Liu Shuangbo, Worme Mali, Yanagawa Bobby, Kumar Naresh, Buller Christopher E, Cheema Asim N, Bagai Akshay
Terrence Donnelly Heart Center, St. Michael's Hospital, University of Toronto, Ontario, Canada.
J Invasive Cardiol. 2018 Oct;30(10):360-366. Epub 2018 Aug 15.
To evaluate the efficacy of drug-coated balloon (DEB) for the treatment of drug-eluting stent (DES) in-stent restenosis (ISR).
A comprehensive literature search was performed. The primary outcome was the composite of death, myocardial infarction (MI), and target-lesion revascularization (TLR) at longest available follow-up (range, 12-36 months). Outcomes for DEB vs balloon angioplasty (BA) and DEB vs DES were analyzed separately using a random-effect Mantel-Haenszel model, as per an a priori protocol.
The study cohort comprised 1526 patients (746 DEB, 537 DES, 243 BA). DEB was associated with lower composite outcome compared with BA alone (19% vs 47%; risk ratio [RR], 0.31; 95% confidence interval [CI], 0.11-0.84; P=.02), driven primarily by lower TLR (17% vs 34%; RR, 0.66; 95% CI, 0.46-0.95; P=.03), with no difference in death or MI. There was no difference in the composite outcome between DEB and DES (20% vs 17%; RR, 1.2; 95% CI, 0.82-1.74; P=.35); DEB was associated with higher TLR (17.4% vs 11.3%; RR, 1.48; 95% CI, 1.08-2.03; P=.01), but lower all-cause mortality (2.2% vs 5.7%; RR, 0.43; 95% CI, 0.22-0.82; P=.01), with no difference in MI or stent thrombosis.
DEB was associated with a lower TLR rate than BA alone, but associated with a higher TLR rate than implantation of another DES. However, additional DES use was associated with an increase in mortality, a finding that requires further investigation.
评估药物涂层球囊（DEB）治疗药物洗脱支架（DES）内支架再狭窄（ISR）的疗效。
进行全面的文献检索。主要结局是在最长可获得随访期（范围为12 - 36个月）时的死亡、心肌梗死（MI）和靶病变血运重建（TLR）的复合结局。根据预先设定的方案，使用随机效应Mantel-Haenszel模型分别分析DEB与球囊血管成形术（BA）以及DEB与DES的结局。
研究队列包括1526例患者（746例接受DEB治疗，537例接受DES治疗，243例接受BA治疗）。与单独使用BA相比，DEB的复合结局更低（19%对47%；风险比[RR]，0.31；95%置信区间[CI]，0.11 - 0.84；P = 0.02），主要是由于TLR较低（17%对34%；RR，0.66；95% CI，0.46 - 0.95；P = 0.03），死亡或MI无差异。DEB与DES的复合结局无差异（20%对17%；RR，1.2；95% CI，0.82 - 1.74；P = 0.35）；DEB的TLR较高（17.4%对11.3%；RR，1.48；95% CI，1.08 - 2.03；P = 0.01），但全因死亡率较低（2.2%对5.7%；RR，0.43；95% CI，0.22 - 0.82；P = 0.01），MI或支架血栓形成无差异。
与单独使用BA相比，DEB的TLR率较低，但与植入另一枚DES相比，TLR率较高。然而，额外使用DES与死亡率增加相关，这一发现需要进一步研究。
