One-Year Outcomes After Intravenous Recombinant Tissue Plasminogen Activator for Ischemic Stroke: A Real-World Study.

Abstract

Background: The longer-term benefits of intravenous recombinant tissue plasminogen activator (IV rt-PA) in Chinese acute ischemic stroke (AIS) patients remain lacking. We aimed to evaluate the 1-year clinical outcomes after IV rt-PA for Chinese AIS patients in a real-world setting.

Methods: Based on a prospective multicenter stroke registry in China, we analyzed the data of patients with AIS (aged ≥ 18 years) who arrived at hospital within 4.5 h of symptom onset. Participants were from 80 stroke centers in China between January 2017 and March 2020. IV rt-PA-treated patients were propensity score-matched (1:1) by baseline characteristics with non-reperfusion patients. Primary outcome was 1-year all-cause mortality. Secondary outcomes included 1-year functional outcomes.

Results: Participants were mostly male (59.9%), with a mean age of 70.2 years. One-year all-cause mortality was similar between the two groups (11.1% vs. 12.2%; HR, 0.90 [95% CI: 0.78-1.05], p = 0.183). At 1 year, the IV rt-PA group had a higher proportion of functional independence (modified Rankin Scale [mRS] 0-2: 70.9% vs. 66.4%; OR, 1.25 [95% CI, 1.12-1.39]) and favorable outcome (mRS 0-1: 59.5% vs. 54.6%; OR, 1.23 [95% CI, 1.11-1.36]) compared to the non-reperfusion group (both p < 0.001). A lower proportion of severe disability/death was also observed in the IV rt-PA group versus the non-reperfusion group (mRS 5-6: 15.9% vs. 20.3%; OR, 0.73 [95% CI, 0.64-0.83]) (all p < 0.001).

Conclusions: IV rt-PA treatment in Chinese AIS patients eligible for thrombolysis was associated with improved 1-year functional outcomes despite having similar mortality to those who did not receive any reperfusion treatments.

Trial registration: This study is registered on https://clinicaltrials.gov; Unique identifier: NCT0539533.