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

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.

2020 ◽  
Vol 26 (44) ◽  
pp. 5739-5745
Author(s):  
Jieqiong Guan ◽  
Wenjing Song ◽  
Pan He ◽  
Siyu Fan ◽  
Hong Zhi ◽  
...  

Objective: The aim was to evaluate the efficacy and safety of duration of dual antiplatelet therapy (DAPT) for patients who received percutaneous coronary intervention (PCI) with a drug-eluting stent. Background: The optimal duration of DAPT to balance the risk of ischemia and bleeding in CAD patients undergoing drug-eluting stent (DES) implantation remains controversial. Methods: PubMed, Cochrane Library, Web of Science, Clinicaltrials.gov, CNKI and Wanfang Databases were searched for randomized controlled trials of comparing different durations of DAPT after DES implantation. Primary outcomes were major adverse cardiac and cerebrovascular events (MACCE), and major bleeding, and were pooled by Bayes network meta-analysis. Net adverse clinical and cerebral events were used to estimate the surface under the cumulative ranking (SUCRA) curves. The subgroup analysis based on clinical status, follow-up and area was conducted using traditional pairwise meta-analysis. Results: A total of nineteen trials (n=51,035) were included, involving six duration strategies. The network metaanalysis showed that T2 (<6-month DAPT followed by aspirin, HR:1.51, 95%CI:1.02-2.22), T3 (standard 6-month DAPT, HR:1.47, 95%CI:1.14-1.91), T4 (standard 12-month DAPT, HR:1.41, 95%CI:1.15-1.75) and T5 (18-24 months DAPT, HR:1.47, 95%CI:1.09-1.97) was associated with significantly increased risk of MACCE compared to T6 (>24-month DAPT). However, no significant difference was found in MACCE risk between T1 (<6-month DAPT followed by P2Y12 monotherapy) and T6. Moreover, T5 was associated with significantly increased risk of bleeding compared to T1(RR:3.94, 95%CI:1.66-10.60), T2(RR:3.65, 95%CI:1.32-9.97), T3(RR:1.93, 95%CI:1.21-3.50) and T4(RR:1.89, 95%CI:1.15-3.30). The cumulative probabilities showed that T6(85.0%), T1(78.3%) and T4(44.5%) were the most efficacious treatment compared to the other durations. In the ACS (<50%) subgroup, T1 was observed to significantly reduce the risk of major bleeding compared to T4, but not in the ACS (≥50%) subgroup. Conclusions: Compared with other durations, short DAPT followed by P2Y12 inhibitor monotherapy showed non-inferiority, with a lower risk of bleeding and not associated with an increased MACCE. In addition, the risk of major bleeding increased significantly, starting with DAPT for 18-month. Compared with the short-term treatment, patients with ACS with the standard 12-month treatment have a better prognosis, including lower bleeding rate and the decreased risk of MACCE. Due to study's limitations, the results should be verified in different risk populations.


2014 ◽  
Vol 111 (04) ◽  
pp. 773-776 ◽  
Author(s):  
Monica Gianni ◽  
Nicola Mumoli ◽  
Marco Cei ◽  
Andrea Bertolini ◽  
Luigina Guasti ◽  
...  

Angiology ◽  
2018 ◽  
Vol 70 (4) ◽  
pp. 325-331 ◽  
Author(s):  
Simone Vidale ◽  
Filippo Russo ◽  
Carlo Campana ◽  
Elio Agostoni

Cryptogenic strokes account for about 25% to 40% of total ischemic strokes, and 1 of the 3 of these have a patent foramen ovale (PFO). A meta-analysis concerning the effectiveness and safety of PFO closure in cryptogenic strokes or transient ischemic attacks (TIAs) was performed. We systematically searched Medline, Embase, and the Cochrane Library through April 2018. Eligible studies were randomized clinical trials. Primary and secondary end points were, respectively, stroke or TIA and stroke recurrences. We calculated risk ratios (RRs) and 95% confidence intervals (CIs) for all end points using fixed- and random-effects meta-analyses. Data were included from 6 trials involving 3560 patients. In the pooled analysis, PFO closure was superior to medical treatment for both primary (RR: 0.39; 95% CI: 0.18-0.82; P < .02) and secondary end points (RR: 0.58; 95% CI: 0.44-0.76; P < .001). Transcatheter closure significantly increased the risk of new-onset atrial fibrillation (AF; RR: 5.74; P < .001). Percutaneous closure is superior to medical treatment in reducing stroke and TIA recurrence, even if with a significant risk increasing for new-onset AF. These findings suggest that transcatheter closure is indicated in patients with cryptogenic strokes and large PFO.


