Mechanical Thrombectomy in Acute Ischemic Stroke Patients Performed Within and Outside Clinical Trials in the United States

Neurosurgery ◽  
2019 ◽  
Author(s):  
Adnan I Qureshi ◽  
Baljinder Singh ◽  
Wei Huang ◽  
Zhiyuan Du ◽  
Iryna Lobanova ◽  
...  

Abstract BACKGROUND A better understanding of differences in outcomes of mechanical thrombectomy performed within and outside clinical trials will assist in optimal implementation of the procedure for acute ischemic stroke patients in general practice. OBJECTIVE To identify differences in demographic and clinical characteristics and outcomes related to mechanical thrombectomy in patients treated within clinical trials and those treated outside clinical trials in a large national cohort. METHODS  We compared the patient characteristics and associated in-hospital outcomes of mechanical thrombectomy in acute ischemic stroke patients performed within and outside clinical trials using the Nationwide Inpatient Sample from 2013 to 2015. We analyzed in-hospital mortality (primary outcome) and moderate to severe disability (secondary outcome) based on discharge disposition after adjusting for potential confounders. RESULTS Of 23 375 patients who underwent mechanical thrombectomy, 430 (1.8%) underwent the procedure as part of a clinical trial. After adjusting for age, gender, and the teaching status of the hospital, patients treated within a clinical trial had lower rates of in-hospital mortality (odds ratio [OR] 0.14; 95% CI .03 to .71; P < .001). Among patients discharged alive, the rate of moderate to severe disability (OR .43; 95% CI .26 to .71; P < .001) was lower among those patients treated within a clinical trial. There was no difference in odds of post-thrombectomy intracerebral or subarachnoid hemorrhage between the two groups. CONCLUSION Mechanical thrombectomy performed as part of clinical trials was associated with lower rates of in-hospital mortality and lower rates of moderate to severe disability compared with those performed outside clinical trials.

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Saqib A Chaudhry ◽  
Ameer E Hassan ◽  
Iqra N Akhtar ◽  
Mohammad Rauf A Chaudhry ◽  
Wei Huang ◽  
...  

Introduction: Several studies have shown improved outcomes in ischemic stroke patients treated with mechanical thrombectomy in clinical trials after introduction of stent retrievers. The outcomes of patients undergoing endovascular treatment in general practice are expected to improve. We performed this analysis to evaluate trends in utilization of endovascular treatment in acute ischemic stroke and associated rates of death and disability in real world practice. Methods: We obtained data for patients admitted with primary diagnosis of ischemic stroke in United States from 2009-2016 using Nationwide Inpatient Sample. We determined the rate and pattern of utilization, and associated in-hospital outcomes of endovascular treatment among them. Outcomes were classified as minimal disability, moderate to severe disability, and death based on discharge disposition and compared between two time periods: 2009-2011 and 2013-2016 to represent pre and post stent retriever approvals in United States. Results: Of the 3,780,955 patients admitted with ischemic stroke, 244,092 (6.46%) received intravenous thrombolytic treatment, and 48,409 (1.28%) underwent endovascular treatment. There was a fourfold increase in patients who underwent endovascular treatment (0.55% of ischemic strokes in 2009 vs. 2.03% in 2016, trend p < 0.001). In multivariate logistic regression analysis, adjusted for age, gender, thrombolytic therapy, in hospital complications including secondary intracranial hemorrhages, the rate of none to minimal disability improved between the two study intervals (2009-2011 versus 2013-2016), odds ratio (OR) 1.82, 95% confidence interval (CI) 1.47-2.67, p=<0.0001) and moderate to severe disability decreased (OR 0.56, 95% CI 0.45- 0.70, p= <0.0001). There was significant decrease inpatient mortality for patients treated during 2013-2016; OR 0.67, 95% CI 0.56- 0.79, p= <0.0001). Conclusion: There has been a significant increase in the proportion of acute ischemic stroke patients receiving endovascular treatment with improvement of outcomes. Our analysis support generalizability of the successful results observed in clinical trials of endovascular treatment in the post-stent retriever approval era in United States.


Neurosurgery ◽  
2020 ◽  
Vol 87 (Supplement_1) ◽  
pp. S24-S24
Author(s):  
Adnan I Qureshi ◽  
Baljinder Singh ◽  
Wei Huang ◽  
Zhiyuan Du ◽  
Iryna Lobanova ◽  
...  

