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Increasing the dose of oral vitamin K prophylaxis and its effect on bleeding risk.

ABSTRACT: Vitamin K prophylaxis in infancy aims to prevent life-threatening vitamin K deficiency bleeding (VKDB). The Dutch prophylactic oral daily regimen was increased sixfold from 25 to 150 ?g because of a high failure rate. To evaluate the efficacy of this new regimen, incidences of intracranial VKDB under both regimens were compared using both general and targeted surveillance. Late VKDB in the general pediatric population was identified by the Netherlands Pediatric Surveillance Unit, between 1 October 2014 and 31 December 2016. Additionally, infants with intracranial vitamin K deficiency bleeding were identified using the Dutch Pediatric Intensive Care Evaluation registry. The incidence of intracranial VKDB as assessed by general and targeted surveillance decreased from 1.6 per 100,000 (95% CI, 0.4-5.1) to 1.3 per 100,000 (95% CI, 0.5-3.2) and from 3.1 per 100,000 live births (95% CI, 1.9-5.0) to 1.2 per 100,000 live births (95% CI, 0.6-2.3), respectively. Median time between consecutive cases in the latter increased from 24 to 154 days (p?

SUBMITTER: Lowensteyn YN

PROVIDER: S-EPMC6565637 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Increasing the dose of oral vitamin K prophylaxis and its effect on bleeding risk.

Löwensteyn Yvette Nicole YN Jansen Nicolaas Johannes Georgius NJG van Heerde Marc M Klein Richard Henryk RH Kneyber Martin Christiaan Jacques MCJ Kuiper Jan Willem JW Riedijk Maaike Anne MA Verlaat Carin Wilhelmus Maria CWM Visser Idse Hendrik Egbert IHE van Waardenburg Dirk Adriaan DA van Hasselt Peter Marin PM

European journal of pediatrics 20190506 7

Vitamin K prophylaxis in infancy aims to prevent life-threatening vitamin K deficiency bleeding (VKDB). The Dutch prophylactic oral daily regimen was increased sixfold from 25 to 150 μg because of a high failure rate. To evaluate the efficacy of this new regimen, incidences of intracranial VKDB under both regimens were compared using both general and targeted surveillance. Late VKDB in the general pediatric population was identified by the Netherlands Pediatric Surveillance Unit, between 1 Octob ...[more]

PMID: 31062090

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Project description:We conducted a systematic review to evaluate the burden of late vitamin K deficiency bleeding (VKDB) and the effect of vitamin K prophylaxis on the incidence of VKDB. We searched MEDLINE and other electronic databases, and included all observational studies including population surveys as well as randomized controlled trials (RCT). The median (interquartile range) burden of late VKDB was 35 (10.5 to 80) per 100 000 live births in infants who had not received prophylaxis at birth; the burden was much higher in low- and middle-income countries as compared with high-income countries-80 (72 to 80) vs 8.8 (5.8 to 17.8) per 100 000 live births. Two randomized trials evaluated the effect of intramuscular (IM) prophylaxis on the risk of classical VKDB. Although one trial reported a significant reduction in the incidence of any bleeding (relative risk (RR) 0.73, 95% confidence interval (CI) 0.56 to 0.96) and moderate to severe bleeding (RR 0.19, 0.08 to 0.46; number needed to treat (NNT) 74, 47 to 177), the other trial demonstrated a significant reduction in the risk of secondary bleeding after circumcision in male neonates (RR 0.18, CI 0.08 to 0.42; NNT 9, 6 to 15). No RCTs evaluated the effect of vitamin K prophylaxis on late VKDB. Data from four surveillance studies indicate that the use of IM/subcutaneous vitamin K prophylaxis could significantly reduce the risk of late VKDB when compared with no prophylaxis (pooled RR 0.02; 95% CI 0.00 to 0.10). When compared with IM prophylaxis, a single oral dose of vitamin K increased the risk of VKDB (RR 24.5; 95% CI 7.4 to 81.0) but multiple oral doses did not (RR 3.64; CI 0.82 to 16.3). There is low-quality evidence from observational studies that routine IM administration of 1 mg of vitamin K at birth reduces the incidence of late VKDB during infancy. Given the high risk of mortality and morbidity in infants with late VKDB, it seems appropriate to administer IM vitamin K prophylaxis to all neonates at birth. Future studies should compare the efficacy and safety of multiple oral doses with IM vitamin K and also evaluate the optimal dose of vitamin K in preterm neonates.

