Summary of findings for the main comparison. Is surgery or thrombolysis more effective for initial management of acute limb ischaemia?
| Surgery versus thrombolysis for initial management of acute limb ischaemia | ||||||
| Patient or population: patients seeking treatment for initial management of acute limb ischaemia Intervention: thrombolysis Comparison: surgery | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Risk with surgery | Risk with thrombolysis | |||||
| Limb salvage at 30 days | Study population | OR 1.02 (0.41 to 2.55) | 636 (4 RCTs) | ⊕⊕⊝⊝ LOWa,b | ||
| 858 per 1000 | 861 per 1000 (713 to 939) | |||||
| Amputation at 30 days | Study population | OR 0.97 (0.51 to 1.85) | 616 (3 RCTs) | ⊕⊕⊝⊝ LOWa,c | ||
| 69 per 1000 | 68 per 1000 (37 to 121) | |||||
| Death at 30 days | Study population | OR 0.59 (0.31 to 1.14) | 636 (4 RCTs) | ⊕⊕⊕⊝ MODERATEa | ||
| 82 per 1000 | 50 per 1000 (27 to 93) | |||||
| Vessel patency at 30 days | Study population | OR 0.46 (0.08 to 2.76) | 20 (1 RCT) | ⊕⊝⊝⊝ VERY LOWa,d | ||
| 556 per 1000 | 365 per 1000 (91 to 775) | |||||
| Major haemorrhage at 30 days | Study population | OR 3.22 (1.79 to 5.78) | 1070 (4 RCTs) | ⊕⊕⊝⊝ LOWa,e | ||
| 33 per 1000 | 100 per 1000 (58 to 166) | |||||
| Stroke at 30 days | No events occurred in the surgery group, so it was not possible to estimate the assumed or corresponding risk | OR 5.33 (0.95 to 30.11) | 1180 (5 RCTs) | ⊕⊕⊝⊝ LOWa,e | 0/540 stroke events in the surgery group vs 8/640 in the thrombolysis group | |
| Distal embolisation at 30 days | No events occurred in the surgery group, so it was not possible to estimate the assumed or corresponding risk | OR 31.68 (6.23 to 161.07) | 678 (3 RCTs) | ⊕⊝⊝⊝ VERY LOWa,e,f | 0/338 events in the surgery group vs 42/340 in the thrombolysis group | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI) CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect | ||||||
aWe downgraded by one step owing to risk of bias: no evidence of blinding of outcome assessors, participants, or investigators bWe downgraded by one step as evidence showed moderate heterogeneity (I² = 56%) cWe downgraded by one step as evidence showed moderate heterogeneity (I² = 43%) dWe downgraded by one step owing to imprecision: only a single study was included in the analysis with very few reported events eWe downgraded by one step owing to imprecision: very few events were included in the analysis, leading to a wide confidence interval and an imprecise effect estimate fWe downgraded by one step as evidence showed moderate heterogeneity (I² = 33%)