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.

Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials

2018 ◽  
Vol 107 (9) ◽  
pp. 745-755 ◽  
Author(s):  
Volker Schulze ◽  
Yingfeng Lin ◽  
Athanasios Karathanos ◽  
Maximilian Brockmeyer ◽  
Tobias Zeus ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled

Abstract 2922: Patent Foramen Ovale Is A Cause Of Ischemic Stroke In Patients With Antiphospholipid Syndrome

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Yoshiaki Shimada
Keyword(s):  
Ischemic Stroke ◽  
Antiphospholipid Syndrome ◽  
Patent Foramen Ovale ◽  
Multiple Logistic Regression Analysis ◽  
Cryptogenic Stroke ◽  
Control Group ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Significant Difference

Background: The antiphospholipid syndrome (APS) is a systemic autoimmune disorder characterized by a combination of arterial and/or venous thrombosis and recurrent fetal loss, and can be an independent risk factor for a first-ever ischemic stroke especially in young female patients. Patent foramen ovale (PFO) has been established as a cause of cryptogenic stroke. Atrial septal aneurysm (ASA) is associated with PFO. Until recently, the precise pathophysiology of APS as causing ischemic stroke has been essentially unknown. In the present study, we investigated the relationship between APS and potential embolic sources including PFO and ASA using transesophageal echocardiography (TEE). Methods: This study was a retrospective case series design. From July 2006 to June 2008, 120 patients with ischemic stroke who admitted to Juntendo University Hospital underwent TEE. In this study period, consecutive ischemic stoke patients diagnosed as APS based on the modified Sapporo criteria were enrolled and classified into APS group. Controls were selected among age- and gender-matched stroke patients without APS who also underwent TEE. We assessed clinical characteristics and presence of embolic sources including PFO and atrial septal aneurysm (ASA) between APS and Control groups. Results: Nine of ischemic stroke patients with APS and 41 controls were included. Primary APS was present in one patient (11.1%) of the APS group, and APS with SLE were found in eight patients (88.9%). There is no significant difference in age, risk factors for ischemic stroke, and MRI findings between two groups. The prevalence of PFO and ASA were significantly higher in APS group compared to Control group (89% vs 41%, P=0.027; 67% vs 20%, P=0.015, respectively). C reactive protein was relatively higher in APS group. Multiple logistic regression analysis showed that PFO (OR: 13.71; 95% CI: 1.01 to 185.62; P=0.049) and ASA (OR: 8.06; 95% CI: 1.17 to 55.59; P=0.034) were independently associated with the APS group. Conclusion: Atrial septal abnormalities including PFO and ASA are strongly associated with APS group, and could be potential embolic sources in ischemic stroke patients with APS.

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.

scholarly journals Antithrombotic Treatment of Embolic Stroke of Undetermined Source

Stroke ◽  
2020 ◽  
Vol 51 (6) ◽  
pp. 1758-1765 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Ralph L. Sacco ◽  
J. Donald Easton ◽  
Christopher B. Granger ◽  
Michal Bar ◽  
...  
Keyword(s):  
Renal Function ◽  
Major Bleeding ◽  
Recurrent Stroke ◽  
Dabigatran Etexilate ◽  
Hazard Ratio ◽  
Embolic Stroke ◽  
Thrombin Inhibitor ◽  
Antithrombotic Treatment ◽  
Double Blind ◽  
The Impact

Background and Purpose— The RE-SPECT ESUS trial (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) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods— RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results— The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39–0.82]; interaction P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43–0.94]; interaction P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions— In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration— URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02239120.

scholarly journals Efficacy and safety of percutaneous patent foramen ovale closure devices for recurrent stroke: A systemic review and network metaanalysis

2019 ◽  
Vol 5 (3) ◽  
pp. 178-188
Author(s):  
Hao Nie ◽  
Yang Hu ◽  
Zhouping Tang
Keyword(s):  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Vascular Complication ◽  
Systemic Review ◽  
Occurrence Rate ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Foramen Ovale ◽  
Increased Risk

Background: Randomized controlled trials (RCTs) that directly compare the efficacy and safety of percutaneous patent foramen ovale (PFO) closure devices have not been conducted. Thus, we performed a network meta-analysis to identify the efficacy and safety of occluder devices. Methods: From 1st January, 2000 to 1st May, 2018, we searched Embase, PubMed, and Cochrane Library for RCTs about percutaneous closure devices (such as STARFlex, GORE, and Amplatzer) and medical therapy for cryptogenic cerebral ischemic patients with PFO. The occurrence rate of recurrent stroke, atrial fibrillation (AF), major vascular complication (MVC), headache, transient ischemic attack, and bleeding were compared with the frequentist and Bayesian methods using R statistics. Results: We included 3747 patients from six RCTs. The GORE and Amplatzer occluders were found to be significantly associated with a decreased risk of recurrent stroke [relative risk (RR): 0.37 and 0.49; 95% confidence interval (CI): 0.17–0.81, 0.29–0.83, respectively]. Moreover, STARFlex was correlated to an increased risk of postoperative AF and MVCs (RR: 11.66 and 7.63; 95% CI: 4.87–21.91, 2.34–24.88). Conclusions: Among the three devices, the GORE and Amplatzer occluders are found to be the most effective in preventing secondary stroke in patients with PFO. Meanwhile, STARFlex is the least recommended device because it cannot decrease the risk of recurrent stroke and is the most likely to cause adverse events.

scholarly journals Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source

Stroke ◽  
2021 ◽  
Vol 52 (3) ◽  
pp. 1069-1073
Author(s):  
Shinichiro Uchiyama ◽  
Kazunori Toyoda ◽  
Byung-Chul Lee ◽  
Chia-Wei Liou ◽  
Lawrence Ka Sing Wong ◽  
...  
Keyword(s):  
East Asia ◽  
Major Bleeding ◽  
Recurrent Stroke ◽  
East Asian ◽  
Hazard Ratio ◽  
Embolic Stroke ◽  
Thrombin Inhibitor ◽  
Asian Patients ◽  
Significant Difference ◽  
East Asian Patients

Background and Purpose: We assessed the outcomes of dabigatran versus aspirin in a prespecified subgroup analysis of East Asian patients with embolic stroke of undetermined source in the RE-SPECT ESUS trial (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). Methods: Patients with a recent embolic stroke of undetermined source were randomized to dabigatran (150 or 110 mg BID) or aspirin (100 mg QD). The primary efficacy outcome was recurrent stroke; the primary safety outcome was major bleeding. The East Asia cohort was compared with patients from all other countries (non-East Asia cohort). Results: Overall, 988 of 5390 patients (18%) were randomized in East Asia. During a median follow-up of 18.8 months, there was no statistically significant difference in recurrent stroke (hazard ratio, 0.65 [95% CI, 0.41–1.03]) or major bleeding (hazard ratio, 1.04 [95% CI, 0.57–1.91]) in East Asian patients receiving dabigatran versus aspirin. Death from any cause occurred more often in the dabigatran versus the aspirin group (hazard ratio, 3.98 [95% CI, 1.32–12.01]). Conclusions: The treatment effect of dabigatran versus aspirin was consistent between cohorts, with no apparent superiority for dabigatran over aspirin in preventing recurrent stroke in patients with embolic stroke of undetermined source. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239120.

Sign in / Sign up

Export Citation Format

Share Document