Comparison of safety and efficacy of using alteplase for intravenous thrombolysis in a second-grand class-A hospital and a third-grand class-A hospital / 中国脑血管病杂志

ABSTRACT

Objective To compare the safety and efficacy of intravenous thrombolysis for patients with acute cerebral infarction in a second-grand class-A hospital and a third-grand class-A hospital. Methods Twenty-one consecutive patients with cerebral infarction treated with alteplase for intravenous thrombolysis were enrolled in a second-grand class-A hospital (Fengtai Hospital,Beijing)prospectively from January 2012 to December 2013 as the study group,and 65 patients in a third-grand class-A teaching hospital (Xuanwu Hospital,Capital Medical University,Beijing)admitted at the same period for intravenous thrombolysis were used as a control group. The differences of efficacy and safety of intravenous thrombolysis in patients of both groups were compared. The primary outcome measures were Barthel Index (BI)at day14 after onset and the modified Rankin Scale (mRS)scores at discharge. The main safety indicator was the incidence of serious adverse events (SAEs)after thrombolysis (symptomatic intracranial hemorrhage and death). Results (1 )In the primary outcome measures,the proportions of mRS≤2 at discharge in the study group and the control group were 71. 4%(n=15)and 58. 5%(n=38)respectively. At day 14 after thrombolysis,the proportions of BI ≥60 were 61. 9%(n=13)and 64. 6%(n=42)respectively. There were no significant differences between the two groups (P>0. 05). (2)The incidences of the primary serious adverse events were 4. 8%(n=1)and 6. 2%(n=4). There was no significant difference (P>0. 05). Other secondary outcome measures,such as the early reperfusion rate,recanalization rate,and the proportion of neurological improvement at day 14 after thrombolysis and the overall incidence of cerebral hemorrhage had no significant differences. The case referral proportion (9. 5%,n=2)of the study group had a trend of lowering than the control group (27. 7%,n=18)P=0. 09. (3)The out-hospital time delay, in-hospital time delay,and overall time delay of the study group were less than those of the control group, and the mean time was 75 ± 33 vs. 102 ± 50 min,and 72 ± 41 vs. 111 ± 38 min,147 ± 41 vs. 212 ± 47 min. There were significant differences (P<0. 01). Conclusion The second-grand hospital selected by our study can relatively safely and effectively perform intravenous thrombolysis for acute cerebral infarction with alteplase. Moreover,the intravenous thrombolysis of the second-grand hospitals may reduce the case referral ratio and visiting time.