Effectiveness of structured, hospital-based, nurse-led atrial fibrillation clinics: a comparison between a real-world population and a clinical trial population

Abstract

Aims: A randomized trial has documented that structured nurse-led Atrial Fibrillation (AF) service is superior to conventional AF service, but there is a need for more data, confirming feasibility and outcome in a real-world setting. We compared patient outcome in nurse-led structured hospital AF clinics between realworld patients from Denmark (DK) and from the randomised trial on efficacy of a nurse-led AF clinic reported from the Netherlands (NL), with respect to a composite outcome of CV hospitalization and CV death. Methods: Real-world data consisted of baseline and follow-up data. All patients were referred by cardiologists. The AF nurse specialist provided patient education, risk factor control, and stimulated empowerment and compliance in these patients. During follow-up treatment was adjusted according to clinical guidelines, supervised by a cardiologist. Patient education was repeated and compliance was controlled. The study size was powered as a non-inferiority study. Outcome measures were adjudicated by same principles in both countries. Results: 596 patients from DK and 356 patients from NL were included. There were no significant differences between groups with respect to age, body mass index, type of AF, CHA2DS2VASc score and co-morbidity. The composite primary end point occurred with an incidence rate of 8.0 in DK and 8.3 per 100 person years in NL, crude HR 0.83 (95% CI 0.56-1.23). Adjustment for covariates and medical treatment did not substantially change HR. Conclusion: Structured nurse-led hospital based AF service is feasible and effective, and patient outcome is in real life hospital based structured AF service is as least as good as in the setting of a randomized trial. (Figure Presented).