Ke Dan, He Xi, Chen Canqiang, Lin Chaogui, Luo Yukun, Fan Lin, Li Sumei, Zheng Xingchun, Chen Lianglong
Department of Cardiology, Fujian Medical University Union Hospital, 350001 Fuzhou, Fujian, China.
Fujian Institute of Coronary Artery Disease, 350001 Fuzhou, Fujian, China.
Rev Cardiovasc Med. 2023 Mar 23;24(4):99. doi: 10.31083/j.rcm2404099. eCollection 2023 Apr.
Dual stenting technique (DST) is still mandatory for some true bifurcation lesions (BLs), but drug-coated balloon (DCB) alone may offer a new optional treatment with the potential benefits of fewer implants. However, procedural safety presents a concern when using DCB-only to treat true BLs. This study sought to explore the safety and efficacy of the DCB-only strategy for the treatment of true BLs.
Sixty patients with TBLs were randomly assigned to be treated by a DCB-based strategy or DST-based strategy. All patients received angiographic follow-up scheduled after one-year and staged clinical follow-up. The primary endpoint was the one-year late lumen loss (LLL) and cumulative major cardiac adverse events (MACEs) composed of cardiac death (CD), target vessel myocardial infarction (TVMI), target lesion thrombosis (TVT), or target vessel/lesion revascularization (TLR/TVR). The secondary endpoint was the one-year minimal lumen diameter (MLD), diameter stenosis percentage (DSP) or binary restenosis (BRS), and each MACE component.
The baseline clinical and lesioncharacteristics were comparable with similar proportions (20.0% vs. 23.3%, 1.000) of the complex BLs between the two groups. At the one-year follow-up, LLL was significantly lower in the DCB-based group (main-vessel: 0.05 0.24 mm vs. 0.25 0.35 mm, 0.013; side-branch: -0.02 0.19 mm vs. 0.11 0.15 mm, 0.005). MLD, DSP and TLR/TVR were comparable between the groups. The one-year cumulative MACE, all driven by TLR/TVR (6.7% vs. 13.3%, 0.667), was low and similar without CD, TVMI or TVT in both groups.
Compared to the DST strategy, the DCB- based strategy may be safe and effective in treatment of the selected true BLs.
Clinical registration number is ChiCTR1900024914.
对于某些真性分叉病变（BLs），双支架技术（DST）仍是必要的，但单纯药物涂层球囊（DCB）可能提供一种新的可选择治疗方法，具有植入物较少的潜在益处。然而，仅使用DCB治疗真性BLs时，手术安全性令人担忧。本研究旨在探讨仅使用DCB策略治疗真性BLs的安全性和有效性。
60例真性分叉病变患者被随机分配接受基于DCB的策略或基于DST的策略治疗。所有患者在1年后接受血管造影随访，并进行阶段性临床随访。主要终点是1年时的晚期管腔丢失（LLL）和由心源性死亡（CD）、靶血管心肌梗死（TVMI）、靶病变血栓形成（TVT）或靶血管/病变血运重建（TLR/TVR）组成的累积主要心脏不良事件（MACEs）。次要终点是1年时的最小管腔直径（MLD）、直径狭窄百分比（DSP）或二元再狭窄（BRS），以及每个MACE组成部分。
两组之间的基线临床和病变特征具有可比性，复杂BLs的比例相似（20.0%对23.3%，P = 1.000）。在1年随访时，基于DCB的组的LLL显著更低（主血管：0.05±0.24mm对0.25±0.35mm，P = 0.013；分支血管：-0.02±0.19mm对0.11±0.15mm，P = 0.005）。两组之间的MLD、DSP和TLR/TVR具有可比性。1年累积MACE均由TLR/TVR驱动（6.7%对13.3%，P = 0.667），较低且相似，两组均无CD、TVMI或TVT。
与DST策略相比，基于DCB的策略在治疗选定的真性BLs中可能是安全有效的。
临床注册号为ChiCTR1900024914。
