Walker Joy P, Owens Christopher D
Division of Vascular and Endovascular Surgery, University of California, San Francisco, 400 Parnassus Ave. A581, San Francisco, CA 94143, USA.
Curr Surg Rep. 2013 Jun 1;1(2):90-97. doi: 10.1007/s40137-013-0018-x.
The endovascular management of symptomatic atherosclerotic superficial femoral artery disease is challenging and requires consideration of unique anatomic, hemodynamic, and biomechanical factors. For innovative local drug delivery technologies to have a cost-effective and clinically meaningful benefit, they must provide patency rates in more complex lesions equivalent or superior to those currently approved devices are able to provide. Several proof-of-concept trials have either been published or been recently presented and many more are in the pipeline suggesting biologic effectiveness of these hybrid devices in reducing restenosis. Local drug delivery technology has already been commercially introduced in some countries for a variety of clinical settings. However, although these technologies offer promise in improving outcomes following lower extremity intervention, caution and safety are paramount. Adequately powered, multicenter, well-designed, randomized controlled trials with long-term follow-up (3-5 years) are still needed to accurately assess safety and efficacy.
有症状的动脉粥样硬化性股浅动脉疾病的血管内治疗具有挑战性，需要考虑独特的解剖、血流动力学和生物力学因素。对于创新的局部药物递送技术而言，若要具有成本效益且在临床上产生有意义的益处，它们必须在更复杂的病变中提供与目前已获批器械相当或更优的通畅率。几项概念验证试验已经发表或近期公布，还有更多试验正在筹备中，这表明这些混合器械在减少再狭窄方面具有生物学有效性。局部药物递送技术已在一些国家针对各种临床情况进行了商业推广。然而，尽管这些技术有望改善下肢介入治疗后的疗效，但谨慎和安全至关重要。仍需要开展有充足样本量、多中心、设计良好且具有长期随访（3至5年）的随机对照试验，以准确评估安全性和有效性。
