Objective. To investigate the efficacy of drug-coated balloon (DCB) treatment for de novo coronary artery lesions in randomized controlled trials (RCTs). Background. DCB was an effective therapy for patients with in-stent restenosis. However, the efficacy of DCB in patients with de novo coronary artery lesions is still unknown. Methods. Eligible studies were searched on PubMed, Web of Science, EMBASE, and Cochrane Library Database. Systematic review and meta-analyses of RCTs were performed comparing DCB with non-DCB devices (such as plain old balloon angioplasty (POBA), bare-metal stents (BMS), or drug-eluting stents (DES)) for the treatment of de novo lesions. Trial sequential meta-analysis (TSA) was performed to assess the false positive and false negative errors. Results. A total of 2,137 patients enrolled in 12 RCTs were analyzed. Overall, no significant difference in target lesion revascularization (TLR) was found, but there were numerically lower rates after DCB treatment at 6 to 12 months follow-up (RR: 0.69; 95% CI: 0.47 to 1.01; ; TSA-adjusted CI: 0.41 to 1.16). TSA showed that at least 1,000 more randomized patients are needed to conclude the effect on TLR. A subgroup analysis from high bleeding risk patients revealed that DCB treatment was associated with lower rate of TLR (RR: 0.10; 95% CI: 0.01 to 0.78; ). The systematic review illustrated that the rate of bailout stenting was lower and decreased gradually. Conclusions. DCB treatment was associated with a trend toward lower TLR when compared with controls. For patients at bleeding risk, DCB treatment was superior to BMS in TLR.

中文翻译：

---

用于新冠动脉病变的药物涂层球囊：随机对照试验的系统评价和试验顺序荟萃分析。

客观。在随机对照试验 (RCT) 中研究药物涂层球囊 (DCB) 治疗冠状动脉新发病变的疗效。背景。DCB是支架内再狭窄患者的有效治疗方法。然而，DCB 对新发冠状动脉病变患者的疗效仍然未知。方法。在 PubMed、Web of Science、EMBASE 和 Cochrane 图书馆数据库中搜索了符合条件的研究。对 DCB 与非 DCB 装置（如普通旧球囊血管成形术 (POBA)、裸金属支架 (BMS) 或药物洗脱支架 (DES)）在治疗 de新病变。进行试验序贯荟萃分析 (TSA) 以评估假阳性和假阴性错误。结果。共分析了 12 项 RCT 中纳入的 2,137 名患者。总体而言，目标病变血运重建 (TLR) 没有显着差异，但 DCB 治疗后 6 至 12 个月的随访率在数值上较低（RR：0.69；95% CI：0.47 至 1.01；; TSA 调整的 CI：0.41 至 1.16）。TSA 表明，至少需要 1,000 多名随机患者才能得出对 TLR 的影响。对高出血风险患者的亚组分析显示，DCB 治疗与较低的 TLR 发生率相关（RR：0.10；95% CI：0.01 至 0.78；）。系统评价表明，救助支架置入率较低并逐渐下降。结论。与对照组相比，DCB 治疗与降低 TLR 的趋势相关。对于有出血风险的患者，DCB 治疗在 TLR 方面优于 BMS。