Patent foramen ovale closure with GORE HELEX or CARDIOFORM Septal Occluder vs. antiplatelet therapy for reduction of recurrent stroke or new brain infarct in patients with prior cryptogenic stroke: Design of the randomized Gore REDUCE Clinical Study

2017 ◽  
Vol 12 (9) ◽  
pp. 998-1004 ◽  
Author(s):  
Scott E Kasner ◽  
Lars Thomassen ◽  
Lars Søndergaard ◽  
John F Rhodes ◽  
Coby C Larsen ◽  
...  
Keyword(s):  
Clinical Study ◽  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Brain Infarct

Abstract TMP13: Baseline DWMRI Characteristics In Patients With Cryptogenic Stroke And Patent Foramen Ovale: Results From The Closure I Trial

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Richard Jung ◽  
Benny Kim ◽  
Joseph Massaro ◽  
Anthony J Furlan
Keyword(s):  
Patent Foramen Ovale ◽  
Cox Regression ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Patient Characteristics ◽  
Paradoxical Embolism ◽  
Foramen Ovale ◽  
Anterior Circulation ◽  
Significant Difference ◽  
Multivariate Proportional Hazard

Background: Cryptogenic stroke may have several etiologies including paradoxical embolism through a patent foramen ovale (PFO). A cardiac source of embolism may be suggested by multiple infarcts, sometimes hemorrhagic, in different vascular distributions or a cortical wedge shaped infarct. We report the baseline diffusion weighted MRI (DWMRI) characteristics in patients with cryptogenic stroke and a patent foramen ovale (PFO) from the CLOSURE I trial. Methods: CLOSURE I compared device closure versus medical therapy for secondary prevention in patients with cryptogenic TIA or stroke and a PFO. Of 909 patients randomized, 562 patients demonstrated acute infarcts on baseline DWMRI and are included in this analysis. Multivariate proportional hazard Cox regression compared imaging subgroups with remaining randomized patients Results: Single infarcts were found in 62% of patients. Of these, 61% were anterior circulation, 30% posterior, and 8.5% were of uncertain territory. Of the anterior circulation infarcts, 40% were cortical, 36% subcortical, and 24% affected both the cortical and subcortical regions. Of the posterior circulation infarcts, 45% were thalamic or cerebellar. Of 562 patients, 18.5% had a single subcortical lesion <1.5cm in diameter and met the radiological definition of an acute lacunar infarct. Multiple infarcts were found in 38%. Infarcts in a single vascular territory were found in 23%, often in the anterior circulation (66%). Infarcts in multiple vascular territories were found in 15%. Hemorrhagic infarction was present in 9%. Adjusting for patient characteristics, no significant difference in 2 year rate of TIA, stroke or death was found compared to remaining randomized patients. Discussion: The specificity of infarct patterns for embolism in patients with cryptogenic stroke and a PFO is uncertain. We found no significant relationship between lacunar or subcortical infarction and the risk of recurrent TIA or stroke. Baseline infarct patterns on DWMRI in patients with cryptogenic stroke and PFO may not be useful in predicting recurrent stroke risk or determining best prevention therapy.

Closure of patent foramen ovale in “cryptogenic” stroke: Has the story come to an end?

2018 ◽  
Vol 13 (3) ◽  
pp. 240-242 ◽  
Author(s):  
Jean-Louis Mas ◽  
Gilles Chatellier
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
Permanent Disability ◽  
Increased Risk ◽  
Procedural Complications

Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.

PP122 A Quick Cost-Effectiveness Analysis Of Patent Foramen Ovale Closure In Korean Patients With Cryptogenic Stroke

2018 ◽  
Vol 34 (S1) ◽  
pp. 112-113
Author(s):  
Jeonghoon Ahn ◽  
Eung Ju Kim ◽  
Kyungmi Oh ◽  
Justin Seung-Ho Yoo ◽  
Maria Koullick
Keyword(s):  
Cost Effectiveness ◽  
Prospective Study ◽  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Effectiveness Analysis ◽  
The Cost ◽  
Pfo Closure

Introduction:Patent foramen ovale (PFO) is an open hole between the right and left upper chambers of the heart. It may increase the risk of stroke, so closure of the hole is considered a secondary prevention in patients who have experienced cryptogenic stroke. Recent evidence has been published on the effectiveness of PFO closure, including a publicly funded prospective study on the effectiveness of PFO closure for preventing recurrent stroke or transient ischemic attack in selected Korean patients who have experienced cryptogenic stroke. The objective of this study was to examine the cost-effectiveness of PFO closure using this recent evidence.Methods:Available clinical data from the aforementioned Korean prospective study and other recent multicenter trials funded by public bodies were used. The cost data were obtained from the current Korean National Health Insurance fee schedule. Utility data were extracted from local research on stroke patients. A cost-effectiveness analysis, based on a 20-year Markov model, was conducted using these data to compare PFO closure plus antiplatelet therapy with oral anticoagulants alone.Results:The initial analysis showed that PFO plus antiplatelet therapy costs KRW 7.13 million (USD 6,547) more than oral anticoagulants alone but has a higher utility of 1.3 quality-adjusted life-years (QALYs) per patient, which corresponds to an incremental cost-effectiveness ratio (ICER) of KRW 5.6 million (USD 5,142) per QALY. The implicit Korean ICER threshold is KRW 25 million (USD 22,955) for non-cancer drugs, so it seems that PFO plus antiplatelet therapy is cost effective in the Korean setting.Conclusions:Since this study used some transition probabilities from foreign sources, the results may not be completely transferable to the Korean setting. However, this is the best available evidence so far in Korea for the economic evaluation of the PFO closure procedure. Therefore, use of PFO closure in carefully selected patients with a history of cryptogenic stroke may benefit the public payer in Korea.

