GRADE evidence profile for PICO 1
Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | MT alone | IVT+ | Relative (95% CI) | Absolute (95% CI) | ||
Good outcome (mRS 0–2 at 90 days) – OR, unadjusted analysis | ||||||||||||
6 | Randomized trials | Not serious | Serious* | Not serious | Not serious | None | 570/1162 (49.1%) | 595/1169 (50.9%) | OR 0.93 (0.79 to 1.10) | 18 fewer per 1000 (from 59 fewer to 24 more) | ⨁⨁⨁◯ Moderate | CRITICAL |
Good outcome (mRS 0–2 at 90 days) – RR, unadjusted analysis | ||||||||||||
6 | Randomized trials | Not serious | Serious* | Not serious | Not serious | None | 570/1162 (49.1%) | 595/1169 (50.9%) | RR 0.96 (0.89 to 1.04) | 20 fewer per 1000 (from 56 fewer to 20 more) | ⨁⨁⨁◯ Moderate | CRITICAL |
Reduced disability (≥1 point reduction across all mRS scores at 90 days) – cOR, adjusted analysis | ||||||||||||
6 | Randomized trials | Not serious | Serious* | Not serious | Not serious | None | cOR 0.92 (0.80 to 1.07) | 1 fewer per 1000 (from 1 fewer to 1 fewer) | ⨁⨁⨁◯ Moderate | CRITICAL | ||
Excellent outcome (mRS 0–1 at 90 days) – OR, unadjusted analysis | ||||||||||||
6 | Randomized trials | Not serious | Serious* | Not serious | Not serious | None | 358/1169 (30.6%) | OR 0.99 (0.82 to 1.18) | 2 fewer per 1000 (from 40 fewer to 36 more) | ⨁⨁⨁◯ Moderate | CRITICAL | |
All-cause mortality at 90 days – OR, unadjusted analysis | ||||||||||||
6 | Randomized trials | Not serious | Not serious | Not serious | Not serious | None | 186/1163 (16.0%) | 175/1169 (15.0%) | OR 1.06 (0.84 to 1.35) | 8 more per 1000 (from 21 fewer to 42 more) | ⨁⨁⨁⨁ High | CRITICAL |
Successful reperfusion (mTICI ≥2 b) at the end of the endovascular procedure | ||||||||||||
6 | Randomized trials | Not serious | Not serious | Not serious | Not serious | None | 935/1108 (84.4%) | 990/1125 (88.0%) | OR 0.72 (0.57 to 0.92) | 39 fewer per 1000 (from 73 fewer to 9 fewer) | ⨁⨁⨁⨁ High | IMPORTANT |
Symptomatic intracranial hemorrhage | ||||||||||||
6 | Randomized trials | Not serious | Serious† | Not serious | Not serious | None | 50/1163 (4.3%) | 67/1166 (5.7%) | OR 0.77 (0.52 to 1.13) | 13 fewer per 1000 (from 27 fewer to 7 more) | ⨁⨁⨁◯ Moderate | CRITICAL |
Any intracranial hemorrhage | ||||||||||||
6 | Randomized trials | Not serious | Not serious | Not serious | Not serious | None | 361/1138 (31.7%) | 415/1140 (36.4%) | OR 0.80 (0.66 to 0.96) | 50 fewer per 1000 (from 90 fewer to 9 fewer) | ⨁⨁⨁⨁ High | IMPORTANT |
*According to each trial’s criteria, non-inferiority was met in DIRECT-MT and DEVT, whereas this was not the case for all other trials.
†Definitions of symptomatic intracranial hemorrhage varied across studies.
cOR, common OR; GRADE, Grading of Recommendations, Assessment, Development and Evaluations ; IVT, intravenous thrombolysis with alteplase; mRS, modified Rankin Scale; MT, mechanical thrombectomy; mTICI, modified Treatment In Cerebral Ischemia; PICO, Population, Intervention, Comparator, Outcome; RR, risk ratio.