Abstract 183: Time to Alteplase and Symptomatic Intracranial Hemorrhage Complication Rates

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Muhammad U Farooq ◽  
Kathie Thomas

Background/Objective: The American Heart Association’s Target Stroke initiative focuses on reducing door-to-needle time for faster treatment with Alteplase and improved patient outcomes. The concern for reducing door-to-needle time is that there will be an increase in complication rates, specifically the rate of symptomatic intracranial hemorrhage (ICH). This study sought to review whether reduced door-to-needle times were associated with increased rates of complications in Midwest hospitals. Methods: A retrospective review of acute ischemic stroke patients treated with Alteplase was conducted from 2010-2018 in 13 Midwestern states (IN, IL, KS, KY, MI, MN, NO, ND, OH, SD, and WI) using the American Stroke Association’s Get With The Guidelines (GWTG) Stroke database. Percentage of eligible patients treated with Alteplase, treatment times, and complication rates were reviewed. Results: From 2010-2018 the rate of ischemic stroke patients treated with Alteplase in the approved 3-hour window increased from 68.9% to 88.5%. The number of patients treated with Alteplase in 60 minutes increased from 24.1% in 2010 to 74.9% in 2018. The median time to treatment for Alteplase was reduced from 80 minutes in 2010 to 46 minutes in 2018. The rate of complications associated with thrombolytics was 6.5% in 2010 and dropped to 4.5% in 2018. This is statistically significant at a p-value of .05. Conclusions: In the Midwest Region, a reduction in door-to-needle times was not associated with increased complication rates. Interestingly, a reduction in door-to-needle times was associated with a reduction in complication rates. This supports the American Heart Association’s new Target Stroke Phase III initiative which seeks to further reduce door-to-needle times.

2016 ◽  
Vol 12 (5) ◽  
pp. 502-509 ◽  
Author(s):  
Jessica Barlinn ◽  
Johannes Gerber ◽  
Kristian Barlinn ◽  
Lars-Peder Pallesen ◽  
Timo Siepmann ◽  
...  

Background Five randomized controlled trials recently demonstrated efficacy of endovascular treatment in acute ischemic stroke. Telestroke networks can improve stroke care in rural areas but their role in patients undergoing endovascular treatment is unknown. Aim We compared clinical outcomes of endovascular treatment between anterior circulation stroke patients transferred after teleconsultation and those directly admitted to a tertiary stroke center. Methods Data derived from consecutive patients with intracranial large vessel occlusion who underwent endovascular treatment from January 2010 to December 2014 at our tertiary stroke center. We compared baseline characteristics, onset-to-treatment times, symptomatic intracranial hemorrhage, in-hospital mortality, reperfusion (modified Treatment in Cerebral Infarction 2b/3), and favorable functional outcome (modified Rankin scale ≤ 2) at discharge between patients transferred from spoke hospitals and those directly admitted. Results We studied 151 patients who underwent emergent endovascular treatment for anterior circulation stroke: median age 70 years (interquartile range, 62–75); 55% men; median National Institutes of Health Stroke Scale score 15 (12–20). Of these, 48 (31.8%) patients were transferred after teleconsultation and 103 (68.2%) were primarily admitted to our emergency department. Transferred patients were younger (p = 0.020), received more frequently intravenous tissue plasminogen activator (p = 0.008), had prolonged time from stroke onset to endovascular treatment initiation (p < 0.0001) and tended to have lower rates of symptomatic intracranial hemorrhage (4.2% vs. 11.7%; p = 0.227) and mortality (8.3% vs. 22.6%; p = 0.041) than directly admitted patients. Similar rates of reperfusion (56.2% vs. 61.2%; p = 0.567) and favorable functional outcome (18.8% vs. 13.7%; p = 0.470) were observed in telestroke patients and those who were directly admitted. Conclusions Telestroke networks may enable delivery of endovascular treatment to selected ischemic stroke patients transferred from remote hospitals that is equitable to patients admitted directly to tertiary hospitals.


Stroke ◽  
2020 ◽  
Vol 51 (9) ◽  
pp. 2690-2696 ◽  
Author(s):  
Xiaohao Zhang ◽  
Yi Xie ◽  
Huaiming Wang ◽  
Dong Yang ◽  
Teng Jiang ◽  
...  

Background and Purpose: Symptomatic intracranial hemorrhage (sICH), potentially associated with poor prognosis, is a major complication of endovascular thrombectomy (EVT) for ischemic stroke patients. We aimed to develop and validate a risk model for predicting sICH after EVT in Chinese patients due to large-artery occlusions in the anterior circulation. Methods: The derivation cohort recruited patients with EVT from the Endovascular Treatment for Acute Anterior Circulation Ischemic Stroke Registry in China. sICH was diagnosed according to the Heidelberg Bleeding Classification within 24 hours of EVT. Stepwise logistic regression was performed to derive the predictive model. The discrimination and calibration of the risk model were assessed using the C index and the calibration plot. An additional cohort of 503 patients from 2 stroke centers was prospectively enrolled to validate the new model. Results: We enrolled 629 patients who underwent EVT as the derivation cohort, among whom 87 developed sICH (13.8%). In the multivariate adjustment, Alberta Stroke Program Early CT Score (odds ratio [OR], 0.85; P =0.005), baseline glucose (OR, 1.13; P =0.001), poor collateral circulation (OR, 3.06; P =0.001), passes with retriever (OR, 1.52; P =0.001), and onset-to-groin puncture time (OR, 1.79; P =0.024) were independent factors of sICH and were incorporated as the Alberta Stroke Program Early CT Score, Baseline Glucose, Poor Collateral Circulation, Passes With Retriever, and Onset-to-Groin Puncture Time (ASIAN) score. The ASIAN score demonstrated good discrimination in the derivation cohort (C index, 0.771 [95% CI, 0.716–0.826]), as well as the validation cohort (C index, 0.758 [95% CI, 0.691–0.825]). Conclusions: The ASIAN score reliably predicts the risk of sICH in Chinese ischemic stroke patients treated by EVT.


2019 ◽  
Vol 15 (3) ◽  
pp. 324-331 ◽  
Author(s):  
Dylan N Wolman ◽  
David G Marcellus ◽  
Maarten G Lansberg ◽  
Gregory Albers ◽  
Adrien Guenego ◽  
...  

Background Acute ischemic stroke patients with a large-vessel occlusion but mild symptoms (NIHSS ≤ 6) pose a treatment dilemma between medical management and endovascular thrombectomy. Aims To evaluate the differences in clinical outcomes of endovascular thrombectomy-eligible patients with target-mismatch perfusion profiles who undergo either medical management or endovascular thrombectomy. Methods Forty-seven patients with acute ischemic stroke due to large-vessel occlusion, NIHSS ≤ 6, and a target-mismatch perfusion imaging profile were included. Patients underwent medical management or endovascular thrombectomy following treating neurointerventionalist and neurologist consensus. The primary outcome measure was NIHSS shift. Secondary outcome measures were symptomatic intracranial hemorrhage, in-hospital mortality, and 90-day mRS scores. The primary intention-to-treat and as-treated analyses were compared to determine the impact of crossover patient allocation on study outcome measures. Results Forty-seven patients were included. Thirty underwent medical management (64%) and 17 underwent endovascular thrombectomy (36%). Three medical management patients underwent endovascular thrombectomy due to early clinical deterioration. Presentation NIHSS ( P = 0.82), NIHSS shift ( P = 0.62), and 90-day functional independence (mRS 0–2; P = 0.25) were similar between groups. Endovascular thrombectomy patients demonstrated an increased overall rate of intracranial hemorrhage (35.3% vs. 10.0%; P = 0.04), but symptomatic intracranial hemorrhage was similar between groups ( P = 0.25). In-hospital mortality was similar between groups ( P = 0.46), though all two deaths in the medical management group occurred among crossover patients. Endovascular thrombectomy patients demonstrated a longer length of stay (7.6 ± 7.2 vs. 4.3 ± 3.9 days; P = 0.04) and a higher frequency of unfavorable discharge to a skilled-nursing facility ( P = 0.03) rather than home ( P = 0.05). Conclusions Endovascular thrombectomy may pose an unfavorable risk-benefit profile over medical management for endovascular thrombectomy-eligible acute ischemic stroke patients with mild symptoms, which warrants a randomized trial in this subpopulation.


