A Comparison of Directional Atherectomy with Coronary Angioplasty in Patients with Coronary Artery Disease
Eric J. Topol, Ferdinand Leya, Cass A. Pinkerton, Patrick L. Whitlow, Berthold Hofling, Charles A. Simonton, Ronald R. Masden, Patrick W. Serruys, Martin B. Leon, David O. Williams, Spencer B. King, Daniel B. Mark, Jeffrey M. Isner, David R. Holmes, Stephen G. Ellis, Kerry L. Lee, Gordon P. Keeler, Lisa G. Berdan, Tomoaki Hinohara, Robert M. Califf, for The CAVEAT Study Group
Background Directional coronary atherectomy is a new techniqueof coronary revascularization by which atherosclerotic plaqueis excised and retrieved from target lesions. With respect tothe rate of restenosis and clinical outcomes, it is not knownhow this procedure compares with balloon angioplasty, whichrelies on dilation of the plaque and vessel wall. We comparedthe rate of restenosis after angioplasty with that after atherectomy.
Methods At 35 sites in the United States and Europe, 1012 patientswere randomly assigned to either atherectomy (512 patients)or angioplasty (500 patients). The patients underwent coronaryangiography at base line and again after six months; the pairedangiograms were quantitatively assessed at one laboratory byinvestigators unaware of the treatment assignments.
Results Stenosis was reduced to 50 percent or less more oftenwith atherectomy than with angioplasty (89 percent vs. 80 percent,P<0.001), and there was a greater immediate increase in vesselcaliber (1.05 vs. 0.86 mm, P<0.001). This was accompaniedby 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 percentfor atherectomy and 57 percent for angioplasty (P = 0.06). However,the probability of death or myocardial infarction within sixmonths was higher in the atherectomy group (8.6 percent vs.4.6 percent, P = 0.007).
Conclusions Removing coronary artery plaque with atherectomyled to a larger luminal diameter and a small reduction in angiographicrestenosis, the latter being confined largely to the proximalleft anterior descending coronary artery. However, atherectomyled to a higher rate of early complications, increased cost,and no apparent clinical benefit after six months of follow-up.
Source Information
From the Cleveland Clinic Foundation, Cleveland (E.J.T., P.L.W., S.G.E.); Loyola Medical Center, Chicago (F.L.); St. Vincent's Hospital, Indianapolis (C.A.P.); Klinikum Grosshadern der Universitat, Munich, Germany (B.H.); Carolina's Medical Center, Charlotte, N.(C.A.S.); Jewish Hospital, Louisville, Ky. (R.R.M.); Erasmus University, Rotterdam, the Netherlands (P.W.S.); Washington Cardiology Center, Washington, D.(M.B.L.); Rhode Island Hospital, Providence (D.O.W.); Emory University Hospital, Atlanta (S.B.K.); Duke University Medical Center, Durham, N.(D.B.M., K.L.L., G.P.K., L.G.B., R.M.C.); St. Elizabeth's Hospital, Boston (J.M.I.); Mayo Foundation, Rochester, Minn. (D.R.H.); and Sequoia Hospital, Redwood City, Calif. (T.H.). The remaining Coronary Angioplasty versus Excisional Atherectomy Trial (CAVEAT) investigators and study groups are listed in the Appendix.
Address reprint requests to Dr. Topol at the Department of Cardiology, Cleveland Clinic Foundation, Desk F25, 9500 Euclid Ave., Cleveland, OH 44195.
Clinical Problem-Solving: Invasive Interventions
Kern M. J., Bach R. G., Kallfelz M. L. d. A., Degrazia R. C., Rashdan I., Tolchin D., Anía B. J., Cárdenes M. A., Pauker S. G., Kopelman R. I.
Extract |
Full Text
N Engl J Med 1995;
332:125-127, Jan 12, 1995.
Correspondence
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