摘要

AIMS:Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited.
METHODS AND RESULTS:The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02-1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58-1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71-1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53-1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80-2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments.
CONCLUSIONS:In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

译文

目的: 关于冠状动脉支架内再狭窄 (ISR) 的最佳治疗缺乏共识。两种最有效的治疗方法是使用紫杉醇涂层的气囊 (PCB) 进行血管成形术，以及使用药物洗脱支架 (DES) 进行重复的支架置入术，但是个人的试验并没有统计出临床终点, 结果是异质的，相关亚群中关于比较疗效和安全性的证据有限。
方法和结果: 药物洗脱支架和药物涂层气囊血管成形术对发生冠状动脉支架内再狭窄 (DAEDALUS) 的抗再狭窄效果的差异是一项全面的研究, 研究者发起的、合作的、个体患者数据荟萃分析，比较了单独使用 PCB 的血管成形术与单独使用 DES 的重复支架植入术治疗冠状动脉 ISR。该协议已在普洛斯彼罗注册 (CRD42017075007)。所有 10 项可用的随机临床试验都纳入了 1976 名患者，1033 名分配给 PCB，943 名分配给 DES。在 3 年的随访中，与 DES [风险比 (HR) 1.32 相比，PCB 与靶病变血运重建 (TLR) 风险的显著增加相关, 95% CI 1.02-1.70，p   =  0。 035; 需要伤害的人数 28.5]。治疗效果与支架类型之间有显著的交互作用 (p   =  0。 029)，在 DES-ISR 患者中具有更明显的差异，在裸金属支架-ISR 患者中具有类似的效果。在 3 年的随访中，全因死亡、心肌梗塞或靶病变血栓形成的主要安全终点在两种治疗中具有可比性 (HR 0.80，95% CI 0.58-1.09, P   0 =。 152)。预先指定的亚组分析表明，治疗效果和用于治疗 ISR 的 DES 类型之间存在显著的交互作用 (p =-0。 033)，与第一代 DES 相比，与多氯联苯相关的事件发生率较低，并且多氯联苯和第二代 DES 之间有相似的影响 (HR 1.06，95% CI 0.71-1.60, P   0 =。 764)。PCB 和 DES 之间的长期全因死亡率相似 (HR 0.81，95% CI 0.53-1.22，p =-0。 310); 比较 PCB 和非紫杉醇基 DES 的结果是一致的 (HR 1.42，95% CI 0.80-2.54，p =-0。 235)。心肌梗死和靶病变血栓形成在治疗之间具有可比性。
结论: 在冠状动脉 ISR 患者中，在减少 3 岁时对 TLR 的需求方面，DES 重复支架植入术比 PCB 血管成形术更有效。全因死亡、心肌梗死或靶病变血栓形成的复合发生率在两组之间相似。个体终点率，包括全因死亡率，在组间没有显著差异。