Yang Xinyue, Lu Wenjie, Pan Liang, Han Zhanying, Pan Sancong, Wang Xi, Zhu Yongjian, Shan Yingguang, Peng Meng, Qin Peng, Zhang Peisheng, Qin Xiaofei, Sun Guoju, Qin Zhongsheng, Dong Jianzeng, Qiu Chunguang
Department of Cardiovascular Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Department of Cardiovascular Medicine, Jincheng People's Hospital, Jincheng, China.
Front Cardiovasc Med. 2022 Sep 23;9:935263. doi: 10.3389/fcvm.2022.935263. eCollection 2022.
Drug-coated balloons (DCB), alone or in combination with drug-eluting stents (DES), may be used to treat diffuse coronary lesions. We aimed to explore the efficacy and safety of DCB in patients with diffuse coronary lesions.
Consecutive patients with diffuse coronary lesions (lesion length > 25 mm) who underwent DCB and/or DES between January 2015 and December 2019 were included in this prospective, observational, multicenter study. The DCB group included 355 patients (360 lesions), of which 142 patients (143 lesions, 39.7%) received the DCB-only strategy and 213 patients (217 lesions, 60.3%) received the hybrid strategy (DCB combined with DES). The DES group included 672 patients (831 lesions) treated with DES alone. Target lesion revascularization (TLR) during 3-year follow-up was the primary outcome of interest. The secondary outcome was major adverse cardiac events (MACE), defined as a composite of all-cause death, non-fatal myocardial infarction, and target vessel revascularization.
The two groups had comparable baseline clinical and lesion characteristics. Lesion length was similar (43.52 ± 16.46 mm vs. 44.87 ± 15.80 mm, = 0.181), but the stent length in the DCB group was significantly shorter (24.02 ± 23.62 mm vs. 51.89 ± 15.81 mm, < 0.001). Ten lesions (2.8%) in the DCB group received bailout stents. Over 3 years of follow-up, no significant difference in TLR incidence between the groups (7.3 vs. 8.3%, log-rank = 0.636) was observed. Incidence of MACE also did not differ significantly (11.3 vs. 13.7%, log-rank = 0.324). No thrombosis events occurred in the DCB group, while four patients (0.6%) in the DES group experienced stent thrombosis (log-rank = 0.193). Moreover, similar TLR and MACE rates were observed between DCB-only and hybrid strategies (TLR: 6.4 vs. 8.0%, log-rank = 0.651; MACE: 11.4 vs. 11.2%, log-rank = 0.884).
Long-term outcomes show that the efficacy and safety of the DCB strategy (DCB alone or combined with DES) are similar to those of DES alone in diffuse coronary lesions. These findings suggest that this strategy is a promising alternative for select patients with diffuse coronary lesions.
药物涂层球囊（DCB）单独使用或与药物洗脱支架（DES）联合使用，可用于治疗弥漫性冠状动脉病变。我们旨在探讨DCB治疗弥漫性冠状动脉病变患者的疗效和安全性。
本前瞻性、观察性、多中心研究纳入了2015年1月至2019年12月期间接受DCB和/或DES治疗的连续性弥漫性冠状动脉病变（病变长度>25mm）患者。DCB组包括355例患者（360处病变），其中142例患者（143处病变，39.7%）采用单纯DCB策略，213例患者（217处病变，60.3%）采用联合策略（DCB联合DES）。DES组包括672例仅接受DES治疗的患者（831处病变）。3年随访期间的靶病变血运重建（TLR）是主要关注的结局。次要结局是主要不良心脏事件（MACE），定义为全因死亡、非致命性心肌梗死和靶血管血运重建的复合事件。
两组患者的基线临床和病变特征具有可比性。病变长度相似（43.52±16.46mm对44.87±15.80mm，P=0.181），但DCB组的支架长度明显更短（24.02±23.62mm对51.89±15.81mm，P<0.001）。DCB组有10处病变（2.8%）接受了补救支架植入。在3年的随访中，两组之间的TLR发生率没有显著差异（7.3%对8.3%，对数秩检验P=0.636）。MACE的发生率也没有显著差异（11.3%对13.7%，对数秩检验P=0.324）。DCB组未发生血栓事件，而DES组有4例患者（0.6%）发生支架血栓形成（对数秩检验P=0.193）。此外，单纯DCB策略和联合策略之间的TLR和MACE发生率相似（TLR：6.4%对8.0%，对数秩检验P=0.651；MACE：11.4%对11.2%，对数秩检验P=0.884）。
长期结果表明，DCB策略（单独使用DCB或联合DES）在弥漫性冠状动脉病变中的疗效和安全性与单纯使用DES相似。这些发现表明，对于某些弥漫性冠状动脉病变患者，该策略是一种有前景的替代方案。
