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.