Dr. Yusuf Bozkurt

Name of the Study: A Novel Model of Integrated Care for Older Patients With Atrial Fibrillation in Rural China: The MIRACLE-AF Trial

Published in Congress: ESC 2024

Link:  https://www.jacc.org/doi/10.1016/j.jacasi.2024.07.006

Background:
Atrial fibrillation (AF) is the most common cardiac arrhythmia encountered in clinical practice and is a significant risk factor for stroke, heart failure, and mortality. The management of AF, especially in rural areas with limited access to healthcare, remains suboptimal. Rural populations in China, particularly the elderly, are highly vulnerable due to their lower awareness of AF, limited access to healthcare services, and a lack of structured care models to manage this condition. Stroke prevention, primarily through oral anticoagulants (OACs), has proven effective in reducing the risk of strokes, but adherence to optimal treatment guidelines remains a challenge in rural settings. The Atrial Fibrillation Better Care (ABC) pathway provides a structured approach to AF management, encompassing anticoagulation, symptom management, and control of comorbidities, and has shown promising results in various patient populations.

Objective:
The MIRACLE-AF trial aims to evaluate the effectiveness of a village doctor-led, telemedicine-based, multifaceted care model in improving adherence to the ABC pathway and reducing adverse clinical outcomes in elderly patients with AF in rural China. The trial seeks to address the barriers to effective AF management in rural settings by leveraging telemedicine to support village doctors in providing integrated AF care.

Methods:
This cluster-randomized controlled trial was conducted across 30 village clinics in Jiangdu County, Jiangsu Province, China. The trial enrolled 1,039 participants aged 65 years and older, who had been diagnosed with AF. Participants were randomized into two groups: the intervention group, which received telemedicine-supported integrated AF care led by village doctors, and the control group, which received enhanced usual care. The village doctors in the intervention group were trained to use a digital health platform to manage AF patients in collaboration with cardiology specialists. The trial follows participants for up to 36 months, with regular assessments every 3 months.
The primary outcome in Stage 1 (12 months) was the proportion of patients adhering to all components of the ABC pathway.
In Stage 2 (36 months), the primary outcome is a composite of cardiovascular death, all strokes (ischemic and hemorrhagic), worsening heart failure, acute coronary syndrome, and emergency visits related to AF. Secondary outcomes include all-cause mortality, bleeding events, and other major cardiovascular events.

Results:

A total of 1,039 participants were enrolled in the MIRACLE-AF trial, with 524 assigned to the intervention group (telemedicine-supported care) and 515 to the control group (enhanced usual care). The study achieved a high level of participant engagement, with nearly all patients in both groups maintaining regular follow-up.
At the 12-month follow-up, the primary outcome for Stage 1—the proportion of patients adhering to the ABC pathway—showed a statistically significant improvement in the intervention group (p < 0.05). There have also been significant improvements in symptom management and control of comorbidities (blood pressure, diabetes and lifestyle factors). Patients in the intervention group reported less severe AF symptoms compared to the control group. The overall results indicated that the composite primary outcome—comprising cardiovascular death, stroke, hospitalization due to worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation—was reduced by 36% in the intervention group compared to the control group. Specifically, the risk of cardiovascular death was 50% lower in the intervention group (24 events vs. 47 events). Furthermore, the risks of stroke and hospitalization due to worsening heart failure or acute coronary syndromes were reduced by 36% and 31%, respectively. The researchers observed a higher incidence of clinically relevant non-major bleeding in the intervention group compared to the control group (9 events vs. 3 events), likely attributable to the use of anticoagulant therapy.

Conclusion:
The MIRACLE-AF study shows that a telemedicine-supported, village doctor-led integrated care model has significant potential to improve health outcomes in older AF patients living in rural areas. The findings of the study suggest that this new model improves treatment adherence and positively affects clinical outcomes in AF management in rural areas. Improving AF treatment in rural areas could be an important step forward, not only for individual patient outcomes but also for overall public health.

Interpretations:
The MIRACLE-AF study is an important initiative evaluating the feasibility and effectiveness of integrated care models in elderly AF patients in rural China. The study shows how effective digital health solutions such as tele-medicine can be in improving the quality of healthcare in rural areas through village doctors. This model offers an approach that can be extended and applied to the management of not only AF but also other chronic diseases such as hypertension and heart failure. If this model is successful, similar structures could be applied to other rural and resource-poor regions of the world.