Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease.
Absorbable Implants
Aged
Angioplasty, Balloon
/ adverse effects
Chronic Disease
Databases, Factual
Female
Humans
Ischemia
/ diagnostic imaging
Male
Middle Aged
Peripheral Arterial Disease
/ diagnostic imaging
Popliteal Artery
/ diagnostic imaging
Prosthesis Design
Retrospective Studies
Risk Factors
Severity of Illness Index
Time Factors
Treatment Outcome
Vascular Patency
angiography
intervention
peripheral
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 Dec 2019
01 Dec 2019
Historique:
received:
06
04
2019
accepted:
05
10
2019
pubmed:
17
10
2019
medline:
2
9
2020
entrez:
17
10
2019
Statut:
ppublish
Résumé
To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12 months. Thirty-one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford-Becker classification. At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.
Sections du résumé
OBJECTIVES
OBJECTIVE
To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia.
BACKGROUND
BACKGROUND
The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS.
METHODS
METHODS
This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12 months.
RESULTS
RESULTS
Thirty-one patients (51.6% male) with a median age of 67 years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12 months driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months. All patients were alive at 12 months, and 96.8% of patients improved their Rutherford-Becker classification.
CONCLUSIONS
CONCLUSIONS
At 12 months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1028-1033Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2019 Wiley Periodicals, Inc.
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