Abstract WP76: Baseline Characteristics of the 3,096 Patients Recruited Into the ‘Triple Antiplatelets for Reducing Dependency After Ischaemic Stroke’ (TARDIS) Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Philip M Bath ◽  
Jason P Appleton ◽  
Maia Beridze ◽  
Hanne Christensen ◽  
Robert A Dineen ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Antiplatelet Agents ◽  
Stroke Recurrence ◽  
Stroke Severity ◽  
Open Label ◽  
Vascular Events ◽  
Serious Adverse Events ◽  
Risk Of Recurrence ◽  
Triple Antiplatelet Therapy

Background: The risk of recurrence following ischaemic stroke (IS) or transient ischaemic attack (TIA) is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus. Design: The Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial was an international multicentre prospective randomised open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute IS or TIA. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life) and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD). Results: Recruitment ran from April 2009 to March 2016. 3,096 patients were recruited from 106 sites in 4 countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomisation characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomisation 29.4 (11.9) hours; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), TIA 953 (30.8%). Conclusion: TARDIS was a large international trial of intensive/triple antiplatelet therapy in acute IS and TIA, and included participants representative of patients in many western stroke services. Funders: National Institute of Health Research Health Technology Assessment Programme and British Heart Foundation. Trial registration: ISRCTN47823388

scholarly journals Baseline characteristics of the 3096 patients recruited into the ‘Triple Antiplatelets for Reducing Dependency after Ischemic Stroke’ trial

2016 ◽  
Vol 12 (5) ◽  
pp. 524-538 ◽  
Author(s):  
Philip MW Bath ◽  
Jason P Appleton ◽  
Maia Beridze ◽  
Hanne Christensen ◽  
Robert A Dineen ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Antiplatelet Therapy ◽  
Transient Ischemic Attack ◽  
Stroke Severity ◽  
Vascular Events ◽  
Risk Of Recurrence ◽  
Triple Antiplatelet Therapy ◽  
Ischemic Attack ◽  
Stroke Trial

Background The risk of recurrence following ischemic stroke or transient ischemic attack is highest immediately after the event. Antiplatelet agents are effective in reducing the risk of recurrence and two agents are superior to one in the early phase after ictus. Design The triple antiplatelets for reducing dependency after ischemic stroke trial was an international multicenter prospective randomized open-label blinded-endpoint trial that assessed the safety and efficacy of short-term intensive antiplatelet therapy with three agents (combined aspirin, clopidogrel and dipyridamole) as compared with guideline treatment in acute ischemic stroke or transient ischemic attack. The primary outcome was stroke recurrence and its severity, measured using the modified Rankin Scale at 90 days. Secondary outcomes included recurrent vascular events, functional measures (cognition, disability, mood, quality of life), and safety (bleeding, death, serious adverse events). Data are number (%) or mean (standard deviation, SD). Results Recruitment ran from April 2009 to March 2016; 3096 patients were recruited from 106 sites in four countries (Denmark 1.6%, Georgia 2.7%, New Zealand 0.2%, UK 95.4%). Randomization characteristics included: age 69.0 (10.1) years; male 1945 (62.8%); time onset to randomization 29.4 (11.9) h; stroke severity (National Institutes for Health Stroke Scale) 2.8 (3.6); blood pressure 143.5 (18.2)/79.5 (11.4) mmHg; IS 2143 (69.2%), transient ischemic attack 953 (30.8%). Conclusion Triple antiplatelets for reducing dependency after ischemic stroke was a large trial of intensive/triple antiplatelet therapy in acute ischemic stroke and transient ischemic attack, and included participants from four predominantly Caucasian countries who were representative of patients in many western stroke services.

Effects of aspirin, clopidogrel and dipyridamole administered singly and in combination on platelet and leucocyte function in normal volunteers and patients with prior ischaemic stroke

2005 ◽  
Vol 93 (03) ◽  
pp. 527-534 ◽  
Author(s):  
Lian Zhao ◽  
Sally Fletcher ◽  
Chris Weaver ◽  
Jo Leonardi-Bee ◽  
Jane May ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Ex Vivo ◽  
Platelet Activating Factor ◽  
Adenosine Diphosphate ◽  
Monocyte Activation ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Triple Antiplatelet Therapy ◽  
Additional Clinical Benefit

