scholarly journals Efficacy and Safety of Non-recommended Dose of New Oral Anticoagulants in Patients With Atrial Fibrillation: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Xiangyun Kong ◽  
Yong Zhu ◽  
Lianmei Pu ◽  
Shuai Meng ◽  
Lihan Zhao ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Low Dose ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Recommended Dose ◽  
Cochrane Library ◽  
High Dose ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Recommended Dosage

Introduction: The real-world treatment of atrial fibrillation (AF) often involves the prescription of new oral anticoagulants (NOACs) using dosing both lower and higher than recommended guidelines. Our study aimed to evaluate the efficacy and safety of non-recommended dosage of NOACs in AF patients.Methods: A systematic search was performed for relevant studies across multiple electronic databases (PubMed, Embase, Cochrane Library, Clinical Trials Registry) from inception to May 1, 2021. Multicenter randomized trials and observational studies were selected with key reporting measures for inclusion involved efficacy outcomes including stroke or systemic thromboembolism along with safety endpoints assessing major or clinically relevant bleeding events.Results: A total of 11 eligible studies were included involving 48,648 patients receiving recommended dose of NOACs and 50,116 patients receiving non-recommended dosage. Compared to AF patients treated with recommended dose regimens, administration of low dose of NOACs was associated with higher risk of stroke/systemic embolism (RR = 1.24, 95% CI 1.14–1.35, P < 0.00001), but without reducing bleeding risk (RR = 1.18, 95% CI 0.91–1.53, P = 0.21) and a higher risk of all-cause mortality (RR = 1.58, 95% CI 1.25–1.99, P = 0.0001). Moreover, high dose of NOACs was associated with higher risk of stroke and systemic embolism efficacy (RR = 1.71, 95% CI 1.06–2.76, P = 0.03) and a non-significant trend to a greater risk of major or clinically relevant bleeding (RR = 1.57, 95% CI 0.96–2.58, P = 0.07).Conclusions: AF patients treated with low dose of NOACs showed equivalent safety but with worse efficacy compared with recommended dose. High dose of NOACs was not superior to recommended dose regimens in preventing stroke/systemic embolism outcomes in AF patients.

Indirect Comparisons of the New Oral Anticoagulants in Patients with Non-Valvular Atrial Fibrillation

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4363-4363 ◽  
Author(s):  
Shabnam Zolfaghari ◽  
Job Harenberg ◽  
Svetlana Marx ◽  
Martin Wehling
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Conflicts Of Interest ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
New Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Indirect Comparisons

Abstract Abstract 4363 The efficacy and safety of new oral anticoagulants has been demonstrated for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) by dabigatran in the RE-LY trial (150mg and 110mg bid), rivaroxaban in the ROCKET AF trial (20mg od), and apixaban in the ARISTOTLE trial (5mg bid) versus INR-adjusted warfarin. Direct comparisons of the NOACs in this indication are unlikely to be performed. A total of 4 indirect comparisons of these trials on the efficacy and safety of NOACs in patients with NVAF have now been published within only 3 months (Lip et al 2012, Harenberg et al 2012, Mantha et al 2012, Wells et al 2012). Here, we compare the results of these 4 network meta-analysis (NMA). In all 4 NMAs of the 3 new oral anticoagulants dabigatran (150mg bid) showed superior efficacy in preventing ischemic stroke plus systemic embolism to dabigatran (110mg bid, p<0.04) and rivaroxaban (p<0.04). Apixaban had equivalent efficacy with rivaroxaban and dabigatran (either dose). Apixaban was safer (less major bleeding) than dabigatran (150mg bid, p<0.04) or rivaroxaban (p<0.005). Intracerebral haemorrhage occurred with equal frequency for all agents and regimens except for rivaroxaban (higher risk than dabigatran 110mg bid, p<0.005). Myocardial infarction occurred less frequently with rivaroxaban and apixaban compared to either dose of dabigatran (all p<0.05). All-cause mortality was not different for any agent or regimen. Some minor differences between the NMAs may result from the approved doses of dabigatran by the FDA (150mg bid and 75mg bid) and EMA (150mg bid and 110mg bid), as the inclusion of the 110 mg bid dose of dabigatran into the NMA may not be seen relevant in the US. Based on this comparison, doctors and patients have to decide which suggestions of the 4 groups of authors seem more convincing: to change to or to start with one of the NOACs depending on the individual thrombotic or bleeding risk or to wait for the results from a large (and expensive) head-to-head randomised controlled trial which may take years to perform. Disclosures: No relevant conflicts of interest to declare.

