Effects of glycated hemoglobin on 2-year clinical outcomes in elderly patients with atrial fibrillation: a sub-analysis of the ANAFIE registry, a large observational study Cardiovascular Diabetology

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patient temperament and characteristics

Of the 32,275 patients enrolled in the ANAFIE registry, 17,526 patients with known HbA1c values ​​at baseline were included in this analysis. The median follow-up (Q1-Q3) for this study was 2.0 years (1.92-2.00) years. By baseline HbA1c group, 8725 patients (49.8%) had an HbA1c of less than 6.0%, 6700 (38.2%) had an HbA1c of 6.0% or more and less than 7.0%, and 1548 (8.8%) had an HbA1c of 7.0% or more and less than 8.0%. %), and 553 (3.2%). It was over 8.0%.

ANAFIE among the overall population [16, 17], the mean age of the patients was 81.5 years. 57.3% were male. MeaningCHA2DS2-VASc score, 4.5; mean HAS-BLED score, 1.9. Percentage of patients with paroxysmal AF, 42.1%. Mean creatinine clearance (CrCl), 48.4 mL/min. OAC use, 92.4% (DOAC, 66.9%, warfarin, 25.5%). Patients with his HbA1c data at baseline (n = 17,526) had similar clinical features, with 40.4% having a clinical diagnosis of diabetes (Table 1). Regarding antidiabetic drug use, 24.6% were taking oral antidiabetic drugs and 3.6% were taking injectable antidiabetic drugs (insulin). [3.2%] and glucagon-like peptide-1 [GLP-1] receptor agonist [0.4%]). The most common oral antidiabetic drugs are dipeptidyl peptidase-4 (DPP-4) inhibitors (19.2%), sulfonylureas (6.1%), α-glucosidase inhibitors (4.9%), sodium glucose cotransporters 2 (SGLT2) inhibitor (2.1%). ), thiazolidinediones (1.9%), others (5.0%) (Table 1).

Table 1. Characteristics of 17,526 patients at baseline by HbA1c level

Patients with HbA1c ≥ 8.0% were significantly more likely to have low CrCl and high CHA2DS2– Prevalence of VASc and HAS-BLED scores, non-paroxysmal AF, hypertension, dyslipidemia, chronic kidney disease, cardiovascular disease, thromboembolism-related disease, cerebrovascular disease, malignancy, dementia within 1 year , with lower DOACs, but higher warfarin doses compared to other subgroups. Regarding the use of oral antidiabetic drugs, sulfonylureas, α-glucosidase inhibitors, DPP-4 inhibitors, SGLT2 inhibitors, etc. high, and the use of oral antidiabetic drugs was also high. Injectable antidiabetic drugs, including insulin and GLP-1 receptor agonists, were compared with other subgroups (Table 1).

Study endpoint

Figure 1 shows Kaplan-Meier estimates of the probability of occurrence of each event. Probabilities of event occurrence differed significantly among HbA1c categories of all-cause mortality (log-rank) P. = 0.003) and net clinical outcome (log-rank) P. = 0.007), and the incidence of both events was visually higher in patients with HbA1c ≥ 8.0%. A similar trend was observed for stroke/SEE in the HbA1c ≥ 8.0% subgroup, but the difference did not reach statistical significance.

Figure 1
Figure 1

Kaplan-Meier curves of clinical outcomes by HbA1c level

HbA1c glycated hemoglobin, look Systemic embolic event

Table 2 summarizes the incidence of events by HbA1c level subgroup. The incidence of events was similar among the HbA1c < 8.0 groups, but a significant increase was observed in the HbA1c ≥ 8.0% subgroup, especially for stroke/SEE (2.50/100 person-years). [95% CI: 1.52–3.49]), all-cause mortality (5.69/100 person-years) [95% CI: 4.23–7.16]), and net clinical outcome (7.83/100 person-years) [95% CI: 6.09–9.57]).

Table 2 Incidence of stroke/SEE, major hemorrhage, ICH, cardiovascular death, all-cause mortality, and net clinical outcome in 17,526 patients

Figure 2 shows the results of multivariate analysis using the Cox proportional hazards model with HbA1c, based on HbA1c < 6.0%. Risk (aHR [95% CI]) Stroke/SEE (1.48 [0.97–2.25]) were numerically higher at HbA1c ≥ 8.0%. All-cause mortality risk (1.46) [1.11–1.93]) and the net clinical outcome (1.33 [1.05–1.68]) was significantly higher in the HbA1c ≥ 8.0% subgroup, but there was no significant difference in the risk of major bleeding (0.94 [0.52–1.70]) or any other result. No significant differences in risk of any event were observed, with HbA1c levels ranging from 6.0% to <7.0% and 7.0% to <8.0%. Supplementary Table 1 shows a multivariate analysis using a Cox proportional hazards model in her AF patients diagnosed with diabetes according to each participating physician's judgment by HbA1c, with HbA1c of 6.0% to <7.0% as the reference. A significantly higher risk of all-cause mortality was observed in patients with HbA1c ≥ 8.0% (1.47 [1.10–1.97]).

Figure 2
Figure 2

Multivariate analysis using Cox proportional hazards model by HbA1c level

HbA1c < 6.0% was the criterion.Bars represent 95% confidence intervals

HbA1c glycated hemoglobin, Human Resources Departmenthazard ratio, lookSystemic embolic event

Table 3 shows multivariate analysis using the Cox proportional hazards model with HbA1c, no OAC, and OAC treatment. In patients with HbA1c 6.0% to <7.0%, DOAC use was associated with a significantly reduced risk (aHR [95% CI]) Stroke/SEE (0.71 [0.53–0.95]), hemorrhage (0.56 [0.39–0.82]), intracranial hemorrhage (0.55 [0.36–0.85]), and the net clinical outcome (0.80 [0.68–0.95]) compared with warfarin. Patients with HbA1c ≥ 8.0% had a higher risk of cardiovascular death (5.52 [1.03–29.62]) and net clinical outcome (1.69 [0.96–2.97]) using DOACs. However, no interaction was observed between HbA1c levels and anticoagulants. Supplementary Table 2 shows the number of events (%) by HbA1c level and anticoagulant treatment (i.e., warfarin, no OAC, or DOAC).

Table 3 Multivariate analysis using Cox proportional hazards model with DOAC (n = 11,921) and without OAC (n = 1262) and warfarin (n = 4,336) by HbA1c level

Table 4 shows multivariate analyzes using the Cox proportional hazards model for HbA1c and oral and injectable DM medications in DM patients. Overall, oral antidiabetic drug use was not associated with risk reduction using the non-oral antidiabetic drug use subgroup as a reference. Similar results were observed in patients receiving injectable antidiabetic drugs. No significant difference in event risk with or without injectable antidiabetic drugs was observed.

Table 4 Multivariate analysis of 8,733 diabetic patients using Cox proportional hazards model with oral and parenteral antidiabetic drugs

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