SummaryThe aim of this study was to assess whether triple antiplatelet therapy is superior to dual and mono therapy in attenuating platelet and leucocyte function. Aspirin (A), clopidogrel (C), and dipyridamole (D) were administered singly and in various combinations (A, C, D, AC, AD, CD, ACD), each for two weeks (without washout) to 11 healthy subjects and to 11 patients with previous ischaemic stroke in two randomised multiway crossover trials. At the end of each two-week period platelet aggregation, platelet-leucocyte conjugate formation and leucocyte activation were measured ex vivo blinded to treatment. Platelets were stimulated with collagen; additional measurements were made with adenosine diphosphate (ADP), platelet activating factor (PAF), adrenaline and the combination of, ADP, PAF and adrenaline. Results show that in the presence of collagen, ACD was superior to all antagonists or combinations, except AC, in reducing aggregation, platelet-leucocyte conjugate formation, and monocyte activation (all p< 0.05). ACD was also more potent than other treatments, except AC, in inhibiting the aggregation and platelet-monocyte conjugate formation induced by the combination of ADP, PAF and adrenaline. The effects were similar in both volunteers and stroke patients. No serious adverse events or major bleeding events occurred. Triple antiplatelet therapy did not appear to be more effective than combined aspirin and clopidogrel in moderating platelet and leucocyte function. Any additional clinical benefit provided by dipyridamole may be through other mechanisms of action.

Effects of Early Hypertension Control after Ischaemic Stroke on the Outcome: A Meta-Analysis

2015 ◽  
Vol 40 (5-6) ◽  
pp. 270-278 ◽  
Author(s):  
Shuping Liu ◽  
Chengyan Li ◽  
Tao Li ◽  
Jing Xiong ◽  
Xueqing Zhao
Keyword(s):  
Ischaemic Stroke ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Good Choice ◽  
Stroke Recurrence ◽  
Hypertension Control ◽  
Vascular Events ◽  
Haemorrhagic Transformation ◽  
Review Manager

Background: Accumulating evidence suggests that high blood pressure (BP) increases the risk of cerebral oedema and haemorrhagic transformation of the ischaemic stroke (IS), and that low BP in acute ischaemic stroke (AIS) is associated with a poor prognosis. The best possible management of hypertension after AIS is still uncertain. Materials and Methods: English databases were searched to identify relevant randomized controlled trials assessing the effects of early BP lowering (started within the first 48 h) after IS on outcome from January 1990 to August 2015. We set strict inclusion criteria and used the Review Manager 5.2 software from Cochrane Collaboration to calculate the combined risk ratio (RR). Result: Eight studies met our criteria. Early BP lowering after AIS did not significantly affect the risk of early and long-term death (RR 1.22; 95% CI 0.69-2.16 and RR 1.03; 95% CI 0.62-1.71), early and long-term dependency (RR 1.02; 95% CI 0.94-1.10 and RR 1.07; 95% CI 0.84-1.36), early and long-term death or dependency (RR 1.04; 95% CI 0.94-1.19 and RR 1.00; 95% CI 0.95-1.05), long-term stroke recurrence (RR 0.74; 95% CI 0.49-1.11), long-term myocardial infarction (RR 0.99; 95% CI 0.27-3.61), and long-term vascular events (RR 0.97; 95% CI 0.72-1.31). Conclusion: Our results revealed neither support nor opposition to early BP lowering (started within 48 h) after AIS; individualized BP management based on the patients' condition may be a good choice.

Abstract TP411: Effects of Triflusal and Clopidogrel in Secondary Prevention of Stroke Based on Cytochrome P450 2C19 Genotyping

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kyung-Yul Lee ◽  
Sang Won Han ◽  
Yong-Jae Kim ◽  
Seong Hwan Ahn ◽  
Woo-Keun Seo ◽  
...  
Keyword(s):  
Cytochrome P450 ◽  
Secondary Prevention ◽  
Recurrent Stroke ◽  
Tertiary Care ◽  
Antiplatelet Agents ◽  
Stroke Recurrence ◽  
Cyp2c19 Genotype ◽  
Open Label ◽  
Genotype Group ◽  
Cytochrome P450 2C19

