Safety and efficacy of extending intravenous thrombolysis treatment for acute ischemic stroke in Taiwan

Recombinant tissue plasminogen activator (rt-PA) is the most effective treatment for acute ischemic stroke and the exclusion criteria of rt-PA has been revised to extend its application. However, in Taiwan, National Health Insurance (NHI) did not follow the latest international consensus due to safety concerns. The present study investigated whether extending the application of rt-PA in Taiwan was safe and effective. The medical records from the Shuang Ho hospital stroke registry between August 2009 and December 2016 were retrospectively reviewed. Post rt-PA intracranial hemorrhage (ICH) and modified Rankin Scale (mRS) score at 3-month after stroke were the primary and secondary outcomes, respectively. Differences were analyzed through Fisher's exact test and Student's t test. A p-value of <0.05 was considered statistically significant. Overall, there were 243 patients categorized into two groups: NHI exclusion criteria adherence (n = 160) and non-adherence (n = 83). There was no significant difference in the risk of post rt-PA ICH (12.50% in adherence group, 4.82% in non-adherence group, p=0.07). Among the non-adherence group, 10 patients breached the latest international exclusion criteria and none of them experienced post n-PA ICH. However, among patients with moderately severe stroke, the odds of mRS <= 2 at 3-month were significantly lower in non-adherence group. This study demonstrated that extending administration of rt-PA in Taiwan was safe but the functional outcome after moderate stroke was not as favorable as adherence group. Old age, long onset-to-treatment time and less efficacy of lower dose of rt-PA were the possible factors for the difference in outcome.