Are the results of intravenous thrombolysis trials reproduced in clinical practice? Comparison of observed and expected outcomes with the stroke-thrombolytic predictive instrument (STPI).

AIM: In patients with cerebral ischemia, intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) increases survival without handicap or dependency despite an increased risk of bleeding. This study evaluated whether the results of randomized controlled trials are reproduced in clinical practice. METHOD: Data from a registry of consecutive patients treated by rt-PA at Lille University Hospital were retrospectively analyzed for outcomes, using modified Rankin Scale (mRS) scores, at 3 months. The observed outcomes were then compared with the probability of good (mRS 0-1) and of catastrophic (mRS 5-6) outcomes, as predicted by the stroke-thrombolytic predictive instrument (STPI). RESULTS: Of the 1000 consecutive patients (469 male, median age 74 years, median baseline National Institutes of Health Stroke Scale 11, median onset-to-needle time 143min), 438 (43.8%) had a good outcome, 565 (56.5%) had an mRS score 0-2 or similar to their pre-stroke mRS, 155 (15.5%) died within 3 months and 74 (7.4%) developed symptomatic intracerebral hemorrhage according to ECASS-II (Second European-Australasian Acute Stroke Study) criteria. Of the 613 patients (61.3%) eligible for evaluation by the s-TPI, the observed rate of good outcomes was 41.3% (95% CI: 37.5-45.3%), while expected rates with and without rt-PA were 48.8% (95% CI: 44.8-52.7%) and 32.5% (95% CI: 28.8-36.2%), respectively; the observed rate of catastrophic outcomes was 17.0% (95% CI: 14.0-19.9%), while the expected rate was 19.2% (95% CI: 16.1-22.4%) with or without rt-PA. CONCLUSION: In clinical practice, the rate of good outcomes is slightly lower than expected, according to the s-TPI, except for the most severe cases, whereas the rate of catastrophic outcomes is roughly similar. However, the rate of good outcomes is higher than predicted without treatment. This finding suggests that rt-PA is effective for improving outcomes in clinical practice.

Rate of intravenous thrombolysis for acute ischaemic stroke in the North-of-France region and evolution over time.

The proportion of patients with ischaemic stroke treated by intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) is an indicator of quality of stroke care. The objective of the study is to evaluate the rate of i.v. thrombolysis in the North-of-France region and its evolution over time. We determined the proportion of inhabitants treated by i.v. rt-PA in 2009-2010 (period A; 8 stroke units, no telemedicine) and 2012 (period B; population campaigns, 12 stroke units with telemedicine in 5). We used hospital registries from the 12 stroke units, and population-based data were collected in a subpopulation of 226,827 inhabitants (5.6% of the whole population). 1,563 inhabitants received i.v. rt-PA for stroke (period A: 835 in 24 months; period B: 728 in 12 months). Hospital and population data were similar. Annual rates of thrombolysis increased from 103 per million inhabitants [95% confidence interval (CI) 85-125] to 181 (95% CI 157-209; relative increase 76%, 95% CI 67-83%). This rate increased in 12 districts (significantly in 6), but the increase was greater in districts where new stroke units, telemedicine, or both were implemented. In conclusion, although the proportion of patients treated was already high in period A, there was still place for improvement. Implementation of new stroke units, extension of the telemedicine network and new population campaigns are necessary to improve the rate of thrombolysis in several areas, to ensure an equal access to treatment over the whole territory. The next step is now to determine whether this high rate of i.v. rt-PA delivery at the population level translates into clinical results.

Cerebral venous thrombosis 3-year clinical outcome in 55 consecutive patients.

An early diagnosis and heparin therapy have contributed to a decreased mortality in cerebral venous thrombosis (CVT). However, predictors of outcome are difficult to identify, because most studies suffered heterogeneity in diagnostic findings and treatments, retrospective design, and recruitment bias. The aim of this study was to evaluate the clinical outcome in 55 consecutive patients with CVT admitted over a 4-year period. The study population consisted of 42 women and 13 men, with a median age of 39 years (range 16-68). The diagnosis was performed with MRI in 53 patients, and angiography in 2. The outcome was assessed with the modified Rankin scale (mRs). After a median follow-up of 36 months (range: 12-60), 45 patients were independent (mRS 0-2), and 10 were dependent or dead (mRS 3-6). Of 48 survivors, 7 had seizures, 6 motor deficits, 5 visual field defects, 29 headache (migraine in 14, tension headache in 13, other in 2). The logistic regression analysis found focal deficits and cancer at time of diagnosis, as independent predictors of dependence or death at year 3, and isolated intra-cranial hypertension as an independent predictor of survival and independence. Mortality rates are low in the absence of cancer and focal deficits, and more than 80 % of survivors are independent after 3 years. However, 3/4 of survivors have residual symptoms. Therefore, despite a low mortality rate, CVT remains a serious disorder.

[Functional characteristics of granulocytes separated by haemonetic cytapheresis (author's transl)]. / Qualités fonctionnelles des polynucléaires séparés par cytaphérèse sur Haemonetics 30.

Granulocytes have been transfused systematically for several years owing to the utilisation of cells separators. It seems profitable to test these granulocytes from a functional standpoint since they are centrifuged and then collected in plastic bags. Several function tests are used and demonstrate that the quality of these granulocytes is on the average diminished without altering them significantly. Morphological studies complementing these qualitative studies demonstrate membrane fusions and partial degranulation.