Introduction: In-stent restenosis (ISR) remains a challenging issue despite the great advance of drug-eluting stents (DES). In addition, the consensus was lacking regarding the optimal strategy for DES-ISR. Therefore, we aimed to evaluate angiographic and clinical outcomes of the two most effective treatments DES vs. drug-eluting balloon (DCB) for patients with DES-ISR.

Methods: This meta-analysis used the data from the randomized controlled trials (RCTs), which were identified by a systematic search in the databases of PubMed, Embase, and Cochrane Library. Target lesion revascularization (TLR) was regarded as the primary endpoint. In addition, the late angiographic outcomes and other clinical outcomes, namely, cardiac death, myocardial infarction (MI), target vessel revascularization, stent thrombosis, and major adverse cardiac events, were also included for analysis.

Results: Five RCTs with about 1,193 patients were included in this meta-analysis for the analysis. For the primary endpoint, the overall pooled outcomes suggested repeat DES implantation was associated with a significant reduction in the term of TLR compared with DCB angioplasty (risk ratio = 1.53, 95% CI 1.15–2.04, p = 0.003). But no significant difference in angiographic outcomes and other clinical endpoints were observed between DES and DCB. In the subgroup analysis, DCB was inferior to new-generation DES (NG-DES)/everolimus-eluting stent (EES) in the term of TLR. In addition, this non-significant trend was also noted in the subgroup of the paclitaxel-eluting stent (PES) vs. DCB. For the angiographic endpoints, EES, not PES, was associated with larger minimum lumen diameter [mean difference (MD) = −0.25, 95% CI −0.38 to −0.11, p = 0.0003], lower percent diameter stenosis (MD = 7.29%, 95% CI 2.86–11.71%, p = 0.001), and less binary restenosis (OR = 2.20, 95% CI 1.18–4.11, p = 0.01). But NG-DES/EES was comparable to DCB in cardiac death, MI, and stent thrombosis.

Conclusions: For the patients with DES-ISR, treatment with DES, especially NG-DES/EES could reduce the risk of TLR significantly compared to DCB at long-term follow-up.

介绍：尽管药物洗脱支架 (DES) 取得了巨大进步，但支架内再狭窄 (ISR) 仍然是一个具有挑战性的问题。此外，关于 DES-ISR 的最佳策略缺乏共识。因此，我们旨在评估两种最有效的治疗方法 DES 与药物洗脱球囊 (DCB) 对 DES-ISR 患者的血管造影和临床结果。

方法：该荟萃分析使用了随机对照试验 (RCT) 的数据，这些数据是通过在 PubMed、Embase 和 Cochrane 图书馆的数据库中系统搜索确定的。靶病变血运重建（TLR）被视为主要终点。此外，晚期血管造影结果和其他临床结果，即心源性死亡、心肌梗死 (MI)、靶血管血运重建、支架血栓形成和主要不良心脏事件也包括在内进行分析。

结果：这项荟萃分析包括了五项随机对照试验，约有 1,193 名患者进行分析。对于主要终点，总体汇总结果表明，与 DCB 血管成形术相比，重复植入 DES 与 TLR 的显着减少相关（风险比 = 1.53，95% CI 1.15–2.04，p= 0.003）。但在 DES 和 DCB 之间没有观察到血管造影结果和其他临床终点的显着差异。在亚组分析中，DCB在TLR方面不及新一代DES（NG-DES）/依维莫司洗脱支架（EES）。此外，在紫杉醇洗脱支架 (PES) 与 DCB 的亚组中也注意到了这种不显着的趋势。对于血管造影终点，EES 而非 PES 与较大的最小管腔直径相关 [平均差 (MD) = -0.25，95% CI -0.38 至 -0.11，p = 0.0003]，直径狭窄百分比较低（MD = 7.29%，95% CI 2.86–11.71%， p = 0.001），以及更少的二元再狭窄（OR = 2.20，95% CI 1.18–4.11， p= 0.01）。但 NG-DES/EES 在心源性死亡、MI 和支架血栓形成方面与 DCB 相当。

结论： 对于DES-ISR患者，在长期随访中，与DCB相比，DES治疗，尤其是NG-DES/EES治疗可以显着降低TLR的风险。