PDF(Pubmed)
Abstract：
UNASSIGNED: Drug-coated balloon (DCB) is a novel approach to avoiding stent-related complications and has proven effective for the treatment of in-stent restenosis (ISR) and small vessels. However, its role in the treatment of de novo lesions in large vessels is less settled.
UNASSIGNED: To estimate the efficacy and safety of drug-coated balloon versus stent in the treatment of de novo lesions in large coronary arteries.
UNASSIGNED: We searched the literature until April 2023. We judged the safety of DCB based on major adverse cardiovascular events (MACEs), cardiac death, all-cause mortality, non-fatal myocardial infarction, target lesion revascularization (TLR), and bleeding event; and efficacy according to late lumen loss (LLL), minimum lumen diameter (MLD). We conducted subgroup analyses according to stent type and whether urgent PCI was required.
UNASSIGNED: A total of 10 RCTs were included. Overall, LLL (mean difference (MD) = -0.19, 95 % confidence interval (CI): -0.32 to -0.06, P = 0.003) was lower in the DCB group than in the Stent arm. This effect was consistent in subgroup analysis regardless of stent type and disease type. In terms of safety indicators, there were no significant differences between DCB and stent. The subgroup analyses found that safety indicators showed no significant differences between DCB and drug-eluting stent (DES), but TLR was lower in the DCB than in the bare metal stent (BMS). Moreover, in ST-elevation myocardial infarction (STEMI), safety indicators and LLL showed no significant differences between DCB and DES, but MLD in the DCB was smaller. While in patients with excluded STEMI, MACE and TLR was lower in the DCB compared with the overall stent.
UNASSIGNED: DCB could be a promising alternative for treating de novo lesions in large coronary arteries with satisfactory efficacy and low risk, superior to BMS and not inferior to DES, with a trend toward lower late lumen loss.
UNASSIGNED: To estimate the efficacy and safety of drug-coated balloon versus stent in the treatment of de novo lesions in large coronary arteries.
UNASSIGNED: We searched the literature until April 2023. We judged the safety of DCB based on major adverse cardiovascular events (MACEs), cardiac death, all-cause mortality, non-fatal myocardial infarction, target lesion revascularization (TLR), and bleeding event; and efficacy according to late lumen loss (LLL), minimum lumen diameter (MLD). We conducted subgroup analyses according to stent type and whether urgent PCI was required.
UNASSIGNED: A total of 10 RCTs were included. Overall, LLL (mean difference (MD) = -0.19, 95 % confidence interval (CI): -0.32 to -0.06, P = 0.003) was lower in the DCB group than in the Stent arm. This effect was consistent in subgroup analysis regardless of stent type and disease type. In terms of safety indicators, there were no significant differences between DCB and stent. The subgroup analyses found that safety indicators showed no significant differences between DCB and drug-eluting stent (DES), but TLR was lower in the DCB than in the bare metal stent (BMS). Moreover, in ST-elevation myocardial infarction (STEMI), safety indicators and LLL showed no significant differences between DCB and DES, but MLD in the DCB was smaller. While in patients with excluded STEMI, MACE and TLR was lower in the DCB compared with the overall stent.
UNASSIGNED: DCB could be a promising alternative for treating de novo lesions in large coronary arteries with satisfactory efficacy and low risk, superior to BMS and not inferior to DES, with a trend toward lower late lumen loss.
摘要：
■药物涂层球囊（DCB）是一种避免支架相关并发症的新颖方法，已被证明可有效治疗支架内再狭窄（ISR）和小血管。然而,其在大血管新生病变治疗中的作用较少。
■评估药物涂层球囊与支架治疗大冠状动脉新生病变的疗效和安全性。
■我们搜索了文献，直到2023年4月。我们根据主要不良心血管事件（MACEs）判断DCB的安全性，心脏死亡,全因死亡率,非致死性心肌梗死,靶病变血运重建(TLR),和出血事件；以及根据晚期管腔丢失（LLL）的疗效，最小管腔直径（MLD）。我们根据支架类型和是否需要紧急PCI进行了亚组分析。
■共包括10项RCT。总的来说,DCB组的LLL（平均差异（MD）=-0.19，95％置信区间（CI）：-0.32至-0.06，P=0.003）低于支架组。无论支架类型和疾病类型如何，这种效应在亚组分析中都是一致的。在安全指标方面，DCB和支架之间无显著差异。亚组分析发现，安全性指标显示DCB和药物洗脱支架（DES）之间没有显着差异。但DCB中的TLR低于裸金属支架(BMS)。此外，在ST段抬高型心肌梗死（STEMI）中，安全指标和LLL在DCB和DES之间没有显着差异，但是DCB中的MLD较小。而在排除STEMI的患者中，与整个支架相比，DCB中的MACE和TLR较低。
■DCB可能是治疗大冠状动脉新生病变的一种有希望的替代方法，疗效满意，风险低。优于BMS，而不低于DES，具有降低晚期管腔损失的趋势。
■评估药物涂层球囊与支架治疗大冠状动脉新生病变的疗效和安全性。
■我们搜索了文献，直到2023年4月。我们根据主要不良心血管事件（MACEs）判断DCB的安全性，心脏死亡,全因死亡率,非致死性心肌梗死,靶病变血运重建(TLR),和出血事件；以及根据晚期管腔丢失（LLL）的疗效，最小管腔直径（MLD）。我们根据支架类型和是否需要紧急PCI进行了亚组分析。
■共包括10项RCT。总的来说,DCB组的LLL（平均差异（MD）=-0.19，95％置信区间（CI）：-0.32至-0.06，P=0.003）低于支架组。无论支架类型和疾病类型如何，这种效应在亚组分析中都是一致的。在安全指标方面，DCB和支架之间无显著差异。亚组分析发现，安全性指标显示DCB和药物洗脱支架（DES）之间没有显着差异。但DCB中的TLR低于裸金属支架(BMS)。此外，在ST段抬高型心肌梗死（STEMI）中，安全指标和LLL在DCB和DES之间没有显着差异，但是DCB中的MLD较小。而在排除STEMI的患者中，与整个支架相比，DCB中的MACE和TLR较低。
■DCB可能是治疗大冠状动脉新生病变的一种有希望的替代方法，疗效满意，风险低。优于BMS，而不低于DES，具有降低晚期管腔损失的趋势。
