Table 5.
GRADE evidence profile for PICO 5.2.
| Certainty assessment |
No of patients |
Effect |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IVT with tenecteplase | IVT with alteplase | Relative(95% CI) | Absolute(95% CI) | ||
| mRS 0–1 at three months | ||||||||||||
| 3 | randomised trials | not serious | seriousa | seriousb | not serious | none | 52/101(51.5%) | 43/101(42.6%) | OR 2.42(0.73–8.04) | 216 more per 1 000(from 75 fewer to 431 more) | ⨁⨁◯◯LOW | CRITICAL |
| Improved mRS score at three months (shift analysis) | ||||||||||||
| 3 | randomised trials | not serious | seriousa | seriousb | not serious | none | cOR 2.09(1.16–3.76) | – per 1 000(from – to –) | ⨁⨁◯◯LOW | CRITICAL | ||
| Death at three months | ||||||||||||
| 1 | randomised trials | not serious | not serious | seriousc | not serious | none | 10/101(9.9%) | 18/101(17.8%) | OR 0.4(0.2–1.1) | 98 fewer per 1 000(from 137 fewer to 14 more) | ⨁⨁⨁◯MODERATE | CRITICAL |
| sICH | ||||||||||||
| 1 | randomised trials | not serious | not serious | not serious | very seriousd | none | 1/101(1.0%) | 1/101(1.0%) | OR 1.0(0.1–16.2) | – per 1 000(from – to 0 fewer) | ⨁⨁◯◯LOW | CRITICAL |
The results regarding functional outcome are based on Bivard et al.55 (pooled analysis of the TAAIS50 and ATTEST48 trials) and the EXTEND IA TNK trial51 (Figure 7). The results about death and sICH are solely based on the EXTEND IA TNK trial.aIn EXTEND IA TNK, tenecteplase was only significantly associated with better functional outcome in shift analysis of the mRS. Furthermore, other RCTs in unselected patients did not suggest superiority of tenecteplase over alterplase.bThis result is based on a secondary outcome of the EXTEND IA TNK trial and subgroup analyses of TAAIS and ATTEST. In those last 2 trials, some patients had distal vessel occlusion (M2, M3, ACA, PCA).cThe primary endpoint was radiological, not clinical.dOnly one event in each treatment group.