Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis,Journal of the American College of Cardiology

当前位置： X-MOL 学术 › J. Am. Coll. Cardiol. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis
Journal of the American College of Cardiology ( IF 21.7 ) Pub Date : 2020-06-01 , DOI: 10.1016/j.jacc.2020.04.006
Daniele Giacoppo ₁ , Fernando Alfonso ₂ , Bo Xu ₃ , Bimmer E P M Claessen ₄ , Tom Adriaenssens ₅ , Christoph Jensen ₆ , María J Pérez-Vizcayno ₇ , Do-Yoon Kang ₈ , Ralf Degenhardt ₉ , Leos Pleva ₁₀ , Jan Baan ₁₁ , Javier Cuesta ₂ , Duk-Woo Park ₈ , Pavel Kukla ₁₀ , Pilar Jiménez-Quevedo ₇ , Martin Unverdorben ₁₂ , Runlin Gao ₃ , Christoph K Naber ₆ , Seung-Jung Park ₈ , José P S Henriques ₁₁ , Adnan Kastrati ₁₃ , Robert A Byrne ₁₄

Affiliation

Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Department of Cardiology, Hospital Universitario de La Princesa Madrid, Madrid, Spain.
Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.
Mount Sinai Heart, The Zena and Michael Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Department of Cardiology, University Hospitals Leuven, Leuven, Belgium.
Department of Cardiology, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany.
Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.
Department of Cardiology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany.
Department of Cardiology, University Hospital Ostrava, Ostrava, Czech Republic.
Department of Cardiology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.
Department of Cardiology, Herz-und Kreislaufzentrum, Rotenburg an der Fulda, Germany; Daiichi-Sankyo, Basking Ridge, New Jersey.
Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research, Munich Heart Alliance, Munich, Germany.
Department of Cardiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Dublin Cardiovascular Research Institute, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.

BACKGROUND In patients with coronary in-stent restenosis (ISR) requiring reintervention, it is unclear if the choice of treatment should depend on whether the restenotic stent was a bare-metal stent (BMS) or a drug-eluting stent (DES). OBJECTIVES This study aimed to assess the comparative efficacy and safety of the 2 most frequently used treatments - angioplasty with drug-coated balloon (DCB) and repeat stenting DES - in patients with BMS-and DES-ISR. METHODS The DAEDALUS (Difference in Antirestenotic Effectiveness of Drug-Eluting Stent and Drug-Coated Balloon Angioplasty for the Occurrence of Coronary In-Stent Restenosis) study was a pooled analysis of individual patient data from all 10 existing randomized clinical trials comparing DCB angioplasty with repeat DES implantation for the treatment of coronary ISR. In this pre-specified analysis, patients were stratified according to BMS- versus DES-ISR and treatment assigned. The primary efficacy endpoint was target lesion revascularization (TLR) at 3 years. The primary safety endpoint was a composite of all-cause death, myocardial infarction, or target lesion thrombosis at 3 years. Primary analysis was performed by mixed-effects Cox models accounting for the trial of origin. Secondary analyses included nonparsimonious multivariable adjustment accounting also for multiple lesions per patient and 2-stage analyses. RESULTS A total of 710 patients with BMS-ISR (722 lesions) and 1,248 with DES-ISR (1,377 lesions) were included. In patients with BMS-ISR, no significant difference between treatments was observed in terms of primary efficacy (9.2% vs. 10.2%; hazard ratio [HR]: 0.83; 95% confidence interval [CI]: 0.51 to 1.37) and safety endpoints (8.7% vs. 7.5%; HR: 1.13; 95% CI: 0.65 to 1.96); results of secondary analyses were consistent. In patients with DES-ISR, the risk of the primary efficacy endpoint was higher with DCB angioplasty than with repeat DES implantation (20.3% vs. 13.4%; HR: 1.58; 95% CI: 1.16 to 2.13), whereas the risk of the primary safety endpoint was numerically lower (9.5% vs. 13.3%; HR: 0.69; 95% CI: 0.47 to 1.00); results of secondary analyses were consistent. Regardless of the treatment used, the risk of TLR was lower in BMS- versus DES-ISR (9.7% vs. 17.0%; HR: 0.56; 95% CI: 0.42 to 0.74), whereas safety was not significantly different between ISR types. CONCLUSIONS At 3-year follow-up, DCB angioplasty and repeat stenting with DES are similarly effective and safe in the treatment of BMS-ISR, whereas DCB angioplasty is significantly less effective than repeat DES implantation in the treatment DES-ISR, and associated with a nonsignificant reduction in the primary composite safety endpoint. Overall, DES-ISR is associated with higher rates of treatment failure and similar safety compared with BMS-ISR.

中文翻译：

冠状动脉支架再狭窄患者的药物涂层球囊血管成形术与药物洗脱支架植入术

背景对于需要再次介入治疗的冠状动脉支架内再狭窄 (ISR) 患者，尚不清楚治疗的选择是否应取决于再狭窄支架是裸金属支架 (BMS) 还是药物洗脱支架 (DES)。目的本研究旨在评估两种最常用的治疗方法——药物涂层球囊 (DCB) 血管成形术和重复支架置入术——在 BMS 和 DES-ISR 患者中的比较疗效和安全性。方法 DAEDALUS（药物洗脱支架和药物涂层球囊血管成形术对冠状动脉支架内再狭窄发生的抗再狭窄有效性的差异）研究是对来自所有 10 项现有随机临床试验的个体患者数据的汇总分析，比较 DCB 血管成形术与重复性血管成形术DES 植入治疗冠状动脉 ISR。在这个预先指定的分析中，根据 BMS- 与 DES-ISR 和分配的治疗对患者进行分层。主要疗效终点是 3 年时的靶病变血运重建 (TLR)。主要安全终点是 3 年时全因死亡、心肌梗死或靶病变血栓形成的复合终点。主要分析是通过考虑原始试验的混合效应 Cox 模型进行的。次要分析包括非简约多变量调整，也考虑到每位患者的多个病变和 2 阶段分析。结果共有 710 名 BMS-ISR 患者（722 个病灶）和 1,248 名 DES-ISR 患者（1,377 个病灶）被纳入。在 BMS-ISR 患者中，在主要疗效方面未观察到治疗之间的显着差异（9.2% 与 10.2%；风险比 [HR]：0.83；95% 置信区间 [CI]：0.51 至 1。37) 和安全性终点（8.7% 与 7.5%；HR：1.13；95% CI：0.65 至 1.96）；二次分析的结果是一致的。在 DES-ISR 患者中，DCB 血管成形术的主要疗效终点风险高于重复植入 DES（20.3% 对 13.4%；HR：1.58；95% CI：1.16 至 2.13），而主要安全终点在数值上较低（9.5% 与 13.3%；HR：0.69；95% CI：0.47 至 1.00）；二次分析的结果是一致的。无论使用何种治疗，BMS- 与 DES-ISR 的 TLR 风险均较低（9.7% 与 17.0%；HR：0.56；95% CI：0.42 至 0.74），而 ISR 类型之间的安全性没有显着差异。结论在 3 年的随访中，DCB 血管成形术和重复支架植入术与 DES 在治疗 BMS-ISR 方面同样有效和安全，而在治疗 DES-ISR 中，DCB 血管成形术的效果明显低于重复 DES 植入术，并且与主要复合安全终点的非显着降低相关。总体而言，与 BMS-ISR 相比，DES-ISR 与更高的治疗失败率和相似的安全性相关。

更新日期：2020-06-01

点击分享查看原文

点击收藏

公开下载

阅读更多本刊新发论文本刊介绍/投稿指南