Conclusions
CLI
ADVERSE EVENTS
In this prospective randomized multicenter study, during the 1-year follow-up, primary stenting with SENS and POBA alone demonstrated a significantly low rate of clinical adverse events in treating patients with CLI and BTK lesions. These results indicate that POBA may be an acceptable option in treating CLI with BTK lesions avoiding stent implantation. Also, based on the non-inferior results of the stenting group, SENS implantation could remain the preferred treatment option in special circumstances such as persistent recoil and flow-limiting dissection despite prolonged balloon dilatation in the treatment of CLI with BTK lesions. Long-term follow-up studies with larger study populations and routine imaging follow-up tests are necessary to elucidate the final conclusions.