Modest blood pressure reduction with valsartan in acute ischemic stroke: a prospective, randomized, open-label, blinded-end-point trial

Abstract

Background and aimsTo assess the efficacy and safety of modest blood pressure (BP) reduction with valsartan within 48h after symptom onset in patients with acute ischemic stroke and high BP. MethodsThis was a multicenter, prospective, randomized, open-label, blinded-end-point trial. A total of 393 subjects were recruited at 28 centers and then randomly assigned in a 1:1 ratio to receive valsartan (n=195) or no treatment (n=198) for seven-days after presentation. The primary outcome was death or dependency, defined as a score of 3-6 on the modified Rankin Scale (mRS) at 90 days after symptom onset. Early neurological deterioration (END) within seven-days and 90-day major vascular events were also assessed. ResultsThere were 372 patients who completed the 90-day follow-up. The valsartan group had 46 of 187 patients (246%) with a 90-day mRS 3-6, compared with 42 of 185 patients (226%) in the control group (odds ratio [OR], 111; 95% confidence interval [CI], 069-179; P=0667). The rate of major vascular events did not differ between groups (OR, 141; 95% CI, 044-449; P=0771). There was a significant increase of END in the valsartan group (OR, 243; 95% CI, 125-473; P=0008). ConclusionsEarly reduction of BP with valsartan did not reduce death or dependency and major vascular events at 90 days, but increased the risk of END.