Impact of evolocumab on the pharmacodynamic profiles of clopidogrel in patients with atherosclerotic cardiovascular disease: a randomised, double-blind, placebo-controlled study
Authors' conclusion
Compared to placebo, evolocumab in adjunct to statin therapy did not significantly reduce platelet reactivity at 30 days in ASCVD patients on clopidogrel treatment despite intense LDL-C reduction.
Study context
- Population
- Atherosclerotic cardiovascular disease (ASCVD) patients on clopidogrel with low-density lipoprotein cholesterol (LDL-C) ≥70 mg/dL despite maximally tolerated statin, stratified into high platelet reactivity (HPR) (P2Y12 reactivity units (PRU) >208) and normal platelet reactivity (NPR) (PRU >85 and ≤208) cohortsHPR n=37
- Participants
- 84 patients
- Comparison
- Evolocumab 420 mg vs placebo
- Primary endpoint
- Difference in PRU
- Follow-up
- 30 days
Methodological detailsdouble-blind, placebo-controlled, pharmacodynamic study, stratified by platelet reactivity (HPR/NPR)
- Double-blind
- Placebo-controlled
- Pharmacodynamic study
- Stratified by platelet reactivity (HPR/NPR)
Primary result
As reported in the abstract
PRU (VerifyNow P2Y12 reaction units), by platelet reactivity cohort
- Evolocumab vs Placebo: P = 0.161
- Evolocumab vs Placebo: P = 0.229
- Values as printed: evolocumab vs placebo, mean ± spread (spread type not stated)
Further findings
| Outcome | Evolocumab (HPR) | Placebo (HPR) | Evolocumab (NPR) | Placebo (NPR) | P value |
|---|---|---|---|---|---|
| PRU at 14 days, by cohortEvolocumab vs Placebo · HPR cohort | 218.2 ± 29.7 | 246.6 ± 35.2 | 141.2 ± 42.8 | 148.2 ± 41.7 | P = 0.017 |
| PRU at 14 days, by cohortEvolocumab vs Placebo · NPR cohort | P = 0.578 |
- LDL-C reduction · 14 and 30 days · 14 days
- P < 0.001
- LDL-C reduction · 14 and 30 days · 30 days
- P = 0.001
LDL-C reduction · 14 and 30 days
- Evolocumab significantly reduced LDL-C vs placebo
Original publication
Impact of evolocumab on the pharmacodynamic profiles of clopidogrel in patients with atherosclerotic cardiovascular disease: a randomised, double-blind, placebo-controlled study. EuroIntervention. Published 20 March 2023. doi:10.
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