Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University and Beijing Institute of Heart, Lung and Blood Vessel Diseases, Beijing 100029, China.
Chin Med J (Engl). 2018 Mar 5;131(5):600-607. doi: 10.4103/0366-6999.226073.
Currently, drug-eluting balloon (DEB) appears to be an attractive alternative option for the treatment of in-stent restenosis (ISR). Nevertheless, the clinical outcomes of DEB have seldom been compared to those of new-generation drug-eluting stent (DES). Thus, this meta-analysis aimed to evaluate the safety and efficacy of DEB compared to those of new-generation DES in the treatment of ISR.
A comprehensive search of electronic databases including PubMed, EMBASE, and Cochrane Library up to November 2, 2017 was performed to identify pertinent articles comparing DEB to new-generation DES for the treatment of ISR. In addition, conference proceedings for the scientific sessions of the American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, and EuroPCR were also searched. The primary endpoint was target lesion revascularization (TLR) at the longest follow-up. Dichotomous variables were presented as risk ratios (RR s) with 95% confidence intervals (CI s), while the overall RR s were estimated using the Mantel-Haenszel random-effects model.
Five randomized controlled trials (RCTs) and eight observational studies involving 2743 patients were included in the present meta-analysis. Overall, DEB was comparable to new-generation DES in terms of TLR (RR = 1.24, 95% CI: 0.89-1.72, P = 0.21), cardiac death (RR = 1.55, 95% CI: 0.89-2.71, P = 0.12), major adverse cardiovascular event (RR = 1.21, 95% CI: 0.98-1.48, P = 0.07), myocardial infarction (RR = 1.12, 95% CI: 0.72-1.76, P = 0.62), and stent thrombosis (RR = 0.95, 95% CI: 0.38-2.42, P = 0.92). However, DEB was associated with higher risk of all-cause mortality than new-generation DES (RR = 1.65, 95% CI: 1.09-2.50, P = 0.02). This was especially true in the real-world observational studies (RR = 1.79, 95% CI: 1.12-2.88, P = 0.02). In RCTs, however, no significant difference was found between the two treatment strategies in the risk of all-cause mortality.
The current meta-analysis showed that DEB and new-generation DES had comparable safety and efficacy for the treatment of ISR in RCTs. However, treatment with DEB was associated with higher risk of all-cause mortality in the real-world nonrandomized studies.
目前，药物洗脱球囊（DEB）似乎是治疗支架内再狭窄（ISR）的一种有吸引力的替代选择。然而，DEB 的临床结果很少与新一代药物洗脱支架（DES）进行比较。因此，本荟萃分析旨在评估 DEB 与新一代 DES 治疗 ISR 的安全性和疗效。
对截至 2017 年 11 月 2 日的 PubMed、EMBASE 和 Cochrane 图书馆等电子数据库进行全面检索，以确定比较 DEB 与新一代 DES 治疗 ISR 的相关文章。此外，还对美国心脏病学会、美国心脏协会、欧洲心脏病学会、经导管心血管治疗和 EuroPCR 科学会议的会议记录进行了检索。主要终点是最长随访时的靶病变血运重建（TLR）。二项变量以风险比（RR）和 95%置信区间（CI）表示，总体 RR 使用 Mantel-Haenszel 随机效应模型进行估计。
本荟萃分析共纳入了 5 项随机对照试验（RCT）和 8 项观察性研究，共涉及 2743 例患者。总体而言，DEB 在 TLR（RR=1.24，95%CI：0.89-1.72，P=0.21）、心脏死亡（RR=1.55，95%CI：0.89-2.71，P=0.12）、主要不良心血管事件（RR=1.21，95%CI：0.98-1.48，P=0.07）、心肌梗死（RR=1.12，95%CI：0.72-1.76，P=0.62）和支架血栓形成（RR=0.95，95%CI：0.38-2.42，P=0.92）方面与新一代 DES 相当。然而，DEB 与新一代 DES 相比，全因死亡率的风险更高（RR=1.65，95%CI：1.09-2.50，P=0.02）。这在真实世界的观察性研究中尤为明显（RR=1.79，95%CI：1.12-2.88，P=0.02）。然而，在 RCT 中，两种治疗策略在全因死亡率风险方面没有发现显著差异。
本荟萃分析表明，DEB 和新一代 DES 在 RCT 中治疗 ISR 的安全性和疗效相当。然而，在真实世界的非随机研究中，DEB 治疗与全因死亡率升高相关。
