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(Circulation. 2000;101:1512.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
From Rotterdam, The Netherlands (P.W.S., D.P.F.); Münich, Germany (B.H.); Toulouse, France (J.P.); Vienna, Austria (H.D.G.); Kiel, Germany (R.S.); Linda-a-Velha, Portugal (R.S.-G.); Madrid, Spain (J.G.); Bordeaux, France (P.C.); Berlin, Germany (W.R.); Heidelberg, Germany (H.K.); Eindhoven, The Netherlands (H.B.); Aalst, Belgium (W.W.); Barcelona, Spain (A.B.); Boehringher Mannheim, Germany (U.H.-Z.); Cardialysis, Rotterdam, The Netherlands (E.M.v.S., R.M.).
Correspondence to Prof P.W. Serruys, MD, PhD, Thoraxcenter Bd418, Academic Hospital Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail serruys{at}card.azr.nl
BackgroundIn addition to its
known properties as a competitive, nonselective ß and
-1 receptor
blocker, carvedilol directly inhibits vascular myocyte migration and
proliferation and exerts antioxidant effects that are considerably
greater than those of vitamin E or probucol. This provides the basis
for an evaluation of carvedilol for the prevention of coronary
restenosis.
Methods and ResultsIn a prospective, double-blind, randomized,
placebo-controlled trial, 25 mg of carvedilol was given twice daily,
starting 24 hours before scheduled directional coronary
atherectomy and continuing for 5 months after a successful procedure.
The primary end point was the minimal luminal diameter as determined
during follow-up angiography 26±2 weeks after the procedure. Of 406
randomized patients, 377 underwent attempted atherectomy, and in 324
(88.9%), a
50% diameter stenosis was achieved without the
use of a stent. Evaluable follow-up angiography was available in 292
eligible patients (90%). No differences in minimal luminal diameter
(1.99±0.73 mm versus 2.00±0.74 mm), angiographic
restenosis rate (23.4% versus 23.9%), target lesion
revascularization (16.2 versus 14.5), or
event-free survival (79.2% versus 79.7%) between the placebo and
carvedilol groups were observed at 7 months.
ConclusionsThe maximum recommended daily dose of the antioxidant and ß-blocker carvedilol failed to reduce restenosis after successful atherectomy. These findings are in contrast to those of the Multivitamins and Probucol Trial, which raises doubts regarding the validity of the interpretation that restenosis reduction by probucol was via antioxidant effects. The relationship between antioxidant agents and restenosis remains to be elucidated.
Key Words: restenosis prevention atherectomy carvedilol angiography ß-blocker antioxidants
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