Frequency Of Symptomatic Intracranial Hemorrhage Research Articles

Symptomatic Intracranial Hemorrhage after Mechanical Thrombectomy - the Difference between Iso-Osmolar and Low-Osmolar Contrast Media.

Symptomatic intracranial hemorrhage (SICH) after mechanical thrombectomy (MT) is generally considered a critical complication. Hemorrhagic transformation after ischemic stroke has also been associated with contrast media administration. The objective of our study was to evaluate correlations between contrast media type and incidence of SICH after MT. Ninety-three consecutive patients (41 men; mean age, 80.2 years; range, 44-98 years) underwent MT reperfusion (expanded thrombolysis in cerebral infarction score, 2a-3) for acute large-vessel occlusion ischemic stroke within 8 h after symptom onset between April 2020 and July 2023 were retrospectively reviewed. Correlations between contrast media type (iso-osmolar or low-osmolar medium) and incidence of SICH were assessed. Contrast media were iso-osmolar in 60 cases or low-osmolar in 33 cases. The overall incidence of SICH was 5.5%. The frequency of SICH was significantly lower in the iso-osmolar group (1.7%) than in the low-osmolar group (12.1%; P = 0.033). Iso-osmolar contrast media was associated with a lower incidence of SICH compared with low-osmolar contrast media in patients after MT.

Extended Window Thrombolytics for Ischemic Stroke: A Telestroke versus In-person Experience.

Telestroke evaluation of patients with acute ischemic stroke is supported by American Heart and Stroke Association Guidelines. However, there is no data on outcomes or safety of administering IV thrombolytic stroke therapy using extended window criteria (>4.5h since onset of symptoms with a hyperacute MRI diffusion T2/FLAIR mismatch) via telestroke. Here, we report adverse events and outcomes of extended-window thrombolysis by telestroke vs in-person care. We performed a retrospective cohort review from 2020 to 2022 of prospectively collected multinstitutional databases from a large, not-for-profit health system with both in-person stroke and telestroke care. The primary outcome was frequency of symptomatic intracranial hemorrhage (sICH). Secondary outcomes were favorable functional outcome at hospital discharge (modified Rankin Scale, mRS, 0-3) and discharge disposition. A total of 33 patients were treated with extended-window thrombolysis (n = 20 in-person, n = 13 telestroke). The median NIH stroke scale was 6, and time since last known normal was similar (median [95% CI]: in-person 13h [11-15h] vs telestroke 12h [9-16h], P = .33). The sICH frequency was low and occurred in one patient (4.8% in-person vs 0% by telestroke). Favorable outcome at discharge was not different between in-person and telestroke care (median mRS [95% CI]: 2 [1-3] vs 1 [0-2], OR .0 [.0-1.8], P = .27), and discharge deposition was also similar. In patients eligible for extended window acute stroke treatment with thrombolytics, there was no difference in adverse events between telestroke and in-person care.

Symptomatic Intracranial Hemorrhage after Ischemic Stroke Treated with Bridging Revascularization Therapy.

(1) Background: bridging revascularization therapy is now the standard of care in patients with ischemic stroke due to large vessel occlusion. This study aimed to determine the frequency of symptomatic intracranial hemorrhage (sICH) related to this treatment, and to assess contributing factors and patients' outcomes. (2) Methods: consecutive ischemic stroke patients treated with bridging therapy were prospectively enrolled. sICH (intracranial hemorrhage with an increase in NIHSS score of ≥4 points) was assessed on imaging at 24 h. The functional status of patients was measured at 6 months using the mRS score; (3) Results: 176 patients were included (mean age 68.7 ± 1.2 years, 52.3% women), among whom 15 (8.5%) had sICH. Patients with sICH had more frequent alcohol abuse (30.1% versus 9.7%, p = 0.023), prestroke use of dual antiplatelet therapy (14.3% versus 1.3%, p = 0.002), higher NIHSS scores at admission (median score 20.5 versus 15, p = 0.01), greater systolic blood pressure upon admission, more frequent vascular intracranial calcifications (p = 0.004), leukoaraiosis (p = 0.001), and intracranial atheroma (p = 0.02), and higher neutrophil-to-lymphocyte ratios (p = 0.02) and neutrophil-to-platelet ratios (p = 0.04). At 6-month follow-up, 9 (60%) patients with sICH died, versus 18% of patients without sICH (p < 0.001). Only 1 (7%) patient with sICH had a good functional outcome, defined as an mRS score of 0 to 2, versus 51% of patients without sICH. (4) Conclusions: one in twelve ischemic stroke patients treated with bridging therapy suffered sICH. Given the observed poor outcomes after sICH, further studies are required to better identify patients at risk to help clinicians in guiding therapeutic strategies.