Stroke ◽  
2021 ◽  
Vol 52 (5) ◽  
pp. 1653-1661
Author(s):  
Jessie Ze-Jun Chen ◽  
Vincent N. Thijs

Background and Purpose: Multiple studies evaluated whether patent foramen ovale (PFO) closure reduces the risk of ischemic stroke. One commonly reported complication of PFO closure is the development of atrial fibrillation (AF), which is itself a powerful stroke risk factor that requires specific management. This study aims to evaluate the frequency of AF in patients post-percutaneous closure of PFO and the clinical factors that predict AF detection. Methods: Studies were identified by systematically searching EMBASE and MEDLINE databases on July 11, 2019. Meta-analysis of proportions was performed, assuming a random-effects model. Results: A total of 6 randomized controlled trials and 26 observational studies were included, comprising 3737 and 9126 patients, respectively. After PFO closure, the rate of AF development was 3.7 patients per 100 patient-years of follow-up (95% CI, 2.6–4.9). The risk of AF development is concentrated in the first 45 days post-procedure (27.2 patients per 100 patient-years [95% CI, 20.1–34.81], compared with 1.3 patients per 100 patient-years [95% CI, 0.3–2.7]) after 45 days. Meta-regression by age suggested that studies with older patients reported higher rate of AF ( P =0.001). In medically treated patients, the rate of AF development was 0.1 per 100 patient-years of follow-up (95% CI, 0.0–0.4). Closure of PFO is associated with increased risk of AF compared with medical management (odds ratio, 5.3 [95% CI, 2.5–11.41]; P <0.001). Conclusions: AF is more common in PFO patients who had percutaneous closure compared with those who were medically treated. The risk of AF was higher in the first 45 days post-closure and in studies that included patients with increased age.


Stroke ◽  
2021 ◽  
Author(s):  
Hans-Christoph Diener ◽  
Aurauma Chutinet ◽  
J. Donald Easton ◽  
Christopher B. Granger ◽  
Eva Kleine ◽  
...  

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.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Stephen B Wilton ◽  
Mohammed A Almekhlafi ◽  
Doreen M Rabi ◽  
William A Ghali ◽  
Diane L Lorenzetti ◽  
...  

In patients with a patent foramen ovale (PFO) and a prior cryptogenic ischemic stroke or transient ischemic attack (TIA), the risk of recurrent events is unclear. To conduct a systematic review and meta-analysis of studies assessing the risk of recurrent cerebrovascular events in patients with cryptogenic cerebral ischemia and PFO. MEDLINE (1950 to February 2008) and EMBASE (1980 to February 2008) databases were searched to identify studies in any language. Searches were supplemented by scanning bibliographies of key articles. Studies reporting original data on recurrent cerebrovascular events in patients with prior cryptogenic stroke or TIA and PFO, with or without a non-PFO comparison group, were included. Uncontrolled case series evaluating device or surgical closure of PFO were excluded. Two authors independently extracted the data from included studies and evaluated study quality. For studies with a non-PFO comparison group, relative risks were pooled using a fixed effects model after confirming homogeneity of results. For all studies, the pooled absolute rate of recurrent events was calculated using a random effects model due to heterogeneity of results. Fifteen studies published between 1994 and 2007, following 2377 patients over a mean of 37 months were included. In the four studies with a non-PFO comparison group, the pooled relative risk of recurrent stroke or TIA associated with the presence of a PFO was 1.1 (95% CI 0.8 to 1.5), while for recurrent ischemic stroke the pooled relative risk associated with the presence of a PFO was 0.8 (95% CI 0.5 to 1.3). The pooled absolute rate of recurrent ischemic stroke or TIA in patients with PFO was 4.0 events per 100 person-years (95% CI 3.0 to 5.1) while the rate of recurrent ischemic stroke was 1.6 events per 100 person years (95% CI 1.1 to 2.1). No clinical or imaging features are reliably associated with increased risk of recurrent events. In medically treated patients with prior cryptogenic stroke, available evidence does not support an increased risk of recurrent ischemic events in those with vs. without a PFO. Routine PFO closure in these patients may not be warranted, outside of ongoing clinical trials.


