Macaya Carlos, García-García Héctor M, Colombo Antonio, Morice Marie-Claude, Legrand Victor, Kuck Karl-Heinz, Sheiban Imad, Suttorp Maarten Jan, Carrie Didier, Vrolix Mathias, Wittebols Kristel, Stoll Hans-Peter, Donohoe Dennis, Bressers Marco, Serruys Patrick W
Hospital Clinico St. Carlos, Madrid, Spain.
EuroIntervention. 2006 May;2(1):69-76.
ARTS-II was designed to evaluate the sirolimus-eluting stent (SES) versus ARTS-I. The objective of this analysis is to assess the safety and efficacy of the SES in diabetic patients with multivessel disease (MVD) versus both arms of ARTS-I.
The ARTS studies included 367 diabetic patients (ARTS-II: 159; ARTS-I-CABG: 96; ARTS-I-PCI: 112). Baseline characteristics showed a more diseased patient population in the ARTS-II study: 50.3% with 3VD vs. 35.4% (ARTS-I-CABG) and 30.8% (ARTS-I-PCI) (p=0.003). Treated or anastomosed lesions were 3.2+/-1.2 (ARTS-II), 2.8+/-0.8 (ARTS-I-CABG) and 2.5+/-1.1 (ARTS-I-PCI). At 30 days there was a significant difference in MACCE between ARTS-II (4.4%) and ARTS-I-PCI (12.5%) (p=0.02). At 1-year, the death rate was 2.5% (ARTS-II) vs. 3.1% (ARTS-I-CABG) and 6.3% (ARTS-I-PCI) without significant differences. Myocardial infarction rate was 0.6% (ARTS-II) vs. 2.1% (ARTS-I-CABG; p=0.56) and 6.3% (ARTS-I-PCI; p=0.01). The need for repeat revascularization was 12.6% (ARTS-II) vs. 4.2% (ARTS-I-CABG; p=0.027) and 22.3% (ARTS-I-PCI; p= 0.046). MACCE-free survival was 84.3% (ARTS-II) vs. 85.4% (ARTS-I-CABG; p=0.86) and 63.4% (ARTS-I-PCI; p<0.001). Also at 1 year, the overall MACCE rate in patients with diabetes was significantly higher than in nondiabetic patients, 15.7% vs. 8.5%, respectively [RR 1.85, 95%CI (1.16,2.97), p=0.015), due to a higher incidence of death and need for repeat revascularization, 2.5% vs. 0.4 and 12.5% vs. 5.6% in diabetes vs. nondiabetes groups, respectively.
Despite more extensive and treated disease, the overall MACCE-free survival in diabetic patients at 1 year in ARTS-II is similar to ARTS-I-CABG.
ARTS-II旨在评估西罗莫司洗脱支架（SES）与ARTS-I的对比情况。本分析的目的是评估SES在患有多支血管病变（MVD）的糖尿病患者中相对于ARTS-I两组的安全性和有效性。
ARTS研究纳入了367例糖尿病患者（ARTS-II：159例；ARTS-I冠状动脉搭桥术（CABG）组：96例；ARTS-I经皮冠状动脉介入治疗（PCI）组：112例）。基线特征显示ARTS-II研究中的患者病变情况更严重：50.3%患有三支血管病变，而ARTS-I-CABG组为35.4%，ARTS-I-PCI组为30.8%（p = 0.003）。接受治疗或吻合的病变血管数为3.2±1.2（ARTS-II）、2.8±0.8（ARTS-I-CABG）和2.5±1.1（ARTS-I-PCI）。在30天时，ARTS-II组（4.4%）与ARTS-I-PCI组（12.5%）的主要不良心血管和脑血管事件（MACCE）存在显著差异（p = 0.02）。在1年时，死亡率方面，ARTS-II组为2.5%，ARTS-I-CABG组为3.1%，ARTS-I-PCI组为6.3%，无显著差异。心肌梗死率方面，ARTS-II组为0.6%，ARTS-I-CABG组为2.1%（p = 0.56），ARTS-I-PCI组为6.3%（p = 0.01）。再次血管重建的需求率方面，ARTS-II组为12.6%，ARTS-I-CABG组为4.2%（p = 0.027），ARTS-I-PCI组为22.3%（p = 0.046）。无MACCE生存率方面，ARTS-II组为84.3%，ARTS-I-CABG组为85.4%（p = 0.86），ARTS-I-PCI组为63.4%（p<0.001）。同样在1年时，糖尿病患者的总体MACCE率显著高于非糖尿病患者，分别为15.7%和8.5%[相对危险度1.85，95%置信区间（1.16，2.97），p = 0.015]，这是由于糖尿病组的死亡发生率和再次血管重建需求率更高，糖尿病组与非糖尿病组的死亡发生率分别为2.5%和0.4%，再次血管重建需求率分别为12.5%和5.6%。
尽管ARTS-II中糖尿病患者的疾病范围更广且接受了治疗，但1年时糖尿病患者的总体无MACCE生存率与ARTS-I-CABG组相似。
