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



Drug-eluting BVS has shown promise in coronary arteries.



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.



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.



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).
Cardiovascular and Interventional Radiology Department, Medical University Vienna, Vienna, Austria. Electronic address: jlammer@gmx.at.
Johannes
J
Lammer
Department of Vascular Surgery, Sint-Blasius Hospital, Dendermonde, Belgium.
Marc
M
Bosiers
Department of Interventional Angiology, University Leipzig, Leipzig, Germany.
Koen
K
Deloose
Department of Angiology, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Andrej
A
Schmidt
Department of Angiology, Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Thomas
T
Zeller
Cardiovascular and Interventional Radiology Department, Medical University Vienna, Vienna, Austria.
Florian
F
Wolf
Vaatcentrum, Oost Limburg Ziekenhuis, Genk, Belgium.
Wouter
W
Lansink
Department of General Interventional Cardiology, Clinique Pasteur, Toulouse, France.
Antoine
A
Sauguet
Department of Vascular Surgery, Ghent University Hospital, Gent, Belgium.
Frank
F
Vermassen
Vaatcentrum, Oost Limburg Ziekenhuis, Genk, Belgium.
Geert
G
Lauwers
Department of Interventional Angiology, University Leipzig, Leipzig, Germany.
Dierk
D
Scheinert
Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Jeffrey J
JJ
Popma
Abbott Vascular, Santa Clara, California.
Robert
R
McGreevy
Abbott Vascular, Santa Clara, California.
Richard
R
Rapoza
Abbott Vascular, Santa Clara, California.
Lewis B
LB
Schwartz
Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, Massachusetts.
Michael R
MR
Jaff
D020341:Absorbable Implants; D000368:Aged; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D017079:Exercise Tolerance; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011474:Prosthesis Design; D020127:Recovery of Function; D012008:Recurrence; D019233:Retreatment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D000068338:Everolimus
bioresorbable vascular scaffold; drug-eluting stent(s); femoropopliteal artery; peripheral artery disease; poly-l-lactide