scholarly journals Safety and Efficacy of Low-Dose Tirofiban Combined With Intravenous Thrombolysis and Mechanical Thrombectomy in Acute Ischemic Stroke: A Matched-Control Analysis From a Nationwide Registry

2021 ◽  
Vol 12 ◽  
Author(s):  
Gaoting Ma ◽  
Shuo Li ◽  
Baixue Jia ◽  
Dapeng Mo ◽  
Ning Ma ◽  
...  

Purpose: Tirofiban administration to acute ischemic stroke patients undergoing mechanical thrombectomy with preceding intravenous thrombolysis remains controversial. The aim of the current study was to evaluate the safety and efficacy of low-dose tirofiban during mechanical thrombectomy in patients with preceding intravenous thrombolysis.Methods: Patients with acute ischemic stroke undergoing mechanical thrombectomy and preceding intravenous thrombolysis were derived from “ANGEL-ACT,” a multicenter, prospective registry study. The patients were dichotomized into tirofiban and non-tirofiban groups based on whether tirofiban was administered. Propensity score matching was used to minimize case bias. The primary safety endpoint was symptomatic intracerebral hemorrhage (sICH), defined as an intracerebral hemorrhage (ICH) associated with clinical deterioration as determined by the Heidelberg Bleeding Classification. All ICHs and hemorrhage types were recorded. Clinical outcomes included successful recanalization, dramatic clinical improvement, functional independence, and mortality at the 3-month follow-up timepoint. Successful recanalization was defined as a modified Thrombolysis in Cerebral Ischemia score of 2b or 3. Dramatic clinical improvement at 24 h was defined as a reduction in NIH stroke score of ≥10 points compared with admission, or a score ≤1. Functional independence was defined as a Modified Rankin Scale (mRS) score of 0–2 at 3-months.Results: The study included 201 patients, 81 in the tirofiban group and 120 in the non-tirofiban group, and each group included 68 patients after propensity score matching. Of the 201 patients, 52 (25.9%) suffered ICH, 15 (7.5%) suffered sICH, and 18 (9.0%) died within 3-months. The median mRS was 3 (0–4), 99 (49.3%) achieved functional independence. There were no statistically significant differences in safety outcomes, efficacy outcomes on successful recanalization, dramatic clinical improvement, or 3-month mRS between the tirofiban and non-tirofiban groups (all p > 0.05). Similar results were obtained after propensity score matching.Conclusion: In acute ischemic stroke patients who underwent mechanical thrombectomy and preceding intravenous thrombolysis, low-dose tirofiban was not associated with increased risk of sICH or ICH. Further randomized clinical trials are needed to confirm the effects of tirofiban in patients undergoing bridging therapy.

2019 ◽  
Vol 28 (6) ◽  
pp. 684-690 ◽  
Author(s):  
Li Gong ◽  
Xiaoran Zheng ◽  
Lijin Feng ◽  
Xiang Zhang ◽  
Qiong Dong ◽  
...  

Mechanical thrombectomy (MT) is effective in managing patients with acute ischemic stroke (AIS) caused by large-vessel occlusions and allows for valuable histological analysis of thrombi. However, whether bridging therapy (pretreatment with intravenous thrombolysis before MT) provides additional benefits in patients with middle cerebral artery (MCA) occlusion remains unclear. Therefore, this study aimed to compare the effects of direct MT and bridging therapy, and to elucidate the correlation between thrombus composition and stroke subtypes. Seventy-three patients with acute ischemic stroke who received MT, were eligible for intravenous thrombolysis, and had MCA occlusion were included. We matched 21 direct MT patients with 21 bridging therapy patients using propensity score matching and compared their 3rd-month clinical outcomes. All MCA thrombi (n = 45) were histologically analyzed, and the red blood cell (RBC) and fibrin percentages were quantified. We compared the clot composition according to stroke etiology (large-artery atherosclerosis and cardioembolism) and intravenous thrombolysis application. The baseline characteristics showed no difference between groups except for a higher atrial fibrillation rate and NIHSS score on admission in the direct MT group. We performed a supportive analysis using propensity score matching but could not find any differences in the functional outcome, mortality, and intracerebral hemorrhage. In the histological clot analysis, the cardioembolic clots without intravenous thrombolysis pretreatment had higher RBC (P = 0.042) and lower fibrin (P = 0.042) percentages than the large-artery atherosclerosis thrombi. Similar findings were observed in the thrombi treated with recombinant tissue plasminogen activator (P = 0.012). In conclusion, there was no difference in the functional outcomes between the direct MT and bridging therapy groups. However, randomized trials are needed to elucidate the high ratio of cardioembolism subtype in our group of patients. The histological MCA thrombus composition differed between cardioembolism and large-artery atherosclerosis, and this finding provides valuable information on the underlying pathogenesis and thrombus origin.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Mikito Hayakawa ◽  
Masatoshi Koga ◽  
Shoichiro Sato ◽  
Shoji Arihiro ◽  
Yoshiaki Shiokawa ◽  
...  

