5-Year Clinical Outcomes of the ARTS II (Arterial Revascularization Therapies Study II) of the Sirolimus-Eluting Stent in the Treatment of Patients With Multivessel De Novo Coronary Artery Lesions
对比ARTS II(动脉血运重建治疗研究II)中西罗莫司洗脱支架(SES)与ARTS I中冠状动脉旁路移植术(CABG)和裸金属支架(BMS)的5年临床结局、安全性及有效性。
目的:对比ARTS II(动脉血运重建治疗研究II)中西罗莫司洗脱支架(SES)与ARTS I中冠状动脉旁路移植术(CABG)和裸金属支架(BMS)的5年临床结局、安全性及有效性。
背景:尚不清楚多支血管病变患者SES置入后的长期结局。
方法:ARTS I是比较CABG和BMS治疗1205例多支血管病变患者的随机试验。ARTS II研究是应用Cypher西罗莫司洗脱支架(强生Cordis)的非随机化试验,其纳入和排除标准、终点及程序定义与前者相同。ARTS II试验收录607例患者,力图保证至少1/3的入选者为三支血管病变患者。
结果:5年时,ARTS II中SES组的无死亡、卒中及心肌梗死事件生存率为87.1%,与之相比ARTS I的CABG和BMS队列分别为86.0%(P=0.1)和81.9%(P=0.007)。ARTS II的5年主要不良心脑血管事件(MACCE)(27.5%)显著高于ARTS I的CABG(21.1%,P=0.02),低于ARTS I的BMS(41.5%,P<0.001)。确定的支架血栓累积发生率为3.8%。5年时32%(176例中的56例)的主要不良心脏事件(MACE)与可能的、很可能的或确定的支架血栓相关。
结论:5年时SES的安全性与CABG相似,优于BMS,其MACE发生率高于应用CABG治疗的患者,低于BMS治疗者。SES治疗中近1/3的事件可通过消除早期、晚期和极晚期支架血栓而预防。
J Am Coll Cardiol 2010; 55:1093-1101
his study reinforces the concept that in moderately complex patients with multivessel disease, DES yield similar outcomes in terms of death and MI compared to CABG. The two keypoints of the study are :1) While the outcomes are equivalent in terms of “hard endpoints”, there is a major opportunity to yield superior outcomes to CABG by refining our ability to reduce early and late stent thrombosis. As such technology and techniques are in use or on the horizon, it only represents the further expansion of the use of this technology in complex multivessel disease. 2) Equally important is the fact that the overall MACE rate is intermediate between the BMS cohort and the surgical cohort of our time. It highlights the need for separating TLR from the more clinically important outcomes of death, MI and stroke. Most patients will willingly yield to the prospect of a one in five chance of repeat revascularization to avoid the trauma and expense of a CABG. As a matter of fact most surveys indicate that most patients would accept two or three revascularizations over time in order to avoid surgery. Thus, these 5 year results are quite encouraging. One must keep in mind that after 5 years vein grafts start deteriorating and if anything, the further convergence of these curves in terms of TLR is inevitable and at 10 years will no doubt look quite different.