Drug-Coated Balloons for the Prevention of Vascular Restenosis
Drug-Coated Balloons for the Prevention of Vascular Restenosis
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DOI：
10.1161/circulationaha.110.936922
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发表时间：
2010-06-22
期刊：
影响因子：
37.8
通讯作者：
Granada, Juan F.
中科院分区：
文献类型：
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作者：
Gray, William A.;Granada, Juan F.
在早期经皮心血管介入治疗的历史中，再狭窄一直是衡量成功与否的最重要的临床和生物学指标之一，人们已经投入了大量的努力来了解其机制。1,2再狭窄是球囊损伤后立即开始的多种机械和生物过程相互作用的结果，包括早期血管反冲，3,4负性血管重塑，5和过度的内膜增殖。5-7球囊血管成形术最重要的局限性是由于弹性反冲和闭塞性斑块剥离导致的血管突然关闭，球囊可膨胀支架的引入有效地解决了这一问题。8然而，支架内再狭窄（ISR），由于初始损伤和血管对植入金属假体的反应导致过度的内膜增殖，仍然是这些装置失败的最重要原因。9,10药物洗脱支架（DES）通过解决新内膜增殖的生物学机制，有效降低了ISR，已成为冠状动脉粥样硬化疾病介入治疗的主要手段。11然而，DES已证实的疗效与非常晚期支架血栓形成的小但不可预测的风险相平衡，这被认为是由于最初的抗增殖作用（以及相关的晚期获得性不完全支架贴置）或对药物、聚合物涂层或其组合的超敏反应导致的血管愈合延迟。12,13此外，除了冠状血管之外，目前还缺乏有效的治疗方法来处理干预后的再狭窄。近年来，药物包被气球（DCBs）已成为介入治疗领域的一种替代方案。使用该技术，无需植入药物输送系统即可将抗增殖药物短期转移到动脉壁，从而潜在地减少了聚合物支架技术相关的不良影响。在小型临床随机试验中，紫杉醇包被球囊在减少冠状动脉ISR15和新发股腘动脉病变患者的再狭窄方面被证明是安全有效的。在这篇综述中，我们讨论了DCB技术的基本原理、药代动力学特征以及目前可用的临床前和临床数据。
From early in the history of percutaneous cardiovascular intervention, restenosis has been one of the most important clinical and biological measures of success, and a great deal of effort has been put into understanding the mechanisms responsible. 1, 2 Restenosis is the result of the interaction of a variety of mechanical and biological processes that begin immediately after balloon injury, including early vessel recoil, 3, 4 negative vascular remodeling, 5 and excessive neointimal proliferation. 5–7 The most important limitations of balloon angioplasty, abrupt vessel closure resulting from elastic recoil and occlusive plaque dissection, were effectively solved by the introduction of balloon-expandable stents. 8 However, in-stent restenosis (ISR), the result of the initial injury and the vascular response to the implanted metallic prosthesis leading to excessive neointimal proliferation, remained as the most important cause of failure of these devices. 9, 10 Drug-eluting stents (DES) effectively reduced ISR by addressing the biological mechanisms of neointimal proliferation and have become the mainstay of the interventional treatment of coronary atherosclerotic disease. 11 However, the demonstrated efficacy of DES is balanced by the small but unpredictable risk of very late stent thrombosis thought to be due to delayed vascular healing resulting from either the initial antiproliferative effect (and associated late acquired incomplete stent apposition) or a hypersensitivity reaction to the drug, polymer coating, or their combination. 12, 13 Moreover, beyond the coronary vasculature, there has been a paucity of effective therapies to manage restenosis after intervention.In recent years, drug-coated balloons (DCBs) have emerged as a therapeutic alternative in the interventional field. 14 With this technology, short-term transfer of antiproliferative drugs to the arterial wall is achieved without the requirement of an implanted drug delivery system, thus potentially reducing the untoward effects associated with polymer-based stent technologies. In small clinical randomized trials, paclitaxel-coated balloons have been shown to be safe and effective in reducing restenosis among patients with coronary ISR15 and de novo femoropopliteal lesions. 16 In this review, we discuss the basic principles of the DCB technology, pharmacokinetic profiles, and current preclinical and clinical data available today.