SCAST: No Joy for Candesartan in Stroke Subgroups

May 27, 2014

NICE, France — Long-term results from the Scandinavian Candesartan Acute Stroke Trial (SCAST) show that blood pressure lowering with candesartan still provides no benefit on vascular events or death in patients with acute stroke.

Main results of the 2000-patient SCAST trial, which were reported in 2011, showed no benefit of 7 days of candesartan treatment, at a dose titrated up to 16 mg daily, on the co-primary endpoints, which included a composite of vascular events at 6 months and functional outcome at 6 months. In fact, there was a nonsignificant trend toward worse outcomes with treatment (hazard ratio, 1.09) on the composite vascular endpoint.

Long-term results at 3 years, presented here at the XXIII European Stroke Conference (ESC), showed no statistical difference between the 2 groups on vascular events, although there was a slight trend toward benefit in the candesartan group. The result for deaths was completely neutral.

Table 1. SCAST: Results at 3 Years

Endpoint Candesartan (%) Placebo (%) Hazard Ratio (95% Confidence Interval) P Value
Vascular events 28.2 32.5 0.87 (0.71 - 1.07) .19
Deaths 17.9 18.8 1.00 (0.77 - 1.30) 1.00

 

Presenting the data, Astrid Hornslien, MD, from Oslo University Hospital, Norway, concluded that "there is no indication for routine blood pressure lowering with candesartan in the acute phase of stroke."

No Effect in Hemorrhagic Subgroup

A separate presentation dealing with the subgroup of patients in SCAST with acute hemorrhagic stroke also suggested no beneficial effect of candesartan in this population at 6 months.

Of the 274 patients with hemorrhagic stroke, 144 patients received candesartan and 130 were allocated to placebo. Baseline characteristics showed there were more patients with atrial fibrillation and diabetes in the candesartan group.

In the hemorrhagic subgroup, 7 days of treatment with candesartan was associated with a slow and gradual lowering of systolic blood pressure of 4 mmHg. The composite vascular endpoint (vascular death, stroke, or myocardial infarction) occurred in a similar percentage of patients in the treated and placebo groups.

Table 2. SCAST: 6-Month Results in Patients With Hemorrhagic Stroke

Endpoint Candesartan (%) Placebo (%) Hazard Ratio (95% Confidence Interval) P Value
Vascular events 11.8 10.0 1.36 (0.65 - 2.83) .41

 

In addition, patients in the candesartan group appeared to have a worse functional outcome than those in the placebo group according to modified Rankin scale scores (common odds ratio, 1.61; 95% confidence interval, 1.03 - 2.50; P = .04).

Presenting the data, Mirza Jusufovic, MD, Oslo University Hospital, Norway, warned that these results must be interpreted with caution because this was a subgroup analysis with small patient numbers.

But he noted that in another trial, INTERACT2 (Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial 2), early intensive blood pressure lowering did appear to be beneficial in patients with hemorrhagic stroke, whereas slow and gradual blood pressure lowering was not beneficial in SCAST.

He said results of other ongoing studies may help clarify whether the different results may be explained by timing and intensity of treatment, choice of agent, or other mechanisms.

XXIII European Stroke Conference (ESC). Presented May 9, 2014.

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