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
Background Antithrombotic drugs are used after coronary-arterystenting to prevent stent thrombosis. We compared the efficacyand safety of three antithrombotic-drug regimens — aspirinalone, aspirin and warfarin, and aspirin and ticlopidine —after coronary stenting.
Methods Of 1965 patients who underwent coronary stenting at50 centers, 1653 (84.1 percent) met angiographic criteria forsuccessful placement of the stent and were randomly assignedto one of three regimens: aspirin alone (557 patients), aspirinand warfarin (550 patients), or aspirin and ticlopidine (546patients). All clinical events reflecting stent thrombosis wereincluded in the prespecified primary end point: death, revascularizationof the target lesion, angiographically evident thrombosis, ormyocardial 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 thecomparison of all three groups). Hemorrhagic complications occurredin 10 patients (1.8 percent) who received aspirin alone, 34(6.2 percent) who received aspirin and warfarin, and 30 (5.5percent) who received aspirin and ticlopidine (P<0.001 forthe comparison of all three groups); the incidence of vascularsurgical 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 neutropeniaor thrombocytopenia (overall incidence, 0.3 percent) among thethree treatment groups.
Conclusions As compared with aspirin alone and a combinationof aspirin and warfarin, treatment with aspirin and ticlopidineresulted in a lower rate of stent thrombosis, although therewere more hemorrhagic complications than with aspirin alone.After coronary stenting, aspirin and ticlopidine should be consideredfor 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.
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.
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N Engl J Med 1999;
340:1365-1368, Apr 29, 1999.
Correspondence
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