Torii Sho, Takahashi Akihiko, Ono Yujiro, Taniwaki Masanori, Oguri Mitsutoshi, Teramura Masanori, Kato Ryuichi, Otsuki Shuji, Suzuki Hiroshi, Yoshimachi Fuminobu, Ueda Hironori, Shioji Keisuke, Nakazawa Gaku, Sakurai Kaoru, Tsujimoto Mitsuru, Ando Motosu, Kozai Toshiyuki, Aoyama Rie, Ikari Yuji
Department of Cardiology, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.
Department of Cardiology, Sakurakai Takahashi Hospital, Kobe, Japan.
Cardiovasc Interv Ther. 2025 Jul 7. doi: 10.1007/s12928-025-01162-1.
Reducing total ischemic time in ST-elevation myocardial infarction (STEMI) is crucial for improving outcomes. While procedural time during primary percutaneous coronary intervention (PCI) is critical, strategies to shorten it need to be explored. To examine whether the single-catheter PCI (SC-PCI) method using a universal guiding catheter, Ikari-Left curve, without catheter exchange reduces PCI time compared to conventional PCI (C-PCI). The Speedy PCI study is a prospective, multicenter, randomized trial comparing SC-PCI versus C-PCI. The primary endpoint was the time from sheath insertion to first device activation (S2B) time. Secondary endpoints included door-to-balloon time, total ischemia time, fluoroscopy time, contrast volume, hospital expenses, and 30-day mortality. A total of 380 patients (SC-PCI: 194; C-PCI: 186) were analyzed. Both groups had high primary PCI success rates (92.3 vs. 91.9%, p = 0.74) and similar radial access usage (higher than 97%). SC-PCI method showed a significantly shorter S2B time (15.8 ± 10.9 min) compared to the C-PCI method (18.7 ± 10.6 min, p = 0.007) with reduced number of total catheters used (1.2 ± 0.6 vs. 2.7 ± 0.7, p < 0.0001, respectively). No cases of coronary dissection caused by the guiding catheter were observed in the SC-PCI method. Clinical outcomes at 30 days and 1-year follow-up, including all-cause mortality and stroke rates, were similar between the groups. The SC-PCI method using the Ikari curve demonstrated a significant reduction in PCI procedure time while maintaining safety and primary PCI success in primary PCI for STEMI.
缩短ST段抬高型心肌梗死(STEMI)的总缺血时间对于改善预后至关重要。虽然直接经皮冠状动脉介入治疗(PCI)期间的手术时间很关键,但仍需探索缩短该时间的策略。为了研究与传统PCI(C-PCI)相比,使用通用引导导管Ikari-Left曲线且无需更换导管的单导管PCI(SC-PCI)方法是否能缩短PCI时间。快速PCI研究是一项前瞻性、多中心、随机试验,比较SC-PCI与C-PCI。主要终点是从鞘管插入到首次器械激活(S2B)的时间。次要终点包括门球时间、总缺血时间、透视时间、造影剂用量、住院费用和30天死亡率。共分析了380例患者(SC-PCI:194例;C-PCI:186例)。两组的直接PCI成功率都很高(92.3%对91.9%,p = 0.74),且桡动脉入路使用率相似(均高于97%)。与C-PCI方法(18.7±10.6分钟,p = 0.007)相比,SC-PCI方法的S2B时间显著缩短(15.8±10.9分钟),且使用的导管总数减少(分别为1.2±0.6对2.7±0.7,p < 0.0001)。在SC-PCI方法中未观察到由引导导管引起的冠状动脉夹层病例。两组在30天和1年随访时的临床结局,包括全因死亡率和卒中发生率相似。使用Ikari曲线的SC-PCI方法在STEMI的直接PCI中显示出PCI手术时间显著缩短,同时保持了安全性和直接PCI成功率。