P2Y12 inhibitors plus aspirin versus aspirin alone in patients with ischemic cerebrovascular events: An updated meta-analysis of randomized controlled trials

Background

The efficacy and safety of P2Y12 inhibitors (P2Y12i) with aspirin in patients with non-cardioembolic ischemic cerebrovascular events remains a topic of ongoing debate. Therefore, we conducted an updated meta-analysis to compare these drugs with aspirin alone.

Methods

We systematically searched PubMed, Embase, and Cochrane Central for randomized controlled trials (RCTs) comparing the two treatment regimens in patients with ischemic cerebrovascular events. Primary outcomes were all-cause mortality, severe bleeding, and stroke recurrence. We performed subgroup analyses stratified by National Institutes of Health Stroke Scale (NIHSS). Risk ratios (RRs) with 95 % confidence intervals were calculated using a random effects model. R software (version 4.3.2) was used for statistical analyses.

Results

Fifteen studies were included, comprising 38,851 patients, of whom 19,483 (50.1 %) received P2Y12i plus aspirin. Follow-up ranged from 7 days to 3.4 years. P2Y12i plus aspirin significantly reduced stroke recurrence (RR 0.78; 95 % CI = 0.71-0.87; p < 0.05), but increased the incidence of all-cause mortality (RR 1.38; 95 % CI = 1.11-1.72; p < 0.05) and severe bleeding (RR 2.07; 95 % CI 1.61 to 2.66; p > 0.05) compared with aspirin. There was no significant difference between groups in all-cause mortality in patients with NIHSS ≤3 or ≤10.

Conclusion

P2Y12i plus aspirin reduced stroke recurrence, but increased all-cause mortality and severe bleeding in patients with non-cardioembolic ischemic events. There was no difference between groups in all-cause mortality in patients with NIHSS scores ≤3 or ≤10.