Randomized trials of directional coronary atherectomy: implications for clinical practice and future investigation.
OBJECTIVES: This study compared and contrasted the randomized trials of directional atherectomy and coronary angioplasty for de novo native coronary artery lesions. BACKGROUND: The results of two randomized trials, the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT) and the Canadian Coronary Atherectomy Trial (CCAT), comparing initial and intermediate-term outcome of directional coronary atherectomy and conventional coronary angioplasty in de novo native vessels, have been reported. In CAVEAT any coronary artery segment that could be treated by either technique was included; in CCAT only nonostial proximal left anterior descending coronary artery stenoses were studied. METHODS: The primary end point was 6-month angiographic restenosis. Clinical outcome end points at 6 months included death, myocardial infarction, emergency bypass surgery and abrupt closure. RESULTS: Initial angiographic success rates were significantly improved with directional coronary atherectomy compared with conventional angioplasty (89% vs. 80% for CAVEAT; 98% vs. 91% for CCAT). Also, the initial improvement in minimal lumen diameter and final immediate postprocedural residual diameter stenosis were better with atherectomy. In CCAT, there was no difference in initial complications; in CAVEAT, non-Q wave myocardial infarction rates and abrupt closure were increased with atherectomy. Despite improved success rates and better lumen achieved with atherectomy, in CCAT there was no difference in angiographic restenosis (46% for directional atherectomy vs. 43% for angioplasty). In CAVEAT, in a prespecified subset analysis involving the proximal left anterior descending coronary artery, restenosis was both significantly and clinically less for directional atherectomy (51% vs. 63%). For non-left anterior descending coronary artery segments, there was no difference. CONCLUSIONS: These studies document the difference between achievement of an excellent initial angiographic result and the longer term issue of clinical restenosis. Widespread use of directional coronary atherectomy to treat lesions that would be well treated by angioplasty in an attempt to decrease restenosis rates substantially does not appear indicated by the data. In individual lesions, directional atherectomy should be selected with the view toward optimizing initial results. Further trials are needed to determine whether more aggressive or better targeted directional coronary atherectomy may improve not only the initial gain but the long-term outcome as well.
Holmes, DR; Topol, EJ; Adelman, AG; Cohen, EA; Califf, RM
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