2019 ◽  
pp. 174749301988452 ◽  
Author(s):  
Akiko Kada ◽  
Kuniaki Ogasawara ◽  
Takanari Kitazono ◽  
Kunihiro Nishimura ◽  
Nobuyuki Sakai ◽  
...  

Background Limited national-level information on temporal trends in comprehensive stroke center capabilities and their effects on acute ischemic stroke patients exists. Aims To examine trends in in-hospital outcomes of acute ischemic stroke patients and the prognostic influence of temporal changes in comprehensive stroke center capabilities in Japan. Methods This retrospective study used the J-ASPECT Diagnosis Procedure Combination database and identified 372,978 acute ischemic stroke patients hospitalized in 650 institutions between 2010 and 2016. Temporal trends in patient outcomes and recombinant tissue plasminogen activator (rt-PA) and mechanical thrombectomy usage were examined. Facility comprehensive stroke center capabilities were assessed using a validated scoring system (comprehensive stroke center score: 1–25 points) in 2010 and 2014. The prognostic influence of temporal comprehensive stroke center score changes on in-hospital mortality and poor outcomes (modified Rankin Scale: 3–6) at discharge were examined using hierarchical logistic regression models. Results Over time, stroke severity at admission decreased, whereas median age, sex ratio, and comorbidities remained stable. The median comprehensive stroke center score increased from 16 to 17 points. After adjusting for age, sex, comorbidities, consciousness level, and facility comprehensive stroke center score, proportion of in-hospital mortality and poor outcomes at discharge decreased (from 7.6% to 5.0%, and from 48.7% to 43.1%, respectively). The preceding comprehensive stroke center score increase (in 2010–2014) was independently associated with reduced in-hospital mortality and poor outcomes, and increased rt-PA and mechanical thrombectomy use (odds ratio (95% confidence interval): 0.97 (0.95–0.99), 0.97 (0.95–0.998), 1.07 (1.04–1.10), and 1.21 (1.14–1.28), respectively). Conclusions This nationwide study revealed six-year trends in better patient outcomes and increased use of rt-PA and mechanical thrombectomy in acute ischemic stroke. In addition to lesser stroke severity, preceding improvement of comprehensive stroke center capabilities was an independent factor associated with such trends, suggesting importance of comprehensive stroke center capabilities as a prognostic indicator of acute stroke care.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Saqib A Chaudhry ◽  
Mohammad Rauf A Chaudhry ◽  
Mohsain Gill ◽  
Iqra N Akhtar ◽  
Adnan I Qureshi

Background and Purpose: The drip and ship paradigm has rapidly expanded in the last decade allowing higher thrombolytic utilization and endovascular treatment. We performed this analysis to evaluate trends in utilization of drip and ship paradigm in United States and associated outcomes. Methods: We analyzed data for patients admitted with primary diagnosis of ischemic stroke in the United States from Nationwide Inpatient Sample, the largest nationally representative data, for the years 2009 to 2015. We studied changes in utilization of drip-and-ship paradigm and subsequent performance of endovascular treatment, and rates of discharge with none to minimal disability and moderate to severe disability. Results: Of the 3,043,190 patients admitted with ischemic stroke, 56,449 (1.85%) patients received thrombolytic treatment through drip-and-ship paradigm over a 7 year period. Of all patients who received thrombolytic treatment (n=243,824), 56,449 (23.15%) received using drip and ship paradigm. There was almost 3 fold increase in drip and ship paradigm (in 0.98% 2009 to 2.80% in 2015 (test for trend= p < 0.001). Among the patients who underwent drip and ship paradigm, 5,061 (8.97%) underwent endovascular treatment. The rate of endovascular treatment increased from 6.62% to 12.39% among patients treated with drip and ship paradigm (test for trend= p < 0.001). The rate of none minimal disability at discharge increased from 39.93% to 47.08%, (test for trend p < 0.001) while moderate to severe disability decreased 51.22% to 47.08%, (test for trend p < 0.001) in ischemic stroke patients treated using drip-and-ship paradigm. Similar trends were observed for hospital outcomes in multivariate logistic regression model, adjusted for age, gender, medical comorbidities and secondary intracranial hemorrhages. Conclusion: There has been a significant increase in the proportion of acute ischemic stroke patients treated using drip-and-ship paradigm (out of proportion to overall thrombolytic use) with increase in subsequent endovascular treatment in United States. The in hospital outcomes of patients have improved perhaps due to higher utilization of endovascular treatment.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Saqib A Chaudhry ◽  
Ameer E Hassan ◽  
Mohammad R Afzal ◽  
Riaz Riaz ◽  
Haseeb Rahman ◽  
...  

