Key result
Genotype-guided antiplatelet therapy shows no benefit over standard of care for MACCE.
Why the study?
Clopidogrel-resistant patients post-PCI face increased risk of MACCEs, but Caribbean Hispanic patients have been underrepresented in pharmacogenomic-guided antiplatelet implementation studies.
Does genotype-guided selection of oral antiplatelet drugs using a clinical decision support algorithm reduce MACCEs in Caribbean Hispanic patients undergoing PCI?
Cohort (n=300)
Open-label
None
Yes
Does genotype-guided selection of oral antiplatelet drugs using a clinical decision support algorithm reduce MACCEs in Caribbean Hispanic patients undergoing PCI?
A pharmacogenomic-driven clinical decision support algorithm successfully identified high-risk Caribbean Hispanic patients post-PCI who benefited from escalating antiplatelet therapy to ticagrelor, significantly reducing MACCEs.
Does not warrant routine adoption post-PCI; leaves open targeted benefit in high-risk Caribbean Hispanic subgroups pending RCTs.
Background: After percutaneous coronary intervention (PCI), clopidogrel resistant patients are at an increased risk of major adverse cardiovascular and cerebrovascular events (MACCEs). We aimed to assess whether genotype-guided selection of oral antiplatelet drugs using a clinical decision support (CDS) algorithm reduces the occurrence of these ischemic events and improves outcomes among Caribbean Hispanic patients from Puerto Rico, who are underrepresented in clinical pharmacogenomic (PGx)-guided implementation studies. Methods: rs662 genotypes, clinical and demographic data from 8 medical facilities were included. Patients were separated into standard of care (SoC) and genotype-guided groups (150 each). Risk scores were calculated based on a previously developed CDS risk prediction algorithm designed to make actionable treatment recommendations for each patient. Alternative therapy with ticagrelor was recommended for patients with a high risk score ≥2. Statistical associations between patient time free of MACCEs and predictor variables (i.e., treatment groups, risk scores) were tested in this population using Kaplan-Meier survival analyses and Cox proportional-hazards regression models. Results: Median age of participants is 67 years; BMI: 27.8; 48% women; 14% smokers; 59% with type-2 diabetes mellitus (T2DM). Among patients with high-risk scores who were free from MACCE events 6 months after coronary stenting, genotype-driven guidance of antiplatelet therapy showed superiority over SoC in terms of reducing the incidence rate of atherothrombotic events. Conclusions: The clinical utility of our PGx-driven CDS algorithm to reduce the incidence rate of MACCEs among post-PCI Caribbean Hispanic patients on clopidogrel was externally demonstrated. Clinical Trial Registration Unique Identifier: NCT03419325.
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Nuñez-Medina et al. (2023) conducted a cohort in Caribbean Hispanic patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndromes or stable ischemic heart disease (n=300). Pharmacogenomic-driven clinical decision support (PGx-CDS) algorithm vs. Standard of care (clopidogrel) was evaluated on Major adverse cardiovascular and cerebrovascular events (MACCEs) at 6 months (HR 0.56, 95% CI 0.19-1.56, p=0.27). Genotype-guided selection of antiplatelet therapy did not significantly reduce the overall risk of major adverse cardiovascular and cerebrovascular events compared to standard of care (HR 0.56).
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