Limitations
above-the-knee, obesity, hypertension hypercholesterolemia
OBESITY
The primary limitation of this study is the utilization of prosthetic bypass grafts for the control arm. Although venous bypass remains the recommended approach for above-the-knee bypass, prosthetic bypass was selected for 2 reasons. Firstly, within the participating centers, there was a prevailing practice to use a prosthetic bypass for above-the-knee procedures, aimed at preserving the saphenous vein for potential future below-the-knee bypass surgeries. Secondly, as previously mentioned, certain studies have indicated comparable patency outcomes between above-the-knee prosthetic and venous conduits, while high-quality evidence is lacking. An additional limitation pertains to the variation in patient population between the 2 study groups, despite randomization. A higher proportion of patients in the BYPASS group exhibited conditions such as hypertension hypercholesterolemia, obesity and CLTI. However, the multivariate analysis illustrated no discernable distinction in terms of primary patency rates. Moreover, a further limitation is the requirement for a 1 cm healthy vessel in the proximal SFA, which might restrict the applicability of this trial. Another limitation to consider is that patients were not included in the endovascular treatment group unless the lesion was effectively crossed. Nevertheless, it is worth noting that all lesions were successfully crossed and no crossover from the ZILVER PTX group to the BYPASS group occurred.