A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods

• Published in: The Lancet (British edition) 2009-03, Vol.373 (9667), p.897-910
• Main Authors: Serruys, Patrick W, Prof, Ormiston, John A, Prof, Onuma, Yoshinobu, MD, Regar, Evelyn, MD, Gonzalo, Nieves, MD, Garcia-Garcia, Hector M, MD, Nieman, Koen, MD, Bruining, Nico, PhD, Dorange, Cécile, MSc, Miquel-Hébert, Karine, PhD, Veldhof, Susan, RN, Webster, Mark, MB, Thuesen, Leif, MD, Dudek, Dariusz, MD
• Format: Article
• Language: English
• Subjects: Absorbable Implants; Biological and medical sciences; Cardiology. Vascular system; Clinical Trials as Topic; Coronary Disease - diagnostic imaging; Coronary Disease - therapy; Coronary heart disease; Coronary Restenosis - etiology; Coronary Restenosis - prevention & control; Coronary vessels; Drug-Eluting Stents - adverse effects; Everolimus; Female; Follow-Up Studies; General aspects; Heart; Heart attacks; Histology; Humans; Immunosuppressive Agents; Internal Medicine; Lesions; Male; Medical imaging; Medical sciences; Middle Aged; Multicenter Studies as Topic; Myocardial infarction; Sirolimus - analogs & derivatives; Stents; Studies; Thromboembolism; Treatment Outcome; Ultrasonography
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(09)60325-1

Summary Background Drug-eluting metallic coronary stents predispose to late stent thrombosis, prevent late lumen vessel enlargement, hinder surgical revascularisation, and impair imaging with multislice CT. We assessed the safety of the bioabsorbable everolimus-eluting stent (BVS). Methods 30 patients with a single de-novo coronary artery lesion were followed up for 2 years clinically and with multiple imaging methods: multislice CT, angiography, intravascular ultrasound, derived morphology parameters (virtual histology, palpography, and echogenicity), and optical coherence tomography (OCT). Findings Clinical data were obtained from 29 of 30 patients. At 2 years, the device was safe with no cardiac deaths, ischaemia-driven target lesion revascularisations, or stent thromboses recorded, and only one myocardial infarction (non-Q wave). 18-month multislice CT (assessed in 25 patients) showed a mean diameter stenosis of 19% (SD 9). At 2-year angiography, the in-stent late loss of 0·48 mm (SD 0·28) and the diameter stenosis of 27% (11) did not differ from the findings at 6 months. The luminal area enlargement on OCT and intravascular ultrasound between 6 months and 2 years was due to a decrease in plaque size without change in vessel size. At 2 years, 34·5% of strut locations presented no discernible features by OCT, confirming decreases in echogenicity and in radiofrequency backscattering; the remaining apparent struts were fully apposed. Additionally, vasomotion occurred at the stented site and adjacent coronary artery in response to vasoactive agents. Interpretation At 2 years after implantation the stent was bioabsorbed, had vasomotion restored and restenosis prevented, and was clinically safe, suggesting freedom from late thrombosis. Late luminal enlargement due to plaque reduction without vessel remodelling needs confirmation. Funding Abbott Vascular (USA).