open access

Vol 46, No 1 (2012)
ARTYKUŁ ORYGINALNY
Submitted: 2011-05-22
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Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland

Michał Karliñski, Adam Kobayashi, Tomasz Litwin, Piotr Sobolewski, Waldemar Fryze, Sławomir Romanowicz, Michał Glonek, Walenty Nyka, Paweł Lisewski, Anna Członkowska
DOI: 10.5114/ninp.2012.27179
·
Neurol Neurochir Pol 2012;46(1):3-14.

open access

Vol 46, No 1 (2012)
ARTYKUŁ ORYGINALNY
Submitted: 2011-05-22

Abstract

Background and purpose

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 methods

We analysed all patient data contributed to the Safe Implementation of Thrombolysis in Stroke registry from Polish centres between October 2003 and July 2009.

Results

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).

Conclusions

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.

Abstract

Background and purpose

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 methods

We analysed all patient data contributed to the Safe Implementation of Thrombolysis in Stroke registry from Polish centres between October 2003 and July 2009.

Results

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).

Conclusions

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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Keywords

acute stroke, thrombolysis, alteplase, off-label use, protocol, outcome

About this article
Title

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

Journal

Neurologia i Neurochirurgia Polska

Issue

Vol 46, No 1 (2012)

Pages

3-14

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

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