Background and Purpose: Hemicraniectomy is carefully selected for patients with acute ischemic stroke in whom endovascular treatment has failed to prevent adverse outcomes of large hemispheric stroke. We evaluated trends in the utilization of hemicraniectomy in patients who underwent endovascular therapy according to the availability of three generations of thrombectomy devices and analyzed the associated rates of death and disability among them over a nine year period. Methods: We obtained data for patients admitted to hospitals in the United States from 2004 to 2012 with a primary diagnosis of ischemic stroke using a large national database. We determined the rate and pattern of hemicraniectomy utilization, and associated in-hospital outcomes of endovascular treatment among ischemic stroke patients. Outcomes were compared between three time periods: 2004-2006 (post MERCI), 2007-2009 (post Penumbra) and 2010-2012 (post Solitaire stent retriever) approvals. Results: Of the 6,021,636 patients admitted with ischemic stroke, 28,956 (0.48%) underwent endovascular treatment. Of the patients who underwent endovascular therapy, 2,219 (7.6%) required subsequent hemicraniectomy. There was a 7 fold decrease in the utilization of hemicraniectomy in these patients between 2004 and 2009 (25.6% in 2004 vs. 3.5% in 2009, p < 0.001) with a yearly trend towards decreased utilization of hemicraniectomy [OR 0.7, 95% CI 0.6- 0.8, p <.0001]. In multivariate logistic regression analysis there was a reduction in the rate of in hospital mortality of the 2007-2009 and the 2010-2012 groups when compared to the 2004-2006 interval group (2007-2009, odds ratio (OR) 0.9, 95% confidence interval (CI) (0.7- 1.2) and 2010-2012, [OR 0.9, 95%CI 0.7- 1.1]). The rate of moderate to severe disability increased for patients treated during 2007-2009 and 2010-2012. Conclusion: In the last 9 years there has been a significant decrease in the utilization of hemicraniectomy in acute ischemic stroke patients who underwent endovascular treatment. Despite reduction in use of hemicraniectomy, the mortality rate in endovascularly treated patients have shown a reduction, but there was an increase in rate of moderate to severe disability.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Shahram Majidi ◽  
Amol Mehta ◽  
Inder P Singh ◽  
Hazem Shoirah ◽  
Tomoyoshi Shigematsu ◽  
...  

Background: The efficacy of endovascular thrombectomy (EVT) for large vessel occlusion in elderly is controversial as this age group is often excluded or under-represented in major randomized clinical trials. We evaluated the real-world trends in utilization and outcome of EVT in patients ≥80 years in a nationally representative database. Methods: Using nationwide inpatient sample (2014-2016), we identified patients admitted to hospitals in the United States with acute ischemic stroke who underwent EVT. Baseline demographics and clinical outcome were assessed among patients with age ≥80 years and those with age <80 years. The primary endpoint was favorable outcome defined as discharge to home or acute rehabilitation center. Hemorrhage and in-hospital mortality rates were assessed as secondary outcome measures. Multivariate analysis was performed to identify independent predictors of favorable clinical outcome in elderly. Results: A total of 6,230 patients were identified and 1,547 (24.83%) of them were ≥80. The number of patients ≥80 years who underwent EVT increased from 323 (22%) in 2014 to 695 (28%) in 2016. The rate of favorable outcome in elderly was 9% which was significantly lower than in younger patients (22%). In-hospital mortality was 19% in patients ≥80 years compared to 13% in their younger counterpart. There was no difference in the rate of hemorrhagic transformation between octogenarians and younger patients (3.2% vs 2.6%). Among patient ≥80, decreasing baseline comorbidity burden (Elixhauser Comorbidity Index) [OR; (95% CI): 1.24; (1.04-1.47)] was an independent predictor of favorable outcome. Conclusions: Two-fold increase in the number of EVT was seen from 2014 to 2016 among patients ≥80 years old. Although the rate of favorable outcome is lower in this age group, comparison to a historical control group suggests significant outcome benefit from EVT in these patients. Future prospectively designed studies are warranted for further characterization of the risks and benefit of EVT in elderly.


2020 ◽  
Vol 84 (4) ◽  
pp. 656-661
Author(s):  
Qiao Han ◽  
Chunyuan Zhang ◽  
Shoujiang You ◽  
Danni Zheng ◽  
Chongke Zhong ◽  
...  

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