Original articleOne-year clinical events and management of patients with atrial fibrillation hospitalized in cardiology centers: Data from the BLITZ-AF study
Introduction
Atrial fibrillation (AF) is associated with a significant risk of ischemic stroke, death and other cardiovascular events as well as with higher medical costs and reduced quality of life [1], [2], [3]. The management of AF has dramatically changed after the introduction of direct oral anticoagulant drugs (DOACs) and advances in rhythm control methods, such as catheter ablation [1]. DOACs have been shown to be safe and effective in clinical trials [4], [5], [6], [7] and have induced a general increase in prevalence of oral anticoagulation. However, there is a dearth of “real world” data where the patients are generally older and with more comorbidities than in trials.
The collection of prospective data from AF patients followed by cardiologists in routine clinical practice is useful to provide information about management and adherence to international guidelines [1].
The BLITZ-AF study is a multicenter observational study, carried out in 2016–2017 in a representative network of Italian Cardiology centers to evaluate the management of AF, the use of new antithrombotic therapies and of catheter ablation techniques [8]. In this paper we report the follow-up data of AF patients enrolled in the centers of the BLITZ-AF who agreed to participate to the follow-up phase of the study.
Section snippets
Methods
The methods and baseline findings from the BLITZ-AF study have been previously published elsewhere [8]. Briefly, 154 cardiology centers enrolled patients with AF (primary or secondary diagnosis) admitted to cardiology wards for urgent or planned hospitalization over a period of 12 consecutive weeks. The diagnosis of AF was confirmed by ECG in all patients. Patients with AF as an early complication of an acute coronary syndrome or associated with cardiothoracic surgery were excluded. Valvular
Statistical analysis
Categorical variables are presented as numbers and percentages, and compared by Chi-square test, while continuous variables are presented as means and standard deviations (SD), with the exception for the time of observation and the CHA2DS2-VASc score which are reported also as median and inter-quartile range (IQR), and compared by t-test, if normally distributed, or by Mann-Withney U test, if not. Treatment at baseline and at follow-up was compared by McNemar's test. Plots of the Kaplan-Meier
Results
Overall, 84 of the 154 centers participating in the baseline phase accepted to collect one-year follow-up data (Supplemental Fig. 1), with a median observation time of 366 days (IQR: 356–378 days, mean 372 days). Supplemental Table 1 shows the baseline characteristics of patients enrolled in center participating or not in the follow-up phase. In the centers that did not participate in the follow-up phase, women were more represented and, consequently, both the mean age and CHA2DS2-VASc score
Discussion
One of the most relevant observation at the follow-up analysis of the BLITZ-AF study is the very high mortality rate (9.2% with a median observation time of 366 days IQR: 356–378), higher than that observed in other cardiovascular diseases, usually considered at higher risk, such as coronary artery disease [10] or heart failure [11]. Mortality is higher also when compared to other observational registries, but comparison is somehow complex because the clinical characteristics (especially age)
Limitations
The main limit of the study is the rate of patients lost to follow-up (161/2320; 6.9%), which however does not affect the observations because of the superimposable characteristics of the lost to follow-up group to the followed population. Other shortcomings of the study are the high rate of phone call follow-up and the fact that all the patients were followed by cardiologists only, which does not reflect daily clinical practice for the whole AF population.
Conclusion
The findings of the 12 months follow-up of the BLITZ-AF study provide an up-to-date picture of the clinical course of patients with AF, who appear to be old and frequently affected by heart failure and severe comorbidities, which might have led to the high all-cause mortality rate observed in the study.
Funding
The sponsor of the study was the Heart Care Foundation, a non-profit independent organization, which also owns the database. Database management, quality control of the data and data analyses were under the responsibility of the ANMCO Research centre of the Heart Care Foundation. The study was partially supported by an unrestricted grant by Bayer, Italy. No compensation was provided to participating sites, investigators, nor members of the Steering Committee. The Steering Committee of the study
Declaration of Competing Interest
MMG, FC, ADL and GDP have no conflict of interest to disclose. RC local expert panel for Daiichi-Sankyo. LDL reported speaker's fees from Bayer, Boehringer and Daiichi-Sankyo. GB reported speaker's fees of small amount from Bayer, Boehringer, Boston and Medtronic. DL is an employee of the Heart Care Foundation, which conducted the study with an unrestricted grant of research from Bayer, Italy. GF is a consultant of the Heart Care Foundation, which conducted the study with an unrestricted grant
Acknowledgement
The authors thank patients and investigators from all participating Centers.
References (19)
- et al.
Causes of death and influencing factors in patients with atrial fibrillation
Am J Med
(2016) - et al.
The changing landscape for stroke prevention in AF. Findings from the GLORIA-AF registry phase 2
J Am Coll Cardiol
(2017) - et al.
Registries in atrial fibrillation: from trials to real-life clinical practice
Am J Med
(2017) - et al.
International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: results from the GARFIELD-AF, ORBIT-AF I and ORBIT-AF II registries
Am Heart J
(2017) - et al.
ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS
Eur Heart J 2016
(2016) - et al.
Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study
Circulation
(2014) - et al.
Atrial fibrillation and risks of cardiovascular disease, renal disease and death: systematic review and meta-analysis
BMJ
(2016) - et al.
Dabigatran versus warfarin in patient with atrial fibrillation
N Eng J Med
(2009) - et al.
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation
N Eng J Med
(2011)
Cited by (7)
Long-term effectiveness and safety of anticoagulation therapy in oldest old, frail people with atrial fibrillation
2021, European Journal of Internal MedicineCitation Excerpt :To the best of our knowledge this is the first real-life study showing a significant positive effect of OAC therapy on overall survival without any impact on clinically relevant bleeding in frail, oldest-old inpatients with AF. Indeed, a recently published multicenter, observational study, the BLITZ-AF, reported on survival, embolic and bleeding events, and hospital admission of patients with AF, but the population enrolled was younger (74±11 years), with a shorter follow-up [median 366 days] and selectively enrolled from a cardiologic environment without frailty evaluation by CGA [38]. Although our findings show that the presence of frail phenotype, mild to moderate cognitive impairment, mild disability and risk of falls should not be regarded as a contraindication, the net clinical benefit of OAC therapy in the oldest and frail patients, with advanced dementia and loss of independence, remains to be confirmed [39].
Beyond the 2020 guidelines on atrial fibrillation of the European society of cardiology
2021, European Journal of Internal MedicineCitation Excerpt :Nonetheless, numerous observational cohorts have shown that such a focus on identifying high risk patients only resulted in anticoagulation in 50-60% of eligible patients, with the rest being offered aspirin or no antithrombotic therapy [35]. In recent years, the landscape for stroke prevention has changed with the introduction of the non-vitamin K antagonist OACs (NOACs) which offer relative effectiveness, safety and convenience compared to the VKAs [34, 36, 37]. The NOACs are supported by well conducted clinical trials and real world observational cohorts supporting their use in clinical practice [38-45].
Beyond anticoagulant therapy. The not benign impact of atrial fibrillation on patients’ outcomes in a real world ‘scenario’
2020, European Journal of Internal MedicineSimple scores to predict 1-year mortality in atrial fibrillation
2024, Journal of Cardiovascular MedicineTrends in Stroke Prevention between 2014 and 2018 in Hospitalized Atrial Fibrillation Patients
2021, Cardiology Research and Practice
- 1
See Appendix for a complete list of Centres and Investigators.