Risk of gastrointestinal bleeding with direct oral anticoagulants: a systematic review and network meta-analysis

Burr, Nicholas; Lummis, Katie; Sood, Ruchit; Kane, John S; Corp, Aaron; Subramanian, Venkataraman

doi:10.1016/s2468-1253(16)30162-5

Cited by 40 publications

(31 citation statements)

References 76 publications

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“…Forty percent of respondents in one study included in our systematic review reported observed bleeding complications in those prescribed DOACs . While the incidence and severity of bleeding were not reported, several systematic reviews have concluded that the risk of major bleeding is generally equivalent to or less than that with warfarin, there is a need for further high‐quality studies . There is therefore a need for intensive patient monitoring and reporting of events to national and international pharmacovigilance schemes.…”

Section: Discussionmentioning

confidence: 98%

A systematic review of clinicians' views and experiences of direct‐acting oral anticoagulants in the management of nonvalvular atrial fibrillation

Generalova

Cunningham

Leslie

et al. 2018

Brit J Clinical Pharma

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Section: Discussionmentioning

confidence: 98%

A systematic review of clinicians' views and experiences of direct‐acting oral anticoagulants in the management of nonvalvular atrial fibrillation

Generalova

Cunningham

Leslie

et al. 2018

Brit J Clinical Pharma

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“…It is important to note that these studies used traditional meta-analysis method and failed to compare the MGI bleeding among all NOAC regimens. Burr et al used network meta-analysis to assess the risk of bleeding following NOAC in 31 RCTs using GI bleeding event as the primary endpoint 58. The authors found that compared to warfarin and low-molecular weight heparin, NOAC did not increase the risk of GI bleeding.…”

Section: Discussionmentioning

confidence: 99%

<p>Differences In Gastrointestinal Safety Profiles Among Novel Oral Anticoagulants: Evidence From A Network Meta-Analysis</p>

Guo¹,

Chen²,

Tian³

et al. 2019

CLEP

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BackgroundThere is no consensus at present regarding the differences in the risk of GI bleeding across various NOAC regimens. Therefore, we performed a network meta-analysis to compare the risk of gastrointestinal bleeding after different NOAC regimens.MethodsPubMed, Cochrane, Web of Science, Clinicaltrial.gov and Clinicaltrialresults.org were searched for randomized controlled trials (RCTs) assessing gastrointestinal bleeding of all NOAC regimens from inception to January 2018. The primary endpoint was major gastrointestinal (MGI) bleeding. The meta-regression was performed to access the association between the MGI bleeding events and mortality. The network meta-analysis was carried out with the Bayesian random-effect model.ResultsA total of 25 RCTs, including 139,392 patients, were identified. Meta-regression analysis showed that MGI bleeding was correlated with fatal bleeding events (odds ratios [OR], 1.76; 95% confidence interval [CI], 1.13–2.77], P=0.015). The network meta-analysis results showed that compared to the conventional regimens, rivaroxaban was associated with increased risk of MGI bleeding (OR, 1.37; 95% credible interval [CrI], 1.00–1.85), but not the apixaban (OR, 0.77; 95% CrI, 0.53–1.07]), edoxaban (OR, 0.86; 95%CrI, 0.52–1.18) and dabigatran etexilate (OR, 1.22; 95% CrI, 0.82–1.69). Compared to rivaroxaban, apixaban (OR, 0.56; 95% CrI, 0.35–0.88) and edoxaban (OR, 0.62; 95% CrI, 0.35–0.96) showed a significantly lower risk of MGI bleeding. Apixaban had the highest probability of being the safest option with regard to the risk of MGI bleeding (89.1%), followed by edoxaban (77.4%), conventional therapy (51.4%), dabigatran etexilate (23.8%) and rivaroxaban (8.3%).ConclusionThe risk of GI bleeding significantly varies among different NOAC regimens, and evidence shows that apixaban and edoxaban had the most favorable MGI bleeding safety profile, while rivaroxaban and dabigatran etexilate were the least safe.

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“…The most serious complication of anticoagulant use is bleeding, [1] and the gastrointestinal tract is the most common site of anticoagulant drug-related injury, where mucosal erosion or ulcers are generally observed as complications. [2] After the first report on ISH by McLauchlan in 1838, [9] it was reported upon very rarely.…”

Section: Discussionmentioning

confidence: 99%

“…[1] Generally, mucosal injury resulting from anticoagulant use is the direct cause. [2] Further, submucosal hematoma is rarely reported. [3] A review of related literature revealed that the most common sites are the esophagus and duodenum; moreover, small intestinal submucosal hematoma (ISH) has been reported in 1 per 2500 patients on AT each year, and colon submucosal hematomas have been described less frequently in the literature.…”

Section: Introductionmentioning

confidence: 99%

Surgically treated rare intestinal bleeding due to submucosal hematoma in a patient on oral anticoagulant therapy

Yu¹,

Feng²,

Han³

et al. 2018

Medicine

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Rationale:Bleeding in the gastrointestinal tract is a common complication of oral anticoagulant therapy (AT), and it usually appears as mucosal erosion or ulcer; however, intestinal submucosal hematoma (ISH) is an uncommon cause of hemorrhage.Patient concerns:This report presents the case of a 70-year-old woman with acute hematochezia induced by AT. She underwent computed tomography and endoscopy.Diagnoses:Colon submucosal hematoma.Interventions:Conservative treatment had no effect, and the patient underwent emergency surgery.Outcomes:Surgical resection showed hemorrhage and necrosis in the left colon, and the patient recovered 24 hours after surgery and continued AT.Lessons:The present case indicates that the ISH should be kept in mind as a complication of AT. It can be managed conservatively in some stable patients, but emergency surgery may be needed in some serious situations.

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Risk of gastrointestinal bleeding with direct oral anticoagulants: a systematic review and network meta-analysis

Cited by 40 publications

References 76 publications

A systematic review of clinicians' views and experiences of direct‐acting oral anticoagulants in the management of nonvalvular atrial fibrillation

A systematic review of clinicians' views and experiences of direct‐acting oral anticoagulants in the management of nonvalvular atrial fibrillation

<p>Differences In Gastrointestinal Safety Profiles Among Novel Oral Anticoagulants: Evidence From A Network Meta-Analysis</p>

Surgically treated rare intestinal bleeding due to submucosal hematoma in a patient on oral anticoagulant therapy

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