Faculty of Medicine

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Comparison of HAS-BLED and ORBIT bleeding risk scores in atrial fibrillation patients treated with non-vitamin K antagonist oral anticoagulants: a report from the ESC-EHRA EORP-AF General Long-Term Registry
(Oxford University Press (OUP), 2021-09-23)
Proietti, Marco
;
Romiti, Giulio Francesco
;
Vitolo, Marco
;
Potpara, Tatjana S
;
Boriani, Giuseppe
Aims Bleeding risk assessment is recommended in guidelines for the management of atrial fibrillation (AF). The HAS-BLED score was proposed prior to non-vitamin K antagonist oral anticoagulants (NOACs) and it has been suggested that the ORBIT score may be superior in predicting bleeds in NOAC users. We aimed to compare the HAS-BLED and ORBIT scores in contemporary AF patients treated with NOACs. Methods and results We analysed patients enrolled in the ESC-EHRA EORP-AF (EURObservational Research Programme in AF) General Long-Term Registry. HAS-BLED and ORBIT scores were computed based on original schemes. The primary outcome was the occurrence of major bleeding (MB). A total of 3018 patients (median age 70; 39.6% females) were included: median [interquartile range (IQR)] HAS-BLED and ORBIT scores were 1 [1–2] and 1 [0–2], respectively; 356 (11.8%) patients were at high risk for MB using HAS-BLED (≥3) and 123 (4.1%) using ORBIT (≥4). Overall, 60 (2.0%) MB events were recorded, with an incidence of 1.1 per 100 patient-years. Both HAS-BLED and ORBIT were associated with outcome, modestly predicting MB [area under the curve (AUC) 0.653, 95% confidence interval (CI) 0.593–0.714 and AUC 0.601, 95% CI 0.526–0.677, respectively]. Calibration plots showed that both scores were poorly calibrated, particularly the ORBIT score, which showed consistent poorer calibration. Time-dependent reclassification analysis showed a trend towards incorrect lower risk reclassification using ORBIT compared with HAS-BLED. Conclusion In this real-life contemporary cohort of AF patients treated with NOACs, the ORBIT score did not provide reclassification improvement, showing even poorer calibration compared with HAS-BLED. Our findings do not support the preferential use of ORBIT in NOAC-treated AF patients.
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Outcomes of digoxin vs. beta blocker in atrial fibrillation: report from ESC–EHRA EORP AF Long-Term General Registry
(Oxford University Press (OUP), 2021-10-19)
Ding, Wern Yew
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Boriani, Giuseppe
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Marin, Francisco
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Blomström-Lundqvist, Carina
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Potpara, Tatjana S
Aims The safety of digoxin therapy in atrial fibrillation (AF) remains ill-defined. We aimed to evaluate the effects of digoxin over beta-blocker therapy in AF. Methods and results Patients with AF who were treated with either digoxin or a beta blocker from the ESC–EHRA EORP AF (European Society of Cardiology–European Heart Rhythm Association EURObservational Research Programme Atrial Fibrillation) General Long-Term Registry were included. Outcomes of interest were all-cause mortality, cardiovascular (CV) mortality, non-CV mortality, quality of life, and number of patients with unplanned hospitalizations. Of 6377 patients, 549 (8.6%) were treated with digoxin. Over 24 months, there were 550 (8.6%) all-cause mortality events and 1304 (23.6%) patients with unplanned emergency hospitalizations. Compared to beta blocker, digoxin therapy was associated with increased all-cause mortality [hazard ratio (HR) 1.90 (95% confidence interval, CI, 1.48–2.44)], CV mortality [HR 2.18 (95% CI 1.47–3.21)], and non-CV mortality [HR 1.68 (95% CI 1.02–2.75)] with reduced quality of life [health utility score 0.555 (±0.406) vs. 0.705 (±0.346), P < 0.001] but no differences in emergency hospitalizations [HR 1.00 (95% CI 0.56–1.80)] or AF-related hospitalizations [HR 0.95 (95% CI 0.60–1.52)]. On multivariable analysis, there were no differences in any of the outcomes between both groups, after accounting for potential confounders. Similar results were obtained in the subgroups of patients with permanent AF and coexisting heart failure. There were no differences in outcomes between AF patients receiving digoxin with and without chronic kidney disease. Conclusion Poor outcomes related to the use of digoxin over beta-blocker therapy in terms of excess mortality and reduced quality of life are associated with the presence of other risk factors rather than digoxin per se. The choice of digoxin or beta-blocker therapy had no influence on the incidence of unplanned hospitalizations.