Objective: Although intravenous thrombolysis (IVT) using alteplase for octogenarians with acute ischemic stroke becomes relatively familiar, it is unclear whether IVT for nonagenarians is a futile intervention. The purpose of this study is to clarify the efficacy and safety of IVT using low-dose alteplase (0.6 mg/kg) for nonagenarians compared with octogenarians. Methods: Stroke Acute Management with Urgent Risk-factor Assessment and Improvement (SAMURAI) rtPA registry retrospectively collected 600 consecutive acute stroke patients receiving IVT from 10 Japanese stroke centers between October 2005 and July 2008. We extracted all octogenarians (O group) and nonagenarians (N group) from the registry. We compared baseline characteristics, symptomatic intracranial hemorrhage (SICH), and 3-month outcomes between the groups. 3-month outcomes include; functional independence (FI) defined as a mRS score 0-2, good outcome (GO) as a mRS score 0-2 or same as the premorbid mRS, poor outcome (PO) defined as a mRS score 5-6, and death. Results: Twenty-five nonagenarians (mean age, 93 years) and 124 octogenarians (mean age, 84 years) were included. N group was more female-predominant (76% versus 56%, p=0.06) and premorbidly dependent (44% versus 14%, p<0.001) than O group. There were no significant differences of median baseline NIHSS score (16 versus 14, p=0.95) and Alberta Stroke Program Early CT Score (9 versus 9, p=0.36) between the groups. The rate of FI tended to be lower in N group than O group (16% versus 36%, p=0.06), otherwise, the differences of the rates of GO (28% versus 37%, p=0.39), PO (40% versus 36%, p=0.73), death (20% versus 11%, p=0.23) and SICH (0% versus 2.4%, p=1.00) were not significant between the groups. In comparison with O group, N group was not associated with 3-month clinical outcomes (FI; OR 0.61; 95% CI, 0.15-2.42, GO; 0.98; 0.31-3.07, PO; 0.63; 0.15-2.70, death; 3.18; 0.62-16.3) and SICH (0.68; 0.17-2.69) after multivariate adjustment. Conclusions: IVT using low-dose alteplase for N group resulted in less frequent achievement of FI mainly because of more premorbid dependency than O group, however, showed at least a similar safety and a potential efficacy.


Biomedicines ◽  
2021 ◽  
Vol 9 (10) ◽  
pp. 1357
Author(s):  
Anthony Winder ◽  
Matthias Wilms ◽  
Jens Fiehler ◽  
Nils D. Forkert

