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Clinical research

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

1. University Medical Center Utrecht, Utrecht, The Netherlands; 2. Helios Klinikum Siegburg, Germany; 3. Cardiovascular Centre Aalst, Aalst, Belgium; 4. Barmherzigen Bruder Krankenhaus, Trier, Germany; 5. Institut Hospitalier Jacques Cartier, Massy, France; 6. Centre Cardiologique du Nord, Saint-Denis, France; 7. Clinique Pasteur, Toulouse, France; 8. Sankt Katharinen Krankenhaus, Frankfurt, Germany

Aims: 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.

Methods and 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 > 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.

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