Topol E J, Leya F, Pinkerton C A, Whitlow P L, Hofling B, Simonton C A, Masden R R, Serruys P W, Leon M B, Williams D O
Cleveland Clinic Foundation, Department of Cardiology, OH 44195.
N Engl J Med. 1993 Jul 22;329(4):221-7. doi: 10.1056/NEJM199307223290401.
Directional coronary atherectomy is a new technique of coronary revascularization by which atherosclerotic plaque is excised and retrieved from target lesions. With respect to the rate of restenosis and clinical outcomes, it is not known how this procedure compares with balloon angioplasty, which relies on dilation of the plaque and vessel wall. We compared the rate of restenosis after angioplasty with that after atherectomy.
At 35 sites in the United States and Europe, 1012 patients were randomly assigned to either atherectomy (512 patients) or angioplasty (500 patients). The patients underwent coronary angiography at base line and again after six months; the paired angiograms were quantitatively assessed at one laboratory by investigators unaware of the treatment assignments.
Stenosis was reduced to 50 percent or less more often with atherectomy than with angioplasty (89 percent vs. 80 percent; P < 0.001), and there was a greater immediate increase in vessel caliber (1.05 vs. 0.86 mm, P < 0.001). This was accompanied by a higher rate of early complications (11 percent vs. 5 percent, P < 0.001) and higher in-hospital costs ($11,904 vs $10,637; P = 0.006). At six months, the rate of restenosis was 50 percent for atherectomy and 57 percent for angioplasty (P = 0.06). However, the probability of death or myocardial infarction within six months was higher in the atherectomy group (8.6 percent vs. 4.6 percent, P = 0.007).
Removing coronary artery plaque with atherectomy led to a larger luminal diameter and a small reduction in angiographic restenosis, the latter being confined largely to the proximal left anterior descending coronary artery. However, atherectomy led to a higher rate of early complications, increased cost, and no apparent clinical benefit after six months of follow-up.
定向冠状动脉斑块旋切术是一种冠状动脉血运重建新技术，通过该技术可从靶病变处切除并取出动脉粥样硬化斑块。关于再狭窄率和临床结局，目前尚不清楚该手术与依赖斑块和血管壁扩张的球囊血管成形术相比效果如何。我们比较了血管成形术后和斑块旋切术后的再狭窄率。
在美国和欧洲的35个地点，1012例患者被随机分为斑块旋切术组（512例患者）和血管成形术组（500例患者）。患者在基线时接受冠状动脉造影，并在6个月后再次接受造影；成对的血管造影照片由不了解治疗分配情况的研究人员在一个实验室进行定量评估。
与血管成形术相比，斑块旋切术更常使狭窄程度降至50%或更低（89%对80%；P<0.001），并且血管直径的即刻增加更大（1.05对0.86mm，P<0.001）。这伴随着更高的早期并发症发生率（11%对5%，P<0.001）和更高的住院费用（11,904美元对10,637美元；P = 0.006）。在6个月时，斑块旋切术组的再狭窄率为50%，血管成形术组为57%（P = 0.06）。然而，斑块旋切术组在6个月内死亡或心肌梗死的概率更高（8.6%对4.6%，P = 0.007）。
用斑块旋切术去除冠状动脉斑块可导致更大的管腔直径，并使血管造影再狭窄略有降低，后者主要局限于左冠状动脉前降支近端。然而，斑块旋切术导致更高的早期并发症发生率、费用增加，并且在随访6个月后没有明显的临床益处。