Functional and technical outcomes in acute ischemic stroke patients with hyperdense middle cerebral artery sign treated with endovascular thrombectomy.

The hyperdense middle cerebral artery sign (HMCAS) is observed in a proportion of patients with acute ischemic stroke (AIS). This sign reflects the presence of an intravascular thrombus rich in red blood cells. Several studies have demonstrated that HMCAS increases the risk of poor outcomes in AIS patients treated with IV thrombolysis or no reperfusion therapy; however, whether HMCAS predicts a poor outcome in patients treated with endovascular thrombectomy (EVT) is less clear. We aimed to evaluate the functional outcome by the modified Rankin scale (mRS) at 90 days and technical challenges in patients with HMCAS undergoing EVT. We studied 143 consecutive AIS patients with middle cerebral artery M1 segment or internal carotid artery + M1 occlusions who underwent EVT. There were 73 patients (51%) with HMCAS. Patients with HMCAS had a higher frequency of cardioembolic stroke (p = 0.038); otherwise, no other baseline difference was observed. No differences in functional outcomes (mRS) at 90 days (p = 0.698), unfavorable outcomes (mRS > 2) (p = 0.929), frequency of symptomatic intracranial hemorrhage (p = 0.924), and mortality (mRS-6) (p = 0.736) were observed between patients with and without HMCAS. In patients with HMCAS, EVT procedures were 9 min longer, requiring a higher number of passes (p = 0.073); however, optimal recanalization scores (modified thrombolysis in cerebral infarction: 2b-3) were equally achieved by both groups. Patients with HMCAS treated with EVT do not have a worse outcome at 3 months compared with no-HMCAS patients. Patients with HMCAS required a greater number of thrombus passes and longer procedure times.

Outcomes of Endovascular Treatment for Posterior Circulation Stroke According to the Underlying Pathologic Mechanism: A Retrospective Single-Center Analysis

Objectives. This study investigated the functional outcomes and safety of endovascular treatment in patients with posterior circulation stroke according to whether the underlying mechanism was arterial embolism or intrinsic atherosclerosis. Materials and Methods. A total of 108 consecutive patients with posterior circulation ischemic stroke who received endovascular treatment between January 2018 and December 2021, 58 with arterial embolism and 50 with intrinsic atherosclerosis, were identified. The overall and basilar artery occlusion subgroup analyses were retrospectively conducted between the two study groups using a logistic regression model. Results. The rate of successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b–3) was comparable in the embolism versus intrinsic group (96.6% versus 90.0%; adjusted odds ratio [aOR] 0.73, 95% confidence interval [CI] 0.01–42.74; P = 0.88 ). There was no significant difference in the frequency of a moderate outcome between the two groups (modified Rankin Scale [mRS] score 0–3: 43.1% versus 58.0%; aOR 0.63, 95% CI 0.15–2.50; P = 0.51 ), frequency of a favorable outcome (mRS 0–2: 39.7% versus 38.0%; aOR 1.59, 95% CI 0.37–6.70; P = 0.52 ), the 90-day mortality rate (34.5% versus 26.0%; aOR 2.31, 95% CI 0.50–10.63; P = 0.28 ), or frequency of symptomatic intracranial hemorrhage (6.9% versus 2.0%, respectively; P = 0.37 ). The subgroup analysis in patients with basilar artery occlusion found no significant between-group difference in any of the abovementioned clinical outcomes (all P &gt; 0.05 ). Conclusion. This study indicated that the mechanism of posterior circulation stroke had no significant effect on the functional outcomes after endovascular treatment or on procedural safety.

