Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland.

II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii w Warszawie.
Neurologia i neurochirurgia polska (Impact Factor: 0.49). 01/2012; 46(1):3-14.
Source: PubMed

ABSTRACT The European licence for alteplase excludes from thrombolysis large groups of acute stroke patients. The Polish licence was revised in 2010, but until then many patients could receive the treatment only off-label. Our aim was to evaluate the safety and effectiveness of intravenous alteplase in Polish patients not fully adhering to the original European drug licence compared to patients treated strictly on-label.
We analysed all patient data contributed to the Safe Implementation of Thrombolysis in Stroke registry from Polish centres between October 2003 and July 2009.
Off-label thrombolysis was administered in 224/946 (23.7%) patients. The most frequent deviations were: use of intravenous antihypertensives (8.2%), age > 80 years (5.4%), time-to-treatment > 3 hours (4.5%), oral anticoagulation (4.2%), previous stroke with concomitant diabetes (2.1%), and previous stroke ≤ 3 months (1.5%). We found no differences in the ratio of symptomatic intracranial haemorrhage (sICH) according to SITS, ECASS and NINDS definitions. Adjusted odds for 3-month mortality were similar (OR 0.86, 95% CI: 0.51-2.41), excluding patients with previous stroke ≤ 3 months (OR 3.48, 95% CI: 0.96-12.7). Adjusted odds for death or dependency were slightly increased (OR 1.40, 95% CI: 0.92-2.13), especially in patients aged > 80 years (OR 2.80, 95% CI: 1.11-7.05), and with previous stroke ≤ 3 months (OR 4.07, 95% CI: 0.97-17.1).
Polish stroke patients receiving off-label thrombolysis tended to achieve a less favourable outcome, but they were not at increased risk of sICH or death. Considering the current Polish license for alteplase, it may be reasonable to additionally stratify the risk in patients aged > 80 years or with previous stroke ≤ 3 months.

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    ABSTRACT: The outcome in acute stroke strongly depends on patient-related issues, as well as on the availability of human and diagnostic resources. Our aim was to evaluate safety and effectiveness of intravenous alteplase for stroke according to the time of admission to the hospital. We analyzed the data of all acute stroke patients treated with alteplase between October 2003 and December 2010, contributed to the Safe Implementation of Thrombolysis for Stroke registry from 27 Polish stroke centers. According to the time of admission we distinguished between: (1) non-working days (Friday 14:30-Monday 08:00 plus national holidays); (2) out-of-office hours (non-working days plus 14:30-08:00 during working days); and (3) night hours (time from 23:00 to 06:00). Patients admitted during regular working hours (Monday 08:00-Friday 14:30, excluding national holidays) were used as the reference. Of 1330 patients, 448 (32.5%) were admitted on non-working days, 868 (65.3%) at out-of-office hours, and 105 (7.9%) during night hours. In multivariate logistic regression, none of the evaluated periods showed association with symptomatic intracranial hemorrhage, 7-day mortality, and neurological improvement ≥4 points in the National Institutes of Health Stroke Scale score at day 7. Patients admitted during night hours had lower odds (OR 0.53, 95% CI: 0.29-0.95, p=0.032) for achieving favorable outcome (modified Rankin Scale score 0-2). There is no bad time for thrombolysis. Stroke centers should feel confident about the treatment outside regular working hours, irrespective of equipment and staff availability. However, it may be reasonable to pay additional attention during nighttime.
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