"PFO Closure vs. Medical Therapy in Stroke Prevention". The New England Journal of Medicine. 2013.
Links to original sources: Wiki Journal Post Full Journal Article
Does patent foramen ovale (PFO) closure reduce the risk of recurrent ischemic stroke compared to medical therapy alone in patients 18 to 60 years of age with a history of cryptogenic stroke?
In patients who had a cryptogenic ischemic stroke and a PFO, closure with the Amplatzer PFO Occluder device did not show a significant benefit over medical therapy alone in the primary intention-to-treat analysis. However, PFO closure was found to be superior to medical therapy alone in the prespecified per-protocol and as-treated analyses, with a low rate of associated risks.
The RESPECT trial was an exploratory study to determine if PFO closure is more effective than medical therapy alone in preventing recurrent ischemic stroke in young and middle-aged adults following a cryptogenic stroke. While primary intention-to-treat analysis did not show significant differences, secondary analyses indicated potential benefits of PFO closure with the Amplatzer PFO Occluder.
Current guidelines do not provide specific recommendations for PFO closure in patients with a cryptogenic stroke due to the mixed evidence from trials.
Prospective, multicenter, randomized, event-driven trial comparing PFO closure to medical therapy alone. N=980 patients enrolled at 69 sites. Patients were 18 to 60 years of age with a history of cryptogenic ischemic stroke. Randomization to PFO closure with the Amplatzer PFO Occluder or medical therapy only.
Inclusion Criteria: - 18 to 60 years of age - Cryptogenic ischemic stroke - PFO identified via transesophageal echocardiography
Exclusion Criteria: - Identifiable causes of stroke apart from paradoxical embolism - Significant shunt or atrial septal defect - Hypercoagulable states
Baseline Characteristics: - Mean age: 45.9 years - 51.4% female - Median follow-up: 2.1 years
- PFO closure within 21 days after randomization - Medical therapy allowed: aspirin, warfarin, clopidogrel, or combined aspirin with extended-release dipyridamole
Primary Outcomes: - Recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death after randomization
- Complete closure of PFO on the 6-month follow-up transesophageal echocardiogram - Absence of recurrent symptomatic nonfatal ischemic stroke or cardiovascular death - Absence of a transient ischemic attack
- Higher dropout rate in the medical-therapy group leading to unequal duration of exposure to the risk of recurrence - The primary analysis not showing superiority of PFO closure - Long-term protective benefit of closure remains uncertain due to modest absolute event reduction
The study was funded by St. Jude Medical.
RESPECT ClinicalTrials.gov number, NCT00465270.