Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation The IVUS-XPL Randomized Clinical Trial
Effect of Intravascular Ultrasound-Guided vs Angiography-Guided Everolimus-Eluting Stent Implantation The IVUS-XPL Randomized Clinical Trial
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DOI：
10.1001/jama.2015.15454
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发表时间：
2015-11-24
影响因子：
120.7
通讯作者：
Hong, Myeong-Ki
中科院分区：
文献类型：
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作者：
Hong, Sung-Jin;Kim, Byeong-Keuk;Hong, Myeong-Ki
重要性 使用血管内超声 (IVUS) 可促进复杂冠状动脉病变的冠状动脉介入治疗获得更好的临床结果。然而，证明IVUS临床有效性的随机数据对于药物洗脱支架治疗的病变是有限的。 目的 确定在长冠脉病变患者中，IVUS引导药物洗脱支架植入的长期临床结果是否优于血管造影引导植入的长期临床结果。 设计、设置和参与者血管内超声引导对长病变Xience Prime支架结果的影响(IVUS-XPL) 随机、多中心试验于 2010 年 10 月至 2014 年 7 月期间在韩国 20 个中心对 1400 名患有长冠状动脉病变（植入支架长度≥28mm）的患者进行。 干预措施 患者被随机分配接受 IVUS 引导（n = 700）或血管造影引导（n = 700）依维莫司洗脱支架植入术。结果和测量主要结果测量是主要不良心脏事件的综合，包括心源性死亡、目标病变相关的心肌梗死或一年时缺血驱动的目标病变血运重建，通过意向治疗进行分析。 结果 1323 名患者 (94.5%) 完成了一年随访。 19 名接受 IVUS 引导的患者 (2.9%) 和 39 名接受血管造影引导支架植入的患者 (5.8%) 发生 1 年时主要不良心脏事件（绝对差异，-2.97% [95% CI，-5.14% 至 -0.79%]）（风险比 [HR]，0.48 [95% CI，0.28 至 0.83]，P =.007）。造成这一差异的原因是，与接受血管造影引导的患者 (33 [5.0%]) 进行支架植入术的患者 (17 [2.5%]) 相比，接受 IVUS 引导的患者 (17 [2.5%]) 因缺血导致的靶病变血运重建风险较低 (HR，0.51 [95% CI，0.28 至 0.91]，P = 0.02)。两组之间的心脏死亡和靶病变相关的心肌梗死没有显着差异。对于心源性死亡，IVUS 引导组中有 3 名患者（0.4%），血管造影引导组有 5 名患者（0.7%）（HR，0.60 [95% CI，0.14 至 2.52]，P = .48）。血管造影引导支架植入组中有 1 例患者（0.1%）发生靶病灶相关心肌梗死（P = .32）。 结论和相关性 在需要植入长冠状动脉支架的患者中，与血管造影引导支架植入相比，使用 IVUS 引导依维莫司洗脱支架植入的 1 年时主要不良心脏事件复合发生率显着降低。这些差异主要是由于目标病变血运重建的风险较低。
IMPORTANCE Use of intravascular ultrasound (IVUS) promotes better clinical outcomes for coronary intervention in complex coronary lesions. However, randomized data demonstrating the clinical usefulness of IVUS are limited for lesions treated with drug-eluting stents.OBJECTIVE To determine whether the long-term clinical outcomes with IVUS-guided drug-eluting stent implantation are superior to those with angiography-guided implantation in patients with long coronary lesions.DESIGN, SETTING, AND PARTICIPANTS The Impact of Intravascular Ultrasound Guidance on Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL) randomized, multicenter trial was conducted in 1400 patients with long coronary lesions (implanted stent >= 28mm in length) between October 2010 and July 2014 at 20 centers in Korea.INTERVENTIONS Patients were randomly assigned to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation.MAIN OUTCOMES AND MEASURES Primary outcome measure was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 1 year, analyzed by intention-to-treat.RESULTS One-year follow-up was complete in 1323 patients (94.5%). Major adverse cardiac events at 1 year occurred in 19 patients (2.9%) undergoing IVUS-guided and in 39 patients (5.8%) undergoing angiography-guided stent implantation (absolute difference, -2.97% [95% CI, -5.14% to -0.79%]) (hazard ratio [HR], 0.48 [95% CI, 0.28 to 0.83], P =.007). The difference was driven by a lower risk of ischemia-driven target lesion revascularization in patients undergoing IVUS-guided (17 [2.5%]) compared with angiography-guided (33 [5.0%]) stent implantation (HR, 0.51 [95% CI, 0.28 to 0.91], P = .02). Cardiac death and target lesion-related myocardial infarction were not significantly different between the 2 groups. For cardiac death, there were 3 patients (0.4%) in the IVUS-guided group and 5 patients (0.7%) in the angiography-guided group (HR, 0.60 [95% CI, 0.14 to 2.52], P = .48). Target lesion-related myocardial infarction occurred in 1 patient (0.1%) in the angiography-guided stent implantation group (P = .32).CONCLUSIONS AND RELEVANCE Among patients requiring long coronary stent implantation, the use of IVUS-guided everolimus-eluting stent implantation, compared with angiography-guided stent implantation, resulted in a significantly lower rate of the composite of major adverse cardiac events at 1 year. These differences were primarily due to lower risk of target lesion revascularization.