A Comparison of Directional Atherectomy with Coronary Angioplasty in Patients with Coronary Artery Disease

Background: 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. Methods: 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. Results: 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). Conclusions: 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., Directional coronary atherectomy was developed by Simpson in 1984, and unlike balloon angioplasty, it allows the resection of coronary atherosclerotic plaque. From October 1986 through December 1989, 1020 procedures were performed at 14 investigational sites in the United States, with a success rate of 85 percent¹. As a result, in September 1990 atherectomy was approved by the Food and Drug Administration for coronary revascularization. The procedure has since become widely used in the United States. In 1991, approximately 17,000 coronary-atherectomy procedures were performed, and it is estimated that in 1992 nearly 33,000 procedures were done, accounting for 10 percent…