3054Efficacy and safety of non-vitamin K oral anticoagulants in patients with atrial fibrillation and cancer

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
I Cavallari ◽  
G Verolino ◽  
G Patti
Keyword(s):  
Atrial Fibrillation ◽  
Venous Thromboembolism ◽  
Intracranial Hemorrhage ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Patients With Cancer ◽  
All Cause Mortality

Abstract Background Anticoagulation in patients with cancer and atrial fibrillation (AF) is particularly challenging given the higher risk of both thrombotic and bleeding complications in this setting. Data regarding the efficacy and safety of non-vitamin K oral anticoagulants (NOACs) in AF patients with malignancy remain unclear. Purpose In the present meta-analysis we further investigate the efficacy and safety of NOACs compared to warfarin in patients with AF and cancer assuming that available studies may be individually underpowered for endpoints at low incidence, i.e. stroke, major and intracranial bleeding. Methods We performed a systematic review and meta-analysis of studies comparing the use of NOACs vs. warfarin in AF patients with cancer. Efficacy outcome measures included stroke or systemic embolism, venous thromboembolism and mortality. Safety outcome measures were major bleeding and intracranial hemorrhage. Results We pooled data from 6 identified studies enrolling a total of 31,756 AF patients with cancer. Mean follow-up was 1.7 years. Patients with cancer had significantly increased annualized rates of venous thromboembolism (1.38% vs. 0.74%), major bleeding (9.01% vs. 5.13%), in particular major gastrointestinal bleeding (2.38% vs. 1.60%), and all-cause mortality (17.73% vs. 8.50%) vs. those without (all P values <0.001), whereas the incidence of stroke or systemic embolism and intracranial hemorrhage did not differ. Compared with warfarin, treatment with NOACs nominally decreased the risk of stroke or systemic embolism (5.41% vs. 2.70%; odds ratio, OR; 95% confidence intervals, CI 0.51, 0.26–1.01; P=0.05; Figure), mainly of ischemic stroke (OR 0.56; 95% CI 0.35–0.89; P=0.01), and the risk of venous thromboembolism (OR 0.51; 95% CI 0.42–0.61; P<0.001). In cancer patients receiving NOACs there was a significant reduction of major bleeding (3.95% vs. 4.66%; OR 0.66, 95% CI 0.46–0.94; P=0.02; Figure) and intracranial hemorrhage (0.26% vs. 0.66%; OR 0.25, 95% CI 0.08–0.82; P=0.02) vs. warfarin, with no difference in gastrointestinal major bleeding rates. Conclusion AF patients on oral anticoagulation and concomitant cancer are at higher risk of venous thromboembolism, major bleeding and all-cause mortality. NOACs may represent a safer and more effective alternative to warfarin also in this setting of patients.

scholarly journals Efficacy and safety of Dabigatran vs. Rivaroxaban among Asians with non-valvular atrial fibrillation：Protocol for a systematic review and meta-analysis

2021 ◽  
Author(s):  
Li Jia ◽  
Mingming Zhou ◽  
Li Sun ◽  
Luhai Yu ◽  
Xiangyan He
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
China National Knowledge Infrastructure ◽  
Asian Patients ◽  
Meta Analyses

