Nakamura 1995.
Study characteristics | ||
Methods | Randomisation method: random number table Allocation: not stated Intervention model: parallel Blinding: none |
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Participants | Country: United States of America No. of participants: 39: 2.7 mm TEC atherectomy plus BA: 13 4.0 mm TEC atherectomy plus BA: 13 BA: 13 Age (mean (years) ± SD): 2.7 mm TEC: 64 ± 6 4.0 mm TEC: 70 ± 6 BA: 61 ± 4.1 Inclusion criteria: occluded SFA with 1 to 2 block claudication Exclusion criteria: those with previous femoropopliteal graft or "insufficient run‐off vessels" |
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Interventions | BA versus 2.7 mm TEC atherectomy plus BA versus 4.0 mm TEC atherectomy plus BA | |
Outcomes | Initial and 6‐month vessel patency Preprocedure and 6‐month ABI |
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Notes | 6‐month ABI only reported for participants with primary patency at 6 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table used for randomisation. |
Allocation concealment (selection bias) | High risk | Not specifically stated. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Neither participants nor personnel were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No mention of blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Complete data available to 6 months. |
Selective reporting (reporting bias) | Unclear risk | Initial and 6 month patencies reported. ABI only reported for participants whose vessels remained patent at 6 months. |
Other bias | High risk | No mention of antiplatelet protocol pre‐ or postprocedure. |