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Effectiveness, safety, and major adverse limb events in atrial fibrillation patients with concomitant diabetes mellitus treated with non-vitamin K antagonist oral anticoagulants.

ABSTRACT: BACKGROUND:Evidence of adverse clinical outcomes for non-vitamin K antagonist oral anticoagulant (NOACs) and warfarin in patients with atrial fibrillation (AF) and diabetes mellitus are limited. We investigated the effectiveness, safety, and major adverse limb events for NOACs versus warfarin among diabetic AF patients. METHODS:In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, we identified a total of 20,967 and 5812 consecutive AF patients with diabetes taking NOACs and warfarin from June 1, 2012, to December 31, 2017, respectively. We used propensity-score stabilized weighting to balance covariates across study groups. RESULTS:NOAC was associated with a lower risk of major adverse cardiovascular events (MACE) (adjusted hazard ratio (aHR):0.88; [95% confidential interval (CI) 0.78-0.99]; P?=?0.0283), major adverse limb events (MALE) (aHR:0.72;[95% CI 0.57-0.92]; P?=?0.0083), and major bleeding (aHR:0.67;[95% CI 0.59-0.76]; P?

SUBMITTER: Chan YH

PROVIDER: S-EPMC7222472 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effectiveness, safety, and major adverse limb events in atrial fibrillation patients with concomitant diabetes mellitus treated with non-vitamin K antagonist oral anticoagulants.

Chan Yi-Hsin YH Lee Hsin-Fu HF Li Pei-Ru PR Liu Jia-Rou JR Chao Tze-Fan TF Wu Lung-Sheng LS Chang Shang-Hung SH Yeh Yung-Hsin YH Kuo Chi-Tai CT See Lai-Chu LC Lip Gregory Y H GYH

Cardiovascular diabetology 20200513 1

<h4>Background</h4>Evidence of adverse clinical outcomes for non-vitamin K antagonist oral anticoagulant (NOACs) and warfarin in patients with atrial fibrillation (AF) and diabetes mellitus are limited. We investigated the effectiveness, safety, and major adverse limb events for NOACs versus warfarin among diabetic AF patients.<h4>Methods</h4>In this nationwide retrospective cohort study collected from Taiwan National Health Insurance Research Database, we identified a total of 20,967 and 5812 c ...[more]

PMID: 32404168

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Project description:Background Vitamin K antagonists (VKAs) are associated with coronary artery calcification in low-risk populations, but their effect on calcification of large arteries remains uncertain. The effect of non-vitamin K antagonist oral anticoagulants (NOACs) on vascular calcification is unknown. We investigated the influence of use of VKA and NOAC on calcification of the aorta and aortic valve. Methods In patients with atrial fibrillation without a history of major adverse cardiac or cerebrovascular events who underwent computed tomographic angiography, the presence of ascending aorta calcification (AsAC), descending aorta calcification (DAC), and aortic valve calcification (AVC) was determined. Confounders for VKA/NOAC treatment were identified and propensity score adjusted logistic regression explored the association between treatment and calcification (Agatston score > 0). AsAC, DAC, and AVC differences were assessed in propensity score-matched groups. Results Of 236 patients (33% female, age: 58 ± 9 years), 71 (30%) used VKA (median duration: 122 weeks) and 79 (34%) used NOAC (median duration: 16 weeks). Propensity score-adjusted logistic regression revealed that use of VKA was significantly associated with AsAC (odds ratio [OR]: 2.31; 95% confidence interval [CI]: 1.16-4.59; p = 0.017) and DAC (OR: 2.38; 95% CI: 1.22-4.67; p = 0.012) and a trend in AVC (OR: 1.92; 95% CI: 0.98-3.80; p = 0.059) compared with non-anticoagulation. This association was absent in NOAC versus non-anticoagulant (AsAC OR: 0.51; 95% CI: 0.21-1.21; p = 0.127; DAC OR: 0.80; 95% CI: 0.36-1.76; p = 0.577; AVC OR: 0.62; 95% CI: 0.27-1.40; p = 0.248). A total of 178 patients were propensity score matched in three pairwise comparisons. Again, use of VKA was associated with DAC ( p = 0.043) and a trend toward more AsAC ( p = 0.059), while use of NOAC was not (AsAC p = 0.264; DAC p = 0.154; AVC p = 0.280). Conclusion This cross-sectional study shows that use of VKA seems to contribute to vascular calcification. The calcification effect was not observed in NOAC users.

