One year results of a new in situ length-adjustable stent platform with a biodegradable biolimus A9 eluting polymer: results of the CUSTOM-II trial.
OBJECTIVE
To assess the safety and efficacy of the XTENT customisable drug-eluting stent system in the treatment of patients with single long or multiple coronary lesions referred for PCI.


RESULTS
The CUSTOM-II trial enrolled 100 patients with de novo lesions in native coronary arteries presenting with either single long lesions (n=69) of > or =20 mm length or up to two lesions with a total cumulative anticipated stent length of 60 mm of stent (n=31). Patients were assessed angiographically at six months, and clinically at one year. Of the 100 patients enrolled, nine patients experienced a MACE, including five patients whose MACE occurred during index hospitalisation (two non-Q-MI, two Q-MI and one probable stent thrombosis-related death), and four target lesion revascularisations (TLR) at six months. No MACE or stent thrombosis was reported between six and 12 months follow-up. In-segment late loss at 6-months was 0.22 +/- 0.28 mm, and in-stent late loss had a range of 0.31 +/- 0.31 mm.


CONCLUSIONS
The XTENT customisable stent is clinically safe and efficacious as judged by angiographic and clinical variables through 12 months follow-up. Further follow-up and larger randomised comparative studies are needed for its clinical positioning.
Stella
Pieter R
PR
University Medical Center Utrecht, Utrecht, The Netherlands. P.Stella@umcutrecht.nl
Mueller
Ralf
R
Pavlakis
George
G
De Bruyne
Bernard
B
Hauptmann
Karl
K
Morice
Marie-Claude
MC
Chevalier
Bernard
B
Fajadet
Jean
J
Sievert
Horst
H
Grube
Eberhard
E
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000628:therapy*; D012307:Risk Factors; D020123:Sirolimus / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; C518022:umirolimus; D020123:Sirolimus