Background: The relationship between stroke recurrence and cytochrome P450 2C19 (CYP2C19) genotype for the secondary prevention of ischemic stroke (IS) is not clearly defined. We investigated the effect of antiplatelet agents based on CYP2C19 genotype in secondary prevention of IS. Methods: In this prospective, multicenter, randomized, parallel-group, open-label, and blind genotype trial, we enrolled first non-cardiogenic IS patients within 30 days prior to screening at the 18 tertiary-care hospitals. Participants received 300 mg triflusal twice a day or 75 mg clopidogrel once daily. CYP2C19 genotyping was done in all patients and genotype results were blind during the study. The primary outcome was the time from randomization to first recurrent IS or hemorrhagic stroke. Efficacy analyses were performed using both the modified intention-to- treat population and the per-protocol population. The study is registered with ClinicalTrials.gov (NCT01174693). Results: This trial failed to meet its recruitment goal due to slow enrollment. A total of 784 (73% of required sample size) patients were followed for a mean of 2.5 years. In poor CYP2C19 genotype group (n=484), 30 (6.2%) patients had a recurrent stroke. The risk of recurrent stroke in triflusal group was 2.9% per year and was not significantly different with clopidogrel group (2.2% per year; hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.6 to 2.53). In clopidogrel treatment group (n=393), 20 (5.1%) had a recurrent stroke. The risk of recurrent stroke in good CYP2C19 genotype was 1.6% per year and was not significantly different with poor genotype (2.2% per year; HR, 0.69; 95% CI, 0.26 to 1.79). Conclusions: In poor CYP2C19 genotype group, either triflusal or clopidogrel was not superior to the other in the prevention of recurrent stroke.

Maintenance Dosing with Epoetin alfa Every Three Weeks (Q3W) in Anemic Patients with Cancer Receiving Chemotherapy Every Three Weeks: Final Results.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3555-3555 ◽  
Author(s):  
Vernon P. Montoya ◽  
John Xie ◽  
Richard C. Woodman
Keyword(s):  
Adverse Events ◽  
Maintenance Therapy ◽  
Maintenance Phase ◽  
Epoetin Alfa ◽  
Open Label ◽  
Vascular Events ◽  
Serious Adverse Events ◽  
Initiation Phase ◽  
Multi Center Study ◽  
Hematopoietic Response

Abstract Although epoetin alfa is commonly used weekly for the treatment of chemotherapy (CT)-induced anemia, most CT is given at three week intervals. Therefore, to provide increased patient convenience we examined a dosing regimen that would allow patients to receive epoetin alfa 80,000 U Q3W during maintenance therapy. This open-label, multi-center study had two phases: Initiation Phase (IP) of 60,000 U QW to achieve target hemoglobin (Hb) of 12 g/dL (maximum duration 12 weeks), followed by a Maintenance Phase (MP) of 80,000 U Q3W to maintain Hb between 11.0 and 12.5 g/dL. Only those patients achieving Hb ≥ 12 g/dL in the IP entered the MP; once target Hb was achieved, patients proceeded to MP at the beginning of their next full CT cycle. Patients were withdrawn from the MP if Hb decreased to &lt; 11 g/dL. Doses were held for Hb &gt; 13 g/dL and reduced for rate of rise &gt; 1.3 g/dL/2 weeks. Maximum study duration (IP + MP) was 24 weeks. Patients ≥ 18 years of age with non-myeloid malignancy, baseline Hb ≤ 11 g/dL, and CT planned Q3W for ≥ 15 weeks were enrolled. Endpoints included proportion of patients achieving hematopoietic response in the IP (≥ 2 g/dL Hb increase from baseline or Hb ≥ 12 g/dL) and proportion maintaining mean Hb between 11.0 and 12.5 g/dL in the MP. Also analyzed was the proportion of patients maintaining mean Hb between 11.0 and 13.0 g/dL in the MP. A total of 115 patients were enrolled and received at least one dose of epoetin alfa; mean age was 62.2 ± 11.9 years, 66.1% were female, mean baseline Hb was 10.2 ± 0.8 g/dL, and 86.1% had solid tumors. During the IP, 84 of 115 (73.0%) patients achieved hematopoietic response (≥ 2 g/dL Hb increase from baseline or Hb ≥ 12 g/dL). Seventy-three patients (63.5%) who achieved Hb ≥ 12 g/dL entered the MP after a median of 6.0 weeks in IP and spent a mean of 9.8 weeks in MP. Fifty-four of 73 (74.0%) maintained an average Hb between 11.0 and 12.5 g/dL over the course of the MP; 64 (87.7%) maintained an average Hb between 11.0 and 13.0 g/dL over the course of the MP. Twenty-five (34.2%) patients were withdrawn from the MP because Hb decreased to &lt; 11 g/dL. Of 115 patients dosed in IP, 30 (26.1%) had doses reduced and 31 (27.0%) had doses held; of 73 patients dosed in MP, 9 (7.8%) had doses reduced and 16 (13.9%) had doses held. Fifty-one (44.3%) patients experienced serious adverse events. Eleven (9.6%) patients experienced clinically relevant thrombotic vascular events. Two and 4 patients discontinued due to adverse events in the IP and MP, respectively. Eight (7.0%) patients died during the study or within 30 days after last study dose. Although 60,000 U QW was used during the IP to achieve a HR, 40,000 U QW is the recommended initiation dose of epoetin alfa. This study suggests that epoetin alfa 80,000 U administered every three weeks to patients on a Q3W CT regimen is an effective option for maintenance therapy of CT-induced anemia.

