Prospective evaluation of a prostacyclin-sparing aspirin formulation and heparin/warfarin in aspirin users with unstable angina or non-Q wave myocardial infarction at rest. The Antithrombotic Therapy in Acute Coronary Syndromes Research Group.
The aim of this trial was to compare the efficacy of combination antithrombotic therapy with a prostacyclin-sparing aspirin plus anticoagulation versus conventional aspirin plus anticoagulation, when added to antianginal therapy, in patients with unstable angina or non-Q wave myocardial infarction already being treated with aspirin. In a double-blind (for the aspirin) study, 144 prior aspirin users were randomized; 72 patients received controlled-release, prostacyclin-sparing aspirin 75 mg daily plus anticoagulation (intravenous heparin followed by warfarin to maintain the international normalized ratio at 2-3), and 72 patients received conventional aspirin 75 mg daily plus the same anticoagulation. Controlled-release aspirin was formulated to preserve endothelial cell prostacyclin synthesis. Trial therapy was begun by 13.2 +/- 12.3 h of qualifying pain, and continued for 12 weeks. The frequency of recurrent angina with electrocardiographic changes, myocardial infarction, or death, was analysed by intention to treat. At 12 weeks, events were: [table: see text] Twenty-six of the 42 (62%) recurrent ischaemic events occurred within 7 days of presentation. Four of the 144 patients (3%) experienced a major bleeding complication. It is concluded that in spite of maximal antithrombotic therapy, there is a significant failure rate of medical therapy in aspirin users presenting with unstable angina or non-Q wave myocardial infarction while at rest. Prostacyclin-sparing aspirin offers no clinical benefit over conventional aspirin.
Cohen
M
M
Department of Medicine, Hahnemann University Hospital, Philadelphia, Pennsylvania.
Parry
G
G
Adams
P C
PC
Xiong
J
J
Chamberlain
D
D
Wieczorek
I
I
Fox
K A
KA
Kronmal
R
R
Fuster
V
V
D000328:Adult; D000789:Angina, Unstable / Q000188:drug therapy*; D001241:Aspirin / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D011464:Epoprostenol / Q000096:biosynthesis*; D005260:Female; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy*; D010865:Pilot Projects; D012146:Rest; D015912:Thrombolytic Therapy / Q000379:methods*; D014859:Warfarin / Q000008:administration & dosage*
D003692:Delayed-Action Preparations; D014859:Warfarin; D006493:Heparin; D011464:Epoprostenol; D001241:Aspirin