Discussion
CLI, iliac artery, amputation, femoral artery lesions, claudication, arterial disease, restenosis, ulcer, diabetes
RECURRENCE, EVENT, ARTERIAL DISEASE, RESTENOSIS, ULCER, DIABETES
The main findings of this study were as follows. In patients with CLI with a BTK lesion undergoing an intervention, (1) clinical outcomes, including amputation and cardiovascular event rates, were similar between the primary stenting and POBA groups; (2) amputation and revascularization rates were relatively low in both groups; and (3) reasonable results could be derived only from short-term clinical follow-up, and imaging follow-up was not compulsory.With the rapid improvement in device technology along with increasing operator experience, interventional treatment is a well-accepted procedure in patients with a BTK lesion and CLI [The most critical limitations of previous studies on patients with CLI were the format of the study and the heterogeneous strategies, including primary and bail-out stenting in patients undergoing stenting with BTK lesions [CLI with a BTK lesion is usually an extensive and multilevel arterial disease that results in adverse clinical outcomes [In this study, the primary stenting (0.0%) and POBA (1.6%) groups showed a low major amputation rate. Even with the use of advanced techniques, the development of an interventional method alone is insufficient to explain the significantly low limb recovery rates demonstrated in both groups. The development of wounds and CLI are related to diabetes [This study also elucidated the importance of setting an appropriate endpoint for the treatment of BTK lesions with CLI. In the coronary era, clinical practices have shifted toward minimizing the use of routine imaging tests and focusing on clinical symptoms, and this has resulted in good patient outcomes [This study had some limitations. First, it addressed only BMS and POBA alone. However, there are several newer devices, such as drug-coated balloons, DES, and polymer-free stents, and a study comparing these devices should be conducted. Second, the relatively small sample size and short duration of the study period did not provide strong evidence of the actual clinical efficacy and safety of the procedures. Third, although this was a multicenter study and the general goal of CLI treatment was early-phase ulcer healing, large-scale and long-term clinical investigations are required. Fourth, this study was designed to focus on a “patient-centric” concept; hence, follow-up imaging modalities, such as computed tomography angiography and conventional angiography, were not routinely performed. These investigations were only performed in the event of wound recurrence or at the physician’s discretion, regardless of ischemic symptoms. Even if restenosis occurred, follow-up imaging tests may not have been performed if the wound did not recur or patients did not complain of definite claudication during the follow-up period after the index procedure. Thus, the actual restenosis rate may not have been reflected. Finally, due to the characteristics of the lesions in the patients with CLI, there were patients with iliac artery or femoral artery lesions [