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Original Article
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Volume 339:1665-1671 December 3, 1998 Number 23
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A Clinical Trial Comparing Three Antithrombotic-Drug Regimens after Coronary-Artery Stenting
Martin B. Leon, M.D., Donald S. Baim, M.D., Jeffrey J. Popma, M.D., Paul C. Gordon, M.D., Donald E. Cutlip, M.D., Kalon K.L. Ho, M.D., Alex Giambartolomei, M.D., Daniel J. Diver, M.D., David M. Lasorda, D.O., David O. Williams, M.D., Stuart J. Pocock, Ph.D., Richard E. Kuntz, M.D., for The Stent Anticoagulation Restenosis Study Investigators

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ABSTRACT

Background Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens — aspirin alone, aspirin and warfarin, and aspirin and ticlopidine — after coronary stenting.

Methods Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days.

Results The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.02). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups.

Conclusions As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.


Source Information

From Washington Hospital Center, Washington, D.C. (M.B.L., J.J.P.); Beth Israel Deaconess Medical Center, Boston (D.S.B., D.E.C., K.K.L.H., R.E.K.); Miriam Hospital, Providence, R.I. (P.C.G.); St. Joseph's Hospital, Syracuse, N.Y. (A.G.); Georgetown Medical Center, Washington, D.C. (D.J.D.); Allegheny General Hospital, Pittsburgh (D.M.L.); Rhode Island Hospital, Providence (D.O.W.); and London School of Hygiene and Tropical Medicine, London (S.J.P.).

Address reprint requests to Dr. Leon at Cardiovascular Research and Education, Cardiology Research Foundation at the Washington Hospital Center, 110 Irving St. NW, Suite 4B-1, Washington, DC 20010.

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Related Letters:

Antithrombotic Therapy after Coronary-Artery Stenting
Ferrer F., Moraleda J. M., Vicente V., LoGerfo F. W., Wohl V. R., Hecht E., Shaughnessy K., Leon M. B., Dangas G., Erbel R., Haude M., The Restenosis Stent Study Group , Topol E. J.
Extract | Full Text  
N Engl J Med 1999; 340:1365-1368, Apr 29, 1999. Correspondence

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