Published Online
on April 12, 2004

A more recent version of this article appeared on April 27, 2004

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Submitted on December 3, 2003
Revised on February 17, 2004
Accepted on February 20, 2004

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

Alexandra J. Lansky MD^*, Ricardo A. Costa MD, Gary S. Mintz MD, Yoshihiro Tsuchiya MD, Mark Midei MD, David A. Cox MD, Charles O’Shaughnessy MD, Robert A. Applegate MD, Louis A. Cannon MD, Michael Mooney MD, Anthony Farah MD, Mark A. Tannenbaum MD, Steven Yakubov MD, Dean J. Kereiakes MD, S. Chiu Wong MD, Barry Kaplan MD, Ecaterina Cristea MD, Gregg W. Stone MD, Martin B. Leon MD, William D. Knopf MD, William W. O’Neill MD, for the DELIVER Clinical Trial Investigators

From the Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY (A.J.L., R.A.C., G.S.M., Y.T., E.C., G.W.S., M.B.L.); St Joseph Medical Center, Towson, Md (M.M.); Presbyterian Hospital, Charlotte, NC (D.A.C.); EMF Regional Medical Center, Elyria, Ohio (C.O.S.); Wake Forest University Baptist Medical Center, Winston-Salem, NC (R.A.A.); Michigan Cardiovascular Institute, Saginaw, Mich (L.A.C.); Minneapolis Heart Institute, Minneapolis, Minn (M.M.); Allegheny General Hospital, Pittsburgh, Pa (A.F.); Iowa Heart Center, Des Moines, Iowa (M.A.T.); Riverside Methodist Hospital, Columbus, Ohio (S.Y.); Ohio Heart Health Center, Cincinnati, Ohio (D.J.K.); New York Presbyterian Hospital, New York, NY (S.C.W.); North Shore University Hospital, Manhasset, NY (B.K.); St Joseph’s Hospital, Atlanta, Ga (W.D.K.); and William Beaumont Hospital, Royal Oak, Mich (W.W.O.).

^* To whom correspondence should be addressed. E-mail: alansky{at}crf.org.

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.

Methods and 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.

Key words: stents • restenosis • angioplasty • coronary artery disease • trials

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