Addition of clopidogrel to aspirin does not significantly reduce the risk of recurrent strokes in patients with lacunar infarcts; in fact it increases the chances of bleeding, according to a recent study published in the New England Journal of Medicine.
Lacunar infarcts are strokes in the brain caused due to a block in small arteries referred to as cerebral penetrating arteries. Aspirin is a standard antiplatelet drug used in patients with lacunar infarcts to prevent recurrent strokes.
AdvertisementThe Secondary Prevention of Small Subcortical Strokes (SPS3) trial was conducted in North America, Latin America, and Spain; one part of the trial aimed to study the antiplatelet effect of aspirin as compared to aspirin plus clopidogrel in patients with lacunar infarcts in reducing stroke recurrence.
The 3020 patients included in the study were 30 years or older who had suffered from a symptomatic lacunar stroke diagnosed by MRI within the previous 6 months but at least more than 2 weeks prior to enrollment in the study. Out of these, 1503 patients received aspirin, whereas the remaining received aspirin plus clopidogrel. The patients were followed up for a mean of 3.4 years.
This part of the trial evaluating antiplatelet medications was terminated 10 months before the planned end date. This was due to the lack of benefit and the excessive harm caused by the combination.
The researchers found that the risk of recurrent stroke was not significantly different in the two groups, irrespective if the patient received additional clopidogrel or not. In addition, patients receiving the two drugs had a higher incidence of bleeding in the brain. The number of deaths was also higher in patients receiving two antiplatelet drugs. The number of patients who died due to bleeding was 9 in the group that received 2 antiplatelet drugs as compared to 4 in the group that received only aspirin. Major bleeding incidences were almost double in the patients who received two drugs.
The rate of recurrent lacunar infarcts was not reduced in the group receiving additional clopidogrel (67 cases in the aspirin alone group as compared to 66 in the other group).
The addition of clopidogrel to aspirin thus does not appear to provide additional benefits in terms of prevention of stroke recurrence in patients of lacunar infarcts. On the contrary, it is associated with a higher incidence of bleeding, which could be fatal.
Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke; The SPS3 Investigators; N Engl J Med 2012; 367:817-825