McQuade 2010.
| Methods | Study design: single‐centre randomised trial, no statement of blinding Method of randomisation: not stated Power calculation performed: 80% power, alpha < 0.05 Losses to follow‐up: 6 participants in the endovascular group and 15 participants in the surgical group Intention‐to‐treat analysis: not stated |
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| Participants | Country: USA Setting: single private institution Number of participants: 86 (100 limbs randomised) Age: mean age in the endovascular group 71.8 years (SD 9.9), mean age in the surgical group 66.9 years (SD 10.7) Sex: males and females Inclusion criteria: atherosclerotic stenotic or occlusive lesions of the SFA with no significant aorto‐iliac disease, patent infra‐popliteal segment, at least 1 vessel run‐off to the ankle, suitability for surgical treatment Exclusion criteria: not stated |
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| Interventions | Treatment: surgical femoro‐popliteal bypass above the knee with synthetic graft Control: percutaneous endovascular treatment of the SFA with stent‐graft Duration: 48‐month follow‐up was available in 64% of limbs in the endovascular group and 52% of limbs in the surgical group |
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| Outcomes | Primary patency Secondary patency Amputation rate |
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| Notes | The study was funded by grants provided by W.L. Gore & Associates, Flagstaff, Arizona. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Prospective randomised study". Comment: No information about the method of randomisation. |
| Allocation concealment (selection bias) | Unclear risk | The method of concealment is not described. |
| Blinding (performance bias and detection bias) All outcomes | Low risk | See below. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Insufficient information to permit judgement, but most probably absence of blinding given the nature of interventions. The review authors judged that the outcome and the outcome measurement were not likely to be influenced by lack of blinding. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "follow‐up at 3, 6, 9, and 12 months included clinical exam, color flow Doppler ultrasound imaging, and determination of the ABI". Comment: Blinding of outcome assessment most probably was not obtained, but objective assessment measures were used, which minimises the risk of bias. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Six patients (12%) were lost to follow‐up" in the stent group; "Fifteen (30%) patients were lost to follow up" in the bypass group. Comment: missing outcome data not balanced in numbers across intervention groups. |
| Selective reporting (reporting bias) | High risk | Insufficient information available concerning whether amputation and mortality were prespecified outcomes. |
| Other bias | Low risk | No other source of bias was identified. |