Format

Send to

Choose Destination
JACC Cardiovasc Interv. 2016 Jun 13;9(11):1178-87. doi: 10.1016/j.jcin.2016.02.051.

Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results.

Author information

1
Cardiovascular and Interventional Radiology Department, Medical University Vienna, Vienna, Austria. Electronic address: jlammer@gmx.at.
2
Department of Vascular Surgery, Sint-Blasius Hospital, Dendermonde, Belgium.
3
Department of Interventional Angiology, University Leipzig, Leipzig, Germany.
4
Department of Angiology, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
5
Cardiovascular and Interventional Radiology Department, Medical University Vienna, Vienna, Austria.
6
Vaatcentrum, Oost Limburg Ziekenhuis, Genk, Belgium.
7
Department of General Interventional Cardiology, Clinique Pasteur, Toulouse, France.
8
Department of Vascular Surgery, Ghent University Hospital, Gent, Belgium.
9
Beth Israel Deaconess Medical Center, Boston, Massachusetts.
10
Abbott Vascular, Santa Clara, California.
11
Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, Massachusetts.

Abstract

OBJECTIVES:

This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA).

BACKGROUND:

Drug-eluting BVS has shown promise in coronary arteries.

METHODS:

The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication.

RESULTS:

Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet.

CONCLUSIONS:

The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974).

KEYWORDS:

bioresorbable vascular scaffold; drug-eluting stent(s); femoropopliteal artery; peripheral artery disease; poly-l-lactide

PMID:
27282601
DOI:
10.1016/j.jcin.2016.02.051
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center