Project description:BackgroundUse of the non-vitamin K antagonist oral anticoagulants (NOACs) is endorsed by current guidelines for stroke prevention in patients with atrial fibrillation (AF). However efficacy and safety of NOACs in patients undergoing catheter ablation (RFCA) of AF has not been well established yet.ObjectivesTo perform a meta-analysis of all studies comparing NOACs and vitamin K antagonist oral anticoagulants (VKAs) in patients undergoing RFCA.Data sourcesStudies were searched for in PubMed and Google Scholar databases.Study eligibility criteriaStudies were considered eligible if: they evaluated the clinical impact of NOACs versus VKAs; they specifically analyzed the use of anticoagulants during periprocedural phase of RFCA; they reported clinical outcome data.Study appraisal and synthesis methods25 studies were selected, including 9881 cases. The summary measure used was the risk ratio (RR) with 95% confidence interval (CI). The random-effects or the fixed effect model were used to synthesize results from the selected studies.ResultsThere was no significant difference in thromboembolic complications (RR 1.39; p=0.13). Bleeding complications were significantly lower in the NOACs-treated arm as compared to VKAs (RR=0.67, p<0.001). Interestingly, a larger number of thromboembolic events was found in the VKAs-treated arm in those studies where VKAs had been interrupted during the periprocedural phase (RR=0.68; p=ns). In this same subgroup a significantly higher incidence of both minor (RR=0.54; p=0.002) and major bleeding (RR=0.41; p=0.01) events was recorded. Conversely, the incidence of thromboembolic events in the VKAs-treated arm was significantly lower in those studies with uninterrupted periprocedural anticoagulation treatment (RR=1.89; p=0.02).LimitationsAs with every meta-analysis, no patients-level data were available.Conclusions and implicationsThe use of NOACs in patients undergoing RFCA is safe, given the lower incidence of bleedings observed with NOACs. On the other side, periprocedural interruption of VKAs and bridging with heparin is associated with a higher bleeding rate with no significant benefit on onset of thromboembolic events.

Project description:Current guidelines do not suggest in which groups of patients with atrial fibrillation (AF) individual non-vitamin K antagonist oral anticoagulants (NOACs) should be used for the prevention of thromboembolic complications. The aim of this study was to evaluate the frequency of use of apixaban, dabigatran, and rivaroxaban, and attempt to identify factors predisposing their administration. The Polish Atrial Fibrillation (POL-AF) registry is a prospective, non-interventional study, including consecutive patients with AF hospitalized in ten Polish cardiology centers during the period ranging from January to December 2019. In this study, all patients were treated with NOACs. Among the 2971 patients included in the analysis, 40.4% were treated with rivaroxaban, 32% with apixaban, and 27.6% with dabigatran. The mean age of the total population was 72 ± 11.5 years and 43% were female. A reduced dose of NOAC was used in 35% of patients treated with apixaban, 39.7% of patients treated with dabigatran, and 34.4% of patients treated with rivaroxaban. Independent predictors of the use of apixaban were previous bleeding (OR 2.37, CI 1.67–3.38), GFR < 60 mL/min (OR 1.38, CI 1.25–1.64), heart failure (OR 1.38, CI 1.14–1.67) and age (per 5 years) (OR 1.14, CI 1.09–1.19). GFR < 60 mL/min (OR 0.79, CI 0.66–0.95), female (OR 0.8, CI 0.67–0.96) and age (per 5 years) (OR 0.95, CI 0.91–0.99) diminished the chance of using dabigatran. Previous bleeding (OR 0.43, CI 0.28–0.64), vascular disease (OR 0.84, CI 0.70–0.99), and age (per 5 years) (OR 0.94, CI 0.90–0.97) diminished the chance of choosing rivaroxaban. In hospitalized patients with AF, the most frequently chosen NOAC was rivaroxaban. Apixaban was chosen more often in patients after bleeding, and in those who were advanced in years, with heart failure and impaired renal function. Impaired renal function and female gender were factors that diminished the chance of using dabigatran. Previous bleeding and vascular disease was the factor that diminished the chance of using rivaroxaban. Dabigatran and rivaroxaban have been used less frequently in elderly patients.

Dataset Information

Effectiveness, safety, and major adverse limb events in atrial fibrillation patients with concomitant diabetes mellitus treated with non-vitamin K antagonist oral anticoagulants.

Publications

Effectiveness, safety, and major adverse limb events in atrial fibrillation patients with concomitant diabetes mellitus treated with non-vitamin K antagonist oral anticoagulants.

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