Intracranial artery stenosis causes up to 10% of all ischaemic strokes. The rate of recurrent vascular ischaemic events is very high. Angioplasty with or without stent placement is a feasible procedure to dilate the vessel affected. However, its safety and efficacy have not been systematically studied.
To determine the efficacy and safety of angioplasty combined with best medical treatment compared with best medical treatment alone in patients with acute ischaemic stroke or transient ischaemic attack (TIA) resulting from intracranial artery stenosis for preventing recurrent ischaemic strokes, death, and vascular events.
We searched the Cochrane Stroke Group Trials Register (last searched March 2006). In addition we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2006), MEDLINE (1966 to March 2006), EMBASE (1980 to February 2006) and Science Citation Index (1945 to March 2006). To identify further published, unpublished and ongoing trials we searched reference lists of relevant articles and contacted authors and experts in the field.
Randomised or otherwise controlled studies comparing best medical care plus angioplasty of the intracranial cerebral arteries, with or without stent placement, with best medical care alone. Studies were only included if data for clinical significant endpoints such as recurrent ischaemic stroke, haemorrhagic stroke and death were available.
Data collection and analysis
Two review authors selected trials for inclusion, and independently assessed trial quality and extracted data. Calculation of relative treatment effects with subgroup analysis was done if possible.
No randomised controlled trials were found. There were 79 articles of interest consisting of open-label case series with three or more cases. The safety profile of the procedure showed an overall perioperative rate of stroke of 7.9% (95% confidence intervals (CI) 5.5% to 10.4%), perioperative death of 3.4% (95% CI 2.0% to 4.8%), and perioperative stroke or death of 9.5% (95% CI 7.0% to 12.0%). No comments can be made on the effectiveness of the procedure.
At present there is insufficient evidence to recommend angioplasty with or without stent placement in routine practice for the prevention of stroke in patients with intracranial artery stenosis. The descriptive studies show that the procedure is feasible although carries a significant morbidity and mortality risk. Evidence from randomised controlled trials is needed to assess the safety of angioplasty and its effectiveness in preventing recurrent stroke.
Plain language summary
Angioplasty for intracranial artery stenosis
There is insufficient evidence to support the use of angioplasty for intracranial artery stenosis. Narrowing of the arteries inside the skull is a significant cause of stroke. Medical treatment for prevention consists of the control of risk factors such as high blood pressure, diabetes, and high cholesterol. Blood thinners are also used, but none has been demonstrated to be superior to another. Angioplasty, a procedure for opening narrowed arteries by means of a balloon or stent, is feasible but its safety and efficacy is not known. This review found no randomised controlled trials and no evidence to support the use of this procedure in routine practice. More research is needed to establish the role of this procedure in the treatment of this disease.