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GESTIONE CLINICA, COMORBIDITÀ ED EVENTI AVVERSI ASSOCIATI IN PAZIENTI CON FIBRILLAZIONE ATRIALE: ANALISI DA UNO STUDIO DI COORTE EUROPEO SU OLTRE 11.000 PAZIENTI
No full textIntroduzione
La fibrillazione atriale (FA) è l’aritmia sostenuta più comune riscontrata nella pratica clinica ed è associata ad un aumento del rischio di ictus e di mortalità per tutte le cause.
Obiettivi
L’obiettivo di questo progetto è quello di indagare l’epidemiologia, le comorbilità e la gestione clinica della FA in una coorte contemporanea di pazienti europei arruolati nello studio multicentrico EORP-AF
Metodi
L’EORP-AF Long-Term è uno studio multicentrico prospettico, osservazionale e su larga scala su pazienti con FA nell’attuale pratica cardiologica. Lo studio ha arruolato 11.096 pazienti consecutivi affetti da FA in 250 centri di 27 paesi europei.
Risultati
Nello studio sono stati arruolati 11.096 pazienti (40,7% donne; età media 69±11 anni). Sono state effettuate diverse analisi:
1.Impatto dei fenotipi clinici sulla gestione clinica ed eventi avversi
Descrivere i fenotipi clinici dei pazienti con FA e analizzare il decorso clinico utilizzando una analisi di cluster gerarchici. Risultati principali: Abbiamo identificato 3 Cluster: Cluster 1 caratterizzato da pazienti anziani e con comorbidità non cardiache; Cluster 2 caratterizzato da pazienti più giovani con bassa prevalenza di comorbidità; Cluster 3 caratterizzato da pazienti con fattori di rischio CV/comorbilità. Il Cluster 3 ha avuto il più alto tasso di eventi avversi rispetto al Cluster 1 e al Cluster 2.
2. Applicabilità nel mondo reale e impatto clinico di una strategia di controllo precoce del ritmo
Valutare l’applicabilità e l’impatto nel mondo reale di una strategia di controllo precoce del ritmo nei pazienti con FA. Risultati principali: Il controllo precoce del ritmo è stato associato a una migliore qualità della vita, ma a un maggiore utilizzo delle risorse sanitarie. L'outcome primario si è verificato meno spesso nei pazienti trattati con controllo precoce del ritmo rispetto a quelli senza controllo precoce del ritmo. Nel modello di regressione di Cox aggiustato, non è stata riscontrata alcuna differenza significativa tra i due gruppi per quanto riguardo l’outcome primario.
3. Impatto della neoplasia e aderenza al trattamento integrato “ABC”
Valutare gli eventi avversi dei pazienti con neoplasie maligne e valutare l'impatto dell'adesione al trattamento integrato “ABC”. Risultati principali: i pazienti sono stati classificati in 3 categorie: pazienti senza tumore (NoMal), pazienti con pregressa diagnosi di tumore (PriorMal) e pazienti con tumore maligno attivo (ActiveMal). I pazienti con tumore attivo sono risultati associato in modo indipendente a un rischio più elevato di morte per tutte le cause e MACE, nonché di eventi emorragici. L'uso di anticoagulanti orali non è risultato associato a un rischio più elevato di morte o sanguinamento nei pazienti con neoplasia attiva. L'adesione al trattamento integrato ABC è stata associata a una frequenza significativamente inferiore dell'outcome primario rispetto alla non-aderenza, sia nei pazienti senza tumore che in quelli con tumore. L'adesione a un numero più elevato di criteri ABC era associata a un rischio inferiore di outcome primario.
Conclusioni
Le nostre analisi hanno evidenziato la complessità della fisiopatologia, dell’epidemiologia e della gestione clinica dei pazienti affetti da FA. I risultati dei nostri studi rafforzano l’importanza di una gestione olistica nella cura dei pazienti con FA che possono essere gravati da una prognosi sfavorevole e da un aumento del rischio di eventi avversi se non adeguatamente trattati. Queste analisi, derivate da questo ampio studio europeo, potranno aiutare ad adattare e rafforzare le raccomandazioni delle linee guida europee nei pazienti con FA del “mondo reale” identificando dove la gestione non è aderente alle linee guida e dove esistono lacune terapeutiche.Background
Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice and it is associated with an increased risk of stroke and all-cause mortality.
Objectives
The general aim of this project is to investigate the epidemiology, comorbidities and clinical management of AF in the contemporary cohort of European patients enrolled in the EURObservational Research Programme on AF (EORP-AF) Long-Term General study.
Methods
The EORP-AF Long-Term General is a prospective, observational, large-scale multicentre study on AF patients in current cardiology practice. The study enrolled 11,096 AF consecutive patients in 250 centres from 27 participating European countries.
Results
A total 11096 patients were enrolled in the study (40.7% female; mean age 69±11years). We performed different analyses:
1.Impact of clinical phenotypes on management and outcomes
To describe AF patients' clinical phenotypes and analyze the differential clinical course using hierarchical cluster analysis. Main results: We identified 3 clusters: Cluster 1 characterized by older patients and prevalent non-cardiac comorbidities; Cluster 2 characterized by younger patients with low prevalence of comorbidities; Cluster 3 characterized by patients' prevalent CV risk factors/comorbidities. Cluster 3 had the highest rate of outcomes compared to Cluster 1 and Cluster 2.
2.Real-world applicability and impact of early rhythm control
To evaluate the real-world applicability and impact of an early rhythm control strategy in patients with AF. Main results: Early rhythm control was associated with better quality of life, but with greater use of health-care resources. The primary outcome occurred less often in early rhythm control patients than in those with no rhythm control (13.6% vs. 18.5%, p < 0.001). In the adjusted Cox regression model, no significant difference was found between no rhythm control and early rhythm control, for the primary outcome. No difference in the primary outcome between early rhythm control and 'no rhythm control patients' adherent to ABC pathway' was evident.
3. Impact of malignancy and adherence to the ABC pathway
To evaluate the outcomes of patients with malignancy and to evaluate the impact of adherence to ABC pathway . Main results: Patients were categorized into 3 categories: No Malignancy (NoMal) patients, 577 (5.6%) Prior Malignancy (PriorMal) and 209 (2%) Active Malignancy (ActiveMal). ActiveMal was independently associated with a higher risk for all-cause death and MACE, as well as any haemorrhagic events and major bleeding. Use of oral anticoagulants was not significantly associated with a higher risk for all-cause death or bleeding in ActiveMal patients. Adherence to the ABC pathway was associated with a significantly lower occurrence of the primary outcome vs. non-adherence, both in 'no malignancy and malignancy patients. Adherence to a higher number of ABC criteria was associated with a lower risk of the primary outcome, being lowest when 3 ABC criteria were fulfilled
Conclusions
Our analyses highlighted the complexity of pathophysiology, epidemiology, and clinical management of European AF patients. Our results reinforce the importance of comprehensive management in the care of AF patients who may be burdened by poor prognosis and increased risk of outcomes if not properly treated. These analyses, derived from this large European study will help to adapt and strengthen European practice guidelines recommendations in “real-world” AF patients identifying where care is not guideline adherent and where treatment gaps exist
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