Effects of Aspirin for Primary Prevention in Persons with Diabetes Mellitus
ASCEND Study Collaborative Group
Effect of Aspirin on Cardiovascular Events and Bleeding in the Healthy Elderly
McNeil JJ et al.
Because of a lack of proved benefit, the current ESC guidelines “Peripheral arterial diseases” do not recommend the use of antiplatelets in isolated asymptomatic lower extremity arterial disease [1]. This recommendation is based on two negative studies with showed no benefit of Aspirin 100 mg versus placebo in patients with a low ankle brachial index [2,3]. Recently two additional negative studies have been published in the New England Journal of Medicine [4-5].
In the ASCEND Trial (A Study of Cardiovascular Events in Diabetes) a total of 15,480 patients with diabetes and no previous cardiovascular disease underwent randomization to 100 mg Aspirin or placebo [4]. After a follow-up of 7.4 years the primary endpoint serious vascular events (i.e. myocardial infarction, stroke, or death from cardiovascular cause excluding intracranial hemorrhage) occurred in in a significant lower percentage in the Aspirin group compared to placebo (8.5% vs. 9.6%, P=0.01). In contrast, patients with Aspirin suffered significantly more often from major bleeding events (4.1% vs. 3.2%, P=0.003). In summary the positive effects on cardiovascular events were counterbalanced by clinically relevant bleeding complications.
The ASPREE (Aspirin in Reducing Events in the Elderly) study included 19,114 elderly persons (>70 years Caucasian, > 65 years Blacks or Hispanics) with no previous history for cardiovascular diseases. Participants were randomized to Aspirin 100 mg or placebo and follow for a median of 4.7 years. There was no significant reduction of cardiovascular events (defined as fatal coronary heart disease, myocardial infarction, stroke or hospitalization for heart failure) but a significant increase of major hemorrhage in the Aspirin group [5]. In addition, all-cause mortality was increased in the Aspirin group compared to placebo.
In conclusion, persons without clinical manifestations of cardiovascular diseases should not take Aspirin for primary prevention because of an excess in bleeding complications not balanced by a benefit for cardiovascular prognosis. Therefore, antithrombotic medication should be limited to patients with clear clinical
indications.
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