Abstract WP63: Safety and Efficacy of Modest Blood Pressure Reduction with Valsartan in Acute Ischemic Stroke
Background and purpose Recently, the lowering of blood pressure (BP) with angiotensin-receptor blocker did not show the beneficial effect in patients with acute stroke. However, the management of BP in acute ischemic stroke has still been a matter of debate in clinical practice. We designed a prospective, randomized, open-labeled, blinded endpoints, multi-center study to evaluate Valsartan Efficacy oN modesT blood pressUre REduction in Acute Ischemic Stroke (VENTURE).
Methods Eligible patients were randomly assigned to receive valsartan or no anti-hypertensive agents as a control for 7 days after symptom onset by the central computerized system. Inclusion criteria were 1) age older than 18 years, 2) admission within 24 hours from onset, 3) treatment initiation within 48 hours, 4) NIH stroke scales 2-21, and 5) Systolic BP 150-185 mmHg. Primary endpoint was death or dependency measured as modified Rankin Scale score ≥ 3 at 90 days. Safety endpoints were early neurological deterioration within 7 days and mortality at 90 days. Thirty centers have participated since October 2008 in South Korea. Analyses were based on intention to treat. This study is registered as number NCT00874601 in ClinicalTrials.gov.
Results 405 patients were randomly assigned to valsartan (n=203) or control group (n=202), and primary endpoints were available for 373 patients (187 valsartan, 186 control). The BP reduction was significantly greater in valsartan group than in control group during the 7-day treatment (mean diastolic BP was 84.7±2.5 mmHg in valsartan group and 87.1±2.67 mmHg in control group; P=0.022). However, there was no difference in the primary endpoint between valsartan (n=46, 24.6%) and control (n=42, 22.6 %) groups (Odds ratio 1.13, 95% CI 0.79-1.63; p=0.643). In addition, safety endpoints including early neurological deterioration within 7 days (20 (10.7%) in valsartan and 11 (5.9%) in control group, p=0.137) and mortality at 90 days (2 in valsartan and 0 in control group, p=0.333) were similar between the two groups.
Conclusion The modest BP reduction with valsartan did not suggest any beneficial effect in patients with acute stroke and raised blood pressure. However, These findings might be because this study was underpowered owing to early termination.
- © 2012 by American Heart Association, Inc.