Dabigatran or Aspirin After ESUS in PFO Patients

Feb 11, 2021
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Authors:
Diener HC, Chutinet A, Easton JD, et al.
Citation:
Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke 2021;Jan 28:[Epub ahead of print].
Summary By:
Mollie McDermott, MD, MS

Quick Takes

  • Some studies have suggested a benefit of anticoagulation over antiplatelet therapy for patients with patent foramen ovale (PFO) who have a history of embolic stroke of undetermined source (ESUS).
  • In this prespecified subgroup analysis of the RE-SPECT ESUS study, dabigatran was not superior to aspirin in preventing recurrent stroke in patients with PFO.
  • Antiplatelet rather than anticoagulant therapy will remain the antithrombotic treatment of choice for PFO patients with a history of ESUS.

Study Questions:

Is anticoagulation more effective than antiplatelet agents in preventing recurrent stroke in patients with patent foramen ovale (PFO) who have a history of embolic stroke of undetermined source (ESUS)?

Methods:

This is a prespecified subgroup analysis of stroke patients enrolled in the RE-SPECT ESUS trial who were randomized to either aspirin or dabigatran. Patients were either ≥60 years of age or 18-59 years with one additional stroke risk factor, including PFO without planned closure. PFO was identified by transthoracic or transesophageal echocardiography.

Results:

In the dabigatran group, 319 of the 2,694 patients had PFO (11.8%). In the aspirin group, 361 of the 2,694 patients had PFO (13.4%). Among PFO patients, a stroke occurred in 2.9% (16/319) in the dabigatran arm and 3.2% (19/361) in the aspirin arm (hazard ratio, 0.88; 95% confidence interval, 0.45-1.71). Major bleeding events were uncommon (<1%) in both groups.

Conclusions:

In this prespecified subgroup analysis of RE-SPECT ESUS, anticoagulation with dabigatran was not more effective than aspirin in preventing recurrent stroke in patients with PFO and a history of ESUS.

Perspective:

In the full cohort of patients with ESUS enrolled in RE-SPECT ESUS, patients on dabigatran had more clinically relevant nonmajor bleeding events than the aspirin group. Given this finding as well as medication expense, antiplatelet rather than anticoagulant therapy will remain the antithrombotic treatment of choice for PFO patients with a history of ESUS.

Clinical Topics: Anticoagulation Management, Congenital Heart Disease and Pediatric Cardiology, Noninvasive Imaging, Prevention, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Quality Improvement, Echocardiography/Ultrasound

Keywords: Anticoagulants, Aspirin, Echocardiography, Transesophageal, Echocardiography, Fibrinolytic Agents, Foramen Ovale, Patent, Heart Defects, Congenital, Hemorrhage, Platelet Aggregation Inhibitors, Primary Prevention, Risk Factors, Stroke, Vascular Diseases


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