Statistical analysis
bleeding
BLEEDING, MINOR, SECONDARY, REGRESSION, EVENTS
The main analysis of the primary endpoint was performed on the per-protocol set (PPS), consisting of all subjects that finished 6 months of follow-up and underwent a final 6-month assessment of ankle brachial index (ABI), CTA or angiography and showing > 80% of medication adherence. The non-inferiority hypothesis for the primary outcome was tested through a one-sided 97.5% confidence interval (CI) approach. The weighted difference of proportion of primary endpoint and the 95% CI around the difference between study treatments was calculated using a Wald test with continuity correction. The ZFor other secondary outcomes, the proportion of subjects meeting the definition of endpoints was summarized using descriptive statistics in both FAS and PPS. The rates of major and minor bleeding and cardiovascular events were compared using the Chi-square test or Fisher exact test as appropriate. The rates of target lesion revascularization, all-cause mortality, and major amputation were compared between groups using log-rank tests and presented as survival curves constructed using Kaplan–Meier methods. Risk factors for the primary outcome were assessed using logistic regression models. Significance tests were two-sided for all analyses unless specified otherwise. A p-value of < 0.05 was considered a statistically significant difference between the groups. Statistical analysis was performed with SAS 9.4 (SAS institute Inc., Cary, NC, USA).