rivaroxaban and Foramen-Ovale--Patent

Stroke is becoming a major cause of morbidity and mortality in the developing world while the trend is actually downward in the developed nations. This is mostly because of the better recognition, treatment options and secondary prevention in addition to changes in lifestyles. There have been significant developments in the secondary prevention of ischaemic stroke in the last decade alone. Newer medications like direct thrombin inhibitors and factor Xa inhibitors have come into common practice. These medications are either equally effective or even better than age-old warfarin. Unlike previous belief, we now know that mechanical closure of the patent foramen ovale does not reduce the rate of stroke recurrence. There is a hint that dual anti-platelet therapy may reduce early recurrence of stroke. Even more exciting news is that closure of left atrial appendage might totally eliminate the need for oral anticoagulation in selected patient population.

Topics: Anticoagulants; Blood Coagulation; Brain Ischemia; Foramen Ovale, Patent; Humans; Intracranial Embolism; Morpholines; Platelet Aggregation Inhibitors; Pyrazoles; Pyridones; Rivaroxaban; Secondary Prevention; Stroke; Thiophenes; Ventricular Dysfunction, Left

Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial.. NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy.. Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk of recurrent ischaemic stroke between rivaroxaban and aspirin (hazard ratio [HR] 0·54; 95% CI 0·22-1·36), and the risk was similar for those without known PFO (1·06; 0·84-1·33; p. Among patients with ESUS who have PFO, anticoagulation might reduce the risk of recurrent stroke by about half, although substantial imprecision remains. Dedicated trials of anticoagulation versus antiplatelet therapy or PFO closure, or both, are warranted.. Bayer and Janssen.

Topics: Aged; Aspirin; Cohort Studies; Double-Blind Method; Factor Xa Inhibitors; Female; Foramen Ovale, Patent; Humans; International Cooperation; Male; MEDLINE; Middle Aged; Platelet Aggregation Inhibitors; Rivaroxaban; Statistics, Nonparametric; Stroke; Treatment Outcome

A 61-year-old man presented with transient dysarthria and left upper extremity numbness. Head MRI showed an acute infarct in the left temporal lobe and multiple old infarcts in the bilateral cortices. A transesophageal echocardiogram revealed a patent foramen ovale with a large shunt. No deep vein thrombosis was found. He suffered a recurrent cerebral infarction while taking antiplatelet therapy. An insertable cardiac monitor was implanted on the 41st day, and the antiplatelet treatment was changed to warfarin. The insertable cardiac monitor did not detect atrial fibrillation, even when the patient had a recurrent transient ischemic attack on the 57th day under warfarin therapy. The patient underwent percutaneous foramen ovale closure on the 63rd day. On postoperative days 18-25, an insertable cardiac monitor detected brief atrial fibrillation, and he took rivaroxaban for three months. Atrial fibrillation may occur secondary to percutaneous patent foramen ovale closure for cryptogenic stroke. The insertable cardiac monitor may help diagnose the pathogenesis of secondary atrial fibrillation and determine the optimal antithrombotic therapy.

Topics: Atrial Fibrillation; Fibrinolytic Agents; Foramen Ovale; Foramen Ovale, Patent; Humans; Ischemic Stroke; Male; Middle Aged; Platelet Aggregation Inhibitors; Rivaroxaban; Secondary Prevention; Stroke; Treatment Outcome; Warfarin

BACKGROUND Transient atrial fibrillation (AF) following percutaneous patent foramen ovale (PFO) closure is common. Anticoagulation therapy should be considered in selected cases of prolonged AF after PFO closure, but guidelines do not provide clear recommendations on indication or choice of anticoagulant therapy for patients with post-procedural AF. CASE REPORT A 45-year-old woman presented with cryptogenic stroke verified by magnetic resonance imaging (MRI). Echocardiography revealed a PFO, which was closed percutaneously using a Gore septal occluder (25 mm). She was discharged on aspirin monotherapy (75 mg oral daily) according to institutional standard. Three weeks later, she presented with atrial fibrillation (AF). A direct oral anticoagulant (DOAC) (rivaroxaban 20 mg once daily) was initiated and aspirin was discontinued. After 4 months of follow-up, a routine echocardiography revealed large thrombi attached to both sides of the PFO occluder. CONCLUSIONS DOACs may be ineffective in preventing thrombus formation on device surfaces. Until more evidence has been provided, we suggest that DOACs are not routinely used for stroke prevention in patients following PFO closure or similar procedures within the first 3 months after device implantation.

Topics: Echocardiography; Factor Xa Inhibitors; Female; Foramen Ovale, Patent; Humans; Middle Aged; Rivaroxaban; Septal Occluder Device; Thrombosis

Topics: Aspirin; Foramen Ovale, Patent; Humans; Recurrence; Rivaroxaban; Stroke

Topics: Aspirin; Foramen Ovale, Patent; Humans; Rivaroxaban; Secondary Prevention; Stroke