Project description:Relative bleeding risks of different antithrombotic agents in heart failure (HF) patients is an important consideration in treatment decision making, making detailed comparative analysis desirable. The aim of this study was to conduct a network meta-analysis to investigate the major bleeding risk for individual novel oral anticoagulants (NOACs) vs. aspirin among patients with HF. We searched Pubmed, EMBASE, Cochrane Collaboration Central Register of Controlled Clinical Trials, and Clinicaltrials.gov from 1966 to November 2019 to identify relevant randomized clinical trials. Studies comparing individual NOACs vs. aspirin were analysed using direct study-level meta-analysis. Studies comparing aspirin to warfarin and NOACs to warfarin were then additionally added using network (direct and indirect) study-level meta-analysis. Primary endpoint was major bleeding. Final analysis included nine trials with 34 367 participants, including one direct comparison trial (apixaban vs. aspirin) and eight indirect comparison trials against the shared warfarin comparator (four aspirin trials and one trial each of apixaban, dabigatran, rivaroxaban, and edoxaban). For apixaban, network meta-analysis combing direct and indirect comparison showed that major bleeding risk might not be different between apixaban and aspirin (odds ratio, 1.18 [95% confidence interval, 0.38 to 3.65]) in HF patients. In contrast, indirect-comparison meta-analysis showed dabigatran, rivaroxaban, and edoxaban compared with aspirin might be associated with a higher risk of major bleeding in HF patients. In network meta-analysis, apixaban might be associated with a comparable risk of major bleeding compared with aspirin in patients with HF, while other NOACs might be associated with a higher risk. However, such results were not strongly convincing because of lack of direct comparison in an original trial and small sample size of trials and participants. A clinical trial directly comparing apixaban vs. aspirin in patients with HF and sinus rhythm may be worth undertaking.

Project description:ObjectiveThe prevalence of non-vitamin K oral anticoagulant use after cardiac surgery is unknown, particularly in patients with bioprosthetic valves. We sought to define the contemporary use and short-term safety of non-vitamin K oral anticoagulants after cardiac surgery.MethodsAll patients undergoing bioprosthetic aortic valve replacement, bioprosthetic mitral valve replacement, or isolated coronary artery bypass grafting (2011-2018) were evaluated from a multicenter, regional Society of Thoracic Surgeons database. Patients were stratified by anticoagulant type (non-vitamin K oral anticoagulant vs vitamin K antagonist) and era (early [2011-2014] vs contemporary [2015-2018]).ResultsOf 34,188 patients, 18% (6063) were discharged on anticoagulation, of whom 23% were prescribed non-vitamin K oral anticoagulants. Among those receiving anticoagulation, non-vitamin K oral anticoagulant use has significantly increased from 10.3% to 35.4% in contemporary practice (P < .01). This trend was observed for each operation type (coronary artery bypass grafting 0.86%/year, bioprosthetic aortic valve replacement: 2.15%/year, bioprosthetic mitral valve replacement: 2.72%/year, all P < .01). In patients with postoperative atrial fibrillation receiving anticoagulation, non-vitamin K oral anticoagulant use has increased from 6.3% to 35.4% and 12.3% to 40.3% after bioprosthetic valve replacement and isolated coronary artery bypass grafting, respectively (both P < .01). In patients receiving anticoagulation at discharge, adjusted 30-day mortality (odds ratio, 1.94; P = .12) and reoperation (odds ratio, 0.79; P = .34) rates were not associated with anticoagulant choice, whereas non-vitamin K oral anticoagulant use was associated with an adjusted 0.9-day decrease (P < .01) in postoperative length of stay.ConclusionsNon-vitamin K oral anticoagulant use after cardiac surgery has dramatically increased since 2011. This trend is consistent regardless of indication for anticoagulation including bioprosthetic valves. Short-term outcomes support their safety in the cardiac surgery setting with shorter postoperative hospital stays. Long-term studies on the efficacy of non-vitamin K oral anticoagulants after cardiac surgery are still necessary.

Dataset Information

Increasing the dose of oral vitamin K prophylaxis and its effect on bleeding risk.

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Increasing the dose of oral vitamin K prophylaxis and its effect on bleeding risk.

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