Wilson Samuel E
Department of Surgery, University of California, Irvine, CA, and Surgical Service, VA Medical Center, Long Beach, CA 92868, USA.
Ann Vasc Surg. 2010 May;24(4):498-502. doi: 10.1016/j.avsg.2009.08.013. Epub 2009 Dec 29.
The prevalence of occlusive peripheral vascular disease in the superficial femoral artery approaches 20% in patients over the age of 60. Symptomatic peripheral arterial disease (intermittent claudication) is present in 3% to 7% of patients over the age of 60. The attraction of minimally invasive, percutaneous endovascular angioplasty (PTA) for this large number of patients has resulted in multiple trials of new PTA +/- stenting devices. The purpose of this report is to determine whether trials should include controlled patients who have optimal medical management including supervised exercise.
In 2007 through 2008, there were 12 active trials of PTA and stent with 9 of the trials randomized and 6 trials using PTA as the control arm. No trial used a medically managed group. Between 1990 and 2008, a search of PubMed disclosed six publications (five randomized trials) comparing PTA +/- stent with medically (exercise) managed claudicants. None of the medically managed patient groups experienced a significant increase in ABI, whereas endovascular patients had an early increase in ABI, which was variably sustained to 1 and 2 years. However, after 6 months, the maximum walking distance was significantly increased in the exercised patients and remained longer than that of the interventional group in four of five trials at 1 to 2 years.
Endovascular treatment was superior to medical treatment in functional outcome at 1 year in only one of the five randomized trials for claudication. In the other four trials, medical treatment produced a greater maximum walking distance at 1 to 2 years. Current trials lack optimal medical controls. New trials of PTA + stent should include a medically managed group of patients in a supervised exercise program as the comparator arm. The outcome measure should be maximum walking distance to demonstrate added functional benefit of the new device.
在60岁以上的患者中，股浅动脉闭塞性外周血管疾病的患病率接近20%。60岁以上的患者中有3%至7%存在有症状的外周动脉疾病（间歇性跛行）。对于大量此类患者而言，微创经皮血管腔内血管成形术（PTA）颇具吸引力，这引发了多项针对新型PTA及/或支架装置的试验。本报告的目的是确定试验是否应纳入接受包括监督下运动在内的最佳药物治疗的对照患者。
2007年至2008年期间，有12项关于PTA和支架的现行试验，其中9项试验为随机试验，6项试验将PTA用作对照臂。没有试验使用药物治疗组。1990年至2008年期间，在PubMed上进行检索，发现了6篇出版物（5项随机试验），比较了PTA及/或支架与接受药物（运动）治疗的跛行患者。接受药物治疗的患者组中，无一例患者的踝臂指数（ABI）出现显著增加，而血管腔内治疗的患者ABI早期有所增加，这种增加在1年和2年时有所不同程度的持续。然而，6个月后，运动患者的最大步行距离显著增加，在1至2年时，五项试验中的四项试验中，运动患者的最大步行距离仍长于介入治疗组。
在五项关于间歇性跛行的随机试验中，只有一项试验显示血管腔内治疗在1年时的功能结局优于药物治疗。在其他四项试验中，药物治疗在1至2年时产生了更长的最大步行距离。当前的试验缺乏最佳药物对照。新的PTA+支架试验应纳入一组接受监督运动计划的药物治疗患者作为对照臂。结局指标应是最大步行距离，以证明新装置的额外功能益处。
