-analysis.Results: We report pooled data on 1955 patients from 8 studies, with a mean age of 61 years and 59.7 years in warfarin and DOACs group, respectively. The pooled odds ratio for thrombus resolution was 1.11 (95% CI 0.51–2.39) on comparing warfarin to DOAC, but it did not reach a statistical significance (p = 0.76). The pooled risk ratio (RR) of stroke or systemic embolization and bleeding in patients treated with warfarin vs DOACs was 1.04 (95% CI 0.64–1.68; p = 0.85), and 1.15 (95% CI 0.62–2.13; p = 0.57), respectively; with an overall RR of 1.09 (95% CI 0.70–1.70; p =0.48) for mortality.Conclusions: DOACs appears to be non-inferior or at least as effective as warfarin in the treatment of left ventricular thrombus without any statistical difference in stroke or bleeding complications.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Tarun Dalia ◽  
Shubham Lahan ◽  
Sagar Ranka ◽  
Amandeep Goyal ◽  
Sara Zoubek ◽  
...  

Abstract Background Left ventricular thrombus (LVT) is not uncommon and pose a risk of systemic embolism, which can be mitigated by adequate anticoagulation. Direct oral anticoagulants (DOACs) are increasingly being used as alternatives to warfarin for anticoagulation, but their efficacy and safety profile has been debated. We aim to compare the therapeutic efficacy and safety of DOACs versus warfarin for the treatment of LVT. Methodology We systematically searched PubMed/Medline, Google Scholar, Cochrane library, and LILCAS databases from inception to 14th August 2020 to identify relevant studies comparing warfarin and DOACs for LVT treatment and used the pooled data extracted from retrieved studies to perform a meta-analysis. Results We report pooled data on 1955 patients from 8 studies, with a mean age of 61 years and 59.7 years in warfarin and DOACs group, respectively. The pooled odds ratio for thrombus resolution was 1.11 (95% CI 0.51–2.39) on comparing warfarin to DOAC, but it did not reach a statistical significance (p = 0.76). The pooled risk ratio (RR) of stroke or systemic embolization and bleeding in patients treated with warfarin vs DOACs was 1.04 (95% CI 0.64–1.68; p = 0.85), and 1.15 (95% CI 0.62–2.13; p = 0.57), respectively; with an overall RR of 1.09 (95% CI 0.70–1.70; p = 0.48) for mortality. Conclusions DOACs appears to be non-inferior or at least as effective as warfarin in the treatment of left ventricular thrombus without any statistical difference in stroke or bleeding complications.


2021 ◽  
Vol 12 ◽  
Author(s):  
Nan-Nan Shen ◽  
Chi Zhang ◽  
Na Wang ◽  
Jia-Liang Wang ◽  
Zhi-Chun Gu ◽  
...  

Background: In routine clinical practice, non-standard doses of direct oral anticoagulants (DOACs) are commonly used in patients with atrial fibrillation (AF). However, data on the clinical outcomes of non-standard doses of DOACs are limited.Methods: The MEDLINE, Embase, and Cochrane Library databases were systematically searched from their inception until 30 June 2020 for studies that reported the effectiveness or safety outcomes of non-standard doses of DOACs compared with on-label doses of DOACs in patients with atrial fibrillation. Non-standard doses of DOACs were defined as under or over-dose of DOACs based on the recommended standard doses in drug labels. A random-effects meta-analysis was performed to calculate the pooled hazard ratio and associated 95% confidence interval (95% confidence interval). Subgroup analyses were conducted according to individual DOACs and different geographic regions.Results: Ten articles involving 148,909 patients with AF were included. There were no significant differences between under-dosing and on-label dosing with respect to stroke/systematic embolism (HR: 1.01, 95% CI: 0.93–1.09), major bleeding (HR: 0.98, 95% CI: 0.77–1.19), intracranial haemorrhage (HR: 1.07, 95% CI: 0.74–1.40), gastrointestinal bleeding (HR: 1.10, 95% CI: 0.82–1.39), and myocardial infarction (HR: 1.07, 95% CI: 0.89–1.25), except for an increased risk of death (HR: 1.37, 95% CI: 1.01–1.73). We observed a significant association between over-dosing of DOACs and increased risk of stroke/systematic embolism (HR: 1.18, 95% CI: 1.04–1.32), major bleeding (HR: 1.16, 95% CI: 1.03–1.29), and death (HR: 1.21, 95% CI: 1.03–1.38) compared with on-label dosing. Furthermore, over-dosing of DOACs increased the risk of stroke/systematic embolism (HR: 1.16; 95% CI: 1.00–1.33) and major bleeding events (HR: 1.18; 95% CI: 1.00–1.37) in Asian patients.Conclusion: A reduced dose of DOACs might be safely and effectively used in clinical practice, especially in Asian patients, whereas high-dose DOACs might not be well tolerated by Asian patients.


PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0252549
Author(s):  
Kazuhiko Kido ◽  
Yasir Abdul Ghaffar ◽  
James C. Lee ◽  
Christopher Bianco ◽  
Mikiko Shimizu ◽  
...  

