Effect of Medical Treatment in Stroke Patients With Patent Foramen Ovale

Abstract

for the PFO in Cryptogenic Stroke Study (PICSS) Investigators* Background-Patent foramen ovale (PFO) is associated with stroke, but there are no randomized studies to evaluate the efficacy of antithrombotic therapies. Methods and Results-The PFO in Cryptogenic Stroke Study was a 42-center study that evaluated transesophageal echocardiographic findings in patients randomly assigned to warfarin or aspirin in the Warfarin-Aspirin Recurrent Stroke Study. In this study, 630 stroke patients were enrolled, of whom 312 (49.5%) were randomized to warfarin and 318 (50.5%) to aspirin. Of these, 265 patients experienced cryptogenic stroke and 365 experienced known stroke subtypes. End points were recurrent ischemic stroke or death. PFO was present in 203 patients (33.8%). There was no significant difference in the time to primary end points between those with and those without PFO in the overall population (Pϭ0.84; hazard ratio 0.96; 95% CI 0.62 to 1.48; 2-year event rates 14.8% versus 15.4%) or in the cryptogenic subset (Pϭ0.65; hazard ratio 1.17; 95% CI 0.60 to 2.37; 2-year event rates 14.3% versus 12.7%). There was no significant difference among those with no, small, or large PFO (Pϭ0.41 for small PFO and Pϭ0.16 for large PFO; 2-year event rates for no, small, and large PFO, 15.4%, 18.5%, and 9.5%, respectively). There was no significant difference between patients with isolated PFO and those with PFO in association with atrial septal aneurysm (Pϭ0.84; 2-year event rates 14.5% versus 15.9%). In patients with PFO, there was no significant difference in the time to primary end points between those treated with warfarin and those treated with aspirin (Pϭ0.49; hazard ratio 1.29; 95% CI 0.63 to 2.64; 2-year event rates 16.5% versus 13.2%). Conclusions-On

Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta‐Analysis, and New Insights From the CLOSE Study

“…We identified 9 articles reporting the results of 8 different RCTs meeting the inclusion criteria 7, 8, 9, 10, 11, 12, 30, 31. Four studies (CLOSURE I,7 PC trial,8 RESPECT,10 and DEFENSE‐PFO13) compared PFO closure with antithrombotic therapy (oral anticoagulation or antiplatelet therapy at the discretion of the investigator).…”

“…The CLOSE study also allowed the post hoc comparison of PFO closure versus anticoagulation. Three studies (PICSS (Patent foramen ovale in cryptogenic stroke study),30 Shariat et al,31 and CLOSE12) compared oral anticoagulation with antiplatelet therapy.…”

“…The PICSS study evaluated transesophageal echocardiographic findings in patients randomly assigned to warfarin or aspirin in the Warfarin‐Aspirin Recurrent Stroke Study 30. Of the 630 patients with stroke enrolled, 98 patients had a cryptogenic stroke associated with a PFO.…”

Efficiency of transcatheter patent foramen ovale closure in children after paradoxical embolism events

“…In patients with cryptogenic stroke, PFO (also coexisting with atrial septal aneurysm) is significantly more common compared to the general population [7]. However, the recurrence of cerebrovascular events in this group of stroke patients, assessed in prospective studies, was comparable to the population of stroke patients with known cause [8].…”

Cryptogenic stroke

“…В исследовании Открытого Овального Окна у боль-ных с криптогенным инсультом (часть исследования WARSS) [31], 260 (45%) из 576 пациентов с криптогенным инсультом согласились на проведение чреспищеводной эхокардиографии (ЭхоКГ) в рамках протокола. В этой под-группе частота первичных исходов (повторный ИИ или смерть в течение 2 лет) была почти в 2 раза меньше при приеме варфарина (9% в группе варфарина против 17% в группе аспирина).…”