Table 5.
Outcomes | No. of Participants (Studies) Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute Effects,
Time Frame 90 d |
|
Risk With No IA tPA | Risk Difference With IA tPA (95% CI) | ||||
Overall mortality |
334 (3 studiesa) 90 d |
Lowb-d due
to indirectness, imprecision |
RR, 0.86 (0.56-1.33) |
210 deaths per 1,000e |
29 fewer deaths per 1,000 (from 92 fewer to 69
more) |
Good functional outcome,f mRS 0-2 |
334 (3 studiesa) 90 d |
Moderateb,c due to indirectness | RR, 1.44 (1.06-1.95) | 290 good outcomes per 1,000g | 128 more good outcomes per 1,000 (from 17 more to 275 more) |
PROACT I (1998), PROACT II (1999), MELT (2007).
I2=0%.
Studies conducted in patients without contraindication for IV tPA; studies used thrombolytics other than rtPA; control patients received heparin in PROACT I (1998) and PROACT II (1999).
CI includes both clinically significant harms and benefits.
Baseline mortality rate derived from mortality in control and treatment arms of PROACT I (1998), PROACT II (1999), MELT (2007), and the control arm of NINDS (1995) as reported in the IMS (2004) study (153 of 727=21%). Intervention and control rates were averaged to determine the baseline rate, because the interventions did not have a notable effect on mortality.
sICH not listed as a separate outcome because it is captured within the good functional outcome and mortality outcomes. sICH occurred in 20 of 191 (10%) patients treated with IA and 3 of 126 (2%) control patients.
Baseline good functional outcome rate derived from control arms of PROACT I (1998) and PROACT II (1999), MELT (2007), and the control arm of NINDS as reported in the IMS study (99 of 341=29%).
IA thrombolysis administered median time of 5.5 h PROACT (1998), 5.3 h PROACT II (1999), and 3.8 h MELT (2007) from symptom onset.