Author(s):  
Shreyansh Shah ◽  
Li Liang ◽  
Andrzej Kosinski ◽  
Adrian F. Hernandez ◽  
Lee H. Schwamm ◽  
...  

Background Guidelines recommend against the use of intravenous tPA (tissue-type plasminogen activator; IV tPA) in acute ischemic stroke patients with prior ischemic stroke within 3 months. However, there are limited data on the safety of IV tPA in this population. Methods and Results A retrospective observational study of patients ≥66 years of age linked to Medicare claims and treated with IV tPA at Get With The Guidelines–Stroke hospitals (February 2009 to December 2015). We identified 293 patients treated with IV tPA who had a prior ischemic stroke within 3 months and 30 655 with no history of stroke. Patients with prior stroke had a higher stroke severity (median National Institutes of Health Stroke Scale, 11 [6–19] versus 11 [6–18]; absolute standardized difference, 11.2%) and a higher prevalence of cardiovascular comorbidities. Patients with prior stroke had a higher unadjusted risk for symptomatic intracranial hemorrhage (7.7% versus 4.8%) and in-hospital mortality (12.6% versus 8.9%), but these differences were not statistically significant after adjustment. When stratified by prespecified time epochs, the elevated risk for symptomatic intracranial hemorrhage was seen only within the first 14 days (16.3% versus 4.8%; adjusted odds ratio [aOR], 3.7 [95% CI, 1.62–8.43]) but not in other epochs (2.1% versus 4.8%; aOR, 0.38 [95% CI, 0.05–2.79] for 15–30 days and 7.4% versus 4.8%; aOR, 1.36 [95% CI, 0.77–2.40] for 31–90 days). In addition, patients with prior stroke were significantly more likely to have a combined outcome of in-hospital mortality or discharge to hospice (25.9% versus 17.0%; aOR, 1.70 [95% CI, 1.21–2.38]), less likely to be discharged to home (28.3% versus 32.3%; aOR, 0.72 [95% CI, 0.54–0.98]), or to have good functional outcomes at discharge (modified Rankin Scale, 0–1; 11.3% versus 20.0%; aOR, 0.46 [95% CI, 0.24–0.89]). Conclusions Stroke providers need to continue to be vigilant about the safety of IV tPA in patients with prior stroke, particularly those with an event in the previous 14 days.


Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Jose G Romano ◽  
Eric E Smith ◽  
Li Liang ◽  
Hannah Gardener ◽  
Sara Camp ◽  
...  

Objective: Mild stroke has traditionally been excluded from thrombolytic treatment trials and only few series have reported outcomes after IV rtPA in this group. The objectives of this study are to determine the proportion of mild stroke patients treated with IV rtPA and evaluate complications and short-term outcomes in this population. Methods: We analyzed patients in the Get With The Guidelines-Stroke registry that arrived within 4.5 hours from symptom onset with a mild ischemic stroke defined as a baseline NIHSS ≤5 who received IV rtPA between May 2010 and October 2012. The following outcomes and complications were analyzed: in-hospital mortality, home discharge, independent ambulation, length of stay (LOS), in-hospital death, and symptomatic intracranial hemorrhage (sICH) <36 h. Multivariable analysis was performed for predictors of outcomes and complications. Results: Of 147,917 patients who arrived <4.5 hours, 39,821 were treated with IV rtPA, of whom 8,243 (20.7%) had an NIHSS ≤5. We analyzed 5,910 treated patients with NIHSS ≤5 and complete data. The mean baseline NIHSS was 3.5 (median 4); 98.2% arrived within 3 hours and 78.6% were treated within 3 hours. Outcomes and predictors of worse outcome are described in the table. There was no difference in short-term outcomes amongst those treated at 0-3 vs. 3-4.5 hours. Conclusions: A sizeable minority of ischemic stroke patients treated with IV rtPA have a NIHSS ≤5. sICH occurred at a low rate of 1.8% and about 30% of these patients were unable to return home and could not ambulate independently. Longer-term outcomes are needed to define predictors of poor outcome in this population and which patients may benefit most from treatment.


