Why the study?
The clinical use and indications of drug-coated balloons for lower extremity vascular disease lack a dedicated consensus document despite their emerging role.
This international positioning document establishes consensus on the clinical applications and indications for drug-coated balloons in lower extremity peripheral vascular interventions.
Answers are grounded in this paper and cite their sources.
Clinicians should select specific drug-coated balloons rather than assume class effects in peripheral interventions; extends consensus on device-specific paclitaxel delivery.
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 …
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Cortese et al. (2015) conducted a review in Lower extremity vascular disease. Drug-coated balloons was evaluated. Drug-coated balloons provide a locally delivered paclitaxel treatment for lower extremity vascular disease, though a class effect cannot be anticipated across different available devices.
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