Interventional neuroradiology is characterized by engineering- and experience-driven device development with design improvements every few months. However, clinical validation of these new devices requires lengthy and expensive randomized controlled trials. This contribution proposes a machine learning-based in silico study design to evaluate new devices more quickly with a small sample size. Acute diffusion- and perfusion-weighted MRI, segmented one-week follow-up imaging, and clinical variables were available for 90 acute ischemic stroke patients. Three treatment option-specific random forest models were trained to predict the one-week follow-up lesion segmentation for (1) patients successfully recanalized using intra-arterial mechanical thrombectomy, (2) patients successfully recanalized using intravenous thrombolysis, and (3) non-recanalizing patients as an analogue for conservative treatment for each patient in the sample, independent of the true group membership. A repeated-measures analysis of the three predicted follow-up lesions for each patient revealed significantly larger lesions for the non-recanalizing group compared to the successful intravenous thrombolysis treatment group, which in turn showed significantly larger lesions compared to the successful mechanical thrombectomy treatment group (p < 0.001). A groupwise comparison of the true follow-up lesions for the three treatment options showed the same trend but did not reach statistical significance (p = 0.19). We conclude that the proposed machine learning-based in silico trial design leads to clinically feasible results and can support new efficacy studies by providing additional power and potential early intermediate results.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Hamza Achit ◽  
Francis guillemin ◽  
Marc Soudant ◽  
Kossar Hosseini ◽  
Aurelie Bannay ◽  
...  

Background and purpose: The benefit of mechanical thrombectomy added to intravenous thrombolysis in patients with acute ischemic stroke has been largely demonstrated. However, evidence on economic incentive of this strategy is still limited, especially in the context of randomized trial. The purpose of this study is to analyze whether the combination of mechanical thrombectomy with intravenous thrombolysis is more cost-effective than implementing intravenous thrombolysis alone. Patients and methods: Individual-level cost and outcome data were collected in the THRACE randomized clinical trial, including patients with acute ischaemic stroke and proximal cerebral artery occlusion. Patients were assigned to either intravenous thrombolysis (IVT; n = 208) or intravenous thrombolysis plus intra-arterial thrombectomy (IVMT; n=204). The primary outcomes were both modified Rankin scale of functional independence at 90 days (score 0-2) and the EuroQol-5D score of quality of life. This study considered the perspective of the National Health Security System in France. Results: Bridging therapy increased by 10.9% the rate of functional independence compared to IVT (53% vs 42,1%) at an increased cost of 1909 є, with no significant difference in mortality (12% vs 13%) or symptomatic intracranial haemorrhage (2% vs 2%). Cost per one averted case of disability was consequently estimated at 17,480 є. The incremental cost per quality-adjusted life year gained was 13,423 є. Sensitivity analysis showed that combined approach had 84.1% probability of being cost-effective regarding cases of averted disability and 92.2% probability regarding quality-adjusted life year outcome. The national implementation of this new strategy would result in additional cost of 12.9 million є and avoid about 737 cases of death or disability. Conclusions: Based on randomized trial, this study demonstrates that intravenous thrombolysis plus mechanical intra-arterial thrombectomy for treating acute ischemic stroke is more cost-effective than intravenous thrombolysis alone.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3212-3212
Author(s):  
Nirav Dhanesha ◽  
Aayushi Garg ◽  
Amir Shaban ◽  
Edgar Samaniego ◽  
Anil K Chauhan ◽  
...  

Abstract Background The mechanism of increased risk of venous thromboembolism (VTE) after acute ischemic stroke (AIS) is unclear. In this study, we aimed to evaluate the risk of VTE in hospitalizations due to AIS as compared to those due to non-vascular neurological conditions. We also aimed to assess any potential association between VTE risk and the use of intravenous thrombolysis (rtPA) among hospitalizations with AIS. Methods In this case-control study, data were obtained from the Nationwide Inpatient Sample 2016-2018. Propensity score matching was used to adjust for the baseline differences between the groups. Logistic regression analysis was used to compare the risk of VTE. Results We identified 1,541,685 hospitalizations due to AIS and 1,453,520 hospitalizations due to non-vascular neurological diagnoses that served as controls. After propensity score matching, 640,560 cases with AIS and corresponding well-matched controls were obtained. Hospitalizations due to AIS had higher odds of VTE as compared to the controls [odds ratio (OR) 1.50, 95% confidence interval (CI) 1.40-1.60, P&lt;0.001]. Among hospitalizations with AIS, 184,065 (11.9%) got rtPA. The odds of VTE were lower among the AIS hospitalizations that received rtPA as compared to those that did not (OR 0.89, 95% CI 0.79-0.99, P0.035). Conclusion Hospitalizations due to AIS have a higher risk of VTE as compared to the non-vascular neurological controls. Among AIS cases, the risk of VTE is lower among patients treated with rtPA. These epidemiological findings support the hypothesis that the risk of VTE after AIS might be partly mediated by an intrinsic pro-coagulant state. Disclosures No relevant conflicts of interest to declare.


