Abstract：
OBJECTIVE: Although a number of studies involving small-vessel de novo coronary disease showed clinical benefits of drug-coated balloons (DCB), the role of DCB in large vessel lesions is still unclear.
METHODS: We searched main electronic databases for randomized controlled trials (RCTs) comparing DCB with stents for large vessel de novo coronary artery disease. The primary endpoint was major cardiovascular adverse events (MACE), composite cardiovascular death (CD), myocardial infarction (MI), or target lesion revascularization (TLR).
RESULTS: This study included 7 RCTs with 770 participants. DCB were associated with a marked risk reduction in MACE [Risk Ratio (RR): 0.48; 95% confidence interval [CI]: 0.24 to 0.97; P = 0.04], TLR (RR: 0.53; 95% CI: 0.25 to 1.14; P = 0.10), and late lumen loss [standard mean difference (SMD): -0.57; 95% CI: -1.09 to -0.05; P = 0.03] as compared with stents. There is no significant difference in MI (RR: 0.58; 95% CI: 0.21 to 1.54; P = 0.27), CD (RR: 0.33; 95% CI: 0.06 to 1.78; P = 0.19), and minimal lumen diameter (SMD: -0.34; 95% CI: -0.72 to 0.05; P = 0.08) between groups. In subgroup analyses, the risk reduction of MACE persisted in patients with chronic coronary syndrome (RR: 0.25; 95% CI: 0.07 to 0.89; P = 0.03), and patients receiving DCB vs. bare metal stent (RR: 0.19; 95% CI: 0.05 to 0.73; P = 0.01). In addition, there was no significant difference between the DCB group and the drug eluting stent group for MACE (RR: 0.69; 95% CI: 0.30 to 1.60; P = 0.38).
CONCLUSIONS: DCB may be an effective therapeutic option in patients with large vessel de novo coronary artery disease.
METHODS: We searched main electronic databases for randomized controlled trials (RCTs) comparing DCB with stents for large vessel de novo coronary artery disease. The primary endpoint was major cardiovascular adverse events (MACE), composite cardiovascular death (CD), myocardial infarction (MI), or target lesion revascularization (TLR).
RESULTS: This study included 7 RCTs with 770 participants. DCB were associated with a marked risk reduction in MACE [Risk Ratio (RR): 0.48; 95% confidence interval [CI]: 0.24 to 0.97; P = 0.04], TLR (RR: 0.53; 95% CI: 0.25 to 1.14; P = 0.10), and late lumen loss [standard mean difference (SMD): -0.57; 95% CI: -1.09 to -0.05; P = 0.03] as compared with stents. There is no significant difference in MI (RR: 0.58; 95% CI: 0.21 to 1.54; P = 0.27), CD (RR: 0.33; 95% CI: 0.06 to 1.78; P = 0.19), and minimal lumen diameter (SMD: -0.34; 95% CI: -0.72 to 0.05; P = 0.08) between groups. In subgroup analyses, the risk reduction of MACE persisted in patients with chronic coronary syndrome (RR: 0.25; 95% CI: 0.07 to 0.89; P = 0.03), and patients receiving DCB vs. bare metal stent (RR: 0.19; 95% CI: 0.05 to 0.73; P = 0.01). In addition, there was no significant difference between the DCB group and the drug eluting stent group for MACE (RR: 0.69; 95% CI: 0.30 to 1.60; P = 0.38).
CONCLUSIONS: DCB may be an effective therapeutic option in patients with large vessel de novo coronary artery disease.
摘要：
目的：尽管许多涉及小血管新生冠状动脉疾病的研究显示了药物涂层球囊（DCB）的临床益处，DCB在大血管病变中的作用尚不清楚.
方法：我们在主要电子数据库中搜索了比较DCB和支架治疗大血管新生冠状动脉疾病的随机对照试验（RCT）。主要终点是主要心血管不良事件（MACE），复合心血管死亡（CD），心肌梗死（MI），或靶病变血运重建（TLR）。
结果：本研究包括7项RCTs和770名参与者。DCB与MACE中明显的风险降低相关[风险比（RR）：0.48;95％置信区间[CI]：0.24至0.97;P=0.04]，TLR（RR：0.53；95%CI：0.25至1.14；P=0.10），和晚期管腔损失[标准平均差（SMD）：-0.57;95％CI：-1.09至-0.05;P=0.03]与支架相比。MI无显著差异(RR:0.58;95%CI:0.21~1.54;P=0.27),CD（RR：0.33；95%CI：0.06至1.78；P=0.19），和最小管腔直径（SMD：-0.34;95％CI：-0.72至0.05;P=0.08）。在亚组分析中，慢性冠脉综合征患者MACE风险持续降低(RR:0.25;95%CI:0.07~0.89;P=0.03),和患者接受DCB与裸金属支架(RR:0.19;95%CI:0.05~0.73;P=0.01)。此外,DCB组与药物洗脱支架组MACE比较差异无统计学意义(RR:0.69;95%CI:0.30~1.60;P=0.38)。
结论：DCB可能是大血管新生冠状动脉疾病患者的有效治疗选择。
方法：我们在主要电子数据库中搜索了比较DCB和支架治疗大血管新生冠状动脉疾病的随机对照试验（RCT）。主要终点是主要心血管不良事件（MACE），复合心血管死亡（CD），心肌梗死（MI），或靶病变血运重建（TLR）。
结果：本研究包括7项RCTs和770名参与者。DCB与MACE中明显的风险降低相关[风险比（RR）：0.48;95％置信区间[CI]：0.24至0.97;P=0.04]，TLR（RR：0.53；95%CI：0.25至1.14；P=0.10），和晚期管腔损失[标准平均差（SMD）：-0.57;95％CI：-1.09至-0.05;P=0.03]与支架相比。MI无显著差异(RR:0.58;95%CI:0.21~1.54;P=0.27),CD（RR：0.33；95%CI：0.06至1.78；P=0.19），和最小管腔直径（SMD：-0.34;95％CI：-0.72至0.05;P=0.08）。在亚组分析中，慢性冠脉综合征患者MACE风险持续降低(RR:0.25;95%CI:0.07~0.89;P=0.03),和患者接受DCB与裸金属支架(RR:0.19;95%CI:0.05~0.73;P=0.01)。此外,DCB组与药物洗脱支架组MACE比较差异无统计学意义(RR:0.69;95%CI:0.30~1.60;P=0.38)。
结论：DCB可能是大血管新生冠状动脉疾病患者的有效治疗选择。