Tenecteplase versus alteplase after acute ischemic stroke at high age.

Stroke prevalence is increasing with age. Alteplase is the only agent approved for thrombolytic treatment for patients with ischemic stroke, including patients ≥80 years. In the present study, the aim was to compare efficacy and safety of tenecteplase and alteplase in patients ≥80 years. Data from the Norwegian Tenecteplase Stroke Trial, a randomized controlled trial comparing alteplase and tenecteplase, were assessed. Of the 273 patients ≥80 years included, mean age was 85.5 years.In the intention-to-treat analyses, 43.1% receiving tenecteplase and 39.9% receiving alteplase reached excellent functional outcome (modified Rankin Scale score 0-1) after 3 months (odds ratio (OR) 1.14, 95% confidence interval (CI) 0.70-1.85, p=0.59). No significant differences among patients in the two treatment groups regarding frequency of symptomatic intracranial hemorrhage during the first 48 h were identified (11 (8.5%) in the tenecteplase group, 10 (7.0%) in the alteplase group, OR 1.23, 95% CI 0.50-3.00, p 0.65). Death within 3 months occurred in 18 patients (14.3%) in the tenecteplase group and in 21 (15.3%) in the alteplase group (p 0.84). After excluding stroke mimics, the proportion of patients with excellent functional outcome was 44.1% in the tenecteplase group and 34.4% in the alteplase group (OR 1.50 CI 0.90-2.52, p 0.12). No differences in the efficacy and safety of tenecteplase versus alteplase in patients ≥80 years were identified. Clinicaltrials.gov (NCT01949948).

Stent-retriever assisted vacuum-locked extraction (SAVE) versus a direct aspiration first pass technique (ADAPT) for acute stroke: data from the real-world

BackgroundEmbolectomy is the standard of care in acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Aim of this study was to compare two techniques: A Direct Aspiration First Pass Technique (ADAPT) and Stent-retriever Assisted Vacuum-locked Extraction (SAVE) stratified by the occluded vessel.MethodsOne hundred seventy-one patients (71 male) treated between January 2014 and September 2017 with AIS due to LVO of the anterior circulation (55 carotid T, 94 M1, 22 M2) were included. Treatment techniques were divided into two categories: ADAPT and SAVE. Primary endpoints were successful reperfusion (mTICI ≥2b), near-perfect reperfusion (mTICI ≥2c) and groin puncture to reperfusion time. Secondary endpoints were the number of device-passes, first-pass reperfusion, the frequency of emboli to new territory (ENT), clinical outcome at 90 days, and the frequency of symptomatic intracranial hemorrhage (sICH). Analysis was performed on an intention to treat basis.ResultsOverall, SAVE resulted in significant higher rates of successful reperfusion (mTICI≥2b) compared to ADAPT (93.5% vs 75.0%; p = 0.006). After stratification for the occluded vessel only the carotid T remained significant with higher rates of near-perfect reperfusion (mTICI≥2c) (55.2% vs 15.4%; p = 0.025), while for successful reperfusion a trend remained (93.1% vs 65.4%; p = 0.10). Groin to reperfusion times were not significantly different. Secondary analysis revealed higher rates of first-pass successful reperfusion (59.6% vs 33.3%; p = 0.019), higher rates of first-pass near-perfect reperfusion in the carotid T (35.4% vs 16.7%; p = 0.038) and a lower number of device-passes overall (median 1 IQR 1–2 vs 2 IQR 2–3; p < 0.001) and in the carotid T (median 2 IQR 1.3 vs 3 IQR 2–5; p < 0.001) for SAVE. Clinical outcome and safety parameters were comparable between groups.ConclusionsEmbolectomy using SAVE appears superior to ADAPT, especially for carotid T occlusions with regard to reperfusion success.

Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging

BackgroundThrombectomy is currently recommended for eligible patients with stroke who are treated within 6 hours after the onset of symptoms.MethodsWe conducted a multicenter, randomized, open-label trial, with blinded outcome assessment, of thrombectomy in patients 6 to 16 hours after they were last known to be well and who had remaining ischemic brain tissue that was not yet infarcted. Patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion, an initial infarct size of less than 70 ml, and a ratio of the volume of ischemic tissue on perfusion imaging to infarct volume of 1.8 or more were randomly assigned to endovascular therapy (thrombectomy) plus standard medical therapy (endovascular-therapy group) or standard medical therapy alone (medical-therapy group). The primary outcome was the ordinal score on the modified Rankin scale (range, 0 to 6, with higher scores indicating greater disability) at day 90.ResultsThe trial was conducted at 38 U.S. centers and terminated early for efficacy after 182 patients had undergone randomization (92 to the endovascular-therapy group and 90 to the medical-therapy group). Endovascular therapy plus medical therapy, as compared with medical therapy alone, was associated with a favorable shift in the distribution of functional outcomes on the modified Rankin scale at 90 days (odds ratio, 2.77; P<0.001) and a higher percentage of patients who were functionally independent, defined as a score on the modified Rankin scale of 0 to 2 (45% vs. 17%, P<0.001). The 90-day mortality rate was 14% in the endovascular-therapy group and 26% in the medical-therapy group (P=0.05), and there was no significant between-group difference in the frequency of symptomatic intracranial hemorrhage (7% and 4%, respectively; P=0.75) or of serious adverse events (43% and 53%, respectively; P=0.18).ConclusionsEndovascular thrombectomy for ischemic stroke 6 to 16 hours after a patient was last known to be well plus standard medical therapy resulted in better functional outcomes than standard medical therapy alone among patients with proximal middle-cerebral-artery or internal-carotid-artery occlusion and a region of tissue that was ischemic but not yet infarcted. (Funded by the National Institute of Neurological Disorders and Stroke; DEFUSE 3 ClinicalTrials.gov number, NCT02586415.)

Variability of stroke patients meeting endovascular stroke trial criteria in a non-clinical trial setting

BackgroundFive randomized trials proving the efficacy and safety of mechanical embolectomy for ischemic stroke within 8hours used differing radiological methods to select patients. We aimed to evaluate the proportion of patients in clinical practice that would meet radiological criteria for inclusion in these trials. MethodsRetrospective study of ischemic stroke patients at a large academic medical center who were considered for endovascular stroke therapy based on confirmed intracranial large vessel occlusion from April 2010–November 2014. All patients underwent computed tomography (CT) perfusion and CT angiogram. ResultsOf 119 patients, median age was 69 years (IQR 57–79) and median NIHSS 18 (IQR 14–21). Most patients had ASPECTS≥6 (n=105, 88.2%). All 119 patients met radiological criteria for MR CLEAN while 105 (88.2%) met criteria for SWIFT-PRIME, 96 (80.7%) for REVASCAT, 80/116 (69.0%) for EXTEND-IA, and 74 (62.2%) for ESCAPE. About half (n=58,48.7%) were treated with IV rtPA and 66 (56%) underwent endovascular therapy. Any intracranial hemorrhage was more common in patients undergoing endovascular therapy than in those who were not (36% vs. 17%, P=0.034). The frequency of symptomatic intracranial hemorrhage (ICH) did not significantly differ between these groups (6% vs. 4%, P=0.691). ConclusionsThe proportion of patients with acute stroke and large vessel occlusion presenting within 8 hours that would meet radiological criteria for endovascular stroke trials varies considerably (62–100%) in a cohort outside of clinical trials from an academic comprehensive stroke center. Thus, the radiological criteria used for candidate selection in daily practice will greatly influence the proportion of patients treated with endovascular therapy.

Mechanical thrombectomy for basilar artery thrombosis: a comparison of outcomes with anterior circulation occlusions

Background and purposeThe benefits of mechanical thrombectomy (MT) in basilar artery occlusions (BAO) have not been explored in recent clinical trials. We compared outcomes and procedural complications of MT in...

