Dataset Information

Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review.

ABSTRACT:

Aims

Oral anticoagulation with direct oral anticoagulants (DOAC) could provide an alternative to vitamin K antagonists (VKA) for patients with atrial fibrillation (AF) undergoing bioprosthetic heart valve replacement or valve repair.

Methods and results

The aim of this meta-analysis was to review the safety and efficacy of DOAC in patients with surgical implanted bioprosthetic heart valves or valve repairs and AF including data from six clinical trials with a total of 1,857 patients. The efficacy and safety data of DOAC and VKA were pooled to perform random-effects meta-analyses using the Mantel-Haenszel method with pooled risk ratios (RR) and 95% confidence interval (CI). A trial sequential analysis (TSA) was performed to assess statistical robustness. Death caused by cardiovascular cause or thromboembolic events were comparable (RR 0.67, 95% CI: 0.42-1.08; p = 0.10) as DOAC significantly reduced the risk for major bleeding (RR 0.55, 95% CI: 0.35-0.88; p = 0.01) and thromboembolic stroke or systemic embolism rates (RR 0.54, 95% CI: 0.32-0.90; p = 0.02). Rates for intracranial bleeding and hemorrhagic stroke (RR 0.27, 95% CI: 0.07-0.99; p = 0.05) show a trend toward fewer events in the DOAC group. Outcomes for major or minor bleeding events and all-cause mortality were comparable for DOAC and VKA.

Conclusion

Cumulative data analysis reveals that DOAC may provide an effective and safe alternative to VKA in patients with AF after surgically implanted bioprosthetic heart valves or repair with AF. Within a relatively heterogeneous study population, this meta-analysis shows a risk reduction of major bleedings and thromboembolic stroke or systemic embolisms for DOAC.

SUBMITTER: Gerfer S

PROVIDER: S-EPMC9058455 | biostudies-literature | 2022 Jan-Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review.

Gerfer Stephen S Djordjevic Ilija I Eghbalzadeh Kaveh K Mader Navid N Wahlers Thorsten T Kuhn Elmar E

Therapeutic advances in cardiovascular disease 20220101

<h4>Aims</h4>Oral anticoagulation with direct oral anticoagulants (DOAC) could provide an alternative to vitamin K antagonists (VKA) for patients with atrial fibrillation (AF) undergoing bioprosthetic heart valve replacement or valve repair.<h4>Methods and results</h4>The aim of this meta-analysis was to review the safety and efficacy of DOAC in patients with surgical implanted bioprosthetic heart valves or valve repairs and AF including data from six clinical trials with a total of 1,857 patien ...[more]

PMID: 35481366

Similar Datasets

Project description:Background and purposeAtrial fibrillation and heart failure with reduced ejection fraction (HFrEF) are common sources of cardioembolism. While oral anticoagulation is strongly recommended for atrial fibrillation, there are marked variations in guideline recommendations for HFrEF due to uncertainty about net clinical benefit. This systematic review and meta-analysis evaluates the comparative association of oral anticoagulation with stroke and other cardiovascular risk in populations with atrial fibrillation or HFrEF in sinus rhythm and identify factors mediating different estimates of net clinical benefit.MethodsPubMed and Embase were searched from database inception to November 20, 2019 for randomized clinical trials comparing oral anticoagulation to control. A random-effects meta-analysis was used to estimate a pooled treatment-effect overall and within atrial fibrillation and HFrEF trials. Differences in treatment effect were assessed by estimating I2 among all trials and testing the between-trial-population P-interaction. The primary outcome measure was all stroke. Secondary outcome measures were ischemic stroke, hemorrhagic stroke, mortality, myocardial infarction, and major hemorrhage.ResultsTwenty-one trials were eligible for inclusion, 15 (n=19 332) in atrial fibrillation (mean follow-up: 23.1 months), and 6 (n=9866) in HFrEF (mean follow-up: 23.9 months). There were differences in primary outcomes between trial populations, with all-cause mortality included for 95.2% of HFrEF trial population versus 0.38% for atrial fibrillation. Mortality was higher in controls groups of HFrEF populations (19.0% versus 9.6%) but rates of stroke lower (3.1% versus 7.0%) compared with atrial fibrillation. The association of oral anticoagulation with all stroke was consistent for atrial fibrillation (odds ratio, 0.51 [95% CI, 0.42–0.63]) and HFrEF (odds ratio, 0.61 [95% CI, 0.47–0.79]; I2=12.4%; P interaction=0.31). There were no statistically significant differences in the association of oral anticoagulation with cardiovascular events, mortality or bleeding between populations.ConclusionsThe relative association of oral anticoagulation with stroke risk, and other cardiovascular outcomes, is similar for patients with atrial fibrillation and HFrEF. Differences in the primary outcomes employed by trials in HFrEF, compared with atrial fibrillation, may have contributed to differing conclusions of the relative efficacy of oral anticoagulation.

