Long-term clinical and economic analysis of the Endeavor zotarolimus-eluting stent versus the cypher sirolimus-eluting stent: 3-year results from the ENDEAVOR III trial (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions).
OBJECTIVE
The aim of this study was to evaluate clinical and economic outcomes for subjects receiving zotarolimus-eluting (ZES) (n = 323) versus sirolimus-eluting stents (SES) (n = 113) in the ENDEAVOR III (Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) clinical trial.


BACKGROUND
Although previous clinical trials have evaluated long-term clinical outcome for drug-eluting stents, none considered their economic implications.


METHODS
We analyzed case report form information with quality-of-life adjustment and Medicare cost weights applied from secondary sources; compared differences in clinical outcomes, quality-adjusted survival, medical resource use, and medical costs; and evaluated cost-effectiveness through 3-year follow-up.


RESULTS
The use of ZES versus SES reduced the 3-year rates/100 subjects of death or myocardial infarction (3.9 vs. 10.8; difference, -6.9; 95% confidence interval [CI]: -13.0 to 0.8; p = 0.028), with no difference in target vessel revascularization rates (17.9 vs. 12.2; difference, 5.7; 95% CI: -3.7 to 15.1; p = 0.23) but greater use of coronary artery bypass graft (CABG) surgery (3.5 vs. 0.0; difference 3.5; 95% CI: 1.3 to 5.7; p = 0.002). After discounting at 3% per annum, total medical costs for ZES versus SES were similar ($23,353 vs. $21,657; difference, $1,696; 95% CI: -$1,089 to $4,482, p = 0.23), and the 3-year cost-effectiveness ratio was $57,002/quality-adjusted life year.


CONCLUSIONS
Despite a reduction in death or myocardial infarction and no difference in total revascularizations, medical costs were not decreased due to increased CABG repeat revascularization procedures for subjects receiving ZES versus SES. If future trials observe similar differences, improved safety with no difference in medical costs, the use of ZES versus SES will be a clinically and economically attractive treatment strategy. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).
Eisenstein
Eric L
EL
Duke Clinical Research Institute, Durham, North Carolina 27705, USA. eric.eisenstein@duke.edu
Leon
Martin B
MB
Kandzari
David E
DE
Mauri
Laura
L
Edwards
Rex
R
Kong
David F
DF
Cowper
Patricia A
PA
Anstrom
Kevin J
KJ
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000191:economics; D001026:Coronary Artery Bypass / Q000191:economics; D003324:Coronary Artery Disease / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D003362:Cost-Benefit Analysis; D054855:Drug-Eluting Stents / Q000191:economics; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D006278:Medicare / Q000191:economics; D008875:Middle Aged; D018803:Models, Economic; D009203:Myocardial Infarction / Q000191:economics / Q000209:etiology; D011474:Prosthesis Design; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D002317:Cardiovascular Agents; C489443:zotarolimus; D020123:Sirolimus