Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Internal Medicine and Cardiovascular Center, Presbyterian Medical Center, Jeonju, Republic of Korea.
JACC Cardiovasc Interv. 2014 May;7(5):471-81. doi: 10.1016/j.jcin.2013.12.201.
This study sought to compare everolimus-eluting stents (EES) versus Resolute zotarolimus-eluting stents (ZES) in terms of patient- or stent-related clinical outcomes in an "all-comer" group of patients with diabetes mellitus (DM) who underwent percutaneous coronary intervention.
DM significantly increases the risk of adverse events after percutaneous coronary intervention. The efficacy and safety of second-generation drug-eluting stents, in particular EES versus ZES, in patients with DM have not been extensively evaluated.
Patients with DM (1,855 of 5,054 patients, 36.7%) from 2 prospective registries (the EXCELLENT [Efficacy of Xience/Promus Versus Cypher in Reducing Late Loss After Stenting] registry and RESOLUTE-Korea [Registry to Evaluate the Efficacy of Zotarolimus-Eluting Stent]) who were treated with EES (n = 1,149) or ZES (n = 706) were compared. Stent-related outcome was target lesion failure (TLF), and patient-oriented composite events were a composite of all-cause mortality, any myocardial infarction, and any revascularization.
Despite a higher risk patient profile in the ZES group, both TLF (43 of 1,149 [3.7%] vs. 25 of 706 [3.5%], p = 0.899) and patient-oriented composite events (104 of 1,149 [9.1%] vs. 72 of 706 [10.2%], p = 0.416) were similar between the EES and ZES in patients with DM at 1 year. In those without DM, EES and ZES also showed comparable incidence of TLF (39 of 1,882 [2.1%] vs. 33 of 1,292 [2.6%], p = 0.370) and patient-oriented composite events (119 of 1,882 [6.3%] vs. 81 of 1,292 [6.3%], p = 0.951), which were all significantly lower than in the DM patients. These results were corroborated by similar findings from the propensity score-matched cohort. Upon multivariate analysis, chronic renal failure was the most powerful predictor of TLF in DM patients (hazard ratio: 4.39, 95% confidence interval: 1.91 to 10.09, p < 0.001).
After unrestricted use of second-generation drug-eluting stents in all-comers receiving percutaneous coronary intervention, both EES and ZES showed comparable clinical outcomes in the patients with DM up to 1 year of follow-up. DM compared with non-DM patients showed significantly worse patient- and stent-related outcomes. Nonetheless, overall incidences of TLF were low, even in the patients with DM, suggesting excellent safety and efficacy of both types of second-generation drug-eluting stents in this high-risk subgroup of patients.
本研究旨在比较在接受经皮冠状动脉介入治疗的糖尿病（DM）“所有患者”亚组中，依维莫司洗脱支架（EES）与雷帕霉素洗脱 RESOLUTE 支架（ZES）在患者或支架相关临床结局方面的表现。
DM 显著增加经皮冠状动脉介入治疗后发生不良事件的风险。第二代药物洗脱支架（尤其是 EES 与 ZES）在 DM 患者中的疗效和安全性尚未得到广泛评估。
从 2 项前瞻性注册研究（EXCELLENT 研究[西地那非/普罗姆斯与西弗尤斯在支架置入后晚期丢失减少方面的疗效]和 RESOLUTE-Korea 研究[评估佐他莫司洗脱支架疗效的登记研究]）中纳入 5054 例患者（1855 例为 DM 患者，占 36.7%），这些患者接受了 EES（n = 1149）或 ZES（n = 706）治疗。支架相关结局为靶病变失败（TLF），患者导向的复合终点为全因死亡率、任何心肌梗死和任何血运重建的复合事件。
尽管 ZES 组患者的风险更高，但 EES 和 ZES 组的 TLF（1149 例患者中 43 例[3.7%] vs. 706 例患者中 25 例[3.5%]，p = 0.899）和患者导向的复合终点事件（1149 例患者中 104 例[9.1%] vs. 706 例患者中 72 例[10.2%]，p = 0.416）在 DM 患者中在 1 年时也相似。在无 DM 的患者中，EES 和 ZES 的 TLF 发生率（1882 例患者中 39 例[2.1%] vs. 1292 例患者中 33 例[2.6%]，p = 0.370）和患者导向的复合终点事件发生率（1882 例患者中 119 例[6.3%] vs. 1292 例患者中 81 例[6.3%]，p = 0.951）也相似，这些发生率均显著低于 DM 患者。倾向评分匹配队列的结果也证实了这一点。多变量分析显示，慢性肾衰竭是 DM 患者 TLF 的最强预测因素（风险比：4.39，95%置信区间：1.91 至 10.09，p < 0.001）。
在经皮冠状动脉介入治疗的所有患者中不受限制地使用第二代药物洗脱支架后，EES 和 ZES 在 1 年随访期间在 DM 患者中均表现出相似的临床结局。与非 DM 患者相比，DM 患者的患者和支架相关结局明显更差。尽管如此，即使在 DM 患者中，TLF 的总体发生率也较低，这表明这两种类型的第二代药物洗脱支架在这一高危亚组患者中具有出色的安全性和疗效。
