Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial
Authors' conclusion
In statin-treated patients with recent acute coronary syndrome, risk of PAD events is related to lipoprotein(a) level and is reduced by alirocumab, particularly among those with high lipoprotein(a).
Study context
- Population
- Patients with recent ACS on intensive or maximum-tolerated statin treatment
- Participants
- 18,924 patients
- Comparison
- Alirocumab vs placebo
- Primary endpoint
- PAD events (critical limb ischemia, limb revascularization, or amputation for ischemia) and VTE (DVT or PE)
Methodological detailsprespecified analysis
- Prespecified analysis
Primary result
As reported in the abstract
Alirocumab vs PlaceboHazard ratio (95% CI)P value
PAD events
0.69(0.54–0.89)
P = 0.004VTE
0.67(0.44–1.01)
P = 0.06- Peripheral artery disease (PAD) events (all patients)
- 246
- Venous thromboembolism (VTE) (all patients)
- 92
Further findings
Lipoprotein(a) and LDL-Ccorrected reduction with alirocumab
- Median relative reduction in lipoprotein(a)
- 23.5%
- Median relative reduction in LDL-Ccorrected
- 70.6%
- Baseline medians 21 and 75 mg/dL
Placebo: risk by baseline quartile
- PAD events by lipoprotein(a) quartile
- P for trend = 0.0021
- PAD events by LDL-Ccorrected quartile
- P for trend = 0.06
- VTE by lipoprotein(a) quartile
- P for trend = 0.06
- VTE by LDL-Ccorrected quartile
- P for trend = 0.85
Reduction in PAD events with alirocumab by baseline quartile
- By lipoprotein(a) quartile
- P for trend = 0.03
- By LDL-Ccorrected quartile
- P for trend = 0.50
Change to Month 4 and VTE risk (alirocumab)
- Change in lipoprotein(a), but not LDL-Ccorrected, associated with risk of VTE and of VTE + PAD events
Original publication
Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial. Circulation. Published 29 March 2020. doi:10.
Summarised from the published abstract; every number is checked against it