JACC:治疗股腘动脉疾病——药物涂层球囊(DCBs)长期效果(24个月)较好

2015-10-28 崔倩 译 MedSci原创

大型,随机,对照外周动脉疾病的临床试验报告显示,使用药物涂层球囊(DCBs)的长期结果是有限的。此前,与传统的经皮腔内血管成形术(PTA)相比,DCB显示出良好的1年结果,但DCBs治疗效果的持久性仍是未知的。本研究旨在探讨治疗股腘动脉病变,紫杉醇洗脱DCB与PTA相比的长期效果。研究人员招募了331患者的症状性(Rutherford2至4)股腘动脉病变,长度高达18厘米。患者被随机以2:1的比例

大型、随机,对照外周动脉疾病的临床试验报告显示,使用药物涂层球囊(DCBs)的长期结果是有限的。此前,与传统的经皮腔内血管成形术(PTA)相比,DCB显示出良好的1年结果,但DCBs治疗效果的持久性仍是未知的。

本研究旨在探讨治疗股腘动脉病变,紫杉醇洗脱DCB与PTA相比的长期效果。

研究人员招募了331患者的症状性(Rutherford 2至4)股腘动脉病变,长度高达18厘米。患者被随机以2:1的比例分配接受DCB或PTA治疗。24个月的评估包括初级通畅,没有临床驱动的靶病变血运重建(CD-TLR)、主要不良事件、生活质量和功能结果、由生活质量的EuroQOL-5D问卷调查评估、行走障碍问卷、6分钟步行试验。

在24个月时,DCB治疗的患者表现出显著高于PTA的通畅性(78.9% vs 50.1%,P<0.001)。DCB和PTA组的CD-TLR率分别为9.1%和28.3%(P<0.001)。DCB组总的死亡率为8.1%,PTA组为0.9%(p=0.008)。经过24个月的随访,任一组都没有设备相关或手术相关的死亡货重大截肢事件。血管栓塞的发生率较低(1.5%DCB vs 3.8%PTA,P=0.243),在1至2年报告中没有新的事件发生。尽管DCB患者达到了这一功能水平,58%的患者需要较少的再次手术,但在2年时这两个群体表现出类似的功能改善。

该试验24个月的结果表明,相比于PTA,DCB有较大的治疗效果的改善,降低了CD-TLR的发生,持久和优异的治疗效果与显著高效通畅,二者有类似的功能状态改善,并且有较少的重复的手术发生。

原始出处:

John R. Laird,Peter A. Schneider,Gunnar Tepe,et al.Sustained Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions,JACC,2015.10.14

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    2016-03-21 quxin068
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    2016-10-11 hbwxf
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    2015-10-30 花花1366
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    2015-10-28 风中云追忆

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