Abstract：
Iliac artery angioplasty with stenting is an effective alternative treatment modality for aortoiliac occlusive diseases. Few randomized controlled trials have compared the efficacy and safety between self-expandable stent (SES) and balloon-expandable stent (BES) in atherosclerotic iliac artery disease. In this randomized, multicenter study, patients with common or external iliac artery occlusive disease were randomly assigned in a 1:1 ratio to either BES or SES. The primary end point was the 1-year clinical patency, defined as freedom from any surgical or percutaneous intervention due to restenosis of the target lesion after the index procedure. The secondary end point was a composite event from major adverse clinical events at 1 year. A total of 201 patients were enrolled from 17 major cardiovascular intervention centers in South Korea. The mean age of the enrolled patients was 66.8 ± 8.5 years and 86.2% of the participants were male. The frequency of critical limb ischemia was 15.4%, and the most common target lesion was in the common iliac artery (75.1%). As the primary end point, the 1-year clinical patency as primary end point was 99% in the BES group and 99% in the SES group (p > 0.99). The rate of repeat revascularization at 1 year was 7.8% in the BES group and 7.0% in the SES group (p = 0.985; confidence interval, 1.011 [0.341-2.995]). In our randomized study, the treatment of iliac artery occlusive disease with self-expandable versus balloon-expandable stent was comparable in 12-month clinical outcomes without differences in the procedural success or geographic miss rate regardless of the deployment method in the distal aortoiliac occlusive lesion (ClinicalTrials.gov, NCT01834495).
摘要：
髂动脉支架成形术是治疗主髂动脉闭塞性疾病的有效替代治疗方式。很少有随机对照试验比较自膨式支架（SES）和球囊扩张式支架（BES）在动脉粥样硬化性髂动脉疾病中的疗效和安全性。在这个随机的，多中心研究，普通或髂外动脉闭塞性疾病患者以1∶1的比例随机分配至BES或SES组.主要终点是1年临床通畅，定义为由于索引程序后目标病变的再狭窄而免于任何手术或经皮干预。次要终点是1年主要不良临床事件的复合事件。来自韩国17个主要心血管干预中心的201例患者被纳入。入选患者的平均年龄为66.8±8.5岁，86.2%的参与者为男性。严重肢体缺血的发生率为15.4%,最常见的靶病变是髂总动脉(75.1%)。作为主要终点,作为主要终点的1年临床通畅率,BES组为99%,SES组为99%(p>0.99).BES组1年重复血运重建率为7.8%,SES组为7.0%(p=0.985;置信区间,1.011[0.341-2.995]）。在我们的随机研究中，在12个月的临床结局中，使用自膨式支架与球囊扩张式支架治疗髂动脉闭塞性疾病具有可比性，无论在远端主动脉髂动脉闭塞性病变中的部署方法如何，手术成功率或地理错失率都没有差异（ClinicalTrial.gov，NCT01834495)。
