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Copyright ©The Author(s) 2021.
World J Cardiol. Sep 26, 2021; 13(9): 472-482
Published online Sep 26, 2021. doi: 10.4330/wjc.v13.i9.472
Table 1 Cardiovascular outcome of proprotein convertase subtilisin kexin 9 inhibitors vs Placebo in different studies and subgroups
ODYSSEY trial subgroup (n = 18924)
Alirocumab vs placebo
Patients with Polyvascular disease
Monovascular (n = 17370)Cardiovascular events: ARR 1.4% (CI 95%; 0.6%-2.3%)Mortality: 0.4% (95%CI: -0.1% to 1.0%)
2 vascular beds (n = 1405)Cardiovascular events: ARR 1.9% (CI 95%; -2.4%-6.2%)Mortality: ARR 1.3% (95%CI: -1.8% to 4.3%)
3 vascular beds (n = 149)Cardiovascular events: ARR 13% (CI 95%; -2%-28%)Mortality: ARR 16.2% (95%CI: 5.5% to 26.8%)
FOURIER Trial (n = 27564) Evolocumab vs placebo
With PAD (n = 2642)Composite of major cardiac events ARR 3.5% HR 0.79; 95%CI, 0.66-0.94; P = 0.0098
Without PAD (n = 24922)Composite of major cardiac events ARR: 1.6% HR 0.86; 95%CI, 0.80-0.93; P = 0.0003
Patients with prior CABG
ODYSSEY trial subgroup (n = 18924)Alirocumab vs placebo
With Prior CABG (n = 1003)Composite of major cardiac events ARR: 6.4%; 95%CI: 0.9 to 12.0
With index CABG (n = 1025)Composite of major cardiac events ARR: 0.9%; 95%CI: 2.3 to 4.0
Without prior CABG (n = 16896)Composite of major cardiac events ARR: 1.3%; 95%CI: 0.5 to 2.2
Patients with diabetes mellitus or metabolic syndrome
FOURIER Trial diabetic subgroup (n = 27564) Evolocumab vs placebo
With diabetes (n = 11031)Composite of major cardiac events HR 0·83 (95%CI 0.75-0.93; P = 0.0008), Absolute risk reduction 2.7% (95%CI 0.7–4.8)
Without diabetes (n = 16533)Composite of major cardiac events HR 0.87 (0.79-0.96; P = 0.0052)Absolute risk reduction 1.6% (95%CI 0.1–3.2)
FOURIER trial metabolic syndrome subgroup (n = 27342) Evolocumab vs placebo
With met syndrome (n = 16361)Composite of major cardiac events HR 0.83 (95%CI; 0.76-0.91)
Without met syndrome (n = 10981)Composite of major cardiac events HR:0.89, CI 95% (0.79-1.01)
ODYSSEY trial subgroup (n = 18924) Alirocumab vs placebo
With diabetic (n = 5444) Composite of major cardiac events ARR 2.3%, 95%CI 0.4 to 4.2
Prediabetic (n = 8246)Composite of major cardiac events ARR 1.2%, 95%CI: 0.0 to 2.4
Normoglycemic (n = 5234)Composite of major cardiac events ARR 1.2%, 95%CI: −0.3 to 2.7
Elderly patients
FOURIER trial (n = 27564) age subgroup[8]Evolocumab vs placebo
Q1Composite of major cardiac events HR 0.83, 95%CI 0.72-0.96
Q2Composite of major cardiac events HR 0.88, 95%CI 0.76-1.01
Q3Composite of major cardiac events HR 0.82, 95%CI 0.71-0.95
Q4Composite of major cardiac events HR 0.86, 95%CI 0.74-1.00
ODYSSEY trial age subgroup (n = 18924) Alirocumab vs placebo
≥ 65 yrComposite of major cardiac events HR 0.78, 95%CI 0.68-0.91
< 65 yrComposite of major cardiac events HR 0.89, 95%CI 0.80-1.00