Abstract Atrial fibrillation(AF) increases the risk of ischemic stroke and systemic embolism in patients. Moreover, Asian patients with AF are more likely to have ischemic stroke than non-Asian patients. Oral anticoagulants could effectively prevent thrombotic events. Dabigatran and Rivaroxaban are two most commonly used novel oral anticoagulants (NOACs) in Asia, but those clinicial studies in relation with them are mostly in American and European countries. Therefore, whether there are differences between Dabigatran and Rivaroxaban among Asian patients with AF in terms of efficacy and safety is still unknown. This systematic review and meta-analysis will mainly assess clinical efficacy and safety of Dabigatran versus Rivaroxaban in Asian patients with AF by a pooled analysis. We will follow the PRISMA (preferred reporting items for systematic reviews and meta-analyses) and the reporting MOOSE (Meta-analyses of Observational Studies in Epidemiology) when performing this study. Then Cochrane Library,Web of Science, PubMed and China national knowledge infrastructure will be searched for eligible retrospective investigation that report the efficacy and safety outcomes of AF patients who utilised Dabigatran or Rivaroxaban for stroke prevention in Asian countries. The abovementioned database will be comprehensively searched from inception to September 30, 2019 to locate all potentially eligible studies. Outcome measures will include safety and efficacy indicators. Safety indicators include intracranial hemorrhage, major bleeding and gastrointestinal bleeding. Efficacy indicators include systemic embolism and stroke. New evidence for clinical profile of Dabigatran versus Rivaroxaban in AF patients will be provided for decision-making of Asian patients.PROSPERO registration number: CRD42020156197

Efficacy and Safety of Nonvitamin K Oral Anticoagulants in Patients with Atrial Fibrillation and Cancer: A Study-Level Meta-Analysis

2019 ◽  
Vol 120 (02) ◽  
pp. 314-321 ◽  
Author(s):  
Ilaria Cavallari ◽  
Giuseppe Verolino ◽  
Silvio Romano ◽  
Giuseppe Patti
Keyword(s):  
Atrial Fibrillation ◽  
Ischemic Stroke ◽  
Venous Thromboembolism ◽  
Meta Analysis ◽  
Oral Anticoagulants ◽  
Intracranial Bleeding ◽  
Efficacy And Safety ◽  
Systemic Embolism ◽  
Primary Analysis ◽  
Patients With Cancer

Abstract Objectives In this study-level meta-analysis, we evaluated the clinical outcome with nonvitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients with cancer. Background Anticoagulation in AF patients with cancer is challenging given the coexistence of elevated thrombotic and bleeding risk. The efficacy and safety of NOACs in this setting remain unclear. Methods We included three randomized trials in our primary analysis (N = 2,661 patients) and three observational studies in our secondary, confirmatory analysis (N = 21,112 patients). Outcome measures were: the composite of any stroke or systemic embolism, ischemic stroke, venous thromboembolism, major bleeding, intracranial bleeding; and all-cause death. Mean follow-up duration was 2.2 years. Results In the primary analysis, the use of NOACs was associated with similar incidence of stroke/systemic embolism (odds ratio [OR] 0.70, 95% confidence interval 0.45–1.09; p = 0.11), ischemic stroke (OR 0.71, 0.31–1.64; p = 0.42), venous thromboembolism (OR 0.91, 0.33–2.53; p = 0.86), all-cause death (OR 1.02, 0.72–1.42; p = 0.93), and major bleeding (OR 0.81, 0.61–1.06; p = 0.13) compared with VKAs. The occurrence of intracranial bleeding was significantly lower in the NOACs versus VKAs group (OR 0.11, 0.02–0.63; p = 0.01). These results were overall confirmed in the secondary analysis, where there was additionally a significant reduction of stroke/systemic embolism, ischemic stroke, and venous thromboembolism with NOACs. Conclusion In AF patients with malignancy, NOACs appear at least as effective as VKAs in preventing thrombotic events and reduce intracranial bleeding. NOACs may represent a valid and more practical alternative to VKAs in this setting of high-risk patients.

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