Question
Is endovascular treatment plus medical treatment beneficial for people with symptomatic vertebral artery stenosis compared to medical treatment alone?
Background
The vertebral artery is the blood vessel that supplies the back of the brain. Narrowing of this vessel (vertebral artery stenosis) is an important cause of stroke, but not everyone who has vertebral artery stenosis will have symptoms. Medical treatment (mainly including controlling risk-factors and drug treatment), surgery, and endovascular treatment (dilation of the artery with a balloon from inside the artery, e.g. percutaneous transluminal angioplasty, with or without insertion of a small mesh tube (stenting)) are the main approaches when vertebral artery stenosis causes symptoms (symptomatic vertebral artery stenosis). However, the optimal management for people with symptomatic vertebral artery stenosis has not yet been established. We reviewed studies that compared endovascular treatment plus medical treatment to medical treatment alone for symptomatic vertebral artery stenosis.
Search date
We searched various electronic databases of clinical trial data on 23 July 2021, to find studies that would help us answer the research question.
Study characteristics
We included three trials with a combined total of 349 people who had symptomatic vertebral artery stenosis. All trials were carried out across multiple centres. Two trials randomised patients with an intracranial or extracranial vertebral artery stenosis to endovascular treatment plus medical treatment or medical treatment alone. One trial randomised patients only with intracranial vertebral artery stenosis to endovascular treatment plus medical treatment or medical treatment alone.
Key results
We did not find any significant differences in the risk of dying or having a stroke between the people who received endovascular treatment as well as medical treatment and those who just received medical treatment.
Certainty of the evidence
We have low to moderate confidence in the results of the studies: our confidence is not higher because people knew who was having which treatment and some outcomes have a wide confidence interval due to a small number of patients with endpoint events.
This Cochrane Review provides low- to moderate-certainty evidence indicating that there are no significant differences in either short- or long-term risks of stroke, death, or TIA between people with symptomatic vertebral artery stenosis treated with ET plus MT and those treated with MT alone.
Vertebral artery stenosis (narrowing of the vertebral artery) is an important cause of posterior circulation ischaemic stroke. Medical treatment (MT) e.g. controlling risk-factors and drug treatment, surgery, and endovascular treatment (ET) are the prevailing treatment strategies for symptomatic vertebral artery stenosis. ET consist s of percutaneous transluminal angioplasty (balloon catheter through the skin), with or without stenting. However, optimal management of people with symptomatic vertebral artery stenosis has not yet been established.
To assess the safety and efficacy of percutaneous transluminal angioplasty, with or without stenting, combined with MT, compared to MT alone, in people with episodes of cerebral ischaemia due to vertebral artery stenosis.
We searched the Cochrane Stroke Group, MEDLINE, Embase, BIOSIS, and two other indexes in Web of Science, China Biological Medicine Database, Chinese Science and Technique Journals Database, China National Knowledge Infrastructure and Wanfang Data, as well as ClinicalTrials.gov trials register and the World Health Organization (WHO) International Clinical Trials Registry Platform to 23 July 2021.
We included all randomised controlled trials (RCTs) that compared ET plus MT with MT alone in treating people aged 18 years or over with symptomatic vertebral artery stenosis. We included all types of ET modalities (e.g. angioplasty alone, balloon-mounted stenting, and angioplasty followed by placement of a self-expanding stent). MT included risk factor control, antiplatelet therapy, lipid-lowering therapy, and individualised management for people with hypertension or diabetes.
Two review authors independently screened potentially eligible studies, extracted data, and assessed trial quality and risk of bias. We applied the GRADE approach to assess the certainty of evidence. The primary outcomes were 30-day post-randomisation death/stroke (short-term outcome) and fatal/non-fatal stroke after 30 days post-randomisation to completion of follow-up (long-term outcome).
We included three RCTs with 349 participants with symptomatic vertebral artery stenosis with a mean age of 64.4 years. The included RCTs were at low risk of bias overall. However, all included studies had a high risk of performance bias because blinding of the ET was not feasible.
There was no significant difference in 30-day post-randomisation deaths/strokes between ET plus MT and MT alone (risk ratio (RR) 2.33, 95% confidence interval (CI) 0.77 to 7.07; 3 studies, 349 participants; low-certainty evidence). There were no significant differences between ET plus MT and MT alone in fatal/non-fatal strokes in the territory of the treated vertebral artery stenosis after 30 days post-randomisation to completion of follow-up (RR 0.51, 95% CI 0.26 to 1.01; 3 studies, 349 participants; moderate-certainty evidence), ischaemic or haemorrhagic stroke during the entire follow-up period (RR 0.77, 95% CI 0.44 to 1.32; 3 studies, 349 participants; moderate-certainty evidence), death during the entire follow-up period (RR 0.78, 95% CI 0.37 to 1.62; 3 studies, 349 participants; low-certainty evidence), and stroke or transient ischaemic attack (TIA) during the entire follow-up period (RR 0.65, 95% CI 0.39 to 1.06; 2 studies, 234 participants; moderate-certainty evidence).