Author(s):  
Rosanna Rossi ◽  
Seán Fitzgerald ◽  
Sara Molina ◽  
Oana Madalina Mereuta ◽  
Andrew Douglas ◽  
...  

Abstract Both intravenous thrombolysis (IVT) and mechanical thrombectomy (MT) are evidence-based treatments for acute ischemic stroke (AIS) in selected cases. Recanalization may occur following IVT without the necessity of further interventions or requiring a subsequent MT procedure. IVT prior to MT (bridging-therapy) may be associated with benefits or hazards. We studied the retrieved clot area and degree of recanalization in patients undergoing MT or bridging-therapy for whom it was possible to collect thrombus material. We collected mechanically extracted thrombi from 550 AIS patients from four International stroke centers. Patients were grouped according to the administration (or not) of IVT before thrombectomy and the mechanical thrombectomy approach used. We assessed the number of passes for clot removal and the mTICI (modified Treatment In Cerebral Ischemia) score to define revascularization outcome. Gross photos of each clot were taken and the clot area was measured with ImageJ software. The non-parametric Kruskal–Wallis test was used for statistical analysis. 255 patients (46.4%) were treated with bridging-therapy while 295 (53.6%) underwent MT alone. By analysing retrieved clot area, we found that clots from patients treated with bridging-therapy were significantly smaller compared to those from patients that underwent MT alone (H1 = 10.155 p = 0.001*). There was no difference between bridging-therapy and MT alone in terms of number of passes or final mTICI score. Bridging-therapy was associated with significantly smaller retrieved clot area compared to MT alone but it did not influence revascularization outcome.


Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Ameer E Hassan ◽  
Christina Sanchez ◽  
Asad Ahrar ◽  
Saqib A Chaudhry ◽  
Adnan I Qureshi

Background: There is controversy regarding the optimal size of stent retriever for achieving timely recanalization in acute ischemic stroke patients. Objective: To determine the relationship between stent retriever diameter and procedure time, and rates of recanalization, and functional independence among acute ischemic stroke patients undergoing mechanical thrombectomy. Methods: We analyzed data from consecutive acute ischemic stroke patients treated with mechanical thrombectomy derived from a prospective database. Baseline demographic and clinical characteristics, NIHSS score on admission and discharge, intracranial hemorrhage occurrence, and mRS at discharge were analyzed. Thrombolysis In Cerebral Infarction (TICI) scale was used to grade pre and post procedure angiographic recanalization. Procedural time was defined by the time interval between microcatheter placement and recanalization. We compared the rates of thrombectomy attempts, complete recanalization (TICI grade of 3), and functional independence (defined by mRS 0-2) between patients treated with 6 mm and 3-4 mm diameter stent retrievers. Results: A total of 230 acute ischemic stroke patients (mean age 71.8 ±12.5; 46.6% women) were treated with stent retrievers. Thrombectomy was performed with a 6mm diameter stent retriever in 107 patients and 3 or 4 mm diameter stent retriever in 123 patients. There were no statistically significant differences in demographics or baseline characteristics, or admission NIHSS score between the two groups. There was a trend towards a fewer number of thrombectomy attempts required with a 6mm diameter stent retriever (p=0.06). There was a higher rate of complete recanalization in patients treated with 6mm diameter stent retriever compared with 3 or 4 mm diameter stent retriever (72% vs 57.7% p=0.02). There was no statistically significant difference in rates of functional independence between the two groups (24.3% vs 25.2% p=0.84) at discharge. Conclusion: Among acute ischemic stroke patients undergoing mechanical thrombectomy, use of a 6 mm diameter stent retriever was associated with a higher rate of complete recanalization and a lower number of thrombectomy attempts compared with 3-4 mm diameter stent retrievers.


Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Woo-Keun Seo ◽  
Mi-Yeon Eun ◽  
Ji Hyun Kim ◽  
Kyungmi Oh ◽  
Seong-Beom Koh

Background This retrospective case-control study was designed to compare the effect of early high-dose atorvastatin treatment on early functional outcome in acute ischemic stroke patients using propensity score matching (PSM). Study design and population Acute ischemic stroke patients were selected from prospectively collected hospital-based stroke registry. Because the purpose of this study was comparing two treatment strategies for statin treatment, patients with cardioembolic stroke subtype or other-etiology were excluded. Patients were allocated into two groups: Intensive treatment group (atorvastatin 80mg; IT) and conventional treatment group (atorvastatin 10-40mg or other lipid-lowering agent; CT). All the patients were prescribed for aspirin 300mg at admission except for the patients who were considered for thrombolysis. After admission, the patients were prescribed for antithrombotics according to the clinical decision of the attending physician. All other practice guidelines except management of dyslipidemia were followed for previously published guidelines for management of stroke patients. Detailed demographic factors, vascular risk factors, laboratory parameters and vascular imaging were recorded. The end points were composed of two parameters. First, early neurological deterioration (END) defined as 4 points or more deterioration of National Institute of Health Stroke Score (NIHSS) from admission to the seventh hospital day. In case of discharge before the seventh hospital day, NIHSS at discharge was substituted for that of the seventh hospital day. Second, favorable outcome was defined as 0-2 of modified Rankin Score (mRS) measured at 3 months from the onset of stroke. Because baseline characteristics between the groups was supposed to be different, propensity score matching was performed to adjust for potential selection biases and confounding. A logistic regression model was fitted relating treatment strategies (IT and CT) to pretreatment patient characteristics. For the comparison between IT and CT in terms of END and favorable outcome, McNemar test were performed. Results: Among the study population, data of 178 patients for IT and 218 patients for CT were collected. Between the groups, history of previous stroke, TOAST classification, and previous medication of clopidogrel showed significant difference. There was no significant difference of 90-day favorable outcome and END. After PSM, 116 patients for each group were selected. There was no significant difference of baseline characteristics between the groups after PSM. There was no significant difference between IT and CT in terms of 90-day favorable outcome (75.3% in IT and 78.4% in CT, p = 0.457) and END (IT 72.3%, CT 78.6%, p = 0.097). Conclusion In this study, effect of intensive lipid-lowering treatment in acute stroke patients was negligible in terms of early functional outcome.


2018 ◽  
Vol 10 (10) ◽  
pp. 975-977 ◽  
Author(s):  
Fabrizio Sallustio ◽  
Enrico Pampana ◽  
Alessandro Davoli ◽  
Stefano Merolla ◽  
Giacomo Koch ◽  
...  

Background and purposeTo report clinical and procedural outcomes of acute ischemic stroke patients after endovascular treatment with the new thromboaspiration catheter AXS Catalyst 6.MethodsPatients with anterior and posterior circulation stroke were selected. Successful reperfusion defined as a Thrombolysis in Cerebral Infarction (TICI) score ≥2 b and 3-month functional independence defined as a modified Rankin Scale (mRS) ≤2 were the main efficacy outcomes. Symptomatic intracranial hemorrhage and mortality were the main safety outcomes.Results107 patients were suitable for analysis. Mean age was 73.18±12.62 year and median baseline NIHSS was 17 (range: 3–32). The most frequent site of occlusion was the middle cerebral artery (MCA) (60.7%). 76.6% of patients were treated with AXS Catalyst 6 alone without the need for rescue devices or thromboaspiration catheters. Successful reperfusion was achieved in 84.1%, functional independence in 47.6%, symptomatic intracranial hemorrhage occurred in 3.7%, and mortality in 21.4%.ConclusionsEndovascular treatment with AXS Catalyst 6 proved to be safe, technically feasible, and effective. Comparison analyses with other devices for mechanical thrombectomy are needed.


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