基于灰区血流储备分数的经皮冠状动脉介入治疗与最佳药物治疗对中度冠状动脉狭窄稳定型心绞痛患者临床结局的比较（COMFORTABLE前瞻性研究）：一项多中心随机对照试验的研究方案
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial.
作者信息
Kitabata Hironori, Kubo Takashi, Shiono Yasutsugu, Shimamura Kunihiro, Ino Yasushi, Tanimoto Takashi, Hayashi Yasushi, Komukai Kenichi, Sougawa Hiromichi, Kimura Keizo, Gohda Masahiro, Hashizume Toshikazu, Obana Masahiro, Maeda Kazuisa, Yamaguchi Junichi, Akasaka Takashi
机构信息
Department of Cardiovascular Medicine, Wakayama Medical University, 811-1, Kimiidera, Wakayama, Wakayama, 641-8509, Japan.
Department of Cardiovascular Medicine, Shingu Municipal Medical Center, 18-7 Hachibuse, Shingu, Wakayama, 647-0072, Japan.
出版信息
Trials. 2019 Jan 28;20(1):84. doi: 10.1186/s13063-019-3182-1.
BACKGROUND
Even in the current drug-eluting stent era, revascularization for coronary stenosis with fractional flow reserve (FFR) between 0.75 and 0.80, the so-called "gray zone," is a matter of debate. Previous studies have reported conflicting results regarding outcomes of revascularization versus deferral for coronary stenosis when FFR values are in the gray zone, but these studies have had differing designs and populations. We therefore will investigate whether medical therapy plus percutaneous coronary intervention (PCI) is superior to medical therapy alone in reducing major cardiovascular events in patients presenting with coronary stenosis with gray zone FFR values.
METHODS/DESIGN: This is a prospective, multicenter, open-label, parallel group, randomized, controlled, superiority study. A total of 410 eligible participants will be recruited and randomized to either the medical therapy plus PCI group or the medical therapy alone group. The primary endpoint is 1-year major adverse cardiac events (MACEs), defined as a combined endpoint of all-cause death, nonfatal myocardial infarction (MI), or unplanned target vessel revascularization (TVR). Secondary endpoints include MACE at 2 and 5 years. Moreover, each individual component of the primary endpoint, cardiovascular death, target vessel-related and non-target vessel-related MI, all MI, clinically driven TVR or non-TVR, all revascularization, stent thrombosis, and angina symptom status will be evaluated at 1, 2, and 5 years.
DISCUSSION
This is the first prospective, multicenter, randomized, controlled study to investigate the superiority of medical therapy plus PCI over medical therapy by itself in reducing major cardiovascular events in patients presenting with coronary stenosis with "gray zone" FFR values. The results will help interventional cardiologists in making revascularization decisions regarding coronary stenosis with gray zone FFR values.
TRIAL REGISTRATION
University Hospital Medical Information Network Clinical Trials Registry, UMIN000031526 . Registered on 1 March 2018.
背景
即使在当前药物洗脱支架时代，对于分数血流储备（FFR）在0.75至0.80之间的冠状动脉狭窄进行血运重建，即所谓的“灰色地带”，仍存在争议。既往研究报道了FFR值处于灰色地带时冠状动脉狭窄血运重建与延期治疗的结果相互矛盾，但这些研究设计和人群各不相同。因此，我们将研究药物治疗联合经皮冠状动脉介入治疗（PCI）在降低FFR值处于灰色地带的冠状动脉狭窄患者主要心血管事件方面是否优于单纯药物治疗。
方法/设计：这是一项前瞻性、多中心、开放标签、平行组、随机、对照、优效性研究。共招募410名符合条件的参与者，随机分为药物治疗联合PCI组或单纯药物治疗组。主要终点是1年主要不良心脏事件（MACE），定义为全因死亡、非致死性心肌梗死（MI）或非计划性靶血管血运重建（TVR）的联合终点。次要终点包括2年和5年时的MACE。此外，将在1年、2年和5年时评估主要终点的各个单独组成部分，即心血管死亡、靶血管相关和非靶血管相关MI、所有MI、临床驱动的TVR或非TVR、所有血运重建、支架血栓形成以及心绞痛症状状态。
讨论
这是第一项前瞻性、多中心、随机、对照研究，旨在调查药物治疗联合PCI在降低FFR值处于“灰色地带”的冠状动脉狭窄患者主要心血管事件方面是否优于单纯药物治疗。研究结果将有助于介入心脏病学家就FFR值处于灰色地带的冠状动脉狭窄做出血运重建决策。
试验注册
大学医院医学信息网络临床试验注册中心，UMIN000031526。于2018年3月1日注册。
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