2019 ◽  
Author(s):  
Yanting Zhu ◽  
Xiaoming Wang ◽  
Yan Sun ◽  
Qiong Wang ◽  
Bing Wu ◽  
...  

Abstract Background: The engulfment and cell motility 1 (ELMO1) and interleukin-8 (IL8) gene polymorphisms have been previously implicated in diabetic nephropathy (DN) susceptibility. However, the results are inconsistent. We aimed to examine this issue by systematic meta-analysis. Methods: An electronic search was conducted in PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure and Wanfang Database to identify all the eligible studies. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to investigate the associations. All statistical analyses were performed by STATA 12.0. Results: Of the 11 studies included, 9 studies were performed to detect EMLO1 rs741301 polymorphism; 5 studies were used to examine IL-8 rs4073 polymorphism. The results revealed no significant association between EMLO1 rs741301 polymorphism and DN risk. While, stratified analysis by ethnicity indicated that EMLO1 rs741301 polymorphism was associated with an increased risk of DN risk among Asians (GG vs. GA +AA: OR= 1.840, 95% CI= 1.338-2.529, P= 0.000; GG vs. AA: OR= 1.834, 95% CI= 1.309-2.569, P= 0.000; G vs. A: OR= 1.222, 95% CI= 1.053-1.417, P= 0.008). As for IL-8 rs4073 polymorphism, a positive correlation between this gene polymorphism and DN risk was found (AA+AT vs. TT: OR= 1.450, 95% CI= 1.166-1.802, P= 0.001; AT vs. TT: OR= 1.420, 95% CI= 1.129-1.786, P= 0.003; AA vs. TT: OR= 1.553, 95% CI= 1.094-2.203, P= 0.014; A vs. T: OR= 1.291, 95% CI= 1.102-1.512, P= 0.002). After stratified population by ethnicity, the results in Caucasians remained significant (AA+AT vs. TT: OR= 1.770, 95% CI= 1.354-2.315, P= 0.000; AT vs. TT: OR= 1.733, 95% CI= 1.304-2.302, P= 0.000; AA vs. TT: OR= 1.939, 95% CI= 1.263-2.976, P= 0.002; A vs. T: OR= 1.494, 95% CI= 1.227-1.820, P= 0.000). Conclusions: This meta-analysis indicates that the GG genotype of EMLO1 rs741301 polymorphism and the A allele of IL-8 rs4073 polymorphism might be risk factors for the development of DN.


Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Georgios Tsivgoulis ◽  
Aristeidis H Katsanos ◽  
Ramin Zand ◽  
Sotirios Giannopoulos ◽  
Christina Zompola ◽  
...  

Background&Purpose: There are contradictory data on the potential association between size of patent foramen ovale (PFO) or coexisting atrial septal aneurysm (ASA) and risk of recurrent stroke. We performed a meta-analysis to evaluate the relationship of PFO size and concomitant ASA with recurrent stroke in medically-treated stroke patients with PFO. Subjects&Methods: We conducted a systematic review and meta-analysis according to PRISMA guidelines of all available prospective studies reporting recurrent cerebrovascular events defined as stroke and/or transient ischemic attacks (TIA) in medically treated patients with PFO diagnosed by echocardiography and/or transcranial Doppler (TCD). Shunt size was stratified according to validated transeosophageal (TEE) or TCD criteria as “small”, “moderate” or “large”. Coexisting ASA was diagnosed using TEE criteria. Results: We identified 6 eligible studies including a total of 1,727 patients. PFO size (large vs. moderate-small PFO) was not associated with a combined higher risk of recurrent stroke/TIA (RR=1.27; 95%CI= 0.52-3.08; p=0.60; Figure, Panel A) or a higher risk of recurrent stroke alone (RR=1.14; 95%CI= 0.56-2.32; p=0.72; Figure, Panel B). Coexisting ASA was not associated with a combiner higher risk of recurrent stroke/TIA (RR=1.63; 95%CI= 0.89-2.98; p=0.11; Figure, Panel C). There was no evidence of heterogeneity for all analyses (I squared statistic < 50%, p > 0.1 Cohran Q test) across the included studies. Conclusions: Our meta-analysis failed to detect any association between PFO-size and risk of recurrent cerebrovascular events in medically-treated stroke patients with PFO. Similarly, the presence of ASA was not related to risk of recurrent cerebral ischemia.


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