Ikari Yuji, Awata Masaki, Mitsudo Kazuaki, Akasaka Takashi, Saito Shigeru, Ishihara Takayuki, Fujii Toshiharu, Hashimoto Hideki, Terashima Mitsuyasu, Ikemoto Tomokazu, Hibi Kiyoshi, Tazaki Junichi, Nakamura Akihiro, Nishikawa Hideo, Sato Tadaya, Nakagawa Yoshihisa
Tokai University School of Medicine, Isehara, Japan.
Kansai Rosai Hospital, Amagasaki, Japan.
Int J Cardiol. 2017 Jan 15;227:94-99. doi: 10.1016/j.ijcard.2016.11.076. Epub 2016 Nov 9.
Although several new techniques have been introduced for CTO such as the retrograde approach, the fundamental question of what type of guidewire is the most appropriate as a primary guidewire in the antegrade approach has not been answered.
The G-FORCE study was designed as a prospective multicenter randomized controlled trial to determine the efficient primary guidewire in antegrade approach for chronic total occlusion (CTO). The first guidewire was randomly assigned to a regular size distal tip group (0.014in. size) or tapered tip group (0.010in. or less). The primary endpoint was defined as successful lesion penetration by the first guidewire into distal true lumen. This study was registered at ClinicalTrials.gov with identifier NCT00987610.
A total of 260 patients were enrolled, with an average age of 66±11years and 16% were female. The average J-CTO score was 1.8±1.1. The primary endpoint was achieved in 38% and 32% of patients using tapered and regular distal tip guidewires, respectively (P=0.80). The final PCI success rate was 81% vs. 85%, respectively (P=0.57). Easy CTO lesions with a J-CTO score=0 exhibited a primary endpoint significantly different between tapered and regular distal tip primary guidewires (79% vs. 40%; P=0.046). Guidewire distal coating or distal tip load did not relate with primary guidewire success rate.
Tapered and regular distal tip guidewires are equivalent as a first choice for CTO. Tapered guidewires are superior for CTO lesions with a J-CTO score=0.
尽管已引入了多种用于慢性完全闭塞病变（CTO）的新技术，如逆行技术，但关于在正向入路中作为首选导丝哪种类型最合适这一基本问题仍未得到解答。
G-FORCE研究设计为一项前瞻性多中心随机对照试验，以确定在慢性完全闭塞病变（CTO）正向入路中有效的首选导丝。将第一根导丝随机分配至常规尺寸远端尖端组（0.014英寸尺寸）或锥形尖端组（0.010英寸或更小）。主要终点定义为第一根导丝成功穿透病变进入远端真腔。本研究已在ClinicalTrials.gov注册，标识符为NCT00987610。
共纳入260例患者，平均年龄66±11岁，16%为女性。平均J-CTO评分为1.8±1.1。分别使用锥形和常规远端尖端导丝的患者中，主要终点达成率分别为38%和32%（P = 0.80）。最终经皮冠状动脉介入治疗（PCI）成功率分别为81%和85%（P = 0.57）。J-CTO评分为0的简单CTO病变在锥形和常规远端尖端首选导丝之间的主要终点有显著差异（79%对40%；P = 0.046）。导丝远端涂层或远端尖端负荷与首选导丝成功率无关。
锥形和常规远端尖端导丝作为CTO的首选等效。锥形导丝对于J-CTO评分为0的CTO病变更具优势。
