Background

Studies examining the efficiency of drug-coated balloon (DCB) compared to drug-eluting stents (DES) for de novo lesions in large vessels have reported inconsistent results.

Objective

This comprehensive meta-analysis of clinical trials compared the efficacy and safety of DCB and DES for the treatment of de novo coronary lesions.

Methods

The authors formally searched electronic databases before October 2019 to identify randomized and non-randomized clinical trials (RCTs and non-RCTs, respectively). Clinical trials were eligible for inclusion if they compared DCB with DES in patients with coronary lumen diameters >2.5 mm.

Results

Three RCTs and one non-RCT with a total of 321 patients were included in our meta-analysis (DCB group = 152, DES group = 169). The primary endpoint was in-segment late lumen loss (LLL) with a standardized mean difference (SMD) of −0.07 (95% confidence interval [CI]: −0.31, 0.316; P = 0.548) and the secondary endpoint was target lesion revascularization (TLR) with a risk ratio (RR) of 1.17 (95% CI: 0.46, 2.95; P = 0.746).

Conclusion

This meta-analysis indicated that DCB might be non-inferior to DES as evidenced by quantitative coronary angiography (QCA) assessed at 6–9 months after percutaneous coronary intervention in patients presenting with coronary artery disease.

中文翻译：

---

药物涂层球囊与药物洗脱支架治疗大血管新生冠状动脉病变：临床试验的荟萃分析。

背景

研究检查了药物涂层球囊（DCB）与药物洗脱支架（DES）相比在大血管中从头病变的效率，该研究报告了不一致的结果。

目的

这项对临床试验进行的综合荟萃分析比较了DCB和DES治疗从头冠状动脉病变的有效性和安全性。

方法

作者于2019年10月之前正式搜索了电子数据库，以识别随机和非随机临床试验（分别为RCT和非RCT）。如果将DCB与DES合并冠状动脉腔直径> 2.5 mm的患者进行比较，则有资格纳入临床试验。

结果

我们的荟萃分析包括三项RCT和一项非RCT，共321例患者（DCB组= 152，DES组= 169）。主要终点为段内晚期管腔丢失（LLL），标准化平均差（SMD）为-0.07（95％置信区间[CI]：-0.31，0.316；P  = 0.548），次要终点为目标病变血管重建（TLR），风险比（RR）为1.17（95％CI：0.46，2.95；P  = 0.746）。

结论

这项荟萃分析表明，经皮冠状动脉介入治疗后出现冠状动脉疾病的患者在6–9个月进行定量冠状动脉造影（QCA）评估，DCB可能不劣于DES。