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.
The 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