Association Between Preoperative Below-The-Knee Runoff and Clinical Outcomes in Patients with Femoropopliteal Occlusive Disease Treated With Drug-Coated Balloons

In patients with FPOD treated with DCB, a higher number of BTK runoff vessels was significantly associated with fewer MALE or death, fewer CD-TLR, and fewer deaths. This association was independent of traditional cardiovascular risk factors and represents an important stratification factor for patient outcomes (The PROMISING Study, NCT04826705).Clinical ImpactThis large, prospective multicenter study demonstrates that preoperative below-the-knee (BTK) runoff remains a strong and independent prognostic factor in patients undergoing femoropopliteal drug-coated balloon (DCB) therapy. Despite the antiproliferative benefits of DCBs, distal hemodynamics continue to influence procedural durability and long-term limb outcomes. Our findings show a graded reduction in MALE, CD-TLR, and mortality with increasing runoff vessels, independent of lesion complexity, stent implantation, and concomitant outflow intervention. These results reinforce the importance of systematic preprocedural runoff assessment and support incorporating BTK runoff into risk stratification, patient counseling, and surveillance planning in contemporary endovascular practice.