Risk of Major Gastrointestinal Bleeding With New vs Conventional Oral Anticoagulants: A Systematic Review and Meta-analysis

Z, Gu; Wei, Anhua; Zhang, Chi; Wang, Xinhua; Le, Zhang; Shen, Long; Li, Zheng; Pan, Mang-Mang; Liu, Xiaoyan; Pu, Jun; Lin, Hou‐Wen

doi:10.1016/j.cgh.2019.05.056

Cited by 61 publications

(60 citation statements)

References 214 publications

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“…Subgroup analysis was conducted by the severity of illness (non-survivors, severe patients, and non-severe patients). The interaction analysis (P for interaction) using Cochran's Q test were applied to evaluate the risk difference of different illness severity (17). Interaction is referred to as effect modification, which investigates whether the effect of intervention in the primacy outcome varied between the subgroup such as disease severity.…”

Section: Data Synthesis and Statistical Analysismentioning

confidence: 99%

Incidence of myocardial injury in coronavirus disease 2019 (COVID-19): a pooled analysis of 7,679 patients from 53 studies

Z¹,

Zhang²,

Kong³

et al. 2020

Cardiovasc Diagn Ther

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Background: Coronavirus disease 2019 (COVID-19) has become global pandemic and resulted in considerable morbidity and mortality since December 2019. Information on the incidence of myocardial injury remains scarce.Methods: English-language databases (PubMed, Embase, Cochrane), Chinese-language databases (CNKI, VIP, WANFANG), and preprint platform were searched to identify studies that reported the myocardial injury data in COVID-19 patients. Random-effects meta-analyses were used to derive the pooled incidence and relative risks (RRs) of myocardial injury. Variations by disease severity were examined by subgroup analyses. Sensitivity analyses were performed to strengthen the results. Meta-regression was applied to explore the risk factors associated with myocardial injury.Results: A total of 53 studies involving 7,679 patients were included. The pooled incidence of myocardial injury was 21% [95% confidence interval (CI), 17-25%; I 2 , 96.5%]. The highest incidence of myocardial injury was found in non-survivors (66%; 95 CI%, 54-78%; I 2 , 85.7%), followed by severe patients (43%; 95 CI%, 33-53%; I 2 , 93.0%) and non-severe patients (11%; 95 CI%, 7-15%; I 2 , 95.2%). Higher risk of myocardial injury was detected in severe patients than non-severe patients (RR, 5.74; 95% CI, 3.74-8.79; I 2 , 86.8%). All the sensitivity analyses confirmed the robustness of primacy results.Conclusions: This meta-analysis showed that myocardial injury occurred in 21% of COVID-19 patients.An elevated rate was observed in non-survivors (66%) and severe patients (43%). Severe patients had a 4.74-fold increase in the risk of myocardial injury than non-severe patients. Aggressive strategy may be considered for COVID-19 patients at high risk of myocardial injury.

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Section: Data Synthesis and Statistical Analysismentioning

confidence: 99%

Incidence of myocardial injury in coronavirus disease 2019 (COVID-19): a pooled analysis of 7,679 patients from 53 studies

Z¹,

Zhang²,

Kong³

et al. 2020

Cardiovasc Diagn Ther

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“…GI hemorrhage and intracranial hemorrhage are the two main adverse reactions that clinicians focus on. A meta-analysis showed rivaroxaban, but not dabigatran, was associated with an increased risk for major GI hemorrhage (RR 1.39; 95% CI, 1.17-1.65 and HR 1.14; 95% CI, 1.04-1.23) [20]. In our study, compared with hemorrhagic event reporting for dabigatran, there was a moderate signal of hemorrhage for rivaroxaban with the ROR (95% CI) in GI was 1.38 (1.34-1.42).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Rivaroxaban- and Dabigatran-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database (FAERS)

