Symptomatic intracranial hemorrhage following intravenous thrombolysis for acute ischemic stroke: a critical review of case definitions.
Symptomatic intracranial hemorrhage (SICH) is a devastating complication of intravenous thrombolysis treatment that is associated with high mortality. Clinical trials, stroke registries and cohort studies employ different case definitions to identify stroke patients with SICH following intravenous thrombolysis. We systematically reviewed the reported rates of SICH following intravenous thrombolysis and compared their consistency with mortality outcomes.
Studies were identified from the PubMed and Embase databases from January 1994 to July 2011 by cross-referencing the following MeSH terms: 'thrombolysis', 'recombinant tissue plasminogen activator', 'rtPA', 'hemorrhagic stroke', 'cerebral hemorrhage', 'hematoma' and 'ischemic stroke'. Demographic information, baseline National Institute of Health Stroke Scale (NIHSS) scores, time from stroke onset to intravenous thrombolysis, SICH and mortality rates were derived from published data in 7 randomized controlled trials, 7 stroke registries and 10 cohort studies (4 multicenter and 6 single center) with more than 200 consecutively recruited patients. Mortality rates were considered as the percentage of patients treated with intravenous thrombolysis who died within 90 days after stroke.
The mean age of patients included in this analysis was 68.8 years (standard deviation, SD 2.9, range 63-75), of whom 56.3% (SD 4.5, range 45-63) were men. They presented with a mean baseline NIHSS of 12.5 (SD 1.4, range 9-15) and received intravenous thrombolysis 175 min (SD 62, range 120-328) from stroke onset. The overall mean SICH and mortality rates of patients treated with intravenous thrombolysis were 5.6% (SD 2.3) and 14.7% (SD 4.8), respectively. A moderate correlation was observed between the incidence of SICH and mortality in patients treated with intravenous thrombolysis (r = 0.401, p = 0.050). The variation in SICH rates was highest across studies that reported SICH rates using the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria compared with the European Cooperative Acute Stroke Study and National Institute of Neurological Disorders and Stroke (NINDS) criteria. Studies that defined SICH as parenchymal hemorrhage with a neurological decline NIHSS ≥4 occurring within 36 h of intravenous thrombolysis reported a higher consistency between SICH and mortality rates (correlation coefficient 0.631).
SICH rates vary considerably between studies and these differences may relate to the differences in the criteria used to define SICH. Until a case definition with high interrater agreement and good correlation with stroke outcomes becomes available, detailed information on the type of bleeding, the extent of NIHSS deterioration, neuroimaging features and the time from thrombolysis to diagnosis of hemorrhage should be reported to permit a correct interpretation of SICH rates.
Seet RC
，Rabinstein AA
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Intravenous thrombolysis with rt-PA in acute ischemic stroke patients aged older than 80 years in Italy.
Intravenous (i.v.) thrombolysis with rt-PA within 3 h from symptom onset is the only approved treatment of pharmacological revascularization in acute ischemic stroke. However, little information exists on its use in elderly patients, in particular those aged >80 years, who at present are excluded from treatment.
In a multicenter Italian study on i.v. thrombolysis, patients aged >80 years (n = 41) were compared with those aged <or=80 years (n = 207) regarding the percentage of symptomatic (nonfatal and fatal) intracerebral hemorrhage (SICH), favorable 3-month functional outcome (modified Rankin Scale score 0-2) and poor outcome (death or dependence, i.e. modified Rankin Scale score 3-5).
The percentage of SICH (nonfatal and fatal) was comparable between older (2.4%, 2.4%) and younger (2.4%, 2.4%) patient groups (p = 1.0). At 3 months, favorable outcome occurred in 44% and dependence in 22% of the older, and respectively in 58.5 and in 30.9% of the younger patients (p = 0.897). Patients aged >80 years had a higher mortality (34.1%) as compared to those aged <or=80 years (10.6%) (p < 0.001). Baseline National Institute of Health Stroke Scale score was the only statistically significant predictor of both mortality (OR = 1.26; 95% CI = 1.07-1.50) and poor outcome (OR = 1.39; 95% CI = 1.14-1.68) in the >80-year-old group.
Acute ischemic stroke patients aged >80 years treated with i.v. rt-PA have a higher mortality than younger patients, but there are no differences for SICH nor for favorable outcome. Our data suggest that thrombolytic therapy should not be a priori denied for appropriately selected >80-year-old patients but randomized controlled clinical trials are necessary before definite recommendations can be given.
Toni D
，Lorenzano S
，Agnelli G
，Guidetti D
，Orlandi G
，Semplicini A
，Toso V
，Caso V
，Malferrari G
，Fanucchi S
，Bartolomei L
，Prencipe M
... -
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Early neurological deterioration within 24 hours after intravenous rt-PA therapy for stroke patients: the Stroke Acute Management with Urgent Risk Factor Assessment and Improvement rt-PA Registry.
The initial 24 h after thrombolysis are critical for patients' conditions, and continuous neurological assessment and blood pressure measurement are required during this time. The goal of this study was to identify the clinical factors associated with early neurological deterioration (END) within 24 h of stroke patients receiving intravenous recombinant tissue plasminogen activator (rt-PA) therapy and to clarify the effect of END on 3-month outcomes.
A retrospective, multicenter, observational study was conducted in 10 stroke centers in Japan. A total of 566 consecutive stroke patients [211 women, 72 ± 12 years old, the median initial NIH Stroke Scale (NIHSS) score of 13] treated with intravenous rt-PA (0.6 mg/kg alteplase) was studied. END was defined as a 4-point or greater increase in the NIHSS score at 24 h from the NIHSS score just before thrombolysis.
END was present in 56 patients (9.9%, 18 women, 72 ± 10 years old) and was independently associated with higher blood glucose [odds ratio (OR) 1.17, 95% confidence intervals (CI) 1.07-1.28 per 1 mmol/l increase, p < 0.001], lower initial NIHSS score (OR 0.92, 95% CI 0.87-0.97 per 1-point increase, p = 0.002), and internal carotid artery (ICA) occlusion (OR 5.36, 95% CI 2.60-11.09, p < 0.001) on multivariate analysis. Symptomatic intracranial hemorrhage within the initial 36 h from thrombolysis was more common in patients with END than in the other patients (per NINDS/Cochrane protocol, OR 10.75, 95% CI 4.33-26.85, p < 0.001, and per SITS-MOST protocol, OR 12.90, 95% CI 2.76-67.41, p = 0.002). At 3 months, no patients with END had a modified Rankin Scale (mRS) score of 0-1. END was independently associated with death and dependency (mRS 3-6, OR 20.44, 95% CI 6.96-76.93, p < 0.001), as well as death (OR 19.43, 95% CI 7.75-51.44, p < 0.001), at 3 months.
Hyperglycemia, lower baseline NIHSS score, and ICA occlusion were independently associated with END after rt-PA therapy. END was independently associated with poor 3-month stroke outcome after rt-PA therapy.
Mori M
，Naganuma M
，Okada Y
，Hasegawa Y
，Shiokawa Y
，Nakagawara J
，Furui E
，Kimura K
，Yamagami H
，Kario K
，Okuda S
，Koga M
，Minematsu K
，Toyoda K
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