Hornslien Astrid G, Sandset Else C, Igland Jannicke, Terént Andreas, Boysen Gudrun, Bath Philip M W, Murray Gordon D, Berge Eivind
Department of Internal Medicine, Oslo University Hospital, Oslo, Norway.
University of Oslo, Oslo, Norway.
Int J Stroke. 2015 Aug;10(6):830-5. doi: 10.1111/ijs.12477. Epub 2015 Mar 22.
Randomized-controlled trials have shown no beneficial short-term effects of blood pressure lowering treatment in the acute phase of stroke.
We aimed to see whether blood pressure lowering treatment with candesartan in the acute phase can lead to benefits that become apparent over a longer period of follow-up.
The Scandinavian Candesartan Acute Stoke Trial was a randomized- and placebo-controlled trial of candesartan in 2,029 patients with acute stroke and systolic blood pressure ≥140 mmHg. Trial treatment was given for seven-days, and the primary follow-up period was six-months. We have used the national patient registries and the cause of death registries in the Scandinavian countries to collect data on vascular events and deaths up to three-years from randomization. The primary end-point was the composite of stroke, myocardial infarction, or vascular death, and we used Cox proportional hazards regression model for analysis.
Long-term data were available for 1,256 of the 1,286 patients (98%) from Scandinavia. The risk of the primary composite end-point did not differ significantly between the groups (candesartan 178/632 events, placebo 203/624 events, hazard ratio = 0·87, 95% confidence interval 0·71-1·07). There were also no statistically significant differences for the secondary end-points stroke and all-cause death, or in any of the pre-specified subgroups.
Treatment with candesartan in the acute phase of stroke was not associated with clear long-term clinical benefits. This result supports the conclusion from trials with short-term follow-up, that blood pressure lowering treatment with candesartan should not be given routinely to patients with acute stroke and raised blood pressure.
随机对照试验表明,在中风急性期进行降压治疗没有短期益处。
我们旨在观察在急性期使用坎地沙坦进行降压治疗是否能在更长的随访期内带来明显益处。
斯堪的纳维亚坎地沙坦急性中风试验是一项针对2029例急性中风且收缩压≥140 mmHg患者的随机、安慰剂对照试验,使用坎地沙坦进行试验性治疗7天,主要随访期为6个月。我们利用斯堪的纳维亚国家的全国患者登记处和死亡原因登记处,收集随机分组后长达3年的血管事件和死亡数据。主要终点是中风、心肌梗死或血管性死亡的复合终点,我们使用Cox比例风险回归模型进行分析。
来自斯堪的纳维亚的1286例患者中有1256例(98%)获得了长期数据。两组之间主要复合终点的风险没有显著差异(坎地沙坦组178/632例事件,安慰剂组203/624例事件,风险比=0.87,95%置信区间0.71 - 1.07)。次要终点中风和全因死亡,或任何预先指定的亚组之间也没有统计学上的显著差异。
在中风急性期使用坎地沙坦治疗与明确的长期临床益处无关。这一结果支持了短期随访试验的结论,即对于急性中风且血压升高的患者,不应常规给予坎地沙坦进行降压治疗。