From the Beth Israel Deaconess Medical Center (D.S.B., D.E.C., K.K.L.H.,
C.S., Y.Z., R.E.K.), Boston, Mass; Mt. Sinai Hospital (S.K.S.), New York, NY;
Scripps Memorial Hospital (R.F.), La Jolla, Calif; St. Johns Hospital
(T.L.S.), Warren, Mich; Munroe Regional Medical Center (R.L.F.), Ocala, Fla;
Maimonides Medical Center (J.S.), Brooklyn, NY; and the Washington Hospital
Center (A.J.L., J.J.P.), Washington, DC.
Background—Previous directional
coronary atherectomy (DCA) trials have shown no significant
reduction in angiographic restenosis, more in-hospital
complications, and higher 1-year mortality than conventional balloon
angioplasty (percutaneous transluminal coronary
angioplasty [PTCA]). DCA, however, has subsequently evolved toward a
more "optimal" technique (larger devices, more extensive tissue
removal, and routine postdilation to obtain diameter stenosis
<20%).
Methods and Results—The Balloon vs Optimal Atherectomy Trial
(BOAT) was conducted to evaluate whether optimal DCA provides short-
and long-term benefits compared with balloon angioplasty. One thousand
patients with single de novo, native vessel lesions were randomized to
either DCA or PTCA at 37 participating centers. Lesion success was
obtained in 99% versus 97% (P=.02) of patients to a
final residual diameter stenosis of 15% versus 28%
(P<.0001) for DCA and PTCA, respectively, the latter
including stents in 9.3% of the patients. There was no increase in
major complications (death, Q-wave myocardial infarction, or emergent
coronary artery bypass graft surgery [2.8% versus 3.3%]),
although creatine kinase–MB >3x normal was more common with DCA
(16% versus 6%; P<.0001). Angiographic restudy (in
79.6% of eligible patients at 7.2±2.6 [median, 6.9] months) showed
a significant reduction in the prespecified primary end point of
angiographic restenosis by DCA (31.4% versus 39.8%;
P=.016). Clinical follow-up to 1 year showed
nonsignificant 13% to 17% reductions in the DCA arm of the study for
mortality rate (0.6% versus 1.6%; P=.14),
target-vessel revascularization (17.1% versus
19.7%; P=.33), target-site
revascularization (15.3% versus 18.3%;
P=.23), and target-vessel failure (death, Q-wave
myocardial infarction, or target-vessel
revascularization, 21.1% versus 24.8%;
P=.17).
Conclusions—Optimal DCA provides significantly higher short-term
success, lower residual stenosis, and lower angiographic
restenosis than conventional PTCA, despite failing to reach
statistical significance for reducing late clinical events compared
with PTCA with stent backup.
© 1998 American Heart Association, Inc.
Clinical Investigation and Reports
Final Results of the Balloon vs Optimal Atherectomy Trial (BOAT)
Key Words: angioplasty • atherectomy • restenosis • coronary intervention • trials
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