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A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.

药物涂层球囊治疗冠状动脉支架内再狭窄的多中心、随机对照临床研究。

  • 影响因子:2.41
  • DOI:10.4244/EIJ-D-19-00051
  • 作者列表:"Hamm CW","Dörr O","Woehrle J","Krackhardt F","Ince H","Zeus T","Berland J","Piot C","Roubille F","Schult I","Allocco DJ","Nef H
  • 发表时间:2020-07-17
Abstract

AIMS:Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please). METHODS AND RESULTS:AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups. CONCLUSIONS:In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months. CLINICAL TRIALS REGISTRATION:NCT02151812 (http://clinicaltrials.gov/).

摘要

目的: 冠状动脉支架内再狭窄的治疗具有挑战性。药物涂层球囊 (DCB) 的使用是一种有前途的技术,用于治疗支架内再狭窄而不添加另一金属层。代理ISR随机试验的目的是评估先前治疗的病变的ISR患者的血管造影和临床结果,这些患者使用新的涂层制剂 (药剂) 或标准DCB (请随后) 治疗DCB。 方法和结果: AGENT ISR是一项多中心、随机、开放标签、非劣效性研究,比较了Agent和SeQuent Please DCB。共有125名患者 (平均年龄 ~ 68岁,18% 为女性) 在欧洲11个地点接受治疗,既往治疗的病变长度 <28毫米cm,支架内再狭窄患者被随机分组,接受药物治疗 (n = 65) 或后续治疗 (n = 60)。主要终点,6个月支架内晚期管腔丢失,在药剂组 (0.397 ± 0.43毫米 [n = 51]) 不劣于后续请组 (0.393 ± 0.536毫米 [n = 49]),由于组间差异的双侧上95% 置信边界小于预先规定的非劣效性界值0.20 (差异0.004,95% CI [-0.189,0.196]; 非劣效性 = 0.046)。1年时,Agent的死亡率为3.1%,SeQuent Please患者的死亡率为1.7% (p>0.99),靶病变血管重建为7.7% 对10.0% (p = 0.89),支架内血栓形成为0% 对3.3% (p = 0.44)。在两组中观察到类似的生活质量改善。 结论: 在两种DCB的头对头比较中,对于6个月的支架内晚期管腔丢失,证明药剂不劣于SeQuent Please。 临床试验注册: NCT02151812 (http://clinicaltrials.gov/)。

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影响因子:2.41
发表时间:2020-06-12
DOI:10.4244/EIJ-D-18-01138
作者列表:["Pellicano M","Di Gioia G","Ciccarelli G","Xaplanteris P","Delrue L","Toth GG","Van Durme F","Heyse A","Wyffels E","Vanderheyden M","Bartunek J","De Bruyne B","Barbato E"]

METHODS:AIMS:Significant platelet activation after long stented coronary segments has been associated with periprocedural microvascular impairment and myonecrosis. In long lesions treated either with an everolimus-eluting bioresorbable vascular scaffold (BVS) or an everolimus-eluting stent (EES), we aimed to investigate (a) procedure-related microvascular impairment, and (b) the relationship of platelet activation with microvascular function and related myonecrosis. METHODS AND RESULTS:Patients (n=66) undergoing elective percutaneous coronary intervention (PCI) in long lesions were randomised 1:1 to either BVS or EES. The primary endpoint was the difference between groups in changes of pressure-derived corrected index of microvascular resistance (cIMR) after PCI. Periprocedural myonecrosis was assessed by high-sensitivity cardiac troponin T (hs-cTnT), platelet reactivity by high-sensitivity adenosine diphosphate (hs-ADP)-induced platelet reactivity with the Multiplate Analyzer. Post-dilatation was more frequent in the BVS group, with consequent longer procedure time. A significant difference was observed between the two groups in the primary endpoint of ΔcIMR (p=0.04). hs-ADP was not different between the groups at different time points. hs-cTnT significantly increased after PCI, without difference between the groups. CONCLUSIONS:In long lesions, BVS implantation is associated with significant acute reduction in IMR as compared with EES, with no significant interaction with platelet reactivity or periprocedural myonecrosis.

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影响因子:1.67
发表时间:2020-01-01
DOI:10.2174/1573403X15666190513105231
作者列表:["Dev M","Sharma M","Rana N"]

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心脏影像技术方向

心脏结构和心脏血流的可视化,用于诊断评估或通过内窥镜、放射性核素成像等技术来指导心脏手术。

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