Table 5.
Outcomes | Participants (Studies), Follow-up | Quality of the Evidence (GRADE) | Relative Effect (95% CI) | Anticipated Absolute
Effects |
|
Risk With Surgery | Risk Difference With Thrombolysis (95% CI) | ||||
Total mortality at 1 ya |
768 (3 RCTs),b 12 mo |
Low due to imprecisionc and inconsistencyd |
RR 0.74 (0.35-1.58) |
169 per 1,000e |
43 fewer per 1,000 (from 109 fewer to 98 more) |
MI nonfatal events |
… |
… |
… |
… |
… |
Strokes at 30 d includes nonfatal ischemic and hemorrhagic
strokesf |
1,180 (5 RCTs),b,g 1-12 mo |
Moderate due to imprecisionh |
0.01 (0.00-0.02)i |
0 per 1,000e |
10 more per 1,000 (from 0 fewer to 20 more) |
Major extracranial bleed at 30 d |
1,070 (4 RCTs),b 1-12 mo |
Moderate due to imprecisionj |
RR 2.34 (1.32-4.14] |
12 per 1,000e |
16 more per 1,000 (from 3 more to 37 more) |
Limb salvage at 1 y |
654 (2 RCTs),b 12 mo |
Low due to imprecisionc and inconsistencyk |
RR 1.00 (0.86-1.17) |
754 per 1,000e |
0 fewer per 1,000 (from 106 fewer to 128 more) |
Amputation at 1 y | 768 (3 RCTs),a 12 mo | Moderate due to imprecisionc | RR 1.10 (0.88-1.38) | 190 per 1,000e | 19 more per 1,000 (from 22 fewer to 72 more) |
Ouriel et al48 reported that one of 54 deaths in the thrombolysis group was from intracranial hemorrhage, whereas none of 46 in the surgery group were from intracranial hemorrhage.
For one study using three different doses of the thrombolytic agent, only the optimal dose is used for comparison with surgery. Control group risk estimates come from control event rates in the median study (after arranging risks in increasing order).
The 95% CI for absolute effect includes important benefit and harm.
I2 = 80%.
Control risk estimates from median or representative control group risk of included studies.
Of reported nonfatal strokes, all happened in the thrombolysis group, and all were intracranial hemorrhages (eight of eight [100%]).
Weaver et al53 included patients with both acute and chronic limb ischemia.
The 95% CI for absolute effect includes important benefit and harm; low number of events (eight).
Pooled risk difference presented instead of relative risk.
The 95% CIs are wide, low number of events (60).
I2 = 49%.