Project description:BackgroundPost-operative atrial fibrillation (POAF) is the most common complication after cardiac surgery. Recent studies had shown this phenomenon is no longer considered transitory and is associated with higher risk of thromboembolic events or death. The aim of this study was to systematically review and analyze previous studies comparing oral anticoagulation therapy with no anticoagulation, regarding these long-term outcomes.MethodsPubMed/MEDLINE, EMBASE, Web of Science and Cochrane Database were systematically searched to identify the studies comparing the risk of stroke, or thromboembolic events or mortality of POAF patients who received anticoagulation compared with those who were not anticoagulated. Incidence of stroke, thromboembolic events and all-cause mortality were evaluated up to 10 years after surgery. Time-to-event outcomes were collected through hazard ratio (HR) along with their variance and the early endpoints using frequencies or odds ratio (OR). Random effect models were used to compute statistical combined measures and 95% confidence intervals (CI). Heterogeneity was evaluated through Q statistic-related measures of variance (Tau2, I2, Chi-squared test).ResultsEight observational cohort studies were selected, including 15,335 patients (3492 on Oral Anticoagulants (OAC) vs 11,429 without OAC) that met the inclusion criteria for qualitative synthesis. Patients had a wide gender distribution (38.6-82.3%), each study with a mean age above 65 years (67.5-85). Vitamin K antagonists were commonly prescribed anticoagulants (74.3-100%). OAC was associated with a protective impact on all-cause mortality at a mean of 5.0 years of follow-up (HR is 0.85 [0.72-1.01]; p = 0.07; I2 = 48%). Thromboembolic events did not differ between the two treatment arms (HR 0.68 [0.40-1.15], p = 0.15).ConclusionCurrent literature suggests a possibly protective impact of OAC therapy for all-cause mortality in patients with new-onset atrial fibrillation after cardiac surgery. However, it does not appear to impact thromboembolism rate.

Project description:BackgroundAtrial fibrillation (AF) is a common tachyarrhythmia, affecting approximately 33 million people worldwide, and is frequently associated with mitral valve disease. Surgical ablation during mitral valve surgery provides an opportune circumstance for arrhythmia correction. The results of recent randomized trial data are promising, demonstrating both safety and efficacy. The aim of this systematic review is to report the efficacy and morbidity of concomitant surgical ablation for AF during mitral valve surgery.MethodsFive electronic databases were searched from inception to March 2023. All studies reporting the primary outcome, freedom from AF (FFAF), for patients with a history of AF undergoing concomitant mitral valve surgery were identified. Studies with patient cohorts less than 100 were excluded. Relevant data were extracted and a meta-analysis of proportions was conducted using a random-effects model. Survival data were pooled from original Kaplan-Meier curves and reconstructed, reporting aggregate FFAF and survival.ResultsThirty-six studies with a total of 8,340 patients were included in the systematic review. All 36 papers reported postoperative FFAF with a pooled result of 76.9% [95% confidence interval (CI): 73.8-79.9%] at a weighted mean follow-up of 40.2 months, however this result was associated with significant heterogeneity (I2=89%). A total of 31 studies reported postoperative short-term mortality, with a pooled result of 1.68% (95% CI: 1.15-2.29%). Aggregate survival at 1 to 5 years was 93.7%, 92.5%, 91.3%, 89.4%, and 87%, respectively, and aggregate FFAF for 1 to 5 years was 90.2%, 83.5%, 79.5%, 76.4% and 73.2%, respectively.ConclusionsEvaluation of the evidence suggests that concomitant ablation for AF during mitral valve surgery is both safe and efficacious. The results were associated with significant heterogeneity, reflective of variable institutional protocols, patient characteristics, and lesion sets. Randomized data with longer term follow-up would help validate these results.

