Novel Approaches to the Management of Advanced Peripheral Artery Disease: Perspectives on Drug-Coated Balloons, Drug-Eluting Stents, and Bioresorbable Scaffolds

Abstract

Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.

Detection and characterization of early plaque formations by Raman probe spectroscopy and optical coherence tomography: an in vivo study on a rabbit model

“…Second-generation balloons for angioplasty and stents, which are coated with drugs to prevent early restenosis, are currently under development. [21][22][23] The efficiency of such drug-coated balloons and drug eluting stents can be investigated by directly monitoring the concentration and long-term release spectroscopically, as the active compounds also exhibit distinct spectroscopic properties. 24,25 The applied conditions of several seconds of nonfocused laser illumination at 100 mW within the artery did not lead to any noticeable alterations of the walls of the blood vessels, as confirmed by subsequent histopathological staining.…”

Ischemic Ulcer Healing: Does Appropriate Flow Reconstruction Stand for All That We Need?

“…Beyond striking surgical arterial reconstructions [76][77][78][79], new tapered nitinol [81], drug-eluting stents (DES) [82], and original drugeluting balloon, (DEB) [83] were imagined. Novel or redesigned directional or rotational atherectomy devices [84], together with latest "bioresorbable scaffolds" technologies [85], represent few additional of numerous achievements that challenge today ancient technical barriers [1,29,75,[81][82][83][84][85][86].…”

“…The complex cascade of tissue regeneration needs precise circumstances to unfold [85]. Beyond high-performance techniques in reconstructing arterial flow [72][73][74][75][76][77][78][79][80][81][82][83][84][85][86], new strategies about "when" and "where" to perform appropriate revascularization emerge today [1,27,30,35].…”

Eluvia™ peripheral stent system for the treatment of peripheral lesions above the knee

“…The composition of these study cohorts suggests that a substantial proportion of atherosclerotic patients undergoing PTA ultimately requires a stent scaffold. In addition, availability of a stent that provides a high patency and associated very low reintervention rate would mitigate the relevance of the 'future options' argument against a stent-based approach [43]. Together, these observations suggest that performance of drug-eluting stents such as Eluvia ™ could challenge the 'leave no implant' philosophy if longer term use continues to demonstrate low reintervention rates.…”