Odyssey Outcomes: Addition of PCSK9i to Background Statin Therapy Further Reduces MACE.

CABG Sub-analysis overview

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

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

Abbreviations

NSTEMI, Non-ST Segment Elevation Myocardial Infarction; STEMI, ST Segment Elevation Myocardial Infarction

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.

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

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

Reference