Late safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent compared with a paclitaxel-eluting stent in patients with de novo coronary lesions: 2-year follow-up from the ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).
OBJECTIVE
The aim of this study was to assess, after 2 years of follow-up, the safety, efficacy, and cost-effectiveness of a zotarolimus-eluting stent (ZES) compared with a paclitaxel-eluting stent (PES) in patients with native coronary lesions.


BACKGROUND
Early drug-eluting stents were associated with a small but significant incidence of very late stent thrombosis (VLST), occurring >1 year after the index procedure. The ZES has shown encouraging results in clinical trials.


METHODS
The ENDEAVOR IV trial (Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions), a randomized (1:1), single-blind, controlled trial (n = 1,548) compared ZES versus PES in patients with single de novo coronary lesions. Two-year follow-up was obtained in 96.0% of ZES and 95.4% of PES patients. The primary end point was target vessel failure (TVF), and safety end points included Academic Research Consortium-defined stent thrombosis. Economic end points analyzed included quality-adjusted survival, medical costs, and relative cost-effectiveness of ZES and PES.


RESULTS
The TVF at 2 years was similar in ZES and PES patients (11.1% vs. 13.1%, p = 0.232). There were fewer myocardial infarctions (MIs) in ZES patients (p = 0.022), due to fewer periprocedural non-Q-wave MIs and fewer late MIs between 1 and 2 years. Late MIs were associated with increased VLST (PES: 6 vs. ZES: 1; p = 0.069). Target lesion revascularization was similar comparing ZES with PES (5.9% vs. 4.6%; p = 0.295), especially in patients without planned angiographic follow-up (5.2% vs. 4.9%; p = 0.896). The cost-effectiveness of ZES and PES was similar.


CONCLUSIONS
After 2 years of follow-up, ZES demonstrated efficacy and cost-effectiveness comparable to PES, with fewer MIs and a trend toward less VLST. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).
Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York 10032, USA. mleon@crf.org
Martin B
MB
Leon
David E
DE
Kandzari
Eric L
EL
Eisenstein
Kevin J
KJ
Anstrom
Laura
L
Mauri
Donald E
DE
Cutlip
Eugenia
E
Nikolsky
Charles
C
O'Shaughnessy
Paul A
PA
Overlie
Ajay J
AJ
Kirtane
Brent T
BT
McLaurin
Stuart L
SL
Solomon
John S
JS
Douglas
Jeffrey J
JJ
Popma
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic / Q000209:etiology; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003362:Cost-Benefit Analysis; D054855:Drug-Eluting Stents; D005260:Female; D017048:Health Care Costs; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment; D016037:Single-Blind Method; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D002317:Cardiovascular Agents; C489443:zotarolimus; D017239:Paclitaxel; D020123:Sirolimus