Statin Recapture Therapy before Coronary Artery Bypass Grafting - StaRT-CABG

May 16, 2023
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC; Amit Saha, MD
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
University of Cologne, Cologne, Germany
Date Published:
04/22/2023
Original Posted Date:
05/16/2023
References

Contribution To Literature:

The StaRT-CABG trial showed that additional statin loading before CABG did not improve 30-day MACCE compared with placebo.

Description:

The goal of the trial was to evaluate the utility of additional statin loading prior to coronary artery bypass grafting (CABG) in patients already on long-term statin therapy.

Study Design

  • Randomized
  • Double-blind
  • Placebo-controlled
  • Parallel

Patients on long-term statin therapy undergoing isolated CABG for coronary artery disease (CAD) were randomized to receive the maximum recommended daily dose of their current statin at 12 and 2 hours prior to surgery (n = 1,203) or matching placebo (n = 1,203). Chronic statin therapy was not interrupted prior to loading.

  • Total number of enrollees: 2,635
  • Total number randomized: 2,406
  • Duration of follow-up: 12 months
  • Mean patient age: 66 years
  • Percentage female: 14.9%
  • Percentage with diabetes: 34.7%

Inclusion criteria:

  • Isolated on- or off-pump CABG
  • Taking simvastatin, atorvastatin, pravastatin, or fluvastatin for ≥30 days prior to CABG

Exclusion criteria:

  • Simultaneous cardiovascular procedure additional to CABG
  • ST-segment elevation myocardial infarction (STEMI)
  • Non-ST-segment elevation acute coronary syndrome (NSTE-ACS) with cardiogenic shock
  • Immediate CABG ≤24 hours from admission
  • Atrial fibrillation
  • Renal failure (serum creatinine ≥2 mg/dL or on dialysis)
  • Liver disease

Other salient features/characteristics:

  • Mean European System for Cardiac Operative Risk Evaluation (EuroSCORE) score: 2.1
  • Three-vessel or left main disease: 78.6% and 31.6%, respectively
  • Simvastatin (64.9%) and atorvastatin (31.0%) were most commonly prescribed
  • Median low-density lipoprotein (LDL): 93 mg/dL
  • Treatment adherence to both protocol-directed doses: 95.3%
  • Left ventricular ejection fraction (LVEF) ≤50%: 21%
  • Use of left internal mammary artery (LIMA) graft: 95%

Principal Findings:

The primary outcome, major adverse cardiac and cerebