Table 5.

—[Section 6.1-6.3] Summary of Findings: Thrombolysis vs Surgery for the Treatment of Acute Limb Ischemia48

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)

See Table 1 and 2 legends for expansion of abbreviations.

^aOuriel 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.

^bFor 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).

^cThe 95% CI for absolute effect includes important benefit and harm.

^dI² = 80%.

^eControl risk estimates from median or representative control group risk of included studies.

^fOf reported nonfatal strokes, all happened in the thrombolysis group, and all were intracranial hemorrhages (eight of eight [100%]).

^gWeaver et al⁵³ included patients with both acute and chronic limb ischemia.

^hThe 95% CI for absolute effect includes important benefit and harm; low number of events (eight).

ⁱPooled risk difference presented instead of relative risk.

^jThe 95% CIs are wide, low number of events (60).

^kI² = 49%.