Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial.
BACKGROUND
Paclitaxel, a microtubule-stabilizing compound with potent antitumor activity, has been shown to inhibit smooth muscle cell proliferation and migration. The DELIVER trial was a prospective, randomized, blinded, multicenter clinical evaluation of the non-polymer-based paclitaxel-coated ACHIEVE stent compared with the stainless steel Multi-Link (ML) PENTA stent.


RESULTS
A total of 1043 patients with focal de novo coronary lesions, <25 mm in length, in 2.5- to 4.0-mm vessels were randomized (ACHIEVE n=524; ML PENTA n=519). Angiographic follow-up was performed in a subset of 442 patients (ACHIEVE n=228; ML PENTA n=214). Prespecified end points were a 40% reduction in target-vessel failure at 9 months (primary clinical end point) and a 50% reduction in binary restenosis at 8 months (major secondary end point). Baseline clinical characteristics were comparable between the groups. Patients in ACHIEVE had more type C lesions and a larger reference diameter. At follow-up, stent late loss was 0.81 versus 0.98 mm (P=0.003), stent binary restenosis was 14.9% versus 20.6% (P=0.076), and target-vessel failure was 11.9% versus 14.5% (P=0.12) for ACHIEVE and ML PENTA, respectively.


CONCLUSIONS
The ACHIEVE paclitaxel-coated stent decreased neointimal proliferation compared with the bare-metal PENTA stent; however, this reduction was insufficient to meet the prespecified primary end point of target-vessel failure and the secondary end point of binary restenosis.
Lansky
Alexandra J
AJ
Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, 55 E 59th St, 6th Floor, New York, NY 10022-1112, USA. alansky@crf.org
Costa
Ricardo A
RA
Mintz
Gary S
GS
Tsuchiya
Yoshihiro
Y
Midei
Mark
M
Cox
David A
DA
O'Shaughnessy
Charles
C
Applegate
Robert A
RA
Cannon
Louis A
LA
Mooney
Michael
M
Farah
Anthony
A
Tannenbaum
Mark A
MA
Yakubov
Steven
S
Kereiakes
Dean J
DJ
Wong
S Chiu
SC
Kaplan
Barry
B
Cristea
Ecaterina
E
Stone
Gregg W
GW
Leon
Martin B
MB
Knopf
William D
WD
O'Neill
William W
WW
D003131:Combined Modality Therapy; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000175:diagnosis / Q000628:therapy*; D016503:Drug Delivery Systems; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome
D017239:Paclitaxel