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

• Published in: The Lancet (British edition) Vol. 371; no. 9616; pp. 899 - 907
• Main Authors: Ormiston, John A, MB, Serruys, Patrick W, Prof, Regar, Evelyn, MD, Dudek, Dariusz, MD, Thuesen, Leif, MD, Webster, Mark WI, MB, Onuma, Yoshinobu, MD, Garcia-Garcia, Hector M, MD, McGreevy, Robert, PhD, Veldhof, Susan, RN
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 15.03.2008; Elsevier Limited
• Subjects: 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
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(08)60415-8

Summary 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 3·0×12 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. Findings 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%. Interpretation 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. Funding Abbott Vascular.