Novel drug eluting stent system for customised treatment of coronary lesions : CUSTOM I feasibility trial 24 month results

• Published in: EuroIntervention Vol. 4; no. 1; pp. 71 - 76
• Main Authors: GRUBE, Eberhard, SIEVERT, Horst, HAUPTMANN, Karl-Eugen, MUELLER, Ralf, GERCKENS, Ulrich, BUELLESFELD, Lutz, AKO, Junya, SHIMOHAMA, Takao, COSTA, Marco, FITZGERALD, Peter
• Format: Journal Article
• Language: English
• Published: Toulouse Société Europa Edition 01-05-2008
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Biological and medical sciences; Cardiology. Vascular system; Coated Materials, Biocompatible; Coronary Artery Disease - therapy; Coronary heart disease; Drug Delivery Systems; Drug-Eluting Stents - adverse effects; Feasibility Studies; Female; Follow-Up Studies; Heart; Humans; Lactic Acid; Male; Medical sciences; Middle Aged; Polyesters; Polymers; Prospective Studies; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Treatment Outcome; Treatment; Biolimus A9; Coronary artery; Cardiovascular disease; Feasibility; Lesion; Coronary heart disease; Drug eluting stent; System; customisation; Result
• ISSN: 1774-024X
• DOI: 10.4244/EIJV4I1A13

The Custom NX 36 Drug Eluting Stent (DES) System is designed to treat coronary lesions via in situ stent length customisation. The stent evaluated in this study consists of nine interdigitated stent segments, each 4 mm in length, coated with a biodegradable formulation of Biolimus A9 and Poly-Lactic-Acid, a biodegradable drug carrier, and loaded into a unique sheath protected, integrated balloon delivery system.
The objective of this non-randomised prospective multicentre CUSTOM I Trial was to demonstrate the safety of in situ stent length customisation in 30 consecutive patients. Angiographic (QCA) and intravascular ultrasound (IVUS) follow-up was performed at two cohort time intervals: four (n=10) or eight (n=20) months. Mean lesion length and reference vessel diameters were 17.7 +/- 9.6 mm and 2.6 +/- 0.3 mm, respectively. Procedural success was 93%. There were three MACEs in the study population from enrollment through to twenty-four month follow-up. The in-hospital MACE rate was 2/30, with non-Q-wave myocardial infarctions events in two patients who recovered without further sequelae. At five months, one patient who had crossed over initially to PTCA required CABG surgery. Results from QCA and IVUS assessments at four and eight months showed no binary restenosis, mean in-stent late luminal loss of 0.25 +/- 0.23 mm and 0.26 +/- 0.23 mm.
This first evaluation of the new customisable Biolimus A9-eluting Custom NX stent suggests safety and efficacy through twenty-four month follow-up. Further evaluations are warranted to confirm the overall favourable outcomes.