Table 4.
GRADE evidence profile for PICO 5.1.
| Certainty assessment |
No of patients |
Effect |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | IVT with tenecteplase 0.25 mg/kg | IVT with alteplase 0.9 mg/kg | Relative(95% CI) | Absolute(95% CI) | ||
| Tenecteplase 0.25 mg/kg vs. Alteplase 0.9 mg/kg (‘unselected’ patients) | ||||||||||||
| mRS 0–1 at three months | ||||||||||||
| 2 | randomised trials | seriousa | not serious | seriousb | not serious | none | 28/78(35.9%) | 23/80(28.7%) | OR 1.40(0.70–2.78) | 73 more per 1 000(from 67 fewer to 241 more) | ⨁⨁◯◯LOW | CRITICAL |
| Death at three months | ||||||||||||
| 2 | randomised trials | seriousa | not serious | seriousb | not serious | none | 15/78(19.2%) | 14/80(17.5%) | OR 0.97(0.45–2.09) | 4 fewer per 1 000(from 88 fewer to 132 more) | ⨁⨁◯◯LOW | CRITICAL |
| sICH | ||||||||||||
| 2 | randomised trials | serious a | not serious | serious c | not serious | none | 5/83(6.0%) | 5/82(6.1%) | OR 1.12(0.49–2.52) | 7 more per 1 000(from 30 fewer to 80 more) | ⨁⨁◯◯LOW | CRITICAL |
| Tenecteplase 0.40 mg/kg vs. Alteplase 0.9 mg/kg (‘unselected’ patients) | ||||||||||||
| mRS 0–1 at three months | ||||||||||||
| 2 | randomised trials | very serious a,d | not serious | not serious | not serious | none | 361/568(63.6%) | 358/582(61.5%) | OR 1.07(0.84–1.36) | 16 more per 1 000(from 42 fewer to 70 more) | ⨁⨁◯◯LOW | CRITICAL |
| Death at three months | ||||||||||||
| 2 | randomised trials | serious d | not serious | not serious | not serious | none | 32/568(5.6%) | 34/582(5.8%) | OR 1.03(0.62–1.72) | 2 more per 1 000(from 21 fewer to 38 more) | ⨁⨁⨁◯MODERATE | CRITICAL |
| sICH | ||||||||||||
| 2 | randomised trials | serious d | not serious | not serious | serious e | none | 18/568(3.2%) | 14/582(2.4%) | OR 1.70(0.45–6.42) | 16 more per 1 000(from 13 fewer to 113 more) | ⨁⨁◯◯LOW | CRITICAL |
aThe TNK-S2B trial was terminated prematurely – in the dose finding phase – because of slow recruitment. The following phase would have investigated the superiority of Tenecteplase over Alteplase 0.9 mg/kg.bDifferences in populationscDifferent definitions of sICH were used across studies.dIn NOR-TEST, 18% of included patients had a stroke mimic and were distributed similarly between the Tenecteplase and Alteplase arm.eClinical recommendation (tenecteplase or alteplase) would markedly differ if the upper versus the lower boundary of the 95% CI of the OR represents the truth.