Key result
Transcatheter PFO closure reduces major events to 0% vs medication in high-risk cryptogenic stroke.
Why the study?
Favorable reports of patent foramen ovale (PFO) closure in cryptogenic stroke raised the question of whether optimal candidates can be selected based on transesophageal echocardiographic morphologic characteristics.
Does transcatheter PFO closure reduce the composite of stroke, vascular death, or major bleeding in patients with cryptogenic stroke and high-risk PFO compared to medication-only therapy?
RCT (n=120)
Does transcatheter PFO closure reduce the composite of stroke, vascular death, or major bleeding in patients with cryptogenic stroke and high-risk PFO compared to medication-only therapy?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure. With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer; in particular, the results suggest that closure is beneficial for those with high-risk PFO.”
“Percutaneous closure of patent foramen ovale (PFO) using a double-disc device has been demonstrated in 4 clinical trials (CLOSE, REDUCE, extended follow-up of RESPECT, DEFENSE-PFO) to be superior to medical therapy alone in preventing recurrent cryptogenic stroke or transient ischemic attack (TIA).”
Transcatheter PFO closure significantly reduces the risk of recurrent stroke and major vascular events compared to medical therapy alone in patients with cryptogenic stroke and high-risk PFO features.
BACKGROUND: Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates. OBJECTIVES: This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography. METHODS: Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding during 2 years of follow-up. RESULTS: From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction-defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1). CONCLUSIONS: PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).
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Lee et al. (2018) conducted an RCT in Cryptogenic stroke and high-risk patent foramen ovale (n=120). Transcatheter PFO closure vs. Medication-only was evaluated on Composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding (p=0.013). Transcatheter PFO closure in patients with cryptogenic stroke and high-risk PFO reduced the composite of stroke, vascular death, or major bleeding compared to medication alone.
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