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Aspirin and coumadin after acute coronary syndromes (the ASPECT-2 study): a randomised controlled trial

High-intensity oral anticoagulation, or moderate intensity oral anticoagulation combined with aspirin, appears more effective than aspirin alone in reducing serious cardiovascular events and death after an acute coronary event.

The benefits of oral anticoagulation were allied with few adverse effects, reports a multi-center collaborative study by Dutch clinicians. While overall rates of major bleeding were low in all three groups, the combination treatment was associated with a two-fold increase.

The clinicians point out that short-term use of aspirin and long-term use of oral anticoagulants are effective in patients following a myocardial infarction. Compared with placebo, antiplatelet treatment - especially aspirin - reduces vascular events by 25 percent, and long-term treatment with coumadin reduces vascular events by 35 percent, previous studies have shown.

Aspirin has been compared directly with coumadin in patients who have had myocardial infarction, but only in two small clinical trials in the 1980s and no difference was recorded for reinfarction and mortality. Since then, the clinicians declare, lower doses of aspirin have been used, making combination treatment with anticoagulants more realistic.

Approximately 1,000 patients were randomized to three groups- aspirin only, anticoagulant therapy and combination therapy throughout 53 sites. Patients were followed up for a maximum of 26 months. Primary composite endpoint was first occurrence of myocardial infarction, stroke, or death.

The primary endpoint was reached in 31 (9 percent) of 336 patients on aspirin, in 17 (5 percent) of 325 patients on anticoagulants and in 16 (5 percent ) of 332 on combination therapy . Major bleeding was recorded in three patients on aspirin, three on anticoagulants, and seven on combination therapy.

Since chronic thrombin activation is seen in patients after acute coronary events, the clinicians continue, anticoagulant treatment must be beneficial. Whether this benefit can be reached in patients already protected with chronic aspirin treatment, remains to be seen.

"Oral anticoagulation without aspirin was also more effective than aspirin on its own in our trial," the clinicians add. " This effect accords with the indirect comparison of either oral anticoagulation or aspirin with placebo."
Lancet 2002; 360: 109-13.

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