Summary of findings 1. Ultrasound‐accelerated thrombolysis compared to thrombolysis alone for initial management of acute limb ischaemia.
| Ultrasound‐accelerated thrombolysis compared to thrombolysis alone for initial management of acute limb ischaemia | ||||||
| Patient or population: adults with ALI Setting: hospital Intervention: USAT Comparison: thrombolysis alone | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with thrombolysis alone | Risk with USAT | |||||
|
Primary patency follow‐up: 30 days |
See comment | See comment | 60 (1 RCT) |
‐ | Schrijver 2015 evaluated the outcome 30‐day patency. No distinction was made between primary and secondary patency. Schrijver 2015 reported that the patency rate in the successfully lysed standard thrombolysis participants was 82% (22/27) versus 71% (15/21) in the USAT participants (P = 0.35). | |
| Amputation rate follow‐up: 30 days | Study population | RR 1.14 (0.17 to 7.59) | 60 (1 RCT) | ⊕⊝⊝⊝ VERY LOW a,b | ‐ | |
| 63 per 1000 | 71 per 1000 (11 to 474) | |||||
| Major bleeding follow‐up: 30 days | Study population | RR 1.71 (0.31 to 9.53) | 60 (1 RCT) | ⊕⊝⊝⊝ VERY LOW a,b | ‐ | |
| 63 per 1000 | 107 per 1000 (19 to 596) | |||||
| Clinical success ‐ increase in ABI by at least 0.2 follow‐up: 30 days | Study population | RR 1.00 (0.94 to 1.07) | 60 (1 RCT) | ⊕⊝⊝⊝ VERY LOW a,b | Increase in ABI by at least 0.2 was achieved by all participants. | |
| 1000 per 1000 | 1000 per 1000 (940 to 1000) | |||||
|
Secondary patency follow‐up: 30 days |
See comment | See comment | 60 (1 RCT) |
‐ | Schrijver 2015 evaluated the outcome 30‐day patency. No distinction was made between primary and secondary patency. Secondary procedures were subdivided into embolectomy and bypass grafting. Embolectomy was performed on 3% (1/32) of the standard thrombolysis participants versus 14% (4/28) of the USAT participants (P = 0.18). Bypass grafting was performed on 0% of the standard thrombolysis participants versus 4% (1/28) of the USAT participants (P = 0.47). | |
|
Adverse events follow‐up: 30 days |
Study population | RR 5.69 (0.28 to 113.72) | 60 (1 RCT) | ⊕⊝⊝⊝ VERY LOW a,b | Schrijver 2015 reported combined distal embolisation and iatrogenic dissection in 7% (2/28) of USAT participants and 0% (0/32) of the standard thrombolysis participants. | |
| 0 per 1000 | 0 per 1000 | |||||
| *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). ALI: acute limb ischaemia; CI: confidence interval; RCT: randomised controlled trial;RR: risk ratio: USAT: ultrasound‐accelerated thrombolysis | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: 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 certainty: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low certainty: 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 two levels due to a high risk of bias in more than two critical domains. bWe downgraded by two levels for imprecision as only one study with a small number of participants was included.