title: Intravenous thrombolysis for acute ischaemic stroke in patients not fully adhering to the European licence in Poland.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: II Klinika Neurologiczna, Instytut Psychiatrii i Neurologii w Warszawie. mkarlinski@ipin.edu.pl
authors.forename: Michał
authors.initials: M
authors.lastname: Karliński
authors.forename: Adam
authors.initials: A
authors.lastname: Kobayashi
authors.forename: Tomasz
authors.initials: T
authors.lastname: Litwin
authors.forename: Piotr
authors.initials: P
authors.lastname: Sobolewski
authors.forename: Waldemar
authors.initials: W
authors.lastname: Fryze
authors.forename: Sławomir
authors.initials: S
authors.lastname: Romanowicz
authors.forename: Michał
authors.initials: M
authors.lastname: Glonek
authors.forename: Walenty
authors.initials: W
authors.lastname: Nyka
authors.forename: Paweł
authors.initials: P
authors.lastname: Lisewski
authors.forename: Anna
authors.initials: A
authors.lastname: Członkowska
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000188:drug therapy* / Q000401:mortality; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D011044:Poland; D011237:Predictive Value of Tests; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality; D015912:Thrombolytic Therapy / Q000706:statistics & numerical data*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator