Document Detail

A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators.
MedLine Citation:
PMID:  9834303     Owner:  NLM     Status:  MEDLINE    
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=0.01). 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.
M B Leon; D S Baim; J J Popma; P C Gordon; D E Cutlip; K K Ho; A Giambartolomei; D J Diver; D M Lasorda; D O Williams; S J Pocock; R E Kuntz
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  339     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  1998 Dec 
Date Detail:
Created Date:  1998-12-04     Completed Date:  1998-12-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1665-71     Citation Subset:  AIM; IM    
Cardiology Research Foundation, Washington Hospital Center, DC 20010, USA.
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MeSH Terms
Angioplasty, Transluminal, Percutaneous Coronary
Anticoagulants / adverse effects,  therapeutic use*
Aspirin / adverse effects,  therapeutic use*
Coronary Disease / mortality,  therapy*
Drug Therapy, Combination
Hemorrhage / chemically induced
Middle Aged
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use*
Single-Blind Method
Thrombosis / prevention & control*
Ticlopidine / adverse effects,  therapeutic use*
Warfarin / adverse effects,  therapeutic use*
Reg. No./Substance:
0/Anticoagulants; 0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 55142-85-3/Ticlopidine; 81-81-2/Warfarin
Comment In:
N Engl J Med. 1998 Dec 3;339(23):1702-4   [PMID:  9834311 ]
N Engl J Med. 1999 Apr 29;340(17):1365; author reply 1367   [PMID:  10223873 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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