A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial.
BACKGROUND
A fully bioabsorbable drug-eluting coronary stent that scaffolds the vessel wall when needed and then disappears once the acute recoil and constrictive remodelling processes have subsided has theoretical advantages. The bioasorbable everolimus-eluting stent (BVS) has a backbone of poly-L-lactic acid that provides the support and a coating of poly-D,L-lactic acid that contains and controls the release of the antiproliferative agent everolimus. We assessed the feasibility and safety of this BVS stent.


METHODS
In this prospective, open-label study we enrolled 30 patients who had either stable, unstable, or silent ischaemia and a single de-novo lesion that was suitable for treatment with a single 3.0 x 12 mm or 3.0 x 18 mm stent. Patients were enrolled from four academic hospitals in Auckland, Rotterdam, Krakow, and Skejby. The composite endpoint was cardiac death, myocardial infarction, and ischaemia-driven target lesion revascularisation. Angiographic endpoints were available for 26 patients and intravascular-ultrasound endpoints for 24 patients. Clinical endpoints were assessed in all 30 patients at 6 and 12 months. In a subset of 13 patients, optical coherence tomography was undertaken at baseline and follow-up. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00300131.


RESULTS
Procedural success was 100% (30/30 patients), and device success 94% (29/31 attempts at implantation of the stent). At 1 year, the rate of major adverse cardiac events was 3.3%, with only one patient having a non-Q wave myocardial infarction and no target lesion revascularisations. No late stent thromboses were recorded. At 6-month follow-up, the angiographic in-stent late loss was 0.44 (0.35) mm and was mainly due to a mild reduction of the stent area (-11.8%) as measured by intravascular ultrasound. The neointimal area was small (0.30 [SD 0.44] mm2), with a minimal area obstruction of 5.5%.


CONCLUSIONS
This study shows the feasibility of implantation of the bioabsorbable everolimus-eluting stent, with an acceptable in-stent late loss, minimal intrastent neointimal hyperplasia, and a low stent area obstruction.


BACKGROUND
Abbott Vascular.
Ormiston
John A
JA
Auckland City Hospital, Auckland, New Zealand.
Serruys
Patrick W
PW
Regar
Evelyn
E
Dudek
Dariusz
D
Thuesen
Leif
L
Webster
Mark W I
MW
Onuma
Yoshinobu
Y
Garcia-Garcia
Hector M
HM
McGreevy
Robert
R
Veldhof
Susan
S
D020341:Absorbable Implants; D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D023903:Coronary Restenosis; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012449:Safety; D020123:Sirolimus / Q000031:analogs & derivatives*; D014463:Ultrasonography
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus