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药物涂层球囊在小血管介入中的应用

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DCB经现阶段临床试验证实在冠脉小血管狭窄干预方向与DES可一决高下，其优势在于：

1) 不改变血管解剖结构；

2) 药物涂层球囊具抗血管壁增生药物，可起到预防支架内再狭窄之目的；

3) 有证据提示DCB术后DAPT服药周期可短于DES术后；

4) DCB可为后续CABG或支架置入赢取更多可能。



将DCB应用在小血管介入领域时应持有的谨慎态度：

1）尽管现有指南尚未对DCB应用前腔内影像学IVUS，OCT的仔细评估做明确规定，但已有证据显示腔内影像学的先进性在指导DES置入或DCB时可转换为更好的预后；

2）应进一步明确DCB适应证及人群。



围绕DCB术后预后非劣效于DES预后的RCT研究包括：


2018年8月“Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial”

样本：欧洲14个介入中心758例，随机比DES (paclitaxel-eluting stent) vs. DCB 1:1

病变：<3 mm直径的冠脉病变

随访：1年

DAPT：DCB组4周，DES组non-ACS患者 6周，ACS患者1年

结论: 在一年内，所有小血管疾病(< 3mm)患者随机分配到DES组和DCB组，组间MACE一年发生率无差异，符合非劣效性标准。



2018年12月“Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial”

样本：多中心230例

病变：2.25 ≤冠脉小血管直径 ≤2.75 mm

随访：9个月和1年

结论：9个月造影随访DCB组节段狭窄直径百分比较DES组下降了10.9%，满足非劣效标准；而一年组间靶病变失败率无统计学差异。




2019年5月“Paclitaxel-Coated Balloon Angioplasty Versus Drug-Eluting Stent in Acute Myocardial Infarction: The REVELATION Randomized Trial”

样本：单中心120例

病变：STEMI, 罪犯病变非严重钙化，预扩后残余冠脉狭窄 <50%

随访：9个月FFR随访

结论：STEMI经PPCI-DCB策略干预后，其FFR评估结果非劣效于DES策略。


更多内容详细参阅“Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review”和《紫杉醇涂层球囊的最新研究进展》。




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