Journal Article

A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial

Dudek, Dariusz, Regar, Evelyn, Garcia-Garcia, Hector M, McGreevy, Robert, Thuesen, Leif, Webster, Mark WI, Veldhof, Susan, Ormiston, John A, Serruys, Patrick W, Onuma, Yoshinobu

2008

Overview

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. 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 3·0×12 mm or 3·0×18 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. 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] mm 2), with a minimal area obstruction of 5·5%. 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. Abbott Vascular.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Absorbable Implants / Angioplasty / Angioplasty, Balloon, Coronary / Clinical trials / Coronary Disease - diagnostic imaging / Coronary Disease - therapy / Coronary Restenosis / Coronary vessels / Drug-Eluting Stents / Everolimus / Female / Heart attacks / Humans / Immunosuppressive Agents / Internal Medicine / Lesions / Male / Middle Aged / Myocardial infarction / Prospective Studies / Safety / Sirolimus - analogs & derivatives / Stents / Thromboembolism / Ultrasonography