Duke Clinical Research Institute, Durham, North Carolina 27705, USA.
JACC Cardiovasc Interv. 2009 Dec;2(12):1199-207. doi: 10.1016/j.jcin.2009.10.009.
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.
Although previous clinical trials have evaluated long-term clinical outcome for drug-eluting stents, none considered their economic implications.
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.
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.
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).
本研究旨在评估在 ENDEAVOR III 临床试验中，接受依维莫司洗脱支架（ZES）（n = 323）与西罗莫司洗脱支架（SES）（n = 113）治疗的患者的临床和经济结局。
尽管先前的临床试验已经评估了药物洗脱支架的长期临床结局，但没有考虑其经济影响。
我们分析了病例报告表信息，并从二级来源应用了生活质量调整和医疗保险成本权重；比较了临床结局、质量调整生存、医疗资源使用和医疗成本的差异，并通过 3 年随访评估了成本效益。
与 SES 相比，ZES 的使用降低了 3 年每 100 例患者的死亡或心肌梗死发生率（3.9% vs. 10.8%；差异-6.9%；95%置信区间[CI]：-13.0 至 0.8；p = 0.028），但靶血管血运重建率无差异（17.9% vs. 12.2%；差异 5.7%；95%CI：-3.7 至 15.1；p = 0.23），但冠状动脉旁路移植术（CABG）的使用率更高（3.5% vs. 0.0%；差异 3.5%；95%CI：1.3 至 5.7；p = 0.002）。在每年贴现 3%的情况下，ZES 与 SES 的总医疗成本相似（$23,353 与 $21,657；差异 $1,696；95%CI：-$1,089 至 $4,482；p = 0.23），且 3 年成本效益比为 $57,002/质量调整生命年。
尽管 ZES 组的死亡或心肌梗死发生率降低，且全血运重建率无差异，但由于 ZES 组重复 CABG 血运重建术的增加，医疗成本并未降低。如果未来的试验观察到类似的差异，且安全性提高，而医疗成本无差异，那么与 SES 相比，ZES 的使用将是一种具有临床和经济吸引力的治疗策略。（依维莫司洗脱冠状动脉支架系统临床试验[ENDEAVOR III]；NCT00217256）。
