Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
J Am Coll Cardiol. 2010 Mar 16;55(11):1093-101. doi: 10.1016/j.jacc.2009.11.049. Epub 2010 Feb 18.
The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I.
The long-term outcomes after SES implantation in patients with multivessel disease remains to be established.
The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease.
At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis.
At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis.
本研究旨在比较 ARTS II 中雷帕霉素洗脱支架（SES）与 ARTS I 中冠状动脉旁路移植术（CABG）和裸金属支架（BMS）的 5 年临床结果、安全性和疗效。
多支血管疾病患者 SES 植入后的长期结果仍有待确定。
ARTS I 是一项比较多支血管疾病患者 CABG 和 BMS 的随机试验，共纳入 1205 例患者。ARTS II 研究是一项非随机试验，采用 Cypher 雷帕霉素洗脱支架（Cordis，Johnson & Johnson 公司，新泽西州沃伦），应用相同的纳入和排除标准、终点和方案定义。ARTS II 试验共纳入 607 例患者，尝试纳入至少三分之一的 3 支血管病变患者。
在 5 年时，ARTS II SES 组的死亡/卒中/心肌梗死无事件生存率为 87.1%，而 ARTS I CABG 和 BMS 组分别为 86.0%（p=0.1）和 81.9%（p=0.007）。ARTS II 组 5 年主要不良心脏和脑血管事件（MACCE）发生率（27.5%）显著高于 ARTS I CABG 组（21.1%，p=0.02），低于 ARTS I BMS 组（41.5%，p<0.001）。明确支架血栓形成的累积发生率为 3.8%。5 年时 56 例（176 例的 32%）主要不良心脏事件（MACE）与可能、很可能或明确的支架血栓形成有关。
在 5 年时，SES 的安全性与 CABG 相当，优于 BMS，MACCE 发生率高于 CABG 组，低于 BMS 组。大约三分之一的 SES 相关事件可通过消除早期、晚期和极晚期支架血栓形成来预防。
