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Safety of low-dose aspirin in endovascular treatment for intracranial atherosclerotic stenosis.

ABSTRACT: OBJECTIVES: To evaluate the safety of low-dose aspirin plus clopidogrel versus high-dose aspirin plus clopidogrel in prevention of vascular risk within 90 days of duration of dual antiplatelet therapy in patients treated with intracranial endovascular treatment. METHODS: From January 2012 to December 2013, this prospective and observational study enrolled 370 patients with symptomatic intracranial atherosclerotic stenosis of ≥70% with poor collateral undergoing intracranial endovascular treatment. Antiplatelet therapy consists of aspirin, at a low-dose of 100 mg or high-dose of 300 mg daily; clopidogrel, at a dose of 75 mg daily for 5 days before endovascular treatment. The dual antiplatelet therapy continued for 90 days after intervention. The study endpoints include acute thrombosis, subacute thrombosis, stroke or death within 90 days after intervention. RESULTS: Two hundred and seventy three patients received low-dose aspirin plus clopidogrel and 97 patients received high-dose aspirin plus clopidogrel before intracranial endovascular treatment. Within 90 days after intervention, there were 4 patients (1.5%) with acute thrombosis, 5 patients (1.8%) with subacute thrombosis, 17 patients (6.2%) with stroke, and 2 death (0.7%) in low-dose aspirin group, compared with no patient (0%) with acute thrombosis, 2 patient (2.1%) with subacute thrombosis, 6 patients (6.2%) with stroke, and 2 death (2.1%) in high-dose aspirin group, and there were no significant difference in all study endpoints between two groups. CONCLUSION: Low-dose aspirin plus clopidogrel is comparative in safety with high-dose aspirin plus clopidogrel within 90 days of duration of dual antiplatelet therapy in patients treated with intracranial endovascular treatment.

SUBMITTER: Ma N

PROVIDER: S-EPMC4140744 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Project description:Background and purposeAdjunctive tirofiban administration in patients undergoing endovascular treatment (EVT) for acute large vessel occlusion (LVO) has been investigated in several studies. However, the findings are conflict. This study aimed to compare the effect of different administration pathways of tirofiban on patients undergoing EVT for acute LVO with intracranial atherosclerotic disease (ICAD).MethodsPatients were selected from the ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischemic Stroke: A Prospective Multicenter Registry Study) and divided into four groups: intra-arterial (IA), intravenous (IV), and intra-arterial plus intravenous (IA+IV) and non-tirofiban. The primary outcome was 90-day ordinal modified Rankin Scale (mRS) score, and the secondary outcomes included the rates of mRS 0-1, 0-2, and 0-3 at 90-day, successful recanalization. The safety outcomes were symptomatic intracranial hemorrhage (sICH) and other safety endpoints. The multivariable logistic regression models adjusting for potential baseline confounders were performed to compare the outcomes. A propensity score matching (PSM) with a 1:1:1:1 ratio was conducted among four groups, and the outcomes were then compared in the post-matched population.ResultsA total of 502 patients were included, 80 of which were in the IA-tirofiban group, 73 in IV-tirofiban, 181 in (IA+IV)-tirofiban group, and 168 in the non-tirofiban group. The median (IQR) 90-day mRS score in the four groups of IA, IV, IA+IV, and non-tirofiban was, respectively 3(0-5) vs. 1(0-4) vs. 1(0-4) vs. 3(0-5). The adjusted common odds ratio (OR) for 90-day ordinal modified Rankin Scale distribution with IA-tirofiban vs. non-tirofiban was 0.77 (95% CI, 0.45-1.30, P = 0.330), with IV-tirofiban vs. non-tirofiban was 1.36 (95% CI, 0.78-2.36, P = 0.276), and with (IA+IV)-tirofiban vs. non-tirofiban was 1.03 (95% CI, 0.64-1.64, P = 0.912). The adjusted OR for mRS 0-1 and mRS 0-2 at 90-day with IA-tirofiban vs. non-tirofiban was, respectively 0.51 (95% CI, 0.27-0.98, P = 0.042) and 0.50 (95% CI, 0.26-0.94, P = 0.033). The other outcomes of each group were similar with non-tirofiban group, all P was >0.05. After PSM, the common odds ratio (OR) for 90-day ordinal modified Rankin Scale distribution with IA-tirofiban vs. non-tirofiban was 0.41 (95% CI, 0.18-0.94, P = 0.036), and the OR for mRS 0-1 and mRS 0-2 at 90-day with IA-tirofiban vs. non-tirofiban was, respectively 0.28 (95% CI, 0.11-0.74, P = 0.011) and 0.25 (95% CI, 0.09-0.67, P = 0.006).ConclusionsIntra-arterial administration of tirofiban was associated with worse outcome than non-tirofiban, which suggested that intra-arterial tirofiban had a harmful effect on patients undergoing EVT for ICAD-LVO.Clinical trial registrationhttp://www.clinicaltrials.gov, Unique identifier: NCT03370939.

Project description:IntroductionAtherosclerotic intracranial artery stenosis (ICAS) is one of most common causes of stroke, which is the second-leading cause of death worldwide. Medical, surgical and endovascular therapy are three major treatments for ICAS. Currently, medical therapy is considered as the standard of care for most patients with ICAS, while extracranial to intracranial bypass is only used in rare situations. Balloon angioplasty alone, balloon-mounted stent and self-expanding stent, collectively called endovascular treatment, have shown promising potentials in treating specific subgroups of patients with symptomatic ICAS; however, their comparative safety and efficacy is still unclear. Therefore, a systematic review with network meta-analysis is needed to establish a hierarchy of these endovascular treatments.Methods and analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols was followed to establish this protocol. The search will be limited to studies published from 1 January 2000 to the formal search date. Major databases including Cochrane Library, MEDLINE, EMBASE, Chinese Biomedical Literature Database, conference proceedings and grey literature database will be searched for clinical studies comparing at least two interventions for patients with symptomatic ICAS. Primary outcomes include short-term and long-term mortality or stroke rate. Random effects pairwise and network meta-analyses of included studies will be performed on STATA (V.14, StataCorp, 2015). The surface under the cumulative ranking curve and mean rank will be calculated in order to establish a hierarchy of the endovascular treatments. Evaluation of the risk of bias, heterogeneity, consistency, transitivity and quality of evidence will follow the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions.Ethics and disseminationEthics approval is not needed as systematic review is based on published studies. Study findings will be presented at international conferences and published on a peer-reviewed journal.Prospero registration numberCRD42018084055; Pre-results.

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Safety of low-dose aspirin in endovascular treatment for intracranial atherosclerotic stenosis.

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