Cardiovascular Center, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Circ Cardiovasc Interv. 2012 Apr;5(2):174-84. doi: 10.1161/CIRCINTERVENTIONS.111.964650. Epub 2012 Mar 6.
The paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) are first-generation drug-eluting stents (DES) that have been the most widely used; however, it is unclear whether there are differences in the long-term safety and efficacy between the 2 stents. The long-term effectiveness of DES in unselected people with diabetes is also currently unclear. Moreover, the possibility of late catch-up is suggested in the DES population.
This study is an 8-center collaborative network analysis of all comers who received SES and PES. All patients who received SES and PES from February 2003 to October 2006 were enrolled. We analyzed 9315 patients (33.3% with diabetes) treated with SES or PES in the major 8 centers representing whole area of Korea. The primary end point was a major adverse cardiac event (MACE) composite of overall death, myocardial infarction, and target lesion revascularization. All analyses were performed using multivariable, adjusted models and propensity score-matching methods. Long-term MACE for 5 years were significantly lower in the SES than the PES group (13.3% versus 15.6%; hazard ratio, 0.82; 95% confidence interval, 0.71 to 0.96; P=0.01), which was mainly driven by the difference of MACE within the first year (hazard ratio, 0.73; 95% CI, 0.59 to 0.90; P=0.003), but the rate of MACE between 1 and 5 years in the landmark analysis was not different between the 2 stents (1.9 versus 2.0%/yr). In the subpopulation of people with diabetes, in contrast to the whole population, PES was comparable to SES in terms of any clinical outcome, both within the first year and from 1 to 5 years (MACE for 5 years, 20.3 versus 17.9%; MACE within the first year, 9.6 versus 8.2%; MACE 1 to 5 years, 2.9 versus 2.6%/yr).
The PES was inferior to the SES in the clinical follow-up of more than 9000 patients' cohort for 5 years, which was mainly driven by the difference in the first year. In the subpopulation of people with diabetes that showed higher MACE than people without diabetes, however, PES was comparable to SES in any clinical outcome for 5 years. Although these 2 stents are not frequently used as before, the data would be useful to expect the long-term clinical course of the current DES.
紫杉醇洗脱支架（PES）和西罗莫司洗脱支架（SES）是第一代药物洗脱支架（DES），应用最为广泛，但两种支架的长期安全性和疗效是否存在差异尚不清楚。DES 在未经选择的糖尿病患者中的长期有效性目前也不清楚。此外，DES 人群中存在迟发追赶的可能性。
本研究是对接受 SES 和 PES 的所有患者进行的 8 个中心合作网络分析。纳入 2003 年 2 月至 2006 年 10 月接受 SES 和 PES 的所有患者。我们分析了代表韩国全域的 8 个主要中心的 9315 名接受 SES 或 PES 治疗的患者（33.3%患有糖尿病）。主要终点是全因死亡、心肌梗死和靶病变血运重建的复合主要不良心脏事件（MACE）。所有分析均采用多变量校正模型和倾向评分匹配方法进行。SES 组 5 年的长期 MACE 显著低于 PES 组（13.3%比 15.6%；风险比，0.82；95%置信区间，0.71 至 0.96；P=0.01），这主要是由于第一年 MACE 差异所致（风险比，0.73；95%CI，0.59 至 0.90；P=0.003），但在 landmark 分析中，1 至 5 年 MACE 率在两种支架之间无差异（1.9%比 2.0%/年）。在糖尿病患者亚组中，与全人群相比，PES 在第一年和 1 至 5 年的任何临床结局方面均与 SES 相当（5 年 MACE，20.3%比 17.9%；第一年 MACE，9.6%比 8.2%；1 至 5 年 MACE，2.9%比 2.6%/年）。
在超过 9000 例患者的队列中进行 5 年临床随访时，PES 劣于 SES，主要原因是第一年的差异。然而，在 MACE 发生率高于非糖尿病患者的糖尿病患者亚组中，PES 在 5 年内的任何临床结局方面均与 SES 相当。尽管这两种支架不像以前那样常用，但这些数据对于预测当前 DES 的长期临床过程将是有用的。