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.


Stroke ◽  
2020 ◽  
Vol 51 (11) ◽  
pp. 3440-3451
Author(s):  
Steven J. Warach ◽  
Adrienne N. Dula ◽  
Truman J. Milling

Tenecteplase is a fibrinolytic drug with higher fibrin specificity and longer half-life than the standard stroke thrombolytic, alteplase, permitting the convenience of single bolus administration. Tenecteplase, at 0.5 mg/kg, has regulatory approval to treat ST-segment–elevation myocardial infarction, for which it has equivalent 30-day mortality and fewer systemic hemorrhages. Investigated as a thrombolytic for ischemic stroke over the past 15 years, tenecteplase is currently being studied in several phase 3 trials. Based on a systematic literature search, we provide a qualitative synthesis of published stroke clinical trials of tenecteplase that (1) performed randomized comparisons with alteplase, (2) compared different doses of tenecteplase, or (3) provided unique quantitative meta-analyses. Four phase 2 and one phase 3 study performed randomized comparisons with alteplase. These and other phase 2 studies compared different tenecteplase doses and effects on early outcomes of recanalization, reperfusion, and substantial neurological improvement, as well as symptomatic intracranial hemorrhage and 3-month disability on the modified Rankin Scale. Although no single trial prospectively demonstrated superiority or noninferiority of tenecteplase on clinical outcome, meta-analyses of these trials (1585 patients randomized) point to tenecteplase superiority in recanalization of large vessel occlusions and noninferiority in disability-free 3-month outcome, without increases in symptomatic intracranial hemorrhage or mortality. Doses of 0.25 and 0.4 mg/kg have been tested, but no advantage of the higher dose has been suggested by the results. Current clinical practice guidelines for stroke include intravenous tenecteplase at either dose as a second-tier option, with the 0.25 mg/kg dose recommended for large vessel occlusions, based on a phase 2 trial that demonstrated superior recanalization and improved 3-month outcome relative to alteplase. Ongoing randomized phase 3 trials may better define the comparative risks and benefits of tenecteplase and alteplase for stroke thrombolysis and answer questions of tenecteplase efficacy in the >4.5-hour time window, in wake-up stroke, and in combination with endovascular thrombectomy.


Biomolecules ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 347
Author(s):  
Zsuzsa Bagoly ◽  
Barbara Baráth ◽  
Rita Orbán-Kálmándi ◽  
István Szegedi ◽  
Réka Bogáti ◽  
...  

Cross-linking of α2-plasmin inhibitor (α2-PI) to fibrin by activated factor XIII (FXIIIa) is essential for the inhibition of fibrinolysis. Little is known about the factors modifying α2-PI incorporation into the fibrin clot and whether the extent of incorporation has clinical consequences. Herein we calculated the extent of α2-PI incorporation by measuring α2-PI antigen levels from plasma and serum obtained after clotting the plasma by thrombin and Ca2+. The modifying effect of FXIII was studied by spiking of FXIII-A-deficient plasma with purified plasma FXIII. Fibrinogen, FXIII, α2-PI incorporation, in vitro clot-lysis, soluble fibroblast activation protein and α2-PI p.Arg6Trp polymorphism were measured from samples of 57 acute ischemic stroke patients obtained before thrombolysis and of 26 healthy controls. Increasing FXIII levels even at levels above the upper limit of normal increased α2-PI incorporation into the fibrin clot. α2-PI incorporation of controls and patients with good outcomes did not differ significantly (49.4 ± 4.6% vs. 47.4 ± 6.7%, p = 1.000), however it was significantly lower in patients suffering post-lysis intracranial hemorrhage (37.3 ± 14.0%, p = 0.004). In conclusion, increased FXIII levels resulted in elevated incorporation of α2-PI into fibrin clots. In stroke patients undergoing intravenous thrombolysis treatment, α2-PI incorporation shows an association with the outcome of therapy, particularly with thrombolysis-associated intracranial hemorrhage.


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