Desmoteplase 3 to 9 Hours After Major Artery Occlusion Stroke

The DIAS-3 trial (Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke [phase 3]) did not demonstrate a significant clinical benefit of desmoteplase administered 3 to 9 hours after stroke in patients with major artery occlusion. We present the results of the prematurely terminated DIAS-4 trial together with a post hoc pooled analysis of the concomitant DIAS-3, DIAS-4, and DIAS-J (Japan) trials to better understand the potential risks and benefits of intravenous desmoteplase for the treatment of ischemic stroke in an extended time window. Ischemic stroke patients with occlusion/high-grade stenosis in major cerebral arteries were randomly assigned to intravenous treatment with desmoteplase (90 μg/kg) or placebo. The primary outcome was modified Rankin Scale (mRS) score of 0 to 2 at day 90. Safety assessments included mortality, symptomatic intracranial hemorrhage, and other serious adverse events. In DIAS-4, 52 of 124 (41.9%) desmoteplase-treated and 46 of 128 (35.9%) placebo-treated patients achieved an mRS score of 0 to 2 (odds ratio, 1.45; 95% confidence interval, 0.79; 2.64; P=0.23) with equal mortality, frequency of symptomatic intracranial hemorrhage, and other serious adverse events in both the treatment arms. In the pooled analysis, mRS score of 0 to 2 was achieved by 184 of 376 (48.9%) desmoteplase-treated versus 171 of 381 (44.9%) placebo-treated patients (odds ratio, 1.33; 95% confidence interval, 0.95; 1.85; P=0.096). Treatment with desmoteplase was safe and increased the recanalization rate (107/217 [49.3%] versus 85/222 [38.3%]; odds ratio, 1.59; 95% confidence interval, 1.08-2.35; P=0.019). Recanalization was associated with favorable outcomes (mRS 0-2) at day 90 in both the treatment arms. Late treatment with intravenous 90 µg/kg desmoteplase is safe, increases arterial recanalization, but does not significantly improve functional outcome at 3 months. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856661.

Abstract T P67: Similar Outcomes With tPA Protocol Violations as with Protocol Adherence

Background: Nearly twenty years after demonstrating the efficacy of IV tPA in clinical trials, it continues to be widely underused. Fibrinolytic therapy is heavily restricted by a long list of laboratory, radiographic, and clinical inclusion/exclusion criteria. We sought to evaluate whether patients who received IV-tPA in violation of these criteria had different outcomes. Methods: We included all ischemic stroke patients who received IV tPA (no intra-arterial therapy) and were followed to 90 -days. Group A: IV-tPA use despite contraindication (protocol violation), Group B: IV-tPA protocol-adherent. We compared baseline variables and demographics (age, sex, race, ethnicity, diabetes, hypertension, atrial fibrillation, cerebrovascular disease, baseline NIHSS, and smoking). We analyzed the frequency of symptomatic intracranial hemorrhage (sICH) and gastrointestinal bleeding (GIB). Measures of good clinical outcome included modified Rankin Scale (mRS) 0-1 and discharge home. Results: A total of 660 tPA-treated patients were included from October 2003 to August 2014, Group A included 22 patients; group B included 638. Group A had 2 patients under 18 years of age, 4 with bleeding risks (low platelets, elevated PTT, or known bleeding diathesis), 4 with recent surgery, trauma, or clinical bleeding, 2 with recent stroke or past ICH, one patient with abnormal glucose accounting for the deficit, and 11 patients outside the time window, rapidly improving, or no disabling deficit. Baseline demographics and stroke severity were similar, except for diabetes, which was more common in Group A (45.5% vs. 24.3%, p=0.04). There was no difference in sICH (4.55 vs. 3.46%, p=0.55) or GIB (0 vs. 0.6%, p&gt;0.99). Good clinical outcomes were similar (mRS 0-1 38.5% vs. 33.2%, p=0.77; discharge home 65.0 vs 61.8%, p=0.82). Conclusions: Clinical outcomes and bleeding risks were similar between patients who received IV tPA despite contraindications. Our analysis is limited by small numbers in Group A. Larger patient samples are needed to better understand the role of individual contraindications.

