Background and Aims
Stroke in nonvalvular atrial fibrillation(NVAF) patients is usually devastating if not adequately prevented. AF patients with stroke are at higher risk of recurrence. Dabigatran, a direct thrombin inhibitor has had been approved as an appropriate preventive option. This multicenter observational prospective cohort study tried to investigate the safety and efficacy of Dabigatran prescribed under routine clinical practice for secondary stroke prevention in NVAF patients.
Method
Patients with history of stroke or TIA, started Dabigatran within 3-months of study initiation or after new index-stroke were enrolled. After patients’ consent, we recorded data on their demographics, AF disease information/medical history, laboratory tests and concomitant medications during baseline and follow-up visits. The rate of stroke recurrence, bleeding, gastrointestinal events as well as the drug adherence were evaluated. 
Results
From Dec 2013 till Apr 2017, 653 patients (M/F:399/254) participated, mean age 71.4±10.4, mean follow-up 205 days. The median CHA2DS2VASc score was 5; HAS-BLED scale was 3. Low dose Dabigatran (110 mg BID) was prescribed in 555(85%) patients. Recurrent ischemic stroke was diagnosed in 18 patients/TIA in 2; MI in 5; death in 17 (3%; 0.77 %; 2.6%) (5.45%; 1.36%; 4.6% per year). Hemorrhagic complications were recorded in 46 patients, 56 events (8.6%; 12.5% per year), of which 13 were major bleeding (1.99%; 3.5% per year): intracerebral (3), gastrointestinal (7), genitourinary (2), retroperitoneum (1). Male, age≧75 y/o were risks of bleeding but no difference between low dose and standard dose. 138 (21.1% ) patients withdrawn prematurely, 37% due to adverse events.   

Conclusion
The use of low dose Dabigatran in real-world clinical setting among high risk NVAF patients in Taiwan was still associated with comparable efficacy and acceptable safety outcomes.

SAFETY AND EFFICACY OF DABIGATRAN FOR SECONDARY STROKE PREVENTION IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION-MULTICENTER PROSPECTIVE REGISTRY BY TAIWAN STROKE SOCIETY