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Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland
Affiliations- II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii w Warszawie
- Centrum Interwencyjnego Leczenia Udaru Mózgu, Instytut Psychiatrii i Neurologii w Warszawie
- Kliniczny Oddział Neurologii, Samodzielny Publiczny Szpital Kliniczny nr 1, Śląski Uniwersytet Medyczny w Katowicach
- Oddział Neurologiczny z Pododdziałem Intensywnego Nadzoru nad Chorymi z Udarem Mózgu i Zespołem ds. Stwardnienia Rozsianego, Szpital Wojewódzki w Poznaniu
- Neurologia A, Wojewódzki Zespół Neuropsychiatryczny w Opolu
- Neurologia B, Wojewódzki Zespół Neuropsychiatryczny w Opolu
- Klinika Neurologii Dorosłych, Akademickie Centrum Kliniczne – Szpital Gdańskiego Uniwersytetu Medycznego
- Katedra i Zakład Farmakologii Doświadczalnej i Klinicznej, Warszawski Uniwersytet Medyczny
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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.
Material and methodsWe analysed all patient data contributed to the Safe Implementation of Thrombolysis in Stroke registry from Polish centres between October 2003 and July 2009.
ResultsOff-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).
ConclusionsPolish 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.
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.
Material and methodsWe analysed all patient data contributed to the Safe Implementation of Thrombolysis in Stroke registry from Polish centres between October 2003 and July 2009.
ResultsOff-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).
ConclusionsPolish 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.
Keywords
acute stroke, thrombolysis, alteplase, off-label use, protocol, outcome
About this articleTitle
Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland
Journal
Neurologia i Neurochirurgia Polska
Issue
Pages
3-14
Page views
250
Article views/downloads
324
DOI
10.5114/ninp.2012.27179
Bibliographic record
Neurol Neurochir Pol 2012;46(1):3-14.
Keywords
acute stroke
thrombolysis
alteplase
off-label use
protocol
outcome
Authors
Michał Karliñski
Adam Kobayashi
Tomasz Litwin
Piotr Sobolewski
Waldemar Fryze
Sławomir Romanowicz
Michał Glonek
Walenty Nyka
Paweł Lisewski
Anna Członkowska
