AbstractBackground

Medical treatment for stroke prevention in cryptogenic stroke (CS) patients with patent foramen ovale (PFO) remains inconclusive. We compared the efficacy and safety of dabigatran with aspirin on stroke prevention for patients with recent CS and PFO.

Methods

In this prospective cohort study, we randomly assigned patients with PFO who had a cryptogenic stroke, in a 1:1 ratio, to dabigatran or aspirin group. Patients were followed for 2 years and the primary efficacy outcome was the recurrence of stroke or systemic embolism. The primary safety outcome was occurrence of bleeding complications.

Results

A total of 375 patients were enrolled in the study, 188 assigned to the dabigatran group and 187 to the aspirin group. During the 2-year follow-up, the primary efficacy outcomes occurred in 4 patients in the dabigatran group (annualized rate, 2.0%) and 11 patients in the aspirin group (annualized rate, 5.1%) (hazard ratio, 0.74; 95% confidence interval, 0.51–0.98; P = 0.049). TIA/acute ischemic stroke occurred in 3 patients in the dabigatran group and 8 patients in the aspirin group (hazard ratio, 0.72; 95% confidence interval, 0.52–0.95; P = 0.039). Bleeding complications occurred in 8 patients in the dabigatran group (annualized rate, 3.9%) and in 7 patients in the aspirin group (annualized rate, 3.5%) (hazard ratio, 1.24; 95% confidence interval, 1.01–1.52; P = 0.886).

Conclusion

For cryptogenic stroke with PFO, dabigatran was superior to aspirin for stroke prevention. There is no increased risk of bleeding complication with dabigatran.

Section snippetsBackground

Cryptogenic stroke (CS) account for about 35% of all ischemic stroke patients and have similar 6-month mortality and 10-year recurrence rate as atherosclerosis and small artery occlusion [1]. Thus, it is significant to determine the underlying causes and to implement targeted secondary prevention therapy. Patent foramen ovale (PFO) has been reported to be significantly associated with cryptogenic stroke [2], especially among young stroke patients and those combined with an associated atrial

Patients and study design

This was a prospective, single-center, cohort study. All consecutive patients were included if they had a PFO who suffered from acute cryptogenic stroke within 180 days before randomization. An ischemic stroke was defined as focal neurologic deficits lasting for 24 h and with relevant infarction confirmed by magnetic resonance imaging (MRI). To rule out atherosclerotic stroke, vessel screening by computerized tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital

Results

A total of 375 patients were recruited from June 1, 2018 to May 31, 2019 and were randomly assigned to dabigatran (188 patients) or aspirin group (187 patients). The mean age of the patients was 53 years old and 67% of the patients were men. The classification of PFO size and RLS were similar between the two groups (Table 1). There were no significant differences between the two groups in the demographic and clinical factors (Table 1). The initial median National Institutes of Health Stroke

Discussion

The antithrombotic treatment for patients with CS and PFO remains uncertain. There is no definite investigation evaluating the efficacy and safety of specific antithrombotic drug in this population. Here in this study, we prospectively assessed dabigatran and aspirin for stroke prevention in patients with CS and PFO. Results showed that dabigatran could better lowered the recurrence rate of acute ischemic stroke and systemic embolism than aspirin. Also, dabigatran did not increase the risk of

Ethics approval and consent to participate

This study was approved by the ethics committee of Guangdong Hospital of Integrated Traditional Chinese and Western Medicine and written informed consents were obtained from each patient or statutory agent.

CRediT authorship contribution statement

SC and DC designed the study and wrote the manuscript. QW, PH, and JH helped to collect the clinical data. YL performed the statistical analysis. LZ and HS revised and approved the paper.

Competing interests

None declared.

Acknowledgements

Not applicable.

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