Fukuoka Ryota, Kawasaki Tomohiro, Umeji Kyoko, Orita Yoshiya, Koga Hisashi, Hirai Keisuke, Haraguchi Kazuki, Fukami Yurie, Kajiyama Kimihiro, Soejiyma Toshiya
Cardiovascular Center, Shin-Koga Hospital, Kurume City, Japan.
J Soc Cardiovasc Angiogr Interv. 2023 Oct 11;3(1):101175. doi: 10.1016/j.jscai.2023.101175. eCollection 2024 Jan.
The challenge with the stentless strategy is that the method of optimal predilatation, and predictors of success remain unknown. Studies involving the stentless strategy prior to predilatation are limited. This study aimed to evaluate the long-term efficacy and safety of a new stentless strategy for treating acute coronary syndrome (ACS) using gradual, prolonged predilation with a perfusion balloon combined with a drug-coated balloon (DCB).
This was a single-center, prospective, single-arm study. A total of 30 patients with ACS underwent gradual, prolonged predilation using a perfusion balloon for 10 minutes, followed by additional dilation using a DCB. The primary end point was target vessel failure at 24 months. Secondary end points were a composite of acute end points, including stentless strategy success rate, procedural complications, final grade of coronary dissection, acute coronary occlusion, in-hospital major adverse cardiac events, and a chronic end point of target vessel failure at 24 months.
A successful stentless strategy was achieved in 24 patients (80%), and 2 (8.3%) patients required ischemic-driven target lesion revascularization in the chronic phase. Six (20%) patients required stent placement due to type C dissection or acute recoil. No acute occlusion and in-hospital major adverse cardiac events were reported.
A novel stentless strategy using predilation with a perfusion balloon and DCB may be helpful for the revascularization of patients with ACS.
无支架策略面临的挑战在于，最佳预扩张方法以及成功的预测因素仍不明确。在预扩张之前涉及无支架策略的研究有限。本研究旨在评估一种新的无支架策略治疗急性冠状动脉综合征（ACS）的长期疗效和安全性，该策略采用灌注球囊联合药物涂层球囊（DCB）进行逐步、延长的预扩张。
这是一项单中心、前瞻性、单臂研究。总共30例ACS患者使用灌注球囊进行10分钟的逐步、延长预扩张，随后使用DCB进行额外扩张。主要终点是24个月时的靶血管失败。次要终点是急性终点的综合指标，包括无支架策略成功率、手术并发症、冠状动脉夹层的最终分级、急性冠状动脉闭塞、院内主要不良心脏事件，以及24个月时靶血管失败的慢性终点。
24例患者（80%）成功实施了无支架策略，2例（8.3%）患者在慢性期需要因缺血驱动的靶病变血运重建。6例（20%）患者因C型夹层或急性回缩需要置入支架。未报告急性闭塞和院内主要不良心脏事件。
使用灌注球囊和DCB进行预扩张的新型无支架策略可能有助于ACS患者的血运重建。
