For which peripheral lesions could we consider drug eluting stents?
1Department of Vascular and Endovascular Surgery, Bonifatius Hospital, Lingen, Germany - Joerg.tessarek@hospital-lingen.de.
Insights
Drug-eluting stents (DES) show promise in preventing restenosis after peripheral endovascular treatment, but clinical benefits like limb salvage remain inconclusive. Further research is needed to address technical challenges and conflicting data.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomaterials Science
Background:
- Intimal hyperplasia is a key complication following endovascular treatment, particularly in peripheral vasculature.
- Drug-eluting stents (DES) have proven effective in coronary arteries for suppressing intimal hyperplasia.
- Translating DES technology to peripheral applications is crucial but faces conflicting evidence.
Purpose of the Study:
- To critically analyze existing data on peripheral drug-eluting stents (DES).
- To evaluate the efficacy of peripheral DES regarding primary patency, clinical benefit, and limb salvage.
- To investigate material testing data related to peripheral DES performance.
Main Methods:
- Systematic review of randomized and non-randomized trials on peripheral DES.
- Analysis of published and presented data on primary patency and target lesion revascularization (TLR).
- Inquiry into material testing data and adverse event profiles.
Main Results:
- Peripheral DES demonstrated effectiveness in improving primary patency and reducing restenosis, aligning with coronary outcomes.
- Meta-analyses did not confirm superiority of DES for major clinical endpoints like limb salvage or mortality.
- Significant variations exist among DES in restenosis prevention and adverse events, complicating evaluations.
Conclusions:
- While peripheral DES show potential for improving patency, their clinical impact on limb salvage and mortality is not definitively established.
- Technical challenges including device limitations and material issues persist.
- Blinded, prospective, randomized studies are essential to minimize bias and clarify the role of peripheral DES.
Abstract:
Intimal hyperplasia is a physiologic response to wall injury and represents the essential weak point of endovascular treatment. In the coronary segment, drug eluting stents (DES) have shown their effectiveness in suppressing this response and the transfer of this technique into the peripheral vasculature was mandatory, but the available data are conflictive and necessitate critical analysis. Peripheral DES related data from randomized or non randomized trials, published or presented, have been reviewed concerning the outcome in terms of "primary patency", "clinical benefit" and "limb salvage". Further inquiry was performed concerning data from material testing. The majority of study endpoints e.g. primary patency and freedom from target lesion revascularization (TLR) comply with the coronary paradigm to prevent restenosis and the peripheral DES proved this concept on an individual basis. DES meta-analytical results remain inconclusive and could not reveal superiority of DES for clinical endpoints such as limb salvage or mortality. DES differ significantly in prevention of restenosis and occurrence of severe adverse events which does impede the clinical and economic evaluations. DES related data are conflicting and partially contradicting the widespread use of this technique. The positive effect of DES in terms of patency and freedom from TLR could not achieve an omnipresent clinical correlate. Technical challenges such as availability of appropriate device length, coating related material fatigue or particulate embolization and delayed intimalization remain an issue and mandate an individual evaluation within a blinded prospective randomized study to minimize bias.
Related Concept Videos
Peripheral Artery Disease III: Interprofessional Care
Peripheral Artery Disease I: Introduction
Peripheral Arterial Disease II: Clinical Manifestations and Diagnostic Evaluation
Peripheral Artery Disease V: Postoperative Nursing Management
Peripheral Artery Disease IV: Nursing Management
Coronary Artery Disease V: Interprofessional Care


