Abstract

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 balloon 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% or less more often with atherectomy than with angioplasty (89% vs. 80%, 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% vs. 5%, 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% for atherectomy and 57% for angioplasty ( p 0.06). However, the probability of death or myocardial infarction within six months was higher in the atherectomy group (8.6% vs. 4.6%, p 0.007). CONCLUSIONS: Removing coronary artery plaque with atherectomy led to a larger luminal diameter and a small reduction in angiographic restenosis, though the latter was not statistically significant. However, atherectomy led to a higher rate of early complications, increased cost, and no apparent clinical benefit after six months of follow-up.

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