Current American College of Cardiology/American Heart Association guidelines for stroke or ST-elevation myocardial infarction recommend the use of oral vitamin K antagonists (VKAs) as a first-line anticoagulant. Although several studies have compared the use of direct oral anticoagulants (DOACs) to VKAs for left ventricular thrombus (LVT) anticoagulation therapy, they are small scale and have produced conflicting results. Thus, this meta-analysis was performed to aggregate these studies to better compare the efficacy and safety of DOACs with VKAs in patients with LVT. Cochrane Library, Google Scholar, MEDLINE, and Web of Science database searches through January 10, 2021 were performed. Eight studies evaluating stroke or systemic embolism (SSE), six studies for LVT resolution, and five studies for bleeding were included. There were no statistically significant differences in SSE (OR 0.89; 95% CI 0.46, 1.71; p = 0.73; I2 = 45%) and LVT resolution (OR 1.13; 95% CI 0.75, 1.71; p = 0.56; I2 = 1%) between DOAC and VKA (reference group) therapy. DOAC use was significantly associated with lower bleeding event rates compared to VKA use (OR 0.61; 95% CI 0.40, 0.93; p = 0.02; I2 = 0%). DOACs may be feasible alternative anticoagulants to vitamin K antagonists for LV thrombus treatment. Randomized controlled trials directly comparing DOACs with VKAs are needed.


2020 ◽  
pp. 1-7 ◽  
Author(s):  
Maryam Saleem ◽  
Maryam Saleem ◽  
Mohammed Osman ◽  
Saira Farid ◽  
Christopher M. Bianco ◽  
...  

There is uncertainty about the choice of anticoagulation therapy in patients with malignancy and venous thromboembolism (VTE). While low-molecular weight heparin (LMWH) remains the current standard, direct oral anticoagulants (DOACs) have emerged as an appealing alternative option. The primary objective of this analysis was to compare the efficacy and safety of DOACs versus LMWH in patients with malignancy and VTE. The secondary objective was to compare the safety and efficacy of the different DOACs. An online search of PubMed, EMBASE, the Cochrane Library and ClinicalTrials.gov from inception until April 2020 was conducted. Four RCTs encompassing 2,907 patients, (50.5% men and mean age of 65.7 ± 10.5) were selected. At a mean follow up of 12 months, moderate certainty evidence showed no differences between DOAC and LMWH in VTE recurrence (HR, 0.54 [CI 0.23 to 1.28], I2 = 56%, p=0.23), in major bleeding (HR, 1.38 [CI 0.45 to 4.22], I2 = 33%, p=0.21) or clinically relevant non-major bleeding (CRNMB) (HR, 1.77 [CI 0.49 to 6.40], I2 = 73.9%, p=0.087). There was no difference between the DOACs when compared to each other. In conclusion, DOACs are an acceptable alternative to LMWHs for the treatment of VTE in patients with malignancy.


Author(s):  
Petar Stanković ◽  
Stephan Hoch ◽  
Stefan Rudhart ◽  
Danilo Obradovic ◽  
Nikolaos Dagres ◽  
...  

Objective: Epistaxis is the most common otolaryngological emergency and up to one third of patients in treated on an inpatient basis take oral anticoagulants (OAC). Direct oral anticoagulants (DOAC), an OAC subgroup, have been on the market since 2010 and are being increasingly prescribed due to the cardiologic and hematologic guidelines that favour them over vitamin K antagonists (VKA), the older of the OAC subgroups. The present study aims to investigate which subgroup of epistaxis patients taking OACs has a more favourable outcome. Design/Setting: A systematic review and meta-analysis were performed according to the PRISMA 2020 statement using the PubMed and Cochrane Library databases. Continuous data was analysed and standardized mean difference (SMD) was calculated according to Hedges’ g. Dichotomous data was analysed and the Mantel-Haenszel method was applied to establish the odds ratio (OR). Heterogeneity was assessed according to the I2 statistics. Main Outcome/Results: A total of 8 reports covering 1390 patients were included in the final synthesis. The pooled analysis demonstrated significantly shorter hospital stays in the DOAC group (SMD= -0.22, 95% CI -0.42 to -0.02, P= .03) and a significantly higher rate of posterior bleeding in the VKA group (OR= .39, 95% CI .23 to .68, P= .001). No statistically significant differences with regard to recurrence rates, admission rates, the need for transfusion, or surgical intervention (P= .57, .12, .57 and .38 respectively) were found. Conclusion: According to this meta-analysis, epistaxis patients taking DOACs have a more favourable outcome than patients taking VKAs.


2021 ◽  
Vol 27 ◽  
pp. 107602962199355
Author(s):  
Job Harenberg ◽  
Andrea Martini ◽  
Shanshan Du ◽  
Sandra Krämer ◽  
Christel Weiss ◽  
...  

Testing for direct oral anticoagulants (DOACs) in patient urine may facilitate medical treatment decisions. The aim of this study was to investigate interobserver variability by 2 independent observers compared to laboratory staff in the visual interpretation of factor Xa (DXI) and thrombin inhibitors (DTI) using the DOAC Dipstick test. We also examined whether test pads reacted to other anticoagulants and abnormal urine colors. The colors of the DOAC Dipstick direct factor Xa inhibitor and thrombin inhibitor pads were interpreted with 100% accuracy (95% confidence interval 0.862 to 1.000) for urine samples from persons treated with apixaban (n = 26), rivaroxaban (n = 24), and dabigatran (n = 29) and without anticoagulant therapy (n = 29). The factor Xa and thrombin inhibitor pads did not interact with heparin, nadroparin, fondaparinux, or coumadin. One µg/mL r-Hirudin and 6 µg/mL argatroban interacted with the DTI pad; however, this is unlikely to cause clinical problems because dabigatran is unlikely to be administered together with r-Hirudin and argatroban in clinical circumstances. Abnormal urine color was reliably detected by the urine color pad, so can prevent false interpretation of the DOAC Dipstick pad colors. In conclusion, we have demonstrated that interobserver variability when interpreting the DOAC Dipstick test strip is low and that factor Xa and thrombin inhibitor pads do not react to other anticoagulants such as heparins and coumadin. R-Hirudin and argatroban can be detected by the thrombin inhibitor pad and abnormal urine colors can be detected by the urine color pad to prevent false interpretation of the results in patient urine samples.


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