Table 2:
Study Characteristics of Included RCTs
| Author, Year | Country | Objective | Eligibility Criteria | Sample Size (Intervention/Control) | Number of Sites | Randomization Method |
|---|---|---|---|---|---|---|
| Berkhemer et al, 201527 | Netherlands | To assess whether mechanical thrombectomy plus IVT would be more effective than IVT alone in patients with a proximal arterial occlusion in the anterior cerebral circulation that could be treated within 6 hours after symptom onset | Eligible patients were 18 years of age or older (no upper age limit) with AIS caused by an intracranial occlusion in the anterior circulation artery. Initiation of endovascular treatment had to be possible within 6 hours of stroke onset. Patients had to have an occlusion of the distal intracranial carotid artery, middle cerebral artery (M1 or M2), or anterior cerebral artery (A1 or A2), and an NIHSS score of 2 or higher | 500 (233/267) | 16 | Web-based, with permuted blocks. Stratified randomization according to medical centre, use of IVT, planned treatment, and stroke severity |
| Campbell et al, 201528 | Australia New Zealand |
To assess whether mechanical thrombectomy after IVT administration, compared with IVT alone, would improve reperfusion in patients with anterior circulation ischemic stroke within 4.5 hours after stroke onset | Eligible patients were included if they could receive IVT within 4.5 hours after the onset of anterior circulation ischemic stroke and had occlusion of the internal carotid artery or of the first or second segment of the middle cerebral artery, as seen on CT angiography. Endovascular treatment had to be initiated (groin puncture) within 6 hours after stroke onset and completed within 8 hours after onset. There were no restrictions on age or clinical severity, as assessed according to the NIHSS score. Patients were required to have functional independence before the stroke episode, which was defined as a score of < 2 on the mRS | 70 (35/35) | 10 | Centralized website and stratified according to the site of arterial occlusion: the internal carotid artery or the first or second segment of the middle cerebral artery |
| Goyal et al, 201529 | Canada United States South Korea Ireland United Kingdom |
To assess whether patients with AIS would benefit from rapid mechanical thrombectomy with or without IVT compared to IVT alone | Eligible participants were adults (no upper age limit) with a disabling ischemic stroke who had been functioning independently in the community (score on the Barthel Index [range, 0 to 100, with higher scores indicating a greater ability to complete activities of daily living] ≥ 90) before the stroke. Enrollment could occur up to 12 hours after the onset of stroke symptoms | 315 (165/150) | 22 | Real-time, dynamic, Internet-based, randomized minimization procedure (minimal sufficient balance method) to achieve distribution balance with regard to age, sex, baseline NIHSS score, site of arterial occlusion, baseline ASPECTS, and IVT status |
| Jovin et al, 201530 | Spain | To assess the safety and efficacy of mechanical thrombectomy with or without IVT versus IVT alone among patients with AIS that could be treated within 8 hours after stroke onset | Eligible patients were between the ages of 18 and 80 years, had an occlusion in the proximal anterior circulation that could be treated within 8 hours after symptom onset, had a prestroke functional ability of 1 or less on the mRS, and had a baseline score of at least 6 points on the NIHSS. After enrollment of 160 patients, the inclusion criteria were modified to include patients up to the age of 85 years with an ASPECTS score of > 8 | 206 (103/103) | 4 | Real-time computerized randomization procedure that was stratified according to age (≤ 70 or > 70 years), baseline NIHSS score (6 to 16 or ≥ 17), therapeutic window (≤ 4.5 or > 4.5 hours), occlusion site (intracranial internal carotid artery or M1 segment [main trunk] of the middle cerebral artery), and participating centre |
| Saver et al, 201531 | United States Europe |
To assess the efficacy and safety of rapid mechanical thrombectomy in conjunction with IVT versus IVT alone in patients with AIS | Eligible patients who had acute ischemic stroke with moderate-to-severe neurologic deficits; had imaging-confirmed occlusion of the intracranial internal carotid artery, the first segment of the middle cerebral artery, or both; met the imaging eligibility requirements; were receiving or had received IVT; and were able to undergo initiation of endovascular treatment within 6 hours after the time they were last known to be well before the onset of acute stroke symptoms | 196 (98/98) | 39 | Minimization algorithm to balance the numbers of patients in the two treatment groups with respect to four factors: investigational site; baseline severity according to the NIHSS score (≤ 17 vs. > 17, on a scale of 0–42, with higher scores indicating greater severity); age (< 70 years vs. ≥ 70 years); and occlusion location (middle cerebral artery vs. internal carotid artery). |
Abbreviations: AIS, acute ischemic stroke; ASPECTS, Alberta Stroke Program Early Computed Tomography Score; CT, computed tomography; IVT, intravenous thrombolysis, mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; RCT, randomized controlled trial.