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Bleeding risk in patients using oral anticoagulants submitted to surgical procedures in dentistry: a systematic review protocol.

ABSTRACT: INTRODUCTION:The management of patients undergoing oral surgical procedures using anticoagulants raises concerns regarding the risk of bleeding. Bleeding rates in those patients during or after oral surgical procedures are uncertain. The aim of this study will be to determine the bleeding rate during and after oral surgeries in patients using anticoagulants. METHODS AND ANALYSIS:A systematic review will be conducted and if appropriate, a meta-analysis of randomised clinical trials evaluating the bleeding risk during and after oral surgical procedures in patients using anticoagulants were selected. The literature search will be conducted using electronic databases, such as the Cochrane Central Register of Controlled Trials, MEDLINE (via Ovid), Embase (via Ovid), Cumulative Index to Nursing and Allied Health Literature (via Ovid), LILACS (SciELO) and CAPES database, without restriction of languages or date of publication. The primary outcome will be the occurrence of local bleeding rate during and after oral surgical procedures, and as secondary outcome, the following complications will be considered: implant failure, healing problems and infections. Groups of two independent reviewers will select the titles and abstracts for full-text eligibility. For eligible studies, the same reviewers will perform data extraction, bias risk assessment and determination of the overall quality of evidence for each of the outcomes using the Grading of Recommendations Assessment, Development and Evaluation classification system. Meta-analysis and subgroup analyses will be conducted, to all outcomes, if appropriate. ETHICS AND DISSEMINATION:The systematic review will be published in a peer-reviewed journal, and brief reports of the review's findings will be released directly to the intended audience. The results will help dentists in the decision-making process to minimise the risk of bleeding in patients using anticoagulants in their clinical practice. PROSPERO REGISTRATION NUMBER:CRD42017056986.

SUBMITTER: Motta RHL

PROVIDER: S-EPMC5778277 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Bleeding risk in patients using oral anticoagulants submitted to surgical procedures in dentistry: a systematic review protocol.

Motta Rogério Heládio Lopes RHL Bergamaschi Cristiane de Cássia CC de Andrade Natalia Karol NK Guimaraes Caio Chaves CC Ramacciato Juliana Cama JC Araújo Jimmy de Oliveira JO Lopes Luciane Cruz LC

BMJ open 20171219 12

<h4>Introduction</h4>The management of patients undergoing oral surgical procedures using anticoagulants raises concerns regarding the risk of bleeding. Bleeding rates in those patients during or after oral surgical procedures are uncertain. The aim of this study will be to determine the bleeding rate during and after oral surgeries in patients using anticoagulants.<h4>Methods and analysis</h4>A systematic review will be conducted and if appropriate, a meta-analysis of randomised clinical trials ...[more]

PMID: 29259064

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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.

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:ObjectivesTo determine the real world safety of dabigatran or rivaroxaban compared with warfarin in terms of gastrointestinal bleeding.DesignRetrospective cohort study.SettingLarge administrative database of commercially insured people in United States from 1 October 2010 through 31 March 2012.ParticipantsEnrollees with a prescription of warfarin, dabigatran, or rivaroxaban between 1 October 2010 and 31 March 2012, who were aged 18 years or older, had continuous enrollment and no oral anticoagulant use during the six months before the entry date, with known age and sex, and with no gastrointestinal bleeding for at least six months before the cohort entry date. The final study sample of 46,163 patients included 4907 using dabigatran, 1649 using rivaroxaban, and 39,607 using warfarin.Main outcome measureTime to gastrointestinal bleeding. Hazard ratios were derived from Cox proportional hazard models with propensity score weighting and robust estimates of errors.ResultsDabigatran users tended to be older (dabigatran v rivaroxaban v warfarin: 62.0 v 57.6 v 57.4 years) and more likely to be male (69% v 49% v 53%). The rate of gastrointestinal bleeding was highest among dabigatran users and lowest among rivaroxaban users (dabigatran v rivaroxaban v warfarin: 9.01 v 3.41 v 7.02 cases per 100 person years). After adjustment for potentially confounding covariates, there was no evidence of a statistically significant difference in the risk of gastrointestinal bleeding between dabigatran and warfarin users (adjusted hazard ratio 1.21, 95% confidence interval 0.96 to 1.53) or between rivaroxaban and warfarin users (0.98, 0.36 to 2.69).ConclusionsAlthough rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.

Project description:ImportanceMany patients with nonvalvular atrial fibrillation (NVAF) are at a high risk of gastrointestinal (GI) bleeding due to conditions including older age; stage III to V chronic kidney disease (CKD); HAS-BLED (hypertension, kidney or liver disease, stroke history, prior bleeding, unstable international normalized ratio, age >65, drug or alcohol use) score of 3 or greater; corticosteroid, antiplatelet or nonsteroidal anti-inflammatory drug (NSAID) use; or GI conditions.ObjectiveTo compare the risk of stroke and/or systemic embolism (SE) and major bleeding (MB) among patients with NVAF and high risk of GI bleeding who received non-vitamin K antagonist oral anticoagulants (NOACs) vs those who received warfarin.Design, setting, and participantsThis retrospective cohort study included patients with NVAF who were 75 years and older; had stage III to V CKD; had an HAS-BLED score of 3 or greater; used corticosteroids, antiplatelets, or NSAIDs; or had GI conditions. Data were collected from the Centers for Medicare & Medicaid Services and 4 commercial insurance databases between January 1, 2012, and September 30, 2015. Data analysis was conducted from January 2012 to September 2015.ExposuresNew prescription for apixaban, dabigatran, rivaroxaban, or warfarin between January 1, 2013, and September 30, 2015 (identification period).Main outcomes and measuresSix propensity score-matched cohorts were created to compare between study drugs. For the primary objective, Cox models were used to estimate stroke and/or SE and MB hazard ratios (HRs).ResultsA total of 381 054 patients (187 489 [49.2%] women) with NVAF and at least 1 high-risk GI bleeding factor were identified (HAS-BLED score ≥3: 284 527 [74.7%]; aged ≥75 years: 252 835 [66.4%]; corticosteroid, antiplatelet, or NSAID therapy: 107 675 [28.3%]; prior GI bleeding conditions: 74 818 [19.6%]; and stage III-V CKD: 56 892 [14.9%]). All NOACs were associated with a lower risk of stroke and/or SE vs warfarin (apixaban: HR, 0.60; 95% CI, 0.52-0.68; dabigatran: HR, 0.75; 95% CI, 0.64-0.88; rivaroxaban: HR, 0.79; 95% CI, 0.73-0.86). Compared with warfarin, apixaban and dabigatran were associated with a lower risk of MB (apixaban: HR, 0.59; 95% CI, 0.56-0.63; dabigatran: HR, 0.78; 95% CI, 0.70-0.86), while rivaroxaban was associated with a higher risk (HR, 1.11; 95% CI, 1.05-1.16).Conclusions and relevanceIn this study of patients with NVAF and high risk of GI bleed, NOACs were associated with lower rates of stroke and/or SE, but NOACs had varying risks of MB compared with warfarin. These results may help inform treatment options in this patient population.

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Bleeding risk in patients using oral anticoagulants submitted to surgical procedures in dentistry: a systematic review protocol.

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Bleeding risk in patients using oral anticoagulants submitted to surgical procedures in dentistry: a systematic review protocol.

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