Duke Clinical Research Institute, Durham, North Carolina 27705, USA.
JACC Cardiovasc Interv. 2009 Dec;2(12):1178-87. doi: 10.1016/j.jcin.2009.10.011.
This study was designed to evaluate long-term clinical and economic outcomes for subjects receiving Endeavor drug-eluting versus Driver bare-metal stents (both Medtronic CardioVascular, Santa Rosa, California).
Early studies found that the drug-eluting stent (DES) was a clinically and economically attractive alternative to the bare-metal stent; however, associations between DES and very late stent thrombosis suggest that longer follow-up is required.
We used clinical, resource use and follow-up data from 1,197 subjects randomized to receive Endeavor (n = 598) versus Driver (n = 599) stents in ENDEAVOR II (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions) study with Medicare cost weights and quality of life adjustments applied from secondary sources. We compared differences through 4-year follow-up (1,440 days).
Patients in both treatment groups had similar baseline characteristics. The use of Endeavor versus Driver reduced 4-year target vessel revascularization rates per 100 subjects (10.4 vs. 21.5; difference: -11.1; 95% confidence interval [CI]: -16.0 to -6.1; p < 0.001), with no difference in the rates per 100 subjects of death (5.0 vs. 5.2; difference: -0.2; 95% CI: -2.7 to 2.4; p = 0.90) or nonfatal myocardial infarction (3.2 vs. 4.4; difference: -1.2; 95% CI: -3.4 to 1.0; p = 0.29). After discounting at a 3% annual rate, there were no differences in quality-adjusted survival days (1,093 vs. 1,090; difference: 3; 95% CI: -13 to 19; p = 0.69) and total medical costs ($21,483 vs. $21,680; difference: -$198; 95% CI: -$1,608 to $1,207; p = 0.78).
The use of Endeavor versus Driver was associated with a significant reduction in target vessel revascularization through 4-year follow-up with no difference in death, nonfatal myocardial infarction, quality-adjusted survival, or total medical costs. These results are comparable to those for other studies evaluating drug-eluting versus bare-metal stents. (Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in De Novo Native Coronary Artery Lesions [ENDEAVOR II]; NCT00614848).
本研究旨在评估接受 Endeavor 药物洗脱支架与 Driver 裸金属支架治疗的患者的长期临床和经济结局（均来自美敦力心血管公司，加利福尼亚州圣罗莎）。
早期研究发现，药物洗脱支架（DES）是一种具有临床和经济吸引力的裸金属支架替代物；然而，DES 与极晚期支架血栓之间的关联表明需要进行更长时间的随访。
我们使用来自 1197 名随机接受 Endeavor（n=598）或 Driver（n=599）支架治疗的患者的临床、资源使用和随访数据，这些数据来自 ENDEAVOR II（评价美敦力 AVE ABT-578 洗脱 Driver 冠状动脉支架在新发病变的原生冠状动脉中的安全性和疗效的随机对照试验）研究，并应用了来自次要来源的医疗保险成本权重和生活质量调整。我们通过 4 年随访（1440 天）比较了差异。
两组患者的基线特征相似。与使用 Driver 相比，使用 Endeavor 降低了每 100 例患者的 4 年靶血管血运重建率（10.4% vs. 21.5%；差值：-11.1；95%置信区间[CI]：-16.0 至-6.1；p<0.001），但每 100 例患者的死亡率（5.0% vs. 5.2%；差值：-0.2；95%CI：-2.7 至 2.4；p=0.90）或非致死性心肌梗死（3.2% vs. 4.4%；差值：-1.2；95%CI：-3.4 至 1.0；p=0.29）无差异。按 3%的年贴现率折现后，质量调整生存天数（1093 天 vs. 1090 天；差值：3；95%CI：-13 至 19；p=0.69）和总医疗费用（21483 美元 vs. 21680 美元；差值：-198 美元；95%CI：-1608 美元至 1207 美元；p=0.78）均无差异。
与使用 Driver 相比，使用 Endeavor 与靶血管血运重建率的显著降低相关，而在死亡率、非致死性心肌梗死、质量调整生存或总医疗费用方面无差异。这些结果与其他评估药物洗脱支架与裸金属支架的研究结果相当。（评价美敦力 AVE ABT-578 洗脱 Driver 冠状动脉支架在新发病变的原生冠状动脉中的安全性和疗效的随机对照试验[ENDEAVOR II]；NCT00614848）。