Project description:BackgroundStroke prophylaxis in patients with atrial fibrillation (AF) and heart failure (HF) in the era of direct oral anticoagulants is not well characterized. Using data from American Heart Association Get With The Guidelines-AFIB, we sought to evaluate oral anticoagulation (OAC) use at discharge among AF patients with concomitant HF.Methods and resultsAF patients with a diagnosis of HF hospitalized from January 2013 to March 2017 were included. We compared patient characteristics and use of OAC at discharge among patients with reduced (redundant ejection fraction [EF], EF≤40%), borderline (40%<EF<50%), and preserved (EF≥50%) EF using multivariable mixed logistic regression models. Among 10 883 patients with AF and HF, 1790 (16.4%) had a reported contraindication to anticoagulation and were excluded from further analysis. Among 9093 patients eligible for OAC, 3499 (38.5%) had HF with reduced EF, 1062 (11.7%) had HF with borderline EF, and 4532 (49.8%) had HF with preserved EF. The median CHA2DS2-VASc score was 5 (Q1, Q3; 3, 6) among all patients and higher among those with HF with preserved EF than HF with reduced EF (5 [4, 6] versus 4 [3, 5]; P<0.0001). The proportion of eligible patients discharged on OAC was 94.9%, with 43.6% discharged on warfarin and 50.7% discharged on direct oral anticoagulants. A higher proportion of patients with HF with reduced EF and HF with borderline EF were discharged on direct oral anticoagulants than with HF with preserved EF, but the difference was small (52.8%, 53.1% versus 48.5%, respectively; P=0.0002). EF group was not significantly associated with a patient's OAC use at discharge.ConclusionsIn the context of American Heart Association Get With The Guidelines-AFIB, a quality improvement program, the rate of use of OAC at discharge in eligible AF patients with HF was almost 95%. To our knowledge, these rates represent some of the highest use of appropriate anticoagulation for patients in a national registry to date.

Project description:ImportanceAnticoagulation management services (AMSs; ie, warfarin clinics) have evolved to include patients treated with direct oral anticoagulants (DOACs), but it is unknown whether DOAC therapy management services improve outcomes for patients with atrial fibrillation (AF).ObjectiveTo compare outcomes associated with 3 DOAC care models for preventing adverse anticoagulation-related outcomes among patients with AF.Design, setting, and participantsThis retrospective cohort study included 44 746 adult patients with a diagnosis of AF who initiated oral anticoagulation (DOAC or warfarin) between August 1, 2016, and December 31, 2019, in 3 Kaiser Permanente (KP) regions. Statistical analysis was conducted from August 2021 through May 2023.ExposuresEach KP region used an AMS to manage warfarin but used distinct approaches to DOAC care: (1) usual care (UC) by the prescribing clinician, (2) UC plus an automated population management tool (PMT), or (3) pharmacist-managed AMS care. Propensity scores and inverse probability of treatment weights (IPTWs) were estimated. Direct oral anticoagulant care models were first indirectly compared using warfarin as a common comparator within each region and then directly compared across regions.Main outcomes and measuresPatients were followed up until the first occurrence of an outcome (composite of thromboembolic stroke, intracranial hemorrhage, other major bleeding, or death), discontinuation of KP membership, or December 31, 2020.ResultsOverall, 44 746 patients were included: 6182 in the UC care model (3297 DOAC; 2885 warfarin), 33 625 in the UC plus PMT care model (21 891 DOAC; 11 734 warfarin), and 4939 in the AMS care model (2089 DOAC; 2850 warfarin). Baseline characteristics (mean [SD] age, 73.1 [10.6] years, 56.1% male, 67.2% non-Hispanic White, median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74 years, female sex] score of 3 [IQR, 2-5]) were well balanced after IPTW. Over a median follow-up of 2 years, patients who received the UC plus PMT or AMS care model did not have significantly better outcomes than those who received UC. The incidence rate of the composite outcome was 5.4% per year for DOAC and 9.1% per year for warfarin for those in the UC group, 6.1% per year for DOAC and 10.5% per year for those in the UC plus PMT group, and 5.1% per year for DOAC and 8.0% per year for those in the AMS group. The IPTW-adjusted hazard ratios (HRs) for the composite outcome comparing DOAC vs warfarin were 0.91 (95% CI, 0.79-1.05) in the UC group, 0.85 (95% CI, 0.79-0.90) in the UC plus PMT group, and 0.84 (95% CI, 0.72-0.99) in the AMS group (P = .62 for heterogeneity across care models). When directly comparing patients receiving DOAC, the IPTW-adjusted HR was 1.06 (95% CI, 0.85-1.34) for the UC plus PMT group vs the UC group and 0.85 (95% CI, 0.71-1.02) for the AMS group vs the UC group.Conclusions and relevanceThis cohort study did not find appreciably better outcomes for patients receiving DOAC who were managed by either a UC plus PMT or AMS care model compared with UC.

Dataset Information

Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review.

Aims

Methods and results

Conclusion

Publications

Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets