Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.
Department of Internal Medicine, Sanggye Paik Hospital, Inje University, Seoul, South Korea.
JACC Cardiovasc Interv. 2016 Nov 14;9(21):2232-2239. doi: 10.1016/j.jcin.2016.07.021. Epub 2016 Oct 12.
The aim of this study was to evaluate the clinical usefulness of intravascular ultrasound (IVUS)-guided new-generation drug-eluting stent (DES) implantation using a meta-analysis of individual patient-level data from randomized trials.
Published randomized trials that compare IVUS-guided versus angiography-guided new-generation DES implantation are scarce.
Searches of the MEDLINE, Embase, and Cochrane databases were performed to find randomized trials that compared IVUS-guided versus angiography-guided new-generation DES implantation. A total of 2,345 patients from 3 randomized trials were identified, and all patients were treated for long lesions or chronic total occlusions. Individual patient-level data were obtained. The primary endpoint was a major adverse cardiac event, a composite of cardiac death, myocardial infarction, or stent thrombosis. An intention-to-treat analysis and per protocol analysis were performed.
By 1 year post-procedure, major adverse cardiac events had occurred in 0.4% of the patients who underwent IVUS-guided DES implantation versus 1.2% of those who underwent angiography-guided DES implantation (hazard ratio [HR]: 0.36; 95% confidence interval [CI]: 0.13 to 0.99; p = 0.040). For the IVUS-guided group, favorable clinical outcomes were observed for myocardial infarction (0% vs. 0.4%; HR: 0.09; p = 0.026). In addition, the clinical benefit of IVUS guidance was stronger in the per protocol analysis (HR: 0.32; 95% CI: 0.12 to 0.89; p = 0.021).
Compared with angiographic guidance, IVUS-guided new-generation DES implantation was associated with favorable outcomes in terms of major adverse cardiac events, the composite of cardiac death, myocardial infarction, or stent thrombosis. These findings must be interpreted only for complex lesions, because all identified patients had long lesions or chronic total occlusions.
本研究旨在通过对随机试验的个体患者水平数据进行荟萃分析,评估血管内超声(IVUS)指导的新一代药物洗脱支架(DES)植入的临床实用性。
比较 IVUS 指导与血管造影指导的新一代 DES 植入的已发表随机试验很少。
对 MEDLINE、Embase 和 Cochrane 数据库进行检索,以查找比较 IVUS 指导与血管造影指导的新一代 DES 植入的随机试验。从 3 项随机试验中确定了 2345 名患者,所有患者均接受长病变或慢性完全闭塞的治疗。获取了个体患者水平的数据。主要终点是主要不良心脏事件,包括心脏死亡、心肌梗死或支架血栓形成的复合事件。进行了意向治疗分析和按方案分析。
在术后 1 年时,IVUS 指导 DES 植入组的主要不良心脏事件发生率为 0.4%,而血管造影指导 DES 植入组为 1.2%(风险比 [HR]:0.36;95%置信区间 [CI]:0.13 至 0.99;p=0.040)。对于 IVUS 指导组,心肌梗死的临床结局较好(0%比 0.4%;HR:0.09;p=0.026)。此外,按方案分析时,IVUS 指导的临床获益更强(HR:0.32;95%CI:0.12 至 0.89;p=0.021)。
与血管造影指导相比,IVUS 指导的新一代 DES 植入与主要不良心脏事件、心脏死亡、心肌梗死或支架血栓形成的复合事件的良好结局相关。这些发现仅适用于复杂病变,因为所有确定的患者均存在长病变或慢性完全闭塞。