PASSReviewer 1· 95% conf
The trial design is rigorous: randomisation method, minimisation, sample size calculation, inclusion/exclusion criteria, and analysis populations are all clearly described.
Evidence
paraphrase[Methods, Randomisation and masking]
“Participants were randomly assigned (1:1:1) using a secure online system to femoro-popliteal PBA±BMS, DCBA±BMS, or DES as their first revascularisation procedure. Minimisation was used to balance assignments according to age, sex, diabetes mellitus, chronic kidney disease, severity of clinical disease, previous (permissible) intervention to the trial leg, target artery, intention for a hybrid procedure, and recruiting centre.”direct quote[Methods, Statistical analysis]
“Allowing for 5% attrition and the BASIL-1 survival estimates, 861 participants (having 342 primary outcome events) would provide 90% power to detect a reduction in amputation free survival of 40% (hazard ratio 0.60, equivalent to an absolute difference in amputation free survival of 13% at year 2, corresponding to one out of seven participants needing to benefit from DES or DCBA over PBA (number needed to treat) at the 2.5% significance level (to account for increased type I error risk associated with making two key comparisons) using the artsurv (version 1.0.7) programme in Stata (version 17.0). However, an error was identified in the implementation of the macro used to compute the original sample size, whereby a smaller effect size (than the targeted 40% relative reduction) had been applied for one of the two comparisons. This resulted in an overestimation of the sample size and number of primary outcome events needed. Using the same parameters as in the original calculation (listed above), the corrected sample size was 749 and the number of primary outcome events required was 291.”direct quote[Methods, Study design and participants]
“Patients were excluded if they were expected to live for less than six months (pragmatic decision by randomising team) or had undergone an intervention to the target femoro-popliteal vessel within the past 12 months.”PASSReviewer 2· 95% conf
The trial design is rigorous: central randomisation with minimisation, clear inclusion/exclusion criteria, a pre-specified statistical analysis plan, and appropriate handling of the analysis population. Blinding was not feasible (open-label) but is stated with rationale.
Evidence
direct quote[Methods, Randomisation and masking]
“Participants were randomly assigned (1:1:1) using a secure online system to femoro-popliteal PBA±BMS, DCBA±BMS, or DES as their first revascularisation procedure.”direct quote[Methods, Randomisation and masking]
“Participants, study staff, and investigators were not masked to treatment allocation.”direct quote[Methods, Statistical analysis]
“However, an error was identified in the implementation of the macro used to compute the original sample size, whereby a smaller effect size (than the targeted 40% relative reduction) had been applied for one of the two comparisons.”