药物涂层球囊与普通球囊用于分叉病变边支的比较：OCVC-BIF研究。
完整摘要 · 中文译文
背景：冠状动脉分叉病变仍然是最具挑战性的病变之一。尤其是边支的令人满意的临床结局尚未实现。药物涂层球囊（DCB）的使用已在自体冠状动脉中显示出可接受的临床结局。本研究旨在评估在分叉病变边支中额外进行DCB扩张的有效性和安全性。 方法：OCVC-BIF研究（药物涂层球囊与常规球囊用于分叉病变边支的比较）作为一项多中心、随机、开放标签试验开展。研究纳入计划在主血管植入药物洗脱支架（DES）后行 kissing balloon 扩张的分叉病变患者。患者被随机分配至在DES植入联合kissing balloon扩张后使用DCB对边支进行额外扩张（DCB组），或仅行DES植入联合使用常规球囊的kissing balloon扩张（非DCB组）。主要终点为边支再狭窄，通过9个月时计划冠状动脉造影或1年随访期间症状驱动的冠状动脉造影进行评估。再狭窄定义为边支狭窄≥50%，采用三维分叉定量冠状动脉造影测定。关键次要终点包括12个月时的主要不良心脏事件，其定义为心源性死亡、心肌梗死、临床驱动的靶病变血运重建和支架血栓形成的复合终点。 结果： 标题：2019年10月至2024年9月期间，共299例患者被随机分为DCB组（151例）和非DCB组（148例）。262例（87.6%）患者接受了连续三维分叉病变定量冠状动脉造影评估。DCB组的再狭窄率低于非DCB组（8.1%对18.3%，P=0.012）。然而，两组12个月时主要不良心脏事件的发生率相似（10.1%对12.4%，P=0.58）。 结论：在主支药物洗脱支架（DES）植入并行球囊对吻扩张后，于边支追加药物涂层球囊（DCB）扩张可降低分叉病变治疗中边支的再狭窄。 注册：网址：https://jrct.mhlw.go.jp/en-latest-detail/jRCTs052200077；唯一标识符：jRCTs052200077。
完整摘要 · 英文原文
BACKGROUND: Coronary bifurcation lesions remain one of the most challenging lesions. In particular, satisfactory clinical outcomes have not yet been achieved for side branches. The use of drug-coated balloons (DCBs) has demonstrated acceptable clinical outcomes in native coronary arteries. This study aimed to evaluate the efficacy and safety of additional DCB inflation in the side branches of bifurcation lesions. METHODS: The OCVC-BIF study (Comparison of Drug-Coated Versus Conventional Balloons for the Side Branch of Bifurcation Lesions) was conducted as a multicenter, randomized, open-label trial. Patients with bifurcation lesions scheduled for drug-eluting stent (DES) implantation in the main vessel followed by kissing balloon inflation were enrolled in the study. The patients were randomized to receive either additional dilatation of the side branch using a DCB after DES implantation with kissing balloon inflation (DCB group) or only DES implantation with kissing balloon inflation using conventional balloons (non-DCB group). The primary end point was restenosis of the side branch, assessed using scheduled coronary angiography at 9 months or symptom-driven coronary angiography during the 1-year follow-up. Restenosis was defined as ≥50% stenosis of the side branch, determined using 3-dimensional bifurcation quantitative coronary angiography. The key secondary end points included major adverse cardiac events at 12 months, which were defined as a composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization, and stent thrombosis. RESULTS: In total, 299 patients were randomized into the DCB (151 patients) and non-DCB (148 patients) groups between October 2019 and September 2024. Serial 3-dimensional bifurcation quantitative coronary angiography evaluation was performed in 262 (87.6%) patients. The restenosis rate was lower in the DCB group than that in the non-DCB group (8.1% versus 18.3%, P=0.012). However, the incidence of major adverse cardiac events at 12 months was similar between them (10.1% versus 12.4%, P=0.58). CONCLUSIONS: Additional DCB inflation in the side branch after main-vessel DES implantation with kissing balloon inflation decreases restenosis in the side branch in the treatment of bifurcation lesions. REGISTRATION: URL: https://jrct.mhlw.go.jp/en-latest-detail/jRCTs052200077; Unique identifier: jRCTs052200077.