Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.
Background and importance Consistent with studies performed in younger patient cohorts, older patients suffering a cryptogenic stroke exhibit a much higher prevalence of patent foramen ovale (PFO) compared to their stroke of known origin counterparts. Several studies have provided promising preliminary data regarding PFO closure in older patients with cryptogenic stroke, with very low stroke recurrence rates at mid- to long-term follow-up. Several randomized trials have shown the beneficial effects of PFO closure vs. medical treatment in patients younger than 60 years with cryptogenic stroke and PFO. Current observational data suggest similar or even more marked effects on stroke recurrence prevention of PFO closure in older patients and would support the design of a randomized trial to provide definite evidence in this field. Therefore, the objective of the present study is to evaluate the efficacy of transcatheter PFO closure for preventing recurrent ischemic stroke (nonlacunar) events in patients \>60 years diagnosed with a cryptogenic stroke and PFO.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
714
Transcatheter PFO closure procedure will be performed according to the standards and experience of each participating center. Any approved PFO occluder device will be allowed in the study. Patients will also receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.
Patients will receive antithrombotic agents (single antiplatelet treatment ), and modifiable vascular risk factors (dyslipidemia, hypertension, diabetes) according to stroke prevention guidelines. The type of antithrombotic therapy will be left to the discretion of the physician responsible for the patient.
IUCPQ-UL
Québec, Quebec, Canada
Rate of ischemic events
New ischemic non-lacunar stroke events
Time frame: 12 months
Rate of stroke events
All new non-lacunar stroke events
Time frame: 12 months
Rate of mortality
All cause mortality
Time frame: 10 year follow-up
Rate of cardiovascular mortality
Cardiovascular death
Time frame: 10 year follow-up
Incidence of cerebral hemorrhage
Cerebral bleeding
Time frame: 10 year follow-up
Rate of new-onset atrial fibrillation
All new onset atrial fibrillation episodes
Time frame: 10 year follow-up
Rate of bleeding
Major/life-threatening bleeding
Time frame: 10 year follow-up
Health-related quality of life
Evaluated by the EQ-5D-5L questionnaire
Time frame: 10 year follow-up
Neurocognitive assessment
Evaluated by the MoCA questionnaire
Time frame: 10 year follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.