scholarly journals Anticoagulant vs. antiplatelet therapy in patients with cryptogenic stroke and patent foramen ovale: an individual participant data meta-analysis

2015 ◽  
Vol 36 (35) ◽  
pp. 2381-2389 ◽  
Author(s):  
David M. Kent ◽  
Issa J. Dahabreh ◽  
Robin Ruthazer ◽  
Anthony J. Furlan ◽  
Christian Weimar ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Individual Participant Data ◽  
Foramen Ovale ◽  
Individual Participant

Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale

Stroke ◽  
2021 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Aurauma Chutinet ◽  
J. Donald Easton ◽  
Christopher B. Granger ◽  
Eva Kleine ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Dabigatran Etexilate ◽  
Embolic Stroke ◽  
Thrombin Inhibitor ◽  
Foramen Ovale ◽  
Significant Difference

Background and Purpose: Patent foramen ovale (PFO) may increase the risk of embolic stroke of undetermined source (ESUS). Guidelines suggest anticoagulation may be more effective than antiplatelets in preventing stroke in patients with ESUS and PFO when interventional closure is not performed. Methods: Patients with ESUS randomized to dabigatran (150/110 mg BID) or aspirin (100 mg QD) from the RE-SPECT ESUS study (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) were included. The rate of recurrent stroke (primary end point) and ischemic stroke was reported for patients with and without baseline PFO. A meta-analysis comparing the effects of anticoagulant and antiplatelet therapy on ischemic stroke in patients with PFO was updated to include RE-SPECT ESUS. Results: PFO was present in 680 of 5388 (12.6%) patients with documented PFO status. The risk of recurrent stroke with dabigatran versus aspirin was similar in patients with and without PFO ( P for interaction, 0.8290). In patients with PFO, the meta-analysis found no statistically significant difference between anticoagulant and antiplatelet therapy (odds ratio, 0.70 [95% CI, 0.43–1.14]) for ischemic stroke. Conclusions: There is insufficient evidence to recommend anticoagulation over antiplatelet therapy for patients with ESUS and a PFO. More data are needed to guide antithrombotic therapy in this population. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239120.

scholarly journals Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke

2017 ◽  
Vol 377 (11) ◽  
pp. 1033-1042 ◽  
Author(s):  
Lars Søndergaard ◽  
Scott E. Kasner ◽  
John F. Rhodes ◽  
Grethe Andersen ◽  
Helle K. Iversen ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Foramen Ovale

scholarly journals Recurrent Stroke/TIA in Cryptogenic Stroke Patients with Patent Foramen Ovale

2007 ◽  
Vol 34 (1) ◽  
pp. 74-80 ◽  
Author(s):  
Leanne Casaubon ◽  
Peter McLaughlin ◽  
Gary Webb ◽  
Erik Yeo ◽  
Darren Merker ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Recurrent Events ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Antiplatelet Agents ◽  
Secondary Outcome ◽  
Foramen Ovale ◽  
Device Closure ◽  
Surgical Closure ◽  
Significant Difference

Background:Patent foramen ovale (PFO) is present in 40% of patients with cryptogenic stroke and may be associated with paradoxical emboli to the brain. Therapeutic options include antiplatelet agents, anticoagulation, percutaneous device and surgical closure. We assessed the hypothesis that there are differences in rates of recurrent TIA or stroke between patients in the four treatment groups.Methods:Patients presenting from January 1997 with cryptogenic stroke or TIA and PFO were followed prospectively until June 2003. Treatment choice was made on an individual case basis. The primary outcome was recurrent stroke. The secondary outcome was a composite of stroke, TIA, and vascular death.Results:Baseline. Our cohort consisted of 121 patients; 64 (53%) were men. Median age was 43 years. Sixty-nine percent presented with stroke and 31% with TIA. One or more vascular risk factor was present in 40%. Atrial septal aneurysm (ASA) was present in 24%. Treatment consisted of antiplatelet agents (34%), anticoagulation (17%), device (39%) and surgical closure (11%). Follow-up. Recurrent events occurred in 16 patients (9 antiplatelet, 3 anticoagulation, 4 device closure); 7 were strokes, 9 were TIA. Comparing individual treatments there was a trend toward more strokes in the antiplatelet arm (p=0.072); a significant difference was seen for the composite endpoint (p=0.012). Comparing closure versus combined medical therapy groups, a significant difference was seen for primary (p=0.014) and secondary (p=0.008) outcomes, favoring closure. Age and pre-study event predicted outcome.Conclusion:Patent foramen ovale closure was associated with fewer recurrent events. Complications of surgical and device closure were self-limited.

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