Dataset Information

Major bleeding in patients with atrial fibrillation receiving vitamin K antagonists: a systematic review of randomized and observational studies.

ABSTRACT:

Aims

Clinical trials have shown that anticoagulation with vitamin K antagonists (VKAs), e.g. warfarin, decreases the risk of stroke in patients with atrial fibrillation (AF); however, increased bleeding risk is one of the safety concerns. The primary objective was to conduct a systematic review of the published literature, assessing the risk of major bleeding and mortality in patients with AF treated with VKAs.

Methods and results

Online searches of MEDLINE, EMBASE, BIOSIS, and the Cochrane Library were performed to a pre-specified protocol from 1960 to March 2012 for randomized controlled trials (RCTs) and from January 1990 to March 2012 for observational studies. A total of 47 studies (16 RCTs and 31 observational studies) were included. Cumulative follow-up was 61,563 patient-years for RCTs and 484 241 patient-years for observational studies. The overall median incidence of major bleeding was 2.1 per 100 patient-years (range, 0.9-3.4 per 100 patient-years) for RCTs and 2.0 per 100 patient-years (range, 0.2-7.6 per 100 patient-years) for observational studies. With study year as a proxy for changing management patterns, some evidence of bleeding rates and/or their reporting increasing over time was noted. Mortality rates from observational studies were inadequately reported to allow comparison with those from RCT data.

Conclusion

The median rate of major bleeding in observational studies and RCTs is similar. The larger heterogeneity in bleeding rates observed in a real-life setting could reflect a high variability in standard of care of patients on VKAs and/or methodological differences between observational studies and/or variability in data sources.

SUBMITTER: Roskell NS

PROVIDER: S-EPMC3663334 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundGood quality anticoagulation among patients with operated valvular heart disease is needed to reduce ischaemic and thromboembolic complications. There is limited evidence regarding factors that affect anticoagulation control in patients implanted with mechanical or tissue prosthetic valve(s).AimTo examine the quality of and factors that affect anticoagulation control, major adverse clinical events and all-cause death in operated valvular heart disease patients with and without atrial fibrillation who are receiving a vitamin K antagonist.MethodsQuality of anticoagulation were retrospectively assessed among 456 operated valvular heart disease patients [164 (36%) with AF and 290 (64%) without AF] via time in therapeutic range (TTR) (Rosendaal method) and percentage of INRs in range (PINRR) over a median of 6.2 (3.3-8.5) years. VHD was defined by the presence of a mechanical or tissue prosthetic valve at the mitral, aortic, or both sites.ResultsMean age 51 (14.7), 64.5% men. Most (96.1%) had a mechanical prosthesis and 64% had aortic valve replacement. Overall, mean TTR was 58.5% (14.6) and PINRR was 50.1% (13.8). Operated valvular heart disease patients with AF had significantly lower mean TTR and PINRR (TTR: 55.7% (14.2) vs. 60.1% (14.6); p = 0.002, respectively, PINRR: 47.4% (13.5) vs. 51.6% (13.7); p = 0.002, respectively), and a lower proportion of TTR ≥ 70%, despite a similar number of INR tests compared to those without AF. Predictors of TTR < 70% were female sex, AF and anaemia/bleeding history. Significantly higher proportions of operated valvular heart disease patients with AF died (20.7% vs. 5.8%; p < 0.001), but ≥1 MACE rates were similar between the two groups.ConclusionsOperated valvular heart disease patients with AF at baseline have poorer anticoagulation control compared to those without AF. The presence of concomitant AF, anaemia/bleeding history and female sex independently predicted poor TTR. Stringent INR monitoring is needed to improve anticoagulation control and prevent major adverse clinical events in patients with operated valvular heart disease.

Project description:BACKGROUND:The relationship between serum vitamin D and atrial fibrillation (AF) or postoperative atrial fibrillation (POAF) in patients undergoing coronary artery bypass graft (CABG) is still debated. It is also unclear whether there is a dose-response relationship between circulating vitamin D and the risk of AF or POAF. METHODS:The Cochrane Library, PubMed, and Embase databases were searched for relevant studies. We used a "one-stage approach" with a restricted cubic spline model to summarize the dose-specific relationships between serum vitamin D and AF. Relative risk (RR) was used to measure the effects in this meta-analysis. RESULTS:In total, 13 studies were included with a total of 6519 cases of AF among 74,885 participants. Vitamin D deficiency (< 20 ng/ml) was associated with increased risks of AF (RR: 1.23, 95% CI: 1.05-1.43). In the dose-response analysis, the summary RR for a 10 ng/ml increased in vitamin D was 0.88 (95% CI: 0.78-0.98) and there was no evidence of a non-linear association, Pnon-linearity = 0.86. In the age subgroup, high vitamin D (per 10 ng/ml increase) reduced the risk of AF in the older group (> 65 years) (RR = 0.68, 95% CI = 0.52-0.89) but not among young individuals (< 65 years) (RR = 0.87, 95% CI = 0.72-1.06). In addition, a strong association was found between a 10 ng/ml increased in vitamin D and POAF incident in the patient after CABG (RR: 0.44, 95% CI: 0.24-0.82). CONCLUSION:Our dose-response meta-analysis suggested serum vitamin D deficiency was associated with an increased risk of AF in the general population and POAF in patients after CABG. Further studies are needed to explore the age difference in the association between serum vitamin D level and the risk of AF and whether vitamin D supplements will prevent AF. TRIAL REGISTRATION:This study has been registered with PROSPERO (International prospective register of systematic reviews)-registration number-CRD42019119258.