Abstract
Background
Most ischaemic strokes are caused by blockage of a cerebral artery by a thrombus. Intravenous administration of recombinant tissue plasminogen activator given within 4.5 hours is now standardtreatment for this condition. Percutaneous vascular interventionsuse an intra‐arterial, mechanical approach for thrombus disruption or removal (thrombectomy). Recent randomised trials indicate thatpercutaneous vascular interventions are superior to usual care (usual care usually included intravenous thrombolysis). However,intravenous thrombolysis was usually given in both arms of the trial and there was a lack of direct comparison of percutaneous vascularinterventions with intravenous thrombolysis.
Objectives
To assess the effectiveness and safety of percutaneous vascularinterventions compared with intravenous thrombolytic treatment foracute ischaemic stroke.
Search methods
We searched the Cochrane Stroke Group Trials Register (last search: August 2018). In addition, in September 2017, we searched the following electronic databases: CENTRAL, MEDLINE, Embase, and Science Citation Index; and Stroke Trials Registry, and US National Institutes of Health Ongoing Trials Register, ClinicalTrials.gov.
Selection criteria
Randomised controlled trials (RCTs) that directly compared apercutaneous vascular intervention with intravenous thrombolytictreatment in people with acute ischaemic stroke.
Data collection and analysis
Two review authors applied the inclusion criteria, extracted data, and assessed risk of bias. We obtained both published and unpublished data. We assessed the quality of the evidence using the GRADE approach.
Main results
We included four trials with 450 participants. Data on functional outcome and death at end of follow‐up were available for 443 participants from three trials. Compared with intravenousthrombolytic therapy, percutaneous vascular intervention did not improve the proportion of participants with good functional outcome (modified Rankin Scale score 0 to 2, risk ratio (RR) 1.01, 95% confidence interval (CI) 0.82 to 1.25, P = 0.92). The quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). At the end of follow‐up, there was a non‐significant increase in the proportion of participants who died in the percutaneous vascular intervention group (RR 1.34, 95% CI 0.84 to 2.14, P = 0.21). The quality of evidence was low (wide confidence interval). There was no difference in the proportion of participants with symptomatic intracranial haemorrhages between the intervention and control groups (RR 0.99, 95% CI 0.50 to 1.95, P = 0.97). The quality of evidence was low (wide confidence interval). Data on vascular status (recanalisation rate) were only available forseven participants from one trial; we considered this inadequate forstatistical analyses.
Authors’ conclusions
The present review directly compared intravenous thrombolytictreatment with percutaneous vascular interventions for ischaemicstroke. We found no evidence from RCTs that percutaneous vascularinterventions are superior to intravenous thrombolytic treatmentwith respect to functional outcome. Quality of evidence was low (outcome assessment was blinded, but not the treating physician or participants). New trials with adequate sample sizes are warranted because of the rapid development of new techniques and devices forsuch interventions.
Plain language summary
Treatments through the artery versus clot‐dissolving drugs forthe early treatment of stroke
Review question
Are there differences in the safety and effectiveness of treatments delivered into the blocked artery (percutaneous vascularinterventions) and clot‐dissolving drugs (intravenous thrombolysis) in the early treatment of stroke.
Background
Most strokes are caused by a blockage of an artery in the brain by a blood clot. Prompt treatment with clot‐dissolving drugs (thrombolysis) can restore blood flow and prevent brain damage. The development of treatments delivered through a tube into the artery (percutaneous vascular interventions) has led to new possibilities in the treatment of stroke. This approach gives direct access to the blood clot, which can be mechanically removed or dissolved. Despite widespread use of these treatments it is unclear whether they are more effective and safe than clot‐dissolving drugs given by injection (intravenous thrombolysis).
Study characteristics
We included four trials with 450 participants randomised to eitherpercutaneous vascular intervention or clot‐dissolving drugs given by injection.
Search date
The evidence is current as of September 2017.
Key results
Compared with clot‐dissolving drugs, percutaneous vascularinterventions did not increase the chance of making a good recovery by the end of the trial. There was no significant increase in the risk of dying or of suffering a brain bleed. New, larger trials are needed, particularly because of the rapid development of new techniques and devices for percutaneous vascular interventions.
Quality of the evidence
We judged the quality of the evidence to be low because of the limited amount of trial information available.
