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Effects of Alirocumab on Cardiovascular Events After Coronary Bypass Surgery
Shaun G Goodman1, Philip E Aylward2, Michael Szarek3
1Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada and St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Insights
Adding alirocumab to statins significantly reduced major adverse cardiovascular events (MACE) and death in acute coronary syndrome (ACS) patients with prior coronary artery bypass grafting (CABG). This benefit was most pronounced in patients who had CABG before their ACS event.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Patients with acute coronary syndrome (ACS) and a history of coronary artery bypass grafting (CABG) face elevated risks of recurrent cardiovascular events and mortality.
- Identifying effective treatments for this high-risk population is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the clinical benefit of alirocumab, when added to statin therapy, in patients with ACS and prior CABG.
- To analyze a pre-specified subgroup of the ODYSSEY OUTCOMES trial to assess alirocumab's efficacy in specific patient profiles.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 18,924 patients 1-12 months post-ACS with high atherogenic lipoproteins despite high-intensity statin therapy.
- Patients received subcutaneous alirocumab or placebo every two weeks for a median follow-up of 2.8 years.
- Patients were categorized based on CABG status: no CABG, index CABG (after qualifying ACS), or prior CABG (before qualifying ACS).
Main Results:
- Alirocumab consistently reduced the risk of major adverse cardiovascular events (MACE) and all-cause death across all CABG subgroups, aligning with overall trial findings.
- Absolute risk reductions for MACE and death varied by CABG category, with the largest reductions observed in patients with CABG preceding the ACS event.
- Specifically, patients with prior CABG experienced substantial absolute risk reductions in MACE (6.4%) and death (3.6%) with alirocumab treatment.
Conclusions:
- In patients with recent ACS and high atherogenic lipoproteins on statin therapy, alirocumab demonstrated significant clinical benefits.
- Alirocumab was associated with substantial absolute reductions in MACE and death, particularly in patients with a history of CABG prior to the ACS event.
Background:
Patients with acute coronary syndrome (ACS) and history of coronary artery bypass grafting (CABG) are at high risk for recurrent cardiovascular events and death.
Objectives:
This study sought to determine the clinical benefit of adding alirocumab to statins in ACS patients with prior CABG in a pre-specified analysis of ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab).
Methods:
Patients (n = 18,924) 1 to 12 months post-ACS with elevated atherogenic lipoprotein levels despite high-intensity statin therapy were randomized to alirocumab or placebo subcutaneously every 2 weeks. Median follow-up was 2.8 years. The primary composite endpoint of major adverse cardiovascular events (MACE) comprised coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint. Patients were categorized by CABG status: no CABG (n = 16,896); index CABG after qualifying ACS, but before randomization (n = 1,025); or CABG before the qualifying ACS (n = 1,003).
Results:
In each CABG category, hazard ratios (95% confidence intervals) for MACE (no CABG 0.86 [0.78 to 0.95], index CABG 0.85 [0.54 to 1.35], prior CABG 0.77 [0.61 to 0.98]) and death (0.88 [0.75 to 1.03], 0.85 [0.46 to 1.59], 0.67 [0.44 to 1.01], respectively) were consistent with the overall trial results (0.85 [0.78 to 0.93] and 0.85 [0.73 to 0.98], respectively). Absolute risk reductions (95% confidence intervals) differed across CABG categories for MACE (no CABG 1.3% [0.5% to 2.2%], index CABG 0.9% [-2.3% to 4.0%], prior CABG 6.4% [0.9% to 12.0%]) and for death (0.4% [-0.1% to 1.0%], 0.5% [-1.9% to 2.9%], and 3.6% [0.0% to 7.2%]).
Conclusions:
Among patients with recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy, alirocumab was associated with large absolute reductions in MACE and death in those with CABG preceding the ACS event. (ODYSSEY OUTCOMES: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402).
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