Early blood pressure-lowering treatment appears to be beneficial in patients with acute intracerebral haemorrhage and potentially in ischaemic stroke. We used a new method for analysis of vascular events in the Scandinavian Candesartan Acute Stroke Trial to see if the effect was dependent on the timing of treatment.
Scandinavian Candesartan Acute Stroke Trial was a randomized controlled and placebo-controlled trial of candesartan within 30 h of ischaemic or haemorrhagic stroke. Of 2029 patients, 231 (11.4%) had a vascular event (vascular death, nonfatal stroke or nonfatal myocardial infarction) during the first 6 months. The modified Rankin Scale (mRS) score following a vascular event was used to categorize vascular events in order of severity: no event (n = 1798), minor (mRS 0–2, n = 59), moderately severe (mRS 3–4, n = 57) and major event (mRS 5–6, n = 115). We used ordinal logistic regression for analysis and adjusted for predefined prognostic variables.
Candesartan had no overall effect on vascular events (adjusted common odds ratio 1.11, 95% confidence interval 0.84–1.47, P = 0.48), and the effects were the same in ischaemic and haemorrhagic stroke. Among the patients treated within 6 h, the adjusted common odds ratio for vascular events was 0.37, 95% confidence interval 0.16–0.84, P = 0.02, and there was no heterogeneity of effect between ischaemic and haemorrhagic strokes.
Ordinal analysis of vascular events showed no overall effect of candesartan in the subacute phase of stroke. The effect of treatment given within 6 h of stroke onset appears promising, and will be addressed in ongoing trials. Ordinal analysis of vascular events is feasible and can be used in future trials.
aDept. of Neurology, Oslo University Hospital, Oslo, Norway
bStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
cDept. of Internal Medicine, Oslo University Hospital, Oslo, Norway
Correspondence to Prof Eivind Berge, Oslo University Hospital, Dept of Internal Medicine, Kirkeveien 166, NO-0407 Oslo, Norway. Tel: +47 22119100; fax: +47 22118280; e-mail: email@example.com
Abbreviations: CI, confidence interval; ENCHANTED, Enhanced Control of Hypertension and Thrombolysis Stroke Study; ENOS, Efficacy of Nitric Oxide in Stroke; INTERACT2, Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial; IST-3, Third International Stroke Trial; mRS, modified Rankin Scale; OR, odds ratio; RIGHT, Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial; SCAST, Scandinavian Candesartan Acute Stroke Trial; SSS, Scandinavian Stroke Scale
Received 2 March, 2016
Revised 11 April, 2016
Accepted 26 April, 2016