Yoshihisa Miyamoto1, Shotaro Aso2, Masao Iwagami3, Kojiro Morita2, Kiyohide Fushimi4, Yoshifumi Hamasaki5, Masaomi Nangaku5, Kent Doi6, Hideo Yasunaga2. 1. Division of Nephrology and Endocrinology, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan. Electronic address: ymiyamoto70-tokyo@umin.ac.jp. 2. Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan. 3. Department of Health Services Research, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan; Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK. 4. Department of Health Policy and Informatics, Tokyo Medical and Dental University Graduate School of Medicine, Tokyo, Japan. 5. Division of Nephrology and Endocrinology, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan; Department of Hemodialysis and Apheresis, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan. 6. Department of Acute Care Medicine, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan.
Abstract
OBJECTIVE: We examined the impact of expansion of the time window (from 3 to 4.5 hours) in the labeled indication for recombinant tissue-plasminogen activator (rt-PA) in August 2012 on the use of rt-PA for patients with acute ischemic stroke (AIS) and the outcomes of patients treated with rt-PA. MATERIALS AND METHODS: Using a Japanese nationwide inpatient claims database, we identified patients with AIS who admitted to hospitals that consecutively participated in the database from 2010 to 2014. We defined the pre-expansion period as before August 2012 and the post-expansion period as after August 2012. We conducted an interrupted time-series analysis using patient-level data to examine the association between the expansion and use of rt-PA. We also assessed the association of the expansion with outcomes in patients treated with rt-PA. RESULTS: Among 257,778 patients with AIS, 4.5% patients (5,796/129,326) were treated with rt-PA in the pre-expansion period and 5.8% patients (7,483/128,452) were treated with rt-PA in the post-expansion period. The expansion was associated with greater use of rt-PA (adjusted odds ratio [aOR], 1.35; 95% confidence interval [CI], 1.24-1.48). Among patients treated with rt-PA, the expansion was associated with functional independence (modified Rankin scale of ≤2) at discharge (aOR, 1.26; 95% CI, 1.03-1.54), but not with in-hospital mortality (aOR, 0.92; 95% CI, 0.68-1.24). CONCLUSIONS: This study showed that expansion of the time window for rt-PA was associated with increased use of rt-PA in patients with AIS, while the functional outcome at discharge was improved after the expansion in patients treated with rt-PA.
OBJECTIVE: We examined the impact of expansion of the time window (from 3 to 4.5 hours) in the labeled indication for recombinant tissue-plasminogen activator (rt-PA) in August 2012 on the use of rt-PA for patients with acute ischemic stroke (AIS) and the outcomes of patients treated with rt-PA. MATERIALS AND METHODS: Using a Japanese nationwide inpatient claims database, we identified patients with AIS who admitted to hospitals that consecutively participated in the database from 2010 to 2014. We defined the pre-expansion period as before August 2012 and the post-expansion period as after August 2012. We conducted an interrupted time-series analysis using patient-level data to examine the association between the expansion and use of rt-PA. We also assessed the association of the expansion with outcomes in patients treated with rt-PA. RESULTS: Among 257,778 patients with AIS, 4.5% patients (5,796/129,326) were treated with rt-PA in the pre-expansion period and 5.8% patients (7,483/128,452) were treated with rt-PA in the post-expansion period. The expansion was associated with greater use of rt-PA (adjusted odds ratio [aOR], 1.35; 95% confidence interval [CI], 1.24-1.48). Among patients treated with rt-PA, the expansion was associated with functional independence (modified Rankin scale of ≤2) at discharge (aOR, 1.26; 95% CI, 1.03-1.54), but not with in-hospital mortality (aOR, 0.92; 95% CI, 0.68-1.24). CONCLUSIONS: This study showed that expansion of the time window for rt-PA was associated with increased use of rt-PA in patients with AIS, while the functional outcome at discharge was improved after the expansion in patients treated with rt-PA.