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


RESULTS
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.


CONCLUSIONS
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.
Grube
Eberhard
E
Department of Cardiology/Angiology, HELIOS Heart Center Siegburg, Siegburg, Germany. GrubeE@aol.com
Sievert
Horst
H
Hauptmann
Karl-Eugen
KE
Mueller
Ralf
R
Gerckens
Ulrich
U
Buellesfeld
Lutz
L
Ako
Junya
J
Shimohama
Takao
T
Costa
Marco
M
Fitzgerald
Peter
P
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D003324:Coronary Artery Disease / Q000628:therapy*; D016503:Drug Delivery Systems; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D019344:Lactic Acid; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); C518022:umirolimus; D020123:Sirolimus