The use of novel platelet function testing to guide personalized antiplatelet therapy can decrease ischemic events without increasing bleedings in patients with stable coronary artery disease (CAD) who have undergone percutaneous coronary intervention (PCI), according to a study recently published in The Journal of Clinical Endocrinology and Metabolism.
This open-label, randomized controlled trial included 2285 participants with stable CAD, all of whom were over 18 years old and who had at least 1 coronary artery stenosis over 70% or a left main stenosis amenable to PCI.
Before PCI, participants were randomly assigned to receive either standard treatment (n=1139; n=335 with diabetes; 75 mg/day clopidogrel + 100 mg/day aspirin for ≥6 months post-procedure with no platelet aggregation rate detection) or personalized therapy (n=1146; n=311 with diabetes; antiplatelet strategy performed according to platelet aggregation rate [MAR]).
MAR involved delivering an additional dose of 300 mg clopidogrel and 300 mg aspirin, then collecting blood samples 12 to 24 hours later; a novel device called PL-12 was used to detect the MAR. Net clinical adverse events comprised the primary endpoint, while major adverse cardiovascular and cerebrovascular events (MACCEs) comprised the secondary endpoint. Follow-up occurred at baseline, 1 month, and 6 months. The relationship between treatment and adverse clinical outcomes was assessed using the Kaplan-Meier analysis.
Among those with diabetes (n=646 total), personalized therapy was associated with significantly lower overall ischemic events compared with standard treatment (6.8% vs 11.3%, respectively; hazard ratio [HR] 0.586; 95% CI, 0.344-0.999; P =.049), and bleeding events were not significantly different (3.5% vs 3.3%, respectively; HR 1.066; 95% CI, 0.462-2.458; P =.882). No significant differences were observed in net adverse clinical events between personalized or standard treatment for those with diabetes (10.3% vs 13.4%, respectively; P =.224) or without (3.1% vs 5.0%, respectively; P =.064). Among those without diabetes, personalized treatment correlated with significantly lower overall ischemic event rates than standard treatment (1.8% vs 4.2%, respectively; HR, 0.428; 95% CI, 0.233-0.758; P =.006), and there was no significant difference in bleedings (1.6% vs 0.9%; HR ,1.802; 95% CI, 0.719-4.516; P =.209).
Limitations to this study included a small subgroup of participants with diabetes and the use of a single trial center.
The study researchers concluded that “personalized antiplatelet therapy according to [platelet function testing] can reduce ischemic events but not increase bleedings in stable CAD patients with or without diabetes who underwent PCI.”
Zheng YY, Wu TT, Yang Y, et al. Diabetes and outcomes following personalized antiplatelet therapy in coronary artery disease patients who underwent PCI. Published August 19, 2021. J Clin Endocr Metab. doi:10.1210/clinem/dgab612