Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial.
OBJECTIVE
This trial examined the relative clinical efficacy, angiographic outcomes, and safety of zotarolimus-eluting coronary stents (ZES) with a phosphorylcholine polymer versus sirolimus-eluting stents (SES).


BACKGROUND
Whether a cobalt-based alloy stent coated with the novel antiproliferative agent, zotarolimus, and a phosphorylcholine polymer may provide similar angiographic and clinical benefit compared with SES is undetermined.


METHODS
A prospective, multicenter, 3:1 randomized trial was conducted to evaluate the safety and efficacy of ZES (n = 323) relative to SES (n = 113) in 436 patients undergoing elective percutaneous revascularization of de novo native coronary lesions with reference vessel diameters between 2.5 mm and 3.5 mm and lesion length > or =14 mm and < or =27 mm. The primary end point was 8-month angiographic in-segment late lumen loss.


RESULTS
Angiographic in-segment late lumen loss was significantly higher among patients treated with ZES compared with SES (0.34 +/- 0.44 mm vs. 0.13 +/- 0.32 mm, respectively; p < 0.001). In-hospital major adverse cardiac events were significantly lower among patients treated with ZES (0.6% vs. 3.5%, p = 0.04). In-segment binary angiographic restenosis was also higher in the ZES cohort (11.7% vs. 4.3%, p = 0.04). Total (clinically and non-clinically driven) target lesion revascularization rates at 9 months were 9.8% and 3.5% for the ZES and SES groups, respectively (p = 0.04). However, neither clinically driven target lesion revascularization (6.3% zotarolimus vs. 3.5% sirolimus, p = 0.34) nor target vessel failure (12.0% zotarolimus vs. 11.5% sirolimus, p = 1.0) differed significantly.


CONCLUSIONS
Compared with SES, treatment with a phosphorylcholine polymer-based ZES is associated with significantly higher late lumen loss and binary restenosis at 8-month angiographic follow-up. (The Endeavor III CR; http://clinicaltrials.gov/ct/show/NCT00265668?order=1?).
Kandzari
David E
DE
Duke Clinical Research Institute, Durham, North Carolina 27705, USA. david.kandzari@duke.edu
Leon
Martin B
MB
Popma
Jeffrey J
JJ
Fitzgerald
Peter J
PJ
O'Shaughnessy
Charles
C
Ball
Michael W
MW
Turco
Mark
M
Applegate
Robert J
RJ
Gurbel
Paul A
PA
Midei
Mark G
MG
Badre
Sejal S
SS
Mauri
Laura
L
Thompson
Kweli P
KP
LeNarz
LeRoy A
LA
Kuntz
Richard E
RE
D000368:Aged; D023921:Coronary Stenosis / Q000188:drug therapy*; D016503:Drug Delivery Systems; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D015607:Stents; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; C489443:zotarolimus; D020123:Sirolimus