Table 6.
GRADE evidence profile table for PICO 7.
| Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Dual antiplatelet | Single antiplatet | Relative (95% CI) | Absolute (95% CI) | ||
| Recurrence of ischemic stroke (aspirin + cilostazol vs aspirin alone) | ||||||||||||
| 3 | Randomized trials (overall analysis) | Serious a | Not serious | Serious b | Serious c | None | 15/425 (3.5%) | 31/420 (7.4%) | OR 0.45 (0.24–0.86) | 39 fewer per 1 000(from 55 fewer to 10 fewer) | ⨁◯◯◯ Very low |
CRITICAL |
| Recurrent stroke or death (aspirin + (P2Y12 inhibitors) clopidogrel or ticagrelor vs aspirin alone) | ||||||||||||
| 2 | Randomized trials (subgroup analysis) | Serious d | Not serious | Serious d | Not serious | None | 79/747 (10.6%) | 119/808 (14.7%) | OR 0.69 (0.51–0.93) | 41 fewer per 1000 (from 66 fewer to 9 fewer) | ⨁◯◯◯ Very low |
CRITICAL |
| Risk of MACE including stroke (aspirin + cilostazol vs aspirin alone) | ||||||||||||
| 2 | Randomized trials | Serious b | Not serious | Serious e | Not serious | None | 16/342 (4.7%) | 33/340 (9.7%) | OR 0.45 (0.24–0.85) | 51 fewer per 1000 (from 72 fewer to 13 fewer) | ⨁◯◯◯ Very low |
CRITICAL |
| Risk of major bleeding including ICH (aspirin + cilostazol vs aspirin alone) | ||||||||||||
| 2 | Randomized trials | Not serious | Not serious | Serious f | Serious c | None | 6/358 (1.7%) | 6/352 (1.7%) | OR 0.98 (0.30–3.13) | 0 fewer per 1000 (from 12 fewer to 34 more) | ⨁◯◯◯ Very low |
CRITICAL |
| Risk of hemorrhagic stroke (aspirin + cilostazol vs aspirin alone) | ||||||||||||
| 2 | Randomized trials | Not serious | Not serious | Not serious | Serious c | None | 1/358 (0.3%) | 4/352 (1.1%) | OR 0.34 (0.05–2.25) | 7 fewer per 1000 (from 11 fewer to 14 more) | ⨁◯◯◯ Very low |
CRITICAL |
| Mortality (aspirin + cilostazol vs aspirin alone) | ||||||||||||
| 2 | Randomized trials | Serious b | Not serious | Serious c | Serious c | None | 1/150 (0.7%) | 1/148 (0.7%) | OR 1.02 (0.06–16.57) | 0 fewer per 1000 (from 6 fewer to 95 more) | ⨁◯◯◯ Very low |
CRITICAL |
CI: confidence interval; OR: odds ratio.
High dropout rate in TOSS, no Placebo use in CSPS.com.
TOSS included patients with acute ischemic stroke within 2 weeks, CATHARSIS between 2 weeks and 6 months.
In TOSS, during the follow-up period, no strokes or transient ischemic attacks occurred. In CATHARSIS, few endpoint events (large confidence interval). High statistical weight of only 1 study (CSPS.com subanalysis).
Both studies are subanalysis culled from CHANCE and THALES. In the CHANCE subgroup analysis, the endpoint reported on and included here was any stroke, in the THALES subanalysis it was recurrent stroke or death. In CHANCE, Aspirin was combined with Clopidogrel, in THALES with Ticagrelor. Inclusion NIHSS was ⩽3 in CHANCE, ⩽5 in THALES.
Definition of MACE varied across studies.
Definitions of major bleeding varied across trials.