Objective: We aim to investigate the effects and safety of clopidogrel plus aspirin in patients with different types of single small subcortical infarction(SSSI) in the Clopidogrel in High-risk patients with Acute Non-disabling Cerebrovascular Events (CHANCE) trial.
Methods: In this subgroup analysis, SSSI was defined as single DWI lesion of ≤2.0 cm and SSSI with stenosis of any degree of the parent artery was regarded as a SSSI+PAD. We assessed the interaction of the treatment effects of clopidogrel plus aspirin versus aspirin alone among patients with and without PAD. Efficacy was assessed by intention to treat analysis and safety was assessed in the on-treatment population.
Results: A total of 338 patients with SSSI were included in the final analysis,105 with SSSI+PAD and 233 SSSI-PAD. In SSSI+PAD patients, 10.9% (5/46) had recurrent stroke in the clopidogrel-aspirin group as compared to 13.6% (8/59) in the aspirin group (adjusted hazard ratio, 0.66; 95% confidence interval, 0.20-2.20; P=0.50). In SSSI-PAD patients, 8.9% (11/124) had recurrent stroke in the clopidogrel-aspirin group as compared 7.3% (8/109) in the aspirin group (adjusted hazard ratio, 1.64; 95% confidence interval, 0.61- 4.38; P=0.32). The number of bleeding events was similar between the clopidogrel-aspirin group and aspirin group regardless of SSSI+PAD or SSSI-PAD.
Conclusions: Although dual antiplatelet therapy did not significantly reduce the risk of recurrent stroke than aspirin alone in patients with SSSI. It was potentially beneficial to the patients with SSSI+PAD. Dual antiplatelet treatment did not increase the risk of bleeding in patients with any kind of SSSI.