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Impact of anthropometric factors on outcomes in atrial fibrillation patients: analysis on 10 220 patients from the European Society of Cardiology (ESC)-European Heart Rhythm Association (EHRA) EurObservational Research Programme on Atrial Fibrillation (EORP-AF) general long-term registry
(Oxford University Press (OUP), 2022-06-07)
Boriani, Giuseppe
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Vitolo, Marco
;
Malavasi, Vincenzo L
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Proietti, Marco
;
Fantecchi, Elisa
Abstract Aim To investigate the association of anthropometric parameters [height, weight, body mass index (BMI), body surface area (BSA), and lean body mass (LBM)] with outcomes in atrial fibrillation (AF). Methods and results Ten-thousand two-hundred twenty patients were enrolled [40.3% females, median age 70 (62–77) years, followed for 728 (interquartile range 653–745) days]. Sex-specific tertiles were considered for the five anthropometric variables. At the end of follow-up, survival free from all-cause death was worse in the lowest tertiles for all the anthropometric variables analyzed. On multivariable Cox regression analysis, an independent association with all-cause death was found for the lowest vs. middle tertile when body weight (hazard ratio [HR] 1.66, 95%CI 1.23–2.23), BMI (HR 1.65, 95%CI 1.23–2.21), and BSA (HR 1.49, 95%CI 1.11–2.01) were analysed in female sex, as well as for body weight in male patients (HR 1.61, 95%CI 1.25–2.07). Conversely, the risk of MACE was lower for the highest tertile (vs. middle tertile) of BSA and LBM in males and for the highest tertile of weight and BSA in female patients. A higher occurrence of haemorrhagic events was found for female patients in the lowest tertile of height [odds ratio (OR) 1.90, 95%CI 1.23–2.94] and LBM (OR 2.13, 95%CI 1.40–3.26). Conclusions In AF patients height, weight, BMI, BSA, and LBM were associated with clinical outcomes, with all-cause death being higher for patients presenting lower values of these variables, i.e. in the lowest tertiles of distribution. The anthropometric variables independently associated with other outcomes were also different between male and female subjects.
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Epidemiology and impact of frailty in patients with atrial fibrillation in Europe
(Oxford University Press (OUP), 2022-08)
Proietti, Marco
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Romiti, Giulio Francesco
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Vitolo, Marco
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Harrison, Stephanie L
;
Lane, Deirdre A
Background: Frailty is a medical syndrome characterised by reduced physiological reserve and increased vulnerability to stressors. Data regarding the relationship between frailty and atrial fibrillation (AF) are still inconsistent. Methods A 40-item frailty index (FI) was built according to the accumulation of deficits model in the AF patients enrolled in the ESC-EHRA EORP-AF General Long-Term Registry. Association of baseline characteristics, clinical management, quality of life, healthcare resources use and risk of outcomes with frailty was examined. Results Among 10,177 patients [mean age (standard deviation) 69.0 (11.4) years, 4,103 (40.3%) females], 6,066 (59.6%) were pre-frail and 2,172 (21.3%) were frail, whereas only 1,939 (19.1%) were considered robust. Baseline thromboembolic and bleeding risks were independently associated with increasing FI. Frail patients with AF were less likely to be treated with oral anticoagulants (OACs) (odds ratio 0.70, 95% confidence interval 0.55–0.89), especially with non-vitamin K antagonist OACs and managed with a rhythm control strategy, compared with robust patients. Increasing frailty was associated with a higher risk for all outcomes examined, with a non-linear exponential relationship. The use of OAC was associated with a lower risk of outcomes, except in patients with very/extremely high frailty. Conclusions In this large cohort of AF patients, there was a high burden of frailty, influencing clinical management and risk of adverse outcomes. The clinical benefit of OAC is maintained in patients with high frailty, but not in very high/extremely frail ones.

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