Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document

The advent of drug-coated balloons (DCBs) provides a novel means to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. The widespread use of these devices in the clinical arena is contemporary with the introduction and adoption of paclitaxel eluting stents for peripheral vascular intervention. However, DCB remain highly attractive approach as the long-term consequences of permanent metallic implants in peripheral applications are still unknown. Notably, the clinical value of DCB is supported by robust pre-clinical evidence regarding safety and efficacy. Likewise, the clinical value of DCB in patients has also been demonstrated by multiple randomized clinical trials in the superficial femoral artery (SFA) and proximal popliteal artery territory. However, the widespread clinical adoption of DCB into routine clinical practice remains elusive. The evidence on the value of DCB has been summarized in consensus documents and in clinical practice guidelines. In the coronary field, currently available information has been summarized in two comprehensive Experts' Consensus Documents and the European Society of Cardiology (ESC) guidelines on coronary revascularization.1–3 These documents emphasized that not all DCB are created equal and that a ‘class effect’ cannot be anticipated as the results obtained with different DCB are not uniform. This remains a major challenge since many CE marked devices are currently available yet many of these have not been supported by robust clinical results. In the peripheral territory, the information regarding the clinical use of DCB is scarce. Moreover, no previous consensus document exists describing the clinical applications and indications for the use of this technology …