Article

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: 0.54). 01/2012; 46(1):3-14. DOI: 10.5114/ninp.2012.27179
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.

Download full-text

Full-text

Available from: Piotr Sobolewski, May 02, 2015
0 Followers
 · 
89 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background and purpose: Patients with prior stroke within 3 months have been mostly excluded from randomized thrombolysis trials mainly because of the fear of an increased rate of symptomatic intracerebral hemorrhage (sICH). The aim of this study was to compare baseline characteristics and clinical outcome of thrombolyzed patients who had a previous stroke within the last 3 months with those not fulfilling this criterion (comparison group). Methods: In all, 1217 patients were included in our analysis (42.2% women, mean age 68.8 � 14.4 years). Results: Patients with previous stroke within the last 3 months (17/1.4%) had more often a basilar artery occlusion (41.2% vs. 10.8%) and less frequently a modified Rankin scale (mRS) score 0–1 prior to index stroke (88.2% vs. 97.3%) and a higher mean time lapse from symptom onset to thrombolysis (321 min vs. 262 min) than those in the comparison group. Stroke severity was not different between the two groups. Rates of sICH were 11.8% vs. 6%. None of the sICHs and only one asymptomatic intracerebral hemorrhage occurred in the region of the former infarct. At 3 months, favorable outcome (mRS ≤ 2) in patients with previous stroke within 3 months was 29.4% (vs. 48.9%) and mortality 41.2% (vs. 22.7%). Conclusions: In patients with prior stroke within the last 3 months, none of the sICHs and only one asymptomatic intracerebral hemorrhage occurred in the region of the former infarct. The high mortality was influenced by four patients, who died until discharge due to acute major index stroke. It is reasonable to include these patients in randomized clinical trials and registries to assess further their thrombolysis benefit�risk ratio.
    European Journal of Neurology 07/2014; 21(12). DOI:10.1111/ene.12519 · 3.85 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Background and purpose: Symptomatic intracerebral haemorrhage (sICH) remains the most feared complication of systemic thrombolysis in patients with ischaemic stroke. The aim of the study was to analyze the impact of different factors on the occurrence of sICH, depending on definition used. Material and methods: We retrospectively evaluated the influence of several factors on the occurrence of sICH (according to definitions used in ECASS2, SITS-MOST and NINDS studies) in 200 patients treated with systemic thrombolysis from 2006 to 2011. Multivariate analysis of impact of individual variables on the occurrence of haemorrhagic transformation (HT) and parenchymal haemorrhage type 2 (PH2) were performed. Results: Haemorrhagic transformation occurred in 35 cases (17.5%). SICH was found in 10 cases according to ECASS2, in 7 cases according to SITS and in 13 cases according to NINDS. Older age was related to higher risk of sICH, regardless which definition was used (ECASS2: p = 0.014, SITS-MOST: p = 0.048, NINDS: p = 0.008), and female sex was related to higher risk of sICH according to NINDS and ECASS2 definition (p = 0.002 and p = 0.04, respectively). Blood glucose level and high NIHSS score (> 14 pts) were found as risk factor of sICH in ECASS2 definition (p = 0.044 and p = 0.03, respectively). In multivariate logistic regression higher NIHSS scores were associated with HT independent of age, gender and glucose level (p = 0.012). Multivariate analysis showed no impact of age, gender, severity of stroke and glucose level on presence of PH2. Conclusions: Definition of sICH can determine variables that are related to a high risk of this complication. In our study most factors correlated with sICH using the ECASS2 definition.
    Neurologia i neurochirurgia polska 09/2013; 47(5):405-13. DOI:10.5114/ninp.2013.38220 · 0.54 Impact Factor
  • [Show abstract] [Hide abstract]
    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.
    Neurologia i neurochirurgia polska 01/2014; 48(1):45-51. DOI:10.1016/j.pjnns.2013.12.003 · 0.54 Impact Factor