Background and purpose
The nomogram is an important component of modern medical decision-making, which calculates the probability of an event entirely based on individual characteristics. We aimed to ...develop and validate a nomogram for individualized prediction of the probability of unfavorable outcome in intravenous thrombolysis-treated stroke patients included in the large multicenter Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register.
Methods
All patients registered in the Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register by 179 Italian centers between May 2001 and March 2016 were originally included. The main outcome measure was three-month unfavorable outcome (modified Rankin Scale 3–6). Four non-categorical predictors of unfavorable outcome (baseline National Institutes of Health (NIH) Stroke Scale score: 0–25, age ≥18 years, pre-stroke modified Rankin Scale score: 0–2, and onset-to-treatment time: 0–270 min) were identified a-priori by three neurologists with expertise in the management of stroke. To generate the NIHSS STroke Scale score, Age, pre-stroke mRS score, onset-to-treatment Time (START), the pre-established predictors were entered into a logistic regression model. The discriminative performance of the model was assessed using the area under the receiver operating characteristic curve.
Results
A total of 15,862 patients with complete data for generating the START was randomly dichotomized into training (2/3, n = 10,574) and test (1/3, n = 5288) sets. The area under the receiver operating characteristic curve of START was 0.800 (95% confidence interval: 0.792–0.809) in the training set and 0.815 (95% confidence interval: 0.804–0.822) in the test set.
Conclusions
By using a limited number of non-categorical predictors, the START is the first nomogram developed and validated in a large Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register cohort, which reliably calculates the probability of unfavorable outcome in intravenous thrombolysis-treated stroke patients.
Rationale and hypothesis
Thrombolytic therapy with recombinant tissue plasminogen activator (rt-PA) is an effective and approved therapy for acute ischemic stroke within 4.5 h of onset except for ...USA, Canada, Croatia, and Moldovia with a current 3 h label. We hypothesized that ischemic stroke patients selected with significant penumbral mismatch on magnetic resonance imaging (MRI) at 4.5–9 h after onset of stroke will have improved clinical outcomes when given intravenous rt-PA (alteplase) compared to placebo.
Study design
ECASS-4: ExTEND is an investigator driven, phase 3, randomized, multi-center, double-blind, placebo-controlled study. Ischemic stroke patients presenting within 4.5 and 9 h of stroke onset, who fulfil clinical requirements (National Institutes of Health Stroke Score (NIHSS) 4–26 and pre-stroke modified Rankin Scale (mRS) 0–1) will undergo MRI. Patients who meet imaging criteria (infarct core volume <100 ml, perfusion lesion: infarct core mismatch ratio >1.2 and perfusion lesion minimum volume of 20 ml) additionally will be randomized to either rt-PA or placebo.
Study outcome
The primary outcome measure will be the categorical shift in the mRS at day 90. Clinical secondary outcomes will be disability at day 90 dichotomized as favorable outcome mRS 0–1 at day 90. Tertiary endpoints include reduction in the NIHSS by 11 or more points or reaching 0–1 at day 90, reperfusion and recanalization at 24 h post stroke as well as depression, life quality, and cognitive impairment at day 90. Safety endpoints will include symptomatic intracranial hemorrhage (ICH) and death.
Background
The Careggi Collateral Score (CCS) (qualitative–quantitative evaluation) was developed from a single-centre cohort as an angiographic score to describe both the extension and effectiveness ...of the pial collateral circulation in stroke patients with occlusion of the anterior circulation. We aimed to examine the association between CCS (quantitative evaluation) and 3-month modified Rankin Scale (mRS) score in a large multi-center cohort of patients receiving thrombectomy for stroke with occlusion of middle cerebral artery (MCA).
Methods
We conducted a study on prospectively collected data from 1284 patients enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke. According to the extension of the retrograde reperfusion in the cortical anterior cerebral artery (ACA)-MCA territories, CCS ranges from 0 (absence of retrograde filling) to 4 (visualization of collaterals until the alar segment of the MCA).
Results
Using CCS of 4 as reference, CCS grades were associated in the direction of unfavourable outcome on 3-month mRS shift (0 to 6); significant difference was found between CCS of 0 and CCS of 1 and between CCS of 3 and CCS of 4. CCS ≥ 3 was the optimal cut-off for predicting 3-month excellent outcome, while CCS ≥ 1 was the optimal cut-off for predicting 3-month survival. CCS of 0 and CCS < 3 were associated in the direction of unfavourable recanalization on TICI shift (0 to 3) compared with CCS ≥ 1 and CCS ≥ 3, respectively. Compared with CCS ≥ 3 as reference, CCS of 0 and CCS 1 to 2 were associated in the direction of unfavourable recanalization on TICI shift. There was no evidence of heterogeneity of effects of successful recanalization and procedure time ≤ 60 min on 3-month mRS shift across CCS categories.