scholarly journals Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a parallel, randomised, open-label, multicentre, prospective study

2018 ◽  
Vol 3 (4) ◽  
pp. 263-267 ◽  
Author(s):  
Xiaowen Hou ◽  
Xiaoqiu Li ◽  
Xinhong Wang ◽  
Huisheng Chen
Keyword(s):  
Adverse Events ◽  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Rational Design ◽  
Dual Antiplatelet Therapy ◽  
Prospective Trial ◽  
Minor Stroke ◽  
Efficacy And Safety ◽  
Open Label ◽  
Nihss Score

BackgroundA recent study shows that dual antiplatelet therapy with clopidogrel plus aspirin is superior to aspirin monotherapy for minor stroke, which is defined as a National Institutes of Health Stroke Scale (NIHSS)score of ≤3. However, acute mild-moderate ischaemic stroke (4≤NIHSS≤10) still needs aggressive antiplatelet intervention to prevent deterioration and recurrence of stroke. The efficacy and safety of dual antiplatelet therapy versus aspirin monotherapy in the population are not clear. A multicentre clinical trial is designed to evaluate the efficacy and safety of clopidogrel plus aspirin therapy versus aspirin monotherapy within 48 hours of symptom onset of mild-moderate ischaemic stroke.Methods/DesignThe study is a randomised, open-label, multicentre, prospective trial with a target enrolment of 2700 patients from 60 centres in Northeast China. A treatment allocation identification number to each enrolled patient will be provided by a random number generator. The follow-up time for the clopidogrel plus aspirin and aspirin monotherapy groups is 90 days. The primary efficacy endpoint is a stroke progression event, which is defined as ≥4 point increase in the NIHSS score in 48 hours. The second efficacy endpoints include new ischaemic stroke within 90 days, change in the NIHSS score within 14 days, modified Rankin Scale score on day 90 and other vascular or death events within 90 days. The safety endpoints include mucocutaneous haemorrhage, organ haemorrhage and intracranial haemorrhage, adverse events and severe adverse events. χ2 test, t-test (or Mann-Whitney test), survival analysis and Cox proportional hazards models will be conducted. The findings of the study may provide an important evidence for clinical practice for these patients.DiscussionThe trial will be conducted under a rational design and will provide valuable evidence on the appropriate treatment for this population.Ethics and disseminationThe study was reviewed and approved by the Ethics Committee of the General Hospital of Shen-Yang Military Region (no K(2016) 6).Trial registration numberNCT02869009; Pre-results.

scholarly journals Oral Anticoagulation Timing in Patients with Acute Ischaemic Stroke and Atrial Fibrillation

2021 ◽  
Author(s):  
Po-Yin Chang ◽  
weiting wang ◽  
Wei-Lun Wu ◽  
Hui-Chin Chang ◽  
Chen-Huan Chen ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Ischaemic Stroke ◽  
Acute Ischaemic Stroke ◽  
Oral Anticoagulants ◽  
Indirect Comparison ◽  
Stroke Recurrence ◽  
Vascular Events ◽  
Safety Outcome ◽  
Immortal Time Bias ◽  
Increased Risk

