OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial
OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON in patients with Acute Coronary Syndrome: Study protocol for a randomized controlled trial
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光学频域成像与血管内超声在急性冠状动脉综合征患者经皮冠状动脉介入治疗中的比较：随机对照试验的研究方案
DOI：
10.1016/j.jjcc.2020.03.010
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发表时间：
2020
影响因子：
2.5
通讯作者：
Akasaka Takashi
中科院分区：
文献类型：
--
作者：
Otake Hiromasa;Kubo Takashi;Shinke Toshiro;Hibi Kiyoshi;Tanaka Shigemitsu;Ishida Masaru;Kataoka Toru;Takaya Tomofumi;Iwasaki Masamichi;Sonoda Shinjo;Ioji Tetsuya;Akasaka Takashi
背景最近的一项临床试验表明，在冠状动脉疾病患者中，经皮冠状动脉介入治疗（PCI）中，光频域成像（OFDI）引导在12个月时靶血管衰竭（包括心源性死亡、靶血管心肌梗死和临床驱动的靶血管血运重建）方面不劣于血管内超声（IVUS）引导。急性冠脉综合征（ACS）患者的PCI的对外直接投资指导的影响仍然uncertaints.MethodsOPINION ACS是一个多中心，前瞻性，随机，对照，开放标签，平行组，非劣效性试验在日本。符合条件的患者将被随机分配接受OFDI或IVUS引导的PCI。PCI采用西罗莫司洗脱支架，符合某些OFDI和IVUS标准，以实现最佳支架部署。所有患者将在8个月时接受随访血管造影和对外直接投资成像。主要终点是最小管腔面积，作为衡量的对外直接投资在8 months.ConclusionThe OPINION ACS试验结果将提供有关的影响，对外直接投资引导PCI支架内再狭窄在8个月的ACS患者的见解。
BackgroundA recent clinical trial demonstrated that optical frequency domain imaging (OFDI) guidance in percutaneous coronary intervention (PCI) is noninferior to intravascular ultrasound (IVUS) guidance in patients with coronary artery disease with regard to target vessel failure (composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization) at 12 months. The impact of OFDI guidance in PCI for patients with acute coronary syndrome (ACS) remains uncertain.MethodsOPINION ACS is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. Eligible patients will be randomly assigned to receive either OFDI- or IVUS-guided PCI. PCI is performed using the sirolimus-eluting stent in accordance with certain OFDI and IVUS criteria for optimal stent deployment. All patients will undergo follow-up angiography and OFDI imaging at 8 months. The primary endpoint is the minimum lumen area, as measured by OFDI at 8 months.ConclusionThe OPINION ACS trial outcomes will provide insights regarding the impact of OFDI-guided PCI on in-stent restenosis at 8 months in patients with ACS.