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Dabigatran versus aspirin for stroke prevention after cryptogenic stroke with patent foramen ovale: A prospective
Shumin Chen1, Dongchun Cai1, Yuzheng Lai1
1Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Chinese Medicine, Foshan, Guangdong 518000, PR China.
Insights
Dabigatran is more effective than aspirin for preventing recurrent strokes in patients with cryptogenic stroke and patent foramen ovale. This study found no increased bleeding risk with dabigatran compared to aspirin.
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- Cryptogenic stroke (CS) in patients with patent foramen ovale (PFO) presents a treatment dilemma.
- Optimal medical therapy for secondary stroke prevention in this population remains unclear.
Purpose of the Study:
- To compare the efficacy and safety of dabigatran versus aspirin for stroke prevention in patients with recent CS and PFO.
Main Methods:
- A prospective cohort study randomly assigned 375 patients with CS and PFO to either dabigatran or aspirin (1:1 ratio).
- Patients were followed for 2 years, monitoring for recurrent stroke, systemic embolism, and bleeding complications.
Main Results:
- Dabigatran significantly reduced the risk of recurrent stroke or systemic embolism (2.0% annualized rate) compared to aspirin (5.1% annualized rate; HR, 0.74).
- Transient ischemic attack/acute ischemic stroke rates were also lower with dabigatran (HR, 0.72).
- Bleeding complication rates were similar between dabigatran (3.9%) and aspirin (3.5%; HR, 1.24).
Conclusions:
- Dabigatran demonstrates superior efficacy over aspirin for stroke prevention in patients with cryptogenic stroke and patent foramen ovale.
- Dabigatran treatment does not appear to increase the risk of bleeding complications in this patient group.
Background:
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.
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