Background and Purpose: Oral anticoagulants (OACs) prevent stroke recurrence and vascular embolism in patients with acute ischaemic stroke (AIS) and atrial fibrillation (AF). Current guidance recommends a “1-3-6-12 day”’ rule to resume OACs after AIS, based mainly on empirical consensus. This study investigated the suitability of guideline-recommended timing for OAC initiation. Methods: To overcome immortal time bias, we emulated a sequence of randomized placebo-controlled trials and constructed 90 propensity score-matched cohorts of 12,307 patients with AF and AIS from 2012 to 2016. We compared the risk of composite effectiveness and safety outcome in the early vs no OAC use group and in the delayed vs no OAC use. Indirect comparison between early and delayed use was conducted using a network meta-analysis. Results: Across the groups of AIS severity, the risks of composite outcome or effectiveness outcome were lower in the OAC use group than the no use group and the risks were similar between the early and delayed use groups. In patients with severe AIS, those receiving early OACs use had an increased risk of safety outcome, with HR of 2.10 (CI: 1.13-3.92) compared with those without OAC use, and HR of 1·44 (CI: 0·99-2·09) compared with those receiving delayed use. Conclusions: In AF patients with severe AIS, early OAC use before the guideline-recommended days appeared to increase the risk of bleeding events, although the OAC initiation time seemed not to affect the risk of serious vascular events. The optimal severity-specific timing for OAC initiation after AIS requires further evaluation

scholarly journals Dual versus mono antiplatelet therapy for acute non-cardioembolic ischaemic stroke or transient ischaemic attack: a systematic review and meta-analysis

2018 ◽  
Vol 3 (2) ◽  
pp. 107-116 ◽  
Author(s):  
Yingying Yang ◽  
Mengyuan Zhou ◽  
Xi Zhong ◽  
Yongjun Wang ◽  
Xingquan Zhao ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Randomised Controlled Trials ◽  
Dual Antiplatelet Therapy ◽  
Meta Analysis ◽  
Stroke Recurrence ◽  
Controlled Trials ◽  
Vascular Events ◽  
Ischaemic Attack ◽  
Randomised Controlled

ObjectiveRecent years have seen new evidence on the efficacy and safety of dual antiplatelet therapy for secondary stroke prevention. We updated a meta-analysis of randomised controlled trials evaluating dual antiplatelet versus monotherapy for patients with acute non-cardioembolic ischaemic stroke (IS) or transient ischaemic attack (TIA).MethodsWe searched PubMed and identified randomised controlled trials evaluating dual antiplatelet versus monotherapy for acute non-cardioembolic IS or TIA within 3 days of ictus up to May 2018. Risk ratio (RR) with 95% CI were calculated using random effects models. Clinical endpoints included stroke recurrence, composite vascular events and major bleeding.Results18 randomised controlled trials including 15 515 patients were pooled in the meta-analysis. When compared with monotherapy among patients with acute IS or TIA, dual antiplatelet therapy reduced the risk of stroke recurrence (RR 0.69; 95% CI 0.61 to 0.78; p<0.001) and composite vascular events (RR 0.72; 95% CI 0.64 to 0.80; p<0.001). Dual therapy was associated with a significant increase in the risk of major bleeding (RR 1.77; 95% CI 1.09 to 2.87; p=0.02) when all trial data were combined. However, when all previous trials before the completion of the POINT trial were analysed, dual antiplatelet versus monotherapy was not associated with a significant increase in the risk of major bleeding (RR 1.46; 95% CI 0.77 to 2.75; p=0.25).ConclusionsAmong patients with acute non-cardioembolic IS or TIA within 3 days of ictus, dual antiplatelet therapy was associated with a reduction in stroke recurrence, and composite vascular events, when compared with monotherapy. However, a significant increase in the risk of major bleeding was observed.

scholarly journals Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e023761 ◽  
Author(s):  
Hassan Mir ◽  
Reed Alexander C Siemieniuk ◽  
Long Cruz Ge ◽  
Farid Foroutan ◽  
Michael Fralick ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Persistent Atrial Fibrillation ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
External Evidence ◽  
Pfo Closure

ObjectiveTo examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone.DesignSystematic review and network meta-analysis (NMA) supported by complementary external evidence.Data sourcesMedline, EMBASE and Cochrane CENTRAL.Study selectionRandomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke.Review methodsWe conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.ResultsTen RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): −87, 95% credible interval (CrI) −100 to −33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD −20, 95% CrI −27 to −2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD −71, 95% CrI −100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI −5 to +65, moderate certainty).ConclusionsIn patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding.PROSPERO registration numberCRD42017081567.

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