Safe implementation of thrombolysis in stroke-monitoring study in Italy.
OBJECTIVE
The safe implementation of thrombolysis in stroke-monitoring (SITS-MOST) study was an unique opportunity to test in Italy, where only few centres were expert in thrombolytic treatment before, safety and efficacy of i.v. alteplase within 3 h of ischaemic stroke outside the setting of clinical trials.


METHODS
In Italy to participate in the study the clinical centres had to possess organizational and structural characteristics certified by Regional Health Authorities.


RESULTS
Seventy-one centres were activated, 56 (79%) treated patients of which 41 (73%) had never used thrombolysis before the study. Globally, 586 patients were included. Baseline median National Institute of Health Stroke Scale of Italian patients was 13 vs. 12 in other European centres (P = 0.0001). Symptomatic intracerebral haemorrhage as per the NINDS/Cochrane definition, mortality and independence (modified Rankin Scale 0-2) rates at 3 months occurred respectively in 6.7% (95% CI: 4.8-9.1), 11.7% (9.2-14.6) and 51.6% (47.4-55.7) of Italian patients compared with 7.3% (6.7-8.0) (P = 0.56), 11.2% (10.4-12.1) (P = 0.75) and 55.1% (53.8-56.4) (P = 0.09) in the European patients and in 8.6% (40/65; 6.3-11.6), 17.3% (14.1-21.1) and 50.1% (44.5-54.7) of the patients treated in the pooled randomized controlled trials.


CONCLUSIONS
The SITS-MOST study showed that in Italy i.v. alteplase is safe and effective in routine clinical use also in non-expert centres.
Lorenzano
S
S
Unità di Trattamento Neurovascolare, Department of Neurological Sciences, Policlinico Umberto I, University of Rome 'La Sapienza', Rome, Italy. svetlana.lorenzano@uniroma1.it
Ahmed
N
N
Rosselli
A
A
Marcello
N
N
Inzitari
D
D
Sterzi
R
R
Wahlgren
N
N
Prencipe
M
M
Toni
D
D
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D017063:Outcome Assessment, Health Care; D020521:Stroke / Q000188:drug therapy* / Q000503:physiopathology / Q000517:prevention & control*; D015912:Thrombolytic Therapy / Q000379:methods* / Q000706:statistics & numerical data; D010959:Tissue Plasminogen Activator / Q000494:pharmacology* / Q000627:therapeutic use; D016896:Treatment Outcome; D055815:Young Adult
D010959:Tissue Plasminogen Activator