Abstract

BACKGROUND: We performed a prespecified subgroup analysis of the CATIS-2 trial (China Antihypertensive Trial in Acute Ischemic Stroke II) to compare the effect of early versus delayed antihypertensive treatment on death and disability in patients with and without medical history of hypertension. METHODS: CATIS-2 is a multicenter randomized clinical trial conducted in 106 hospitals in China. The trial randomized 4810 patients with acute ischemic stroke within 24 to 48 hours of symptom onset and elevated systolic blood pressure between 140 and <220 mm Hg to receive antihypertensive treatment immediately after randomization or to discontinue antihypertensive medications for 7 days and then receive treatment on day 8. The primary outcome was a combination of death or functional dependency (modified Rankin Scale score ≥3) at 90 days. RESULTS: At the 90-day follow-up, the primary outcome of death or functional dependency was not different between early- and delayed-treatment groups according to the history of hypertension; the odds ratios (95% CIs) associated with the early-treatment group were 1.11 (0.91–1.36) and 1.38 (0.92–2.08) for participants with and without a history of hypertension. However, the ordinal logistic regression showed that early antihypertensive treatment was associated with the odds of a higher modified Rankin Scale score in patients without hypertension (odds ratio, 1.35 [95% CI, 1.01–1.82]), but not in those with hypertension (odds ratio, 0.95 [95% CI, 0.82–1.10]; P =0.04 for interaction). CONCLUSIONS: Early antihypertensive treatment did not reduce the odds of dependency or death at 90 days by hypertension history among patients with ischemic stroke but worsened functional outcomes for patients without hypertension in the ordinal analysis. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03479554.