Mild stroke: safety and outcome in patients receiving thrombolysis

The aim of this study was to compare the short-term clinical outcome of patients with acute cerebral ischemia and mild symptoms receiving rt-PA with that of patients with acute cerebral ischemia and mild symptoms not treated with rt-PA, and to investigate the frequency of symptomatic intracranial hemorrhage (sICH) in these patients. All patients with confirmed ischemic stroke/TIA and mild symptoms were included. Mild symptoms were defined as NIHSS score≤5 on admission. Functional outcome was assessed with modified Rankin Scale (mRS) at day 7 or at earlier discharge. Excellent outcome was defined as mRS=0. sICH was defined according to both NINDS and ECASS III criteria. Of 2753 patients with confirmed ischemic stroke/TIA admitted between February 2006 and February 2013, 966 (35.3%) were excluded because of having admission NIHSS>5. A total of 1791 patients presented with mild symptoms on admission (NIHSS≤5), of which 158 (8.8%) patients received rt-PA. Treatment with rt-PA and early admission were independently associated with excellent outcome. Higher NIHSS score on admission and prior ischemic stroke were independently associated with poor outcome. Three (1.9%) sICH were diagnosed in rt-PA-treated patients and one (0.1%) in patients not receiving rt-PA. This study highlights the efficacy of rt-PA in patients with acute cerebral ischemia presenting with mild symptoms and confirms the low-risk profile of this treatment.

Improved Clinical Outcome after Acute Basilar Artery Occlusion since the Introduction of Endovascular Thrombectomy Devices

Background: Thrombectomy devices are increasingly used for intra-arterial recanalization therapy in stroke. We analyzed whether the use of these devices modified the outcome of patients with acute basilar occlusion (BAO) at our institution. Methods: Between 1998 and 2012, one hundred forty-seven consecutive patients with acute BAO received recanalization therapy. In July 2009, for the first time, a thrombectomy device was used and hence the cohort was split into two chronological groups: BAO-1 (before July 2009) and BAO-2 (after July 2009). All patients were treated at a dedicated neurological ICU following institutional standard operating procedures. A good clinical outcome was defined as a modified Rankin scale score of 0-2 after 3 months. Univariate and multivariate analyses were applied using outcome parameters as dependent variables and baseline variables with a significant p value in univariate tests as independent variables. Results: One hundred eleven patients (BAO-1) were treated before and 36 were treated after July 2009 (BAO-2). Patients in the BAO-1 and BAO-2 groups had similar neurological deficits on admission as expressed by the Glasgow Coma Scale (BAO-1: median 4, IQR 5, vs. BAO-2: median 4.5, IQR 8, p = 0.41) and the proportion of patients who were presented intubated and ventilated was similar in both groups as well (49.5 vs. 47.7%, p = 0.85). Bridging concepts with intravenous recombinant tissue plasminogen activator (rtPA) were applied in 18.9% (BAO-1) versus 63.9% (BAO-2, p < 0.001) of cases, whereas glycoprotein IIb/IIIa antagonists were used significantly more frequently in the BAO-1 cohort (57.7 vs. 33.3%, p = 0.034). Thrombectomies were performed in 20 patients (55.5%) of the BAO-2 group but in none of the BAO-1 cohort. Complete recanalization (TICI 3) was achieved in 45.1% (BAO-1) versus 66.7% (BAO-2, p = 0.062) of patients. A good clinical outcome was observed in 13.5% of the BAO-1 group and 30.6% of the BAO-2 cohort (p = 0.026); mortality was 57.7% in the earlier group and 36.1% in the later group (p = 0.034). The frequency of symptomatic intracranial hemorrhage was similar in both groups (8.1% BAO-1 vs. 2.8% BAO-2, p = 0.45). Treatment in the BAO-2 cohort was an independent predictor of good clinical outcome (OR 2.56; 95% CI 1.01-6.78) and mortality (OR 0.36; 95% CI 0.15-0.86) in an adjusted logistic regression model. Conclusion: Our results show improved outcomes in patients in the BAO-2 cohort. The treatment approach in this group was an independent predictor of both good outcome and mortality. Especially in patients with BAO - where endovascular treatment strategies are common clinical practice - bridging protocols with rtPA and modern thrombectomy devices should be used more frequently.

