Refaat Hesham, Arab Mohamed
Cardiology Department, Zagazig University, Zagazig, Egypt.
Cardiology Department, Zagazig University, Zagazig, Egypt.
Indian Heart J. 2025 May-Jun;77(3):174-181. doi: 10.1016/j.ihj.2025.03.015. Epub 2025 Mar 29.
Drug eluting stent (DES) could result in both in-stent restenosis and high bleeding risk due to long-term anti-platelet therapy. Drug-coated balloon (DCB) delivers anti-proliferative drugs without implanting metal into vascular wall. Our aim was to investigate its feasibility in large vessel coronary artery disease (LvCAD), compared to small vessel coronary artery disease (SvCAD).
This study enrolled 237 patients with de novo coronary lesions treated with DCB-only strategy and categorized according to the reference vessel diameter of 3 mm into SvCAD and LvCAD groups. The primary endpoint was in-lesion late lumen loss (LLL). The secondary endpoints included composite major adverse cardiac events (MACE), cardiac death, non-fatal myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and vessel thrombosis.
The immediate (3.06 ± 0.25 vs. 2.33 ± 0.21 mm, p = 0.001) and follow up minimal lumen diameter (3.13 ± 0.25 vs. 2.41 ± 0.21 mm, p = 0.001) and acute gain (1.92 ± 0.29 vs. 1.5 ± 0.26 mm, p = 0.04) were significantly higher in LvCAD group. In-lesion LLL was negative without significant difference (-0.07 ± 0.02 vs. - 0.06 ± 0.04 mm, p = 0.69). The incidence of adverse clinical events was not statistically significant accounting for 6.5 % vs. 10.5 % for composite MACE (p = 0.27), 0.8 % vs. 0.9 % for cardiac death (p = 0.96), 4.9 % vs.7 % for non-fatal MI (p = 0.49), 4.1 % vs. 6.1 % for TLR (p = 0.47), 2.4 % vs. 3.5 % for TVR (p = 0.63) and 1.6 % vs. 2.6 % for vessel thrombosis (p = 0.59).
DCB-only strategy is effective in treating LvCAD with comparable outcomes to SvCAD.
药物洗脱支架（DES）由于长期抗血小板治疗可能导致支架内再狭窄和高出血风险。药物涂层球囊（DCB）可输送抗增殖药物，而无需将金属植入血管壁。我们的目的是研究其在大血管冠状动脉疾病（LvCAD）中的可行性，并与小血管冠状动脉疾病（SvCAD）进行比较。
本研究纳入了237例采用单纯DCB策略治疗的初发冠状动脉病变患者，并根据3毫米的参考血管直径分为SvCAD组和LvCAD组。主要终点是病变内晚期管腔丢失（LLL）。次要终点包括复合主要不良心脏事件（MACE）、心源性死亡、非致命性心肌梗死（MI）、靶病变血运重建（TLR）、靶血管血运重建（TVR）和血管血栓形成。
LvCAD组的即刻最小管腔直径（3.06±0.25 vs. 2.33±0.21毫米，p = 0.001）和随访时最小管腔直径（3.13±0.25 vs. 2.41±0.21毫米，p = 0.001）以及急性管腔增益（1.92±0.29 vs. 1.5±0.26毫米，p = 0.04）显著更高。病变内LLL为阴性，无显著差异（-0.07±0.02 vs. - 0.06±0.04毫米，p = 0.69）。不良临床事件发生率无统计学意义，复合MACE分别为6.5%和10.5%（p = 0.27），心源性死亡分别为0.8%和0.9%（p = 0.96），非致命性MI分别为4.9%和7%（p = 0.49），TLR分别为4.1%和6.1%（p = 0.47），TVR分别为2.4%和3.5%（p = 0.63），血管血栓形成分别为1.6%和2.6%（p = 0.59）。
单纯DCB策略治疗LvCAD有效，其结果与SvCAD相当。