Conclusion
The CCS could provide a future advantage for improving the prognosis in patients receiving thrombectomy for stroke with M1 or M1–M2 segment of the MCA occlusion.
Mechanical thrombectomy is now standard of care for treatment of acute ischemic stroke secondary to large vessel occlusion in the setting of high NIHSS. We analysed a large nationwide registry ...focusing on patients with large vessel occlusion and low NIHSS on admission to evaluate the efficacy and safety of thrombectomy in this patient population
2826 patients treated with mechanical thrombectomy were included in a multicentre registry from January 1, 2011 to December 31, 2015. We included patients with large vessel occlusion and NIHSS ≤ 6 on admission. Baseline characteristics, imaging, clinical outcome, procedure adverse events and positive and negative outcome predictors were analysed.
134 patients were included. 90/134 had an anterior circulation and 44 a posterior circulation stroke. One patient died before treatment. Successful revascularization (mTICI 2b-3) was achieved in 73.7% (98/133) of the patients. Intraprocedural adverse event was observed in 3% (4/133) of cases. Symptomatic intracranial haemorrhage rate was 5.3% (7/133). At three months, 70.9% (95/134) of the patients had mRS score 0-2, 15.7% (21/134) mRS 3-5 and 13.4% (18/134) mRS 6. Age and successful recanalization were significant predictors of a good clinical outcome on both univariate (p= 0.005 and p=0.007) and multivariable (p=0.0018 and p=0.009 nat log) analysis. Absence of vessel recanalization and symptomatic intracranial hemorrhage were independent predictors of poor outcome (p=0.021) .
Our study suggests that patients with large vessel occlusion and low NIHSS score on admission can benefit from mechanical thrombectomy. Randomized trials are warranted.
In sub-Saharan Africa (SSA), stroke incidence is ~316 cases per 100,000 inhabitants and in 75% of SSA countries stroke is among the top three causes of death. This epidemiological evolution results ...from the exponential growth of the African population as well as the lack of policies for prevention and therapy. The Democratic Republic of Congo is one of the countries included as a “low-income country” in the 2023 Organization for Economic Co-operation and Development's Development Assistance Committee List; its capital, Kinshasa, is a megalopolis with more than 18 million inhabitants. According to our knowledge, no hospital in Kinshasa is currently capable of admitting and treating patients with stroke according to international guidelines. The Italian Stroke Association—Associazione Italiana Ictus (ISA-AII) is a multidisciplinary scientific society for the fight against cerebrovascular diseases. Some members of the ISA-AII joined to form a working group dedicated to the care of stroke in Africa. In this article, we explain the project designed by ISA Africa that, in collaboration with the referral hospital of a district of Kinshasa, has the aim of building a network for diagnosing and treating stroke, including ambulance services, a stroke team in the emergency room, a stroke unit, an outpatient clinic, and primary prevention activities among the population.
Acute ischemic stroke with isolated occlusion of the M2-segment middle cerebral artery (MCA) has not been a focus of trials on mechanical thrombectomy (MT) thus far. We aimed to assess outcomes in ...stroke patients treated with different endovascular procedures versus direct MT alone for isolated M2-MCA occlusion. We conducted a cohort study on data from 506 stroke patients with isolated M2-MCA occlusion who were enrolled in the Italian Registry of Endovascular Treatment in Acute Stroke cohort. We calculated odds ratio (OR) with confidence interval (CI) of different endovascular procedures (vs direct MT alone) for outcomes after adjustment for age, enrollment period, pre-stroke mRS score, NIHSS score, ASPECT score, onset-to-groin time, and procedure time. Endovascular procedures were direct MT alone (n = 156), intravenous thrombolysis (IVT) plus MT (n = 266), MT plus intra-arterial thrombolysis (IAT) (n = 43), and IAT alone (n = 41). MT plus IAT was associated with higher rates of TICI 2b/3 (OR 3.281, 95% CI 1.006–10.704), 3-month mRS 0–1 (OR 4.153, 95% CI 1.267–13.612), and 3-month mRS 0–2 (OR 4.497, 95% CI 1.485–13.617). IAT alone was associated with lower rates of TICI 3 (OR 0.348, 95% CI 0.139–0.874) and TICI 2b/3 (OR 0.369, 95% CI 0.144–0.948). IVT plus MT was associated with higher rate of asymptomatic ICH (OR 2.526, 95% CI 1.145–5.571). No significant difference was found between different endovascular procedures and direct MT alone as regards symptomatic ICH and 3-month death. In stroke patients with isolated M2-MCA occlusion, MT plus IAT was associated with better outcomes as compared with direct MT alone.
Background
Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown.
Aims
To assess the ...incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies.
Methods
At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression.
Results
Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52–1.7).
Conclusions
Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.
Registration: https://www.clinicaltrials.gov. Unique identifier: NCT 02313909
IntroductionPoststroke spasticity (PSS) affects up to 40% of patients who had a stroke. Botulinum neurotoxin type A (BoNT-A) has been shown to improve spasticity, but the optimal timing of its ...application remains unclear. While several predictors of upper limb PSS are known, their utility in clinical practice in relation to BoNT-A treatment has yet to be fully elucidated. The COLOSSEO-BoNT study aims to investigate predictors of PSS and the effects of BoNT-A timing on spasticity-related metrics in a real-world setting.Methods and analysisThe recruitment will involve approximately 960 patients who have recently experienced an ischaemic stroke (within 10 days, V0) and will follow them up for 24 months. Parameters will be gathered at specific intervals: (V1) 4, (V2) 8, (V3) 12, (V4) 18 months and (V5) 24 months following enrolment. Patients will be monitored throughout their rehabilitation and outpatient clinic journeys and will be compared based on their BoNT-A treatment status—distinguishing between patients receiving treatment at different timings and those who undergo rehabilitation without treatment. Potential predictors will encompass the Fugl-Meyer assessment, the National Institute of Health Stroke Scale (NIHSS), stroke radiological characteristics, performance status, therapies and access to patient care pathways. Outcomes will evaluate muscle stiffness using the modified Ashworth scale and passive range of motion, along with measures of quality of life, pain, and functionality.Ethics and disseminationThis study underwent review and approval by the Ethics Committee of the Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy. Regardless of the outcome, the findings will be disseminated through publication in peer-reviewed journals and presentations at national and international conferences.Trial registration numberNCT05379413.
Objective The purpose of this study was to examine the safety of emergency carotid endarterectomy (CEA) in patients with carotid stenosis and unstable neurological symptoms. Methods This prospective, ...single-center study involved patients with stroke in evolution (SIE) or fluctuating stroke or crescendo transient ischemic attack (cTIA) related to a carotid stenosis ≥50% who underwent emergency surgery. Preoperative workup included National Institute of Health Stroke Scale (NIHSS) neurological assessment on admission, immediately before surgery and at discharge, carotid duplex scan, brain contrast-enhanced head computed tomography (CT) or magnetic resonance imaging (MRI). End points were perioperative (30-day) neurological mortality, NIHSS score variation, and hemorrhagic or ischemic stroke recurrence. Patients were evaluated according to clinical presentation (SIE or cTIA), timing of surgery, and presence of brain infarction on neuroimaging. Results Between January 2005 and December 2009, 48 patients were submitted to emergency surgery. CEAs were performed from 1 to 24 hours from onset of symptoms (mean, 10.16 ± 7.75). Twenty-six patients presented an SIE with a worsening NIHSS score between admission and surgery, and 22 presented ≥3 cTIAs with a normal NIHSS score (= 0) immediately before surgery. An ischemic brain lesion was detected in four patients with SIE and eight patients with cTIA. All patients with cTIA presented a persistent NIHSS normal score before and after surgery. Twenty-five patients with SIE presented an NIHSS score improvement after surgery. Mean NIHSS score was 5.30 ± 2.81 before surgery and 0.54 ± 0.77 at discharge in the SIE group ( P < .0001). One patient with SIE had a hemorrhagic transformation of an undetected brain ischemic lesion after surgery, with progressive neurological deterioration and death (2%). Conclusions Due to the absence of randomized controlled trials of CEA for neurologically unstable patients, data currently available do not support a policy of emergency CEA in those patients. Our results suggest that a fast protocol, including CT scans and carotid duplex ultrasound scans in neurologically unstable patients, could help identify those that can be safely submitted to emergency CEA.
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