From the Carolinas Heart Institute, Charlotte, NC (C.A.S., R.M.B.,
B.H.W.); Washington Hospital Center, Washington, DC (M.B.L., K.M.K., G.S.M.,
J.J.P.); Beth Israel Deaconess Medical Center, Boston, Mass (D.S.B., K.K.L.H.,
D.E.C., C.S., R.E.K.); Sequoia Hospital, Redwood City, Calif (T.H.); and
Stanford Medical Center, Palo Alto, Calif (P.J.F., P.G.Y.).
Background—Previous clinical trials
of directional coronary atherectomy (DCA) have failed to show
significant improvement in early or late outcomes compared with balloon
angioplasty (PTCA). The present study tested the hypothesis that
more aggressive "optimal" atherectomy could be performed safely to
produce larger initial lumen diameters and a lower late restenosis
rate.
Methods and Results—The present study was a prospective
multicenter registry of consecutive patients undergoing optimal DCA of
de novo or restenotic lesions in 3.0- to 4.5-mm native
coronary arteries. Optimal DCA was defined as using a 7F
atherectomy device and adjunctive PTCA if necessary to achieve a <15%
residual stenosis. Six-month angiographic and 1-year clinical
follow-up was planned in all patients. A total of 199 patients with 213
lesions met eligibility criteria for enrollment. Short-term procedural
success was achieved in 97.5%, with a major complication rate (death,
emergency bypass surgery, or Q-wave myocardial infarction [MI]) of
2.5%. There were no early deaths. Non–Q-wave MI (CK-MB >3 times
normal) occurred in 14% of patients. Mean reference vessel diameter
was 3.28 mm. Mean diameter stenosis was reduced from
63.5% to a final stenosis of 7%. Late 1-year clinical
follow-up revealed one cardiac death and a target lesion
revascularization rate of 17.8%. The angiographic
restenosis rate at 6 months was 28.9%, with the major
predictor of restenosis being a smaller postprocedure lumen
diameter.
Conclusions—Optimal DCA produced a low residual percent diameter
stenosis and a lower restenosis rate than seen in
previous trials without an increase in early or late major adverse
events.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
`Optimal' Directional Coronary Atherectomy
Final Results of the Optimal Atherectomy Restenosis Study (OARS)
Key Words: atherectomy • restenosis • angioplasty
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