Guo

Thai

Zhou

et al. 2021

Preprint

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Background Rivaroxaban and dabigatran are non-vitamin K antagonist oral anticoagulants that are widely used for treatment and prevention of venous thrombo-embolism and prevention of stroke in patients with atrial fibrillation.Objective To estimate and compare hemorrhagic events reported for rivaroxaban and dabigatran.Setting FDA Adverse Event Reporting System (FAERS) database.Methods The reporting odds ratio (ROR) was used to analyze the reporting of hemorrhagic events.Main outcome measure The overall hemorrhagic events and hemorrhagic events in different physiological systems and indications.Results A total of 53,085 reports of hemorrhage related to rivaroxaban, accounting for 49.79% of all rivaroxaban-related ADR reports and 13151 hemorrhagic reports related to dabigatran, accounting for 38.51% of all dabigatran-related ADR reports. The overall ROR (95% CI) for hemorrhagic event reporting for rivaroxaban compared with dabigatran was 1.58 (95% CI 1.54-1.62). The RORs (95% CI) in gastrointestinal systems, nervous system, renal and urinary system, skin and subcutaneous tissue, and eye system were 1.38 (1.34-1.42), 0.94 (0.90-0.98), 1.07 (1.01-1.13), 0.80 (0.70-0.90), and 1.38 (1.19-1.60), respectively. The RORs (95% CI) for hemorrhagic events in patients with atrial fibrillation, pulmonary embolism and deep vein thrombosis comparing rivaroxaban with dabigatran were 1.85 (1.79-1.91), 2.02 (1.67-2.47) and 2.17 (1.82-2.59).Conclusions Overall, a moderate signal for hemorrhage associated with rivaroxaban use was observed when compared with dabigatran. Hemorrhagic events in different physiological systems were not have a higher risk in case reports of rivaroxaban compared to dabigatran. But for the treatment of patients with pulmonary embolism or deep vein thrombosis, rivaroxaban are associated with more hemorrhagic events compared to dabigatran.

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“…The other systematic review and meta-analysis enrolling data from RCTs and real-world studies reported no significant difference in the risk of major GIB between the patients receiving NOACs and conventional anticoagulants. Rivaroxaban users had a 39% increase in the risk for major GIB [ 56 ]. However, the recruited patients were nearly from the non-Asia regions.…”

Section: Discussionmentioning

confidence: 99%

The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis

Yang

Sun

Tsai

et al. 2020

IJERPH

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Background: Non-vitamin K antagonist oral anticoagulants (NOACs) are more commonly used to prevent atrial fibrillation (AF) patients from thromboembolic events than vitamin K antagonists (VKAs). However, the gastrointestinal bleeding (GIB) risk in the Asian AF patients associated with NOACs in comparison with VKAs remained unaddressed. Materials and Methods: A systematic search of studies on NOACs and VKAs in the Asian AF patients was conducted in PubMed, Cochrane Library, and ClinicalTrials.gov. The primary outcome was the hazard ratio (HR) of any GIB associated with NOACs versus VKAs. The secondary outcome was the GIB risks in different kinds of NOACs compared with VKAs. Results: This meta-analysis included two randomized controlled trials (RCTs) and four retrospective studies, comprising at least 200,000 patients in total. A significantly lower HR of GIB risks was found in all kinds of NOACs than VKAs in the Asian AF patients (HR: 0.633; 95% confidence interval: 0.535–0.748; p < 0.001). Additionally, the GIB risks of different NOACs were apixaban (HR: 0.392), edoxaban (HR: 0.603), dabigatran (HR: 0.685), and rivaroxaban (HR: 0.794), respectively. Conclusions: NOACs significantly reduced the risk of GIB in the Asian AF patients compared with VKAs. In the four NOACs compared with VKAs, apixaban probably had a trend of the least GIB risk. We need further head-to-head studies of different NOACs to confirm which NOAC is the most suitable for Asian AF patients and to know the optimal dosage regimen of different NOACs.

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Risk of Major Gastrointestinal Bleeding With New vs Conventional Oral Anticoagulants: A Systematic Review and Meta-analysis

Cited by 61 publications

References 214 publications

Incidence of myocardial injury in coronavirus disease 2019 (COVID-19): a pooled analysis of 7,679 patients from 53 studies

Incidence of myocardial injury in coronavirus disease 2019 (COVID-19): a pooled analysis of 7,679 patients from 53 studies

Evaluation of Rivaroxaban- and Dabigatran-Associated Hemorrhagic Events Using the FDA-Adverse Event Reporting System Database (FAERS)

The Risk of Gastrointestinal Bleeding between Non-Vitamin K Antagonist Oral Anticoagulants and Vitamin K Antagonists in the Asian Atrial Fibrillation Patients: A Meta-Analysis

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