OBJECTIVES The goal of this study was to evaluate whether the beneficial effect of use of intravascular ultrasound (IVUS) is sustained for long-term follow-up. BACKGROUND The use of IVUS promoted favorable 1-year clinical outcome in the IVUS-XPL (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions) trial. It is not known, however, whether this effect is sustained for long-term follow-up. METHODS The IVUS-XPL trial randomized 1,400 patients with long coronary lesions (implanted stent length ≥28 mm) to receive IVUS-guided (n = 700) or angiography-guided (n = 700) everolimus-eluting stent implantation. Five-year clinical outcomes were investigated in patients who completed the original trial. The primary outcome was the composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or ischemia-driven target lesion revascularization at 5 years, analyzed by intention-to-treat. RESULTS Five-year follow-up was completed in 1,183 patients (85%). Major adverse cardiac events at 5 years occurred in 36 patients (5.6%) receiving IVUS guidance and in 70 patients (10.7%) receiving angiographic guidance (hazard ratio: 0.50; 95% confidence interval: 0.34 to 0.75; p = 0.001). The difference was driven mainly by a lower risk for target lesion revascularization (31 [4.8%] vs. 55 [8.4%]; hazard ratio: 0.54; 95% confidence interval: 0.33 to 0.89; p = 0.007). By landmark analysis, major adverse cardiac events between 1 and 5 years occurred in 17 patients (2.8%) receiving IVUS guidance and in 31 patients (5.2%) receiving angiographic guidance (hazard ratio: 0.53; 95% confidence interval: 0.29 to 0.95; p = 0.031). CONCLUSIONS Compared with angiography-guided stent implantation, IVUS-guided stent implantation resulted in a significantly lower rate of major adverse cardiac events up to 5 years. Sustained 5-year clinical benefits resulted from both within 1 year and from 1 to 5 years post-implantation. (Impact of Intravascular Ultrasound Guidance on the Outcomes of Xience Prime Stents in Long Lesions [IVUS-XPL Study]: Retrospective and Prospective Follow-Up Study; NCT03866486).

中文翻译：

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血管内超声引导药物洗脱支架植入的效果：IVUS-XPL随机试验的5年随访。

目的本研究的目的是评估长期随访是否能够持续使用血管内超声（IVUS）。背景技术IVUS-XPL（血管内超声引导对长病变的Xience Prime支架结局的影响）试验中，IVUS的使用促进了良好的1年临床预后。但是，对于长期随访该效果是否持续尚不明确。方法IVUS-XPL试验将1,400例长冠状动脉病变（植入支架长度≥28mm）患者随机分配接受IVUS引导（n = 700）或血管造影术引导（n = 700）依维莫司洗脱支架植入。在完成原始试验的患者中调查了五年临床结局。主要结果是主要不良心脏事件（包括心脏死亡，通过意向性治疗分析5年内靶病变相关的心肌梗塞或缺血驱动的靶病变血运重建情况。结果对1,183例患者（85％）完成了五年的随访。接受IVUS指导的36位患者（5.6％）和接受血管造影指导的70位患者（10.7％）在5年时发生了严重的不良心脏事件（危险比：0.50; 95％置信区间：0.34至0.75; p = 0.001）。造成这种差异的主要原因是目标病变血运重建的风险较低（31 [4.8％]比55 [8.4％]；危险比：0.54； 95％置信区间：0.33至0.89； p = 0.007）。通过地标分析，接受IVUS指导的17例患者（2.8％）和接受血管造影指导的31例患者（5.2％）发生了1至5年之间的严重不良心脏事件（危险比：0.53; 95％置信区间：0.29至0。95; p = 0.031）。结论与血管造影引导的支架植入术相比，IVUS引导的支架植入术导致严重不良心脏事件的发生率显着降低，直至5年。植入后1年内和1至5年内均可获得持续的5年临床收益。（血管内超声引导对长病变Xience原始支架结果的影响[IVUS-XPL研究]：回顾性和前瞻性随访研究； NCT03866486）。