Abstract 195: Reducing Frequency of Symptomatic Intracranial Hemorrhage in Patients With Acute Ischemic Stroke Treated by Recombinant Tissue-Plasminogen Activator; Interim Result of a Prospective Observational Cohort Study

[Introduction] Combination therapy with rt-PA and edaravone, a free radical scavenger, has become a prevalent treatment for acute ischemic stroke in Japan. PROTECT4.5 (Post marketing Registry OnTreatment with Edaravone in acute Cerebral infarction by the Time window of 4.5 hours) is a prospective observational cohort study to evaluate the efficacy and safety of the combination therapy. [Hypothesis] We assessed the hypothesis that combination therapy will reduce frequency of symptomatic intracranial hemorrhage in patients with acute ischemic stroke. [Methods] Patients treated by rt-PA and edaravone within 4.5 hours after onset of ischemic stroke were enrolled. The primary endpoints were proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months after onset, and frequency of symptomatic intracranial hemorrhage (sICH) within 36 hours after initiating treatment. Mortality at 3 months after onset was assessed as a secondary endpoint. [Results] Between Apr 2010 and May 2012, 2814 patients from 839 institutes received combination therapy with edaravone and rt-PA. The mean age was 71.9 years old; 62.2% were male. The median score of NIHSS at baseline was 13 and the median time from onset to treatment with rt-PA was 2.25 hours. The most common type of stroke was cardioembolic (57.7%). Concomitant hypertension was present in 58.3% and diabetes mellitus in 17.1%. Estimated glomerular filtration rate &lt; 60 mL/min/1.73m 2 was observed in 34.2% of patients. The proportion of patients with mRS 0-1 was 38.8% [709/1826, 95%Confidence Interval 36.6-41.1%]. Frequency of sICH and mortality were 1.7%[48/2814, 1.3-2.3%] and 8.9%[162/1826, 7.6-10.3%], respectively. [Conclusions] The severity and the proportion of mRS 0-1 in the patients enrolled in PROTECT4.5 were similar to those in the prospective single-arm open-label trial and the previous observational studies of rt-PA [J-ACT (Stroke 2006; 37:1810-1815), CASES (CMAJ 2005; 172:1307-12), STARS (JAMA 2000; 283:1145-50)], but frequency of sICH and mortality were lower.

Thrombolysis Outcomes among Obese and Overweight Stroke Patients: An Age- and National Institutes of Health Stroke Scale–matched Comparison

Whether obese and overweight stroke patients respond differently to intravenous thrombolysis is unclear. The purpose of this study is to determine the influence of obesity and risk components of metabolic syndrome to stroke recovery in patients undergoing intravenous thrombolysis. Outcomes after recombinant tissue plasminogen activator treatment were compared between obese (body mass index [BMI] >30 kg/m(2)), overweight (BMI 25-30 kg/m(2)), and normal weight (BMI <25 kg/m(2)) patients. The association between BMI, risk components of the metabolic syndrome, and dose of recombinant tissue plasminogen activator per kilogram of body weight to stroke outcomes were assessed in a multivariable model. A total of 169 patients (mean age 75 years; baseline National Institutes of Health Stroke Scale score 11) were included. No differences in the frequency of symptomatic intracranial hemorrhage and poor functional recovery were observed among obese, overweight, and normal weight patients. A linear trend toward worse stroke recovery was observed in patients with a greater number of metabolic risk components (P for trend .043). By contrast, there were no significant associations between the number of risk components of metabolic syndrome with respect to symptomatic intracranial hemorrhage. Using stepwise regression analyses, age, baseline stroke severity, and the number of risk components of the metabolic syndrome accounted for 52% variation in functional recovery after intravenous thrombolysis. Acute stroke outcomes do not differ between obese and overweight patients undergoing intravenous thrombolysis. The number of metabolic risk components contributes more significantly to functional recovery following intravenous thrombolysis.

Thrombolytic Therapy for Acute Stroke in the Elderly: An Emergent Condition in Developing Countries

Elderly patients may represent an important group when considering new stroke treatments, particularly in developing countries. The aim of this study was to analyze the use of recombinant tissue plasminogen activator (rtPA) in elderly Brazilian patients with acute ischemic stroke. Clinical and neuroimaging parameters at admission, frequency of symptomatic intracranial hemorrhage, and outcome were compared between elderly (≥80 years) and nonelderly (<80 years) stroke patients treated with rtPA in the Porto Alegre Stroke Network. We evaluated 183 nonelderly patients (mean age, 63 ± 12 years) and 55 elderly patients (mean age, 84 ± 3 years). Female sex, hypertension, congestive heart failure, atrial fibrillation, and previous history of stroke or transient ischemic attack were more frequent in the elderly patients. Elderly patients also presented with higher mean systolic blood pressure (P = .03) and National Institutes of Health Stroke Scale (NIHSS) score (P < .0001), whereas the nonelderly patients had a higher serum glucose level (P = .03). The rate of symptomatic intracranial hemorrhage was 10.9% in the elderly patients and 6.6% in the nonelderly patients (P = .28), and a substantial proportion of the elderly patients achieved a favorable outcome (modified Rankin Scale score ≤1) at 90 days, although this proportion was lower than that in the nonelderly patients (42% vs 58%; P = .04). Poorer outcomes were generally seen in elderly patients with an anterior circulation stroke, a higher NIHSS score, hypoattenuation in ≥1/3 lf the middle cerebral artery territory, and an Alberta Stroke Program Early CT score of ≤7 on an initial computed tomography scan. Our results support the administration of intravenous rtPA in selected elderly stroke patients presenting early to the hospital in developing countries.

Prior Statin Use, Intracranial Hemorrhage, and Outcome After Intra-Arterial Thrombolysis for Acute Ischemic Stroke

There are only limited data on whether prior statin use and/or cholesterol levels are associated with intracranial hemorrhage (ICH) and outcome after intra-arterial thrombolysis. The purpose of this study was to evaluate the association of statin pretreatment and cholesterol levels with the overall frequency of ICH, the frequency of symptomatic ICH, and clinical outcome at 3 months. We analyzed 311 consecutive patients (mean age, 63 years; 43% women) who received intra-arterial thrombolysis. Statin pretreatment was present in 18%. The frequency of any ICH was 20.6% and of symptomatic ICH 4.8%. Patients with any ICH were more often taking statins (30% versus 15%, P=0.005), more often had atrial fibrillation (45% versus 30%, P=0.016), had more severe strokes (mean National Institute of Health Stroke Scale score 16.5 versus 14.7, P=0.022), and less often good collaterals (16% versus 24%, P=0.001). Patients with symptomatic ICH were more often taking statins (40% versus 15%, P=0.009) and had less often good collaterals (0% versus 24%, P<0.001). Any ICH or symptomatic ICH were not associated with cholesterol levels. After multivariate analysis, the frequency of any ICH remained independently associated with previous statin use (OR, 3.1; 95% CI, 1.53 to 6.39; P=0.004), atrial fibrillation (OR, 2.5; CI, 1.35 to 4.75; P=0.004), National Institutes of Health Stroke Scale score (OR, 1.1; CI, 1.00 to 1.10; P=0.037), and worse collaterals (OR, 1.7; CI, 1.19 to 2.42; P=0.004). There was no association of outcome with prior statin use, total cholesterol level, or low-density lipoprotein cholesterol level. Prior statin use, but not cholesterol levels on admission, is associated with a higher frequency of any ICH after intra-arterial thrombolysis without impact on outcome.