Objective: To systematically evaluate the efficacy of drug coated balloon (DCB) versus conventional balloon in the treatment of coronary de novo bifurcation lesions. Methods: The databases of PubMed, Embase, Cochrane Library, Web of science, CNKI (China National Knowledge Infrastructure), Wanfang database, VIP, China Biology Medicine disc, Chinese clinical trial registry, American clinical trial registry and cardiovascular related websites until September 2020 were retrieved for collecting the randomized controlled trials (RCT) comparing DCB versus conventional balloon in the treatment of coronary de novo bifurcation lesions. The risk of bias of included studies was assessed using the Cochrane risk assessment tool. The meta-analysis was performed by using Revman 5.3 and Stata 14.0 software. Results: Seven RCTs with a total of 613 patients were included in this meta-analysis. Among the included studies, 4 articles reached the low risk of bias, and the other 3 articles reached the medium risk of bias. The results of meta-analysis showed that there was no significant difference in the major adverse cardiac events (RR=0.65, 95%CI 0.39-1.08, P=0.10), myocardial infarction (RR=0.68, 95%CI 0.25-1.80, P=0.43), target lesion revascularization (RR=0.94, 95%CI 0.53-1.67, P=0.83) between DCB group and conventional balloon group. Late lumen loss of side branch was less in the DCB group than that in the conventional balloon group (WMD=-0.25, 95%CI -0.41--0.09, P<0.01) and the risk of side branch restenosis was also lower in the DCB group than that in the conventional balloon group (RR=0.47, 95%CI 0.22-0.98, P<0.05). However, subgroup analysis showed that the conclusions of domestic studies and foreign studies on late lumen loss and side branch restenosis were inconsistent. The meta-analysis based on domestic literature showed that the risk of side branch restenosis after DCB treatment was lower compared with conventional balloon group (RR=0.29, 95%CI 0.15-0.57, P<0.05), while this parameter derived from foreign literatures remained unchanged between two groups (P=0.53). The meta-analysis results of domestic literature showed that late lumen loss in DCB group was less than that in conventional balloon group (WMD=-0.32, 95%CI -0.51--0.13, P<0.05), but this phenomenon was not observed in foreign literatures (P=0.30). Conclusions: The use of DCB in the treatment of coronary de novo bifurcation lesions has the potential to reduce the rate of restenosis and late lumen loss of side branch compared with conventional balloon group. However, due to the limitation on quantity, quality and results of published studies, more high-quality and large scale RCTs are still needed to confirm these findings.
目的： 系统评价药物涂层球囊（DCB）对比普通球囊治疗冠状动脉原发分叉病变的疗效。 方法： 检索PubMed、Embase、Cochrane图书馆、Web of science、中国期刊全文数据库（CNKI）、万方数据库（Wanfang database）、维普数据库（VIP）、中国生物医学文献数据库（CBM）、中国临床试验注册中心、美国临床试验注册中心，同时查阅心血管专业相关网站。检索时间均为从建库至2020年9月。收集关于DCB对比普通球囊治疗原发冠状动脉分叉病变的随机对照试验。使用Cochrane风险偏倚评估工具进行文献质量评价，运用Revman 5.3和Stata 14.0软件进行统计学分析。 结果： 最终纳入7项随机对照试验，共613例患者，其中4篇文献达到低度偏倚风险，其余3篇达到中度偏倚风险。荟萃分析结果显示，DCB组和普通球囊组在主要不良心血管事件（RR=0.65，95%CI 0.39~1.08，P=0.10）、心肌梗死（RR=0.68，95%CI 0.25~1.80，P=0.43）、靶病变再次血运重建（RR=0.94，95%CI 0.53~1.67，P=0.83）上差异无统计学意义。DCB组的分支晚期管腔丢失少于普通球囊组（WMD=-0.25，95%CI -0.41~-0.09，P<0.01）且分支血管再狭窄发生风险较普通球囊组低（RR=0.47，95%CI 0.22~0.98，P<0.05）。但亚组分析结果显示，所纳入国内文献和国外文献在分支晚期管腔丢失、分支血管再狭窄上得出的结论有差异：国内文献的荟萃分析结果示DCB治疗后发生分支血管再狭窄的风险较普通球囊低（RR=0.29，95%CI 0.15~0.57，P<0.05），而国外文献的荟萃分析结果显示组间比较差异无统计学意义（P=0.53）；国内文献的荟萃分析结果示DCB组的分支晚期管腔丢失少于普通球囊组（WMD=-0.32，95%CI -0.51~-0.13，P<0.05），而国外文献的荟萃分析结果显示组间比较差异无统计学意义（P=0.30）。 结论： 在冠状动脉原发分叉病变治疗中，与普通球囊相比运用DCB有降低分支血管再狭窄率、减少分支晚期管腔丢失的可能，但鉴于目前已发表研究的数量、质量及结果，仍然需要更多高质量、大样本的随机对照试验进一步验证。.