ODYSSEY OUTCOMES: Addition of PCSK9i to Background Statin Therapy Further Reduces MACE

CABG Sub-analysis Overview

Study Design

  • Prespecified analysis
  • Patients were categorized by coronary artery bypass graft (CABG) status:
    • No CABG (n=16,896)
    • CABG after the index ACS but before randomization (index CABG; n=1,025, including n=44 with prior CABG), or
    • CABG prior to the index ACS (prior CABG; n=1 ,003)
  • The primary composite endpoint of MACE encompassed CHD death, nonfatal MI, ischemic stroke, or unstable angina requiring hospitalization
    • The secondary endpoint was all-cause death

Baseline Demographics and Index Events

No CABG (n=16,896)

Index CABG (n=1,025)

Prior CABG (n=1,003)

P-value

Age, years, median (Q1, Q3)

58 (51, 65)

60 (53, 65)

63 (57, 70)

<0.0001

Female, % (n)

25.8 (4,354)

20.6 (211)

19.6 (197)

<0.0001

Body mass index, kg/m2, median (Q1, Q3)

28 (25, 31)

28 (25, 31)

29 (26, 32)

<0.0001

Region, % (n)

 

 

 

<0.0001

Western Europe

22.3 (3,767)

22.4 (230)

17.7 (178)

 

Eastern Europe

29.9 (5,049)

17.6 (180)

20.7 (208)

 

North America

13.5 (2,273)

24.1 (247)

35.0 (351)

 

South America

13.6 (2,293)

17.6 (180)

11.5 (115)

 

Asia

13.0 (2,196)

5.5 (56)

4.1 (41)

 

Rest of the world

7.8 (1,318)

12.9 (132)

11.0 (110)

 

Index event, % (n)

 

 

 

<0.0001

NSTEMI

46.9 (7,913)

59.8 (612)

64.9 (650)

 

STEMI

36.5 (6,156)

20.9 (214)

16.6 (166)

 

Unstable angina

16.6 (2,798)

19.3 (198)

18.6 (186)

 

Time from index event to randomization, months, median (Q1, Q3)

2.6 (1.7, 4.2)

3.8 (2.7, 6.8)

2.5 (1.7, 4.1)

<0.0001

NSTEMI, non-ST segment elevation myocardial infarction; STEMI, ST segment elevation myocardial infarction

Lipid-Lowering Therapy at Randomization and Baseline Laboratory Parameters

No CABG (n=16,896)

Index CABG (n=1,025)

Prior CABG (n=1,003)

P-value

Lipid-lowering therapy at randomization, % (n)

 

 

 

<0.0001

High-dose atorvastatin or rosuvastatin

89.2 (15,077)

87.8 (900)

83.2 (834)

 

Other lipid-lowering therapy3

10.0 (1,690)

10.4 (107)

13.8 (138)

 

No lipid-lowering therapy

0.8 (129)

1.8 (18)

3.1 (31)

 

Lipid measurements, mg/dL, median (Q1, Q3), unless stated

 

 

 

 

LDL-C

86 (73, 103)

87 (74, 107)

94 (78, 116)

<0.0001

LDL-C≥100 mg/dL,% (n)

28.9 (4,878)

32.5 (333)

41.7 (418)

<0.0001

HDL-C

42 (36, 50)

42 (36, 50)

42 (35, 50)

0.0166

Non-HDL-C

114 (99, 136)

117 (102, 140)

126 (107, 153)

<0.0001

Triglicerides

128 (94, 181)

137 (98, 192)

139 (102, 195)

<0.0001

Apoliproprotein B

79 (69, 92)

82 (70, 96)

85 (75, 103)

<0.0001

Lipoprotein(a)

20.3 (6.6, 58.1)

27.8 (7.5, 69.0)

33.2 (8.1, 79.9)

<0.0001

Estimated GFR <60 mL/min per 1.73 m2, % (n)

12.7 (2138)

13.8 (141)

25.9 (260)

<0.0001

ᵃ low-/moderate-dose atorvastatin/rosuvastatin, other statin, any lipid-lowering therapy other than statin.

Effect of Alirocumab in Patients with ACS, Elevated Atherogenic Lipoproteins and Prior CABG

ᵃ index CABG is CABG between the index ACS event and randomization (including 44 patients with prior CABG);

ᵇ Prior CABG is CABG prior to the index ACS event. HRs reflect stratification by geographic region

CABG Sub-analysis Conclusions

  • In this sub-analysis, it was observed that, in a population that has not been fully investigated with regards to the effect of LDL-C lowering therapies, the addition of alirocumab to patients with prior CABG, recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy was associated with consistent relative but greater ARR in MACE and death when compared to patients with an index or no CABG

    Goodman SG, et al. JACC. 2019; 74(9):1177-86.

MAT-BH-2100548/V1/JUN2021