Dataset Information

The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis.

ABSTRACT: New oral anticoagulants (NOACs; ie, direct thrombin inhibitor [DTI] and factor Xa [FXa] inhibitors) were used as alternatives to warfarin. Specific antidotes (idarucizumab for dabigatran and andexanet alfa for FXa inhibitors) and hemostatic reversal agents were used for lowering bleeding, but their efficacies were still uncertain. The objectives of this study were to estimate and compare the efficacy of NOAC antidotes on bleeding reversal and death. Studies were identified from MEDLINE and Scopus databases until May 2018. Case reports/series and cohorts were selected if they assessed reversal or death rates. Data were independently extracted by 2 reviewers. Individual patient data and aggregated data of outcomes were extracted from case reports/series and cohorts. Binary regression was used to estimate outcome rates, risk ratio (RR) along with 95% confidence interval (CI). Interventions were NOACs and reversal agents (ie, DTI-specific, DTI-standard, FXa-specific, and FXa-standard). Among 220 patients of 93 case reports/series, reversal rates were 95.9%, 77.6%, and 71.5% for DTI-specific, FXa-standard, and DTI-standard. Pooled RRs for DTI-specific and FXa-standard versus DTI-standard, respectively, were 1.34 (CI: 1.13-1.60) and 1.09 (CI: 0.84-1.40). Death rate was 0.18 (CI: 0.06-0.57) times lower in DTI-specific versus DTI-standard. For pooling 10 subcohorts, pooled RRs were 1.08 (CI: 1.00-1.16), 1.29 (CI: 1.20-1.39), and 1.13 (CI: 1.01-1.25) for DTI-specific, FXa-specific, and FXa-standard versus DTI-standard. In conclusion, specific reversal agents might be useful for reversal of bleeding and lowering the risk of death than standard reversal agents. Our findings were based on case reports/series and selected cohorts, further comparative studies are thus needed.

SUBMITTER: Udayachalerm S

PROVIDER: S-EPMC6714855 | biostudies-other | 2018 Sep

REPOSITORIES: biostudies-other

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The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis.

Udayachalerm Sariya S Rattanasiri Sasivimol S Angkananard Teeranan T Attia John J Sansanayudh Nakarin N Thakkinstian Ammarin A

Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis 20180903 9_suppl

New oral anticoagulants (NOACs; ie, direct thrombin inhibitor [DTI] and factor Xa [FXa] inhibitors) were used as alternatives to warfarin. Specific antidotes (idarucizumab for dabigatran and andexanet alfa for FXa inhibitors) and hemostatic reversal agents were used for lowering bleeding, but their efficacies were still uncertain. The objectives of this study were to estimate and compare the efficacy of NOAC antidotes on bleeding reversal and death. Studies were identified from MEDLINE and Scopu ...[more]

PMID: 30176738

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Project description:ImportanceIt is unclear if the risk of intraocular bleeding with novel oral anticoagulants differs compared with warfarin.ObjectiveTo characterize the risk of intraocular bleeding with novel oral anticoagulants compared with warfarin.Data sourcesA systematic review and meta-analysis was undertaken in an academic medical setting. MEDLINE and ClinicalTrials.gov were searched for randomized clinical trials published up until August 2016. This search was supplemented by manual bibliography searches of identified trials and other review articles.Study selectionStudies were eligible for inclusion if they were phase 3 randomized clinical trials, enrolled patients with atrial fibrillation or venous thromboembolism, compared a novel oral anticoagulant (dabigatran, rivaroxaban, apixaban, or edoxaban) with warfarin, and recorded event data on intraocular bleeding. Data on intraocular bleeding were pooled using inverse-variance, weighted, fixed-effects meta-analysis.Data extraction and synthesisThe PRISMA guidelines were used for abstracting data and assessing quality. Independent extraction was performed by 2 investigators.Main outcomes and measuresIntraocular bleeding events and associated risk ratio for novel oral anticoagulants compared with warfarin.ResultsTwelve trials investigating 102?627 patients were included. Randomization to novel oral anticoagulants was associated with a 22% relative reduction in intraocular bleeding compared with warfarin (risk ratio, 0.78; 95% CI, 0.61-0.99). There was no significant heterogeneity observed (I2?=?4.8%, P?=?.40). Comparably lower risks of intraocular bleeding with novel oral anticoagulants were seen in subgroup analyses, with no significant difference according to the indication for anticoagulation (P for heterogeneity?=?.49) or the novel oral anticoagulant type (P for heterogeneity?=?.15). Summary estimates did not differ materially when random-effects meta-analytic techniques were used.Conclusions and relevanceThese results suggest that novel oral anticoagulants reduce the risk of intraocular bleeding by approximately one-fifth compared with warfarin. Similar benefits were seen in both patients with atrial fibrillation and venous thromboembolism. Our data have particular relevance for patients at higher risk of spontaneous retinal and subretinal bleeding. These findings may also have important implications in the perioperative period, in which the use of novel oral anticoagulants may be superior. Future studies are required to better characterize the optimal management of patients with both ophthalmic disease and cardiovascular comorbidities requiring anticoagulation.

Project description:The management of patients who undergo dental surgical procedures and receive oral anticoagulant therapy requires particular attention due to the risk of bleeding that may occur during the procedure. Bleeding rates in these trans- or post-operative patients tend to be unpredictable. The aim of this study was to conduct a systematic review in order to assess the risk of bleeding during and after performing oral surgery in patients administered oral anticoagulants compared with a group that discontinued anticoagulant therapy. For the purposes of this review, we searched the databases of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), and the Virtual Health Library (VHL) from inception of the database to December 2018. The primary outcome was defined as the occurrence of local bleeding during and after oral surgical procedures. Four reviewers, independently and in pairs, screened titles and abstracts for full-text eligibility. Data regarding participant characteristics, interventions, and design and outcomes of the included studies were extracted. The data were pooled using random-effects meta-analyses and described as risk ratios (RRs) with a 95% confidence interval (95% CI). The confidence for the pooled estimates was ascertained through the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, and the protocol of this review was recorded in PROSPERO (CRD42017056986). A total of 58 eligible studies were identified, of which three randomized controlled trials were included in the meta-analysis, covering a total of 323 adult participants, among whom 167 were taking anticoagulants at the time they underwent dental surgery. Of these patients, 14.2% had reported bleeding. The risk of bleeding was found to be one to almost three times greater in patients taking warfarin compared with patients who discontinued the use of anticoagulant during the trans-operative period (RR = 1.67, 95% CI = 0.97 to 2.89) and in the post-operative period (RR = 1.44, 95% CI = 0.71 to 2.92), although the quality of evidence was very low. The results indicate that there is no evidence that the use of anticoagulants eliminates the risk of bleeding during surgical dental procedures.

Dataset Information

The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis.

Publications

The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis.

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