Laurila 2004.
| Methods | Randomisation: Central block stratified randomisation. | |
| Participants |
Country: Finland: Multicentre (4 centres) 59 patients with critical limb ischaemia (31 to AVF group and 28 to control group) Age: Average age 73.7 years (74.3 AVF, 73 control) Sex: 58% F, 42% M (M/F: 15/16 AVF, 10/18 control) Diabetic 41% (39% AVF, 43% control), coronary heart disease 61% (71% AVF, 50% control), cerebrovascular disease (19% AVF, 29% control), pulmonary disease (19% AVF, 7% control), renal failure (6% AVF, 7% control), smoking (29% AVF, 43% control), 71% previous vascular surgery, 58% prosthetic bypass as a re‐do procedure. |
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| Interventions | Femoro‐infrapopliteal PTFE graft with interposition vein cuff at the distal anastomosis with adjuvant AVF versus without adjuvant AVF. | |
| Outcomes | Primary patency rate, secondary patency rate, limb salvage rate. number of patients alive with a leg, the dependency of graft patency on the patency of the fistula. | |
| Source of funding | None declared. | |
| Notes | Pilot trial, patients excluded if only have claudication or bypass to popliteal or pedal artery. Vancomycin and cefuroxime or cefuroxime alone prophylaxis to all, all heparinised intraoperatively and oral antiplatelets postoperatively. Vein cuff: Miller 33 patients, St Mary's Boot 19, Modified Miller 7. AVF group had common ostium AVF (25) or proximal AVF (6) according to surgeon's discretion. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Central randomisation. |
| Allocation concealment (selection bias) | Low risk | Central block stratified randomisation. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients were accounted for, six patients were lost to follow up. None excluded from analysis. |
| Selective reporting (reporting bias) | Low risk | All outcomes as stated in methods have been addressed. |
| Other bias | Low risk | No other issues identified. |