A Randomized Comparison of Antiplatelet and Anticoagulant Therapy after the Placement of Coronary-Artery Stents
Albert Schömig, M.D., Franz-Josef Neumann, M.D., Adnan Kastrati, M.D., Helmut Schühlen, M.D., Rudolf Blasini, M.D., Martin Hadamitzky, M.D., Hanna Walter, M.D., Eva-Maria Zitzmann-Roth, M.D., Gert Richardt, M.D., Eckhard Alt, M.D., Claus Schmitt, M.D., and Kurt Ulm, Ph.D.
Background The clinical benefit of coronary-artery stentingperformed in conjunction with coronary angioplasty is limitedby the risk of thrombotic occlusion of the stent as well ashemorrhagic and vascular complications of intensive anticoagulation.We compared antiplatelet therapy with conventional anticoagulanttherapy with respect to clinical outcomes 30 days after coronary-arterystenting.
Methods After successful placement of PalmazSchatz coronary-arterystents, 257 patients were randomly assigned to receive antiplatelettherapy (ticlopidine plus aspirin) and 260 to receive anticoagulanttherapy (intravenous heparin, phenprocoumon, and aspirin). Theprimary cardiac end point was a composite measure reflectingdeath from cardiac causes or the occurrence of myocardial infarction,aortocoronary bypass surgery, or repeated angioplasty. The primarynoncardiac end point comprised death from noncardiac causes,cerebrovascular accident, severe hemorrhage, and peripheralvascular events.
Results Of the patients assigned to antiplatelet therapy, 1.6percent reached a primary cardiac end point, as did 6.2 percentof those assigned to anticoagulant therapy (relative risk, 0.25;95 percent confidence interval, 0.06 to 0.77). With antiplatelettherapy, there was an 82 percent lower risk of myocardial infarctionthan in the anticoagulant-therapy group, and a 78 percent lowerneed for repeated interventions. Occlusion of the stented vesseloccurred in 0.8 percent of the antiplatelet-therapy group andin 5.4 percent of the anticoagulant-therapy group (relativerisk, 0.14; 95 percent confidence interval, 0.02 to 0.62). Aprimary noncardiac end point was reached by 1.2 percent of theantiplatelet-therapy group and 12.3 percent of the anticoagulant-therapygroup (relative risk, 0.09; 95 percent confidence interval,0.02 to 0.31). Hemorrhagic complications occurred only in theanticoagulant-therapy group (in 6.5 percent). An 87 percentreduction in the risk of peripheral vascular events was observedwith antiplatelet therapy.
Conclusions As compared with conventional anticoagulant therapy,combined antiplatelet therapy after the placement of coronary-arterystents reduces the incidence of both cardiac events and hemorrhagicand vascular complications.
Source Information
From the 1. Medizinische Klinik (A.S., F.-J.N., A.K., H.S., R.B., M.H., H.W., E.-M.Z.-R., G.R., E.A., C.S.), and the Institut für Medizinische Statistik und Epidemiologie (K.U.), Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Address reprint requests to Dr. Schömig at the 1. Medi-zinische Klinik der Technischen Universität München, Klinikum rechts der Isar, Ismaninger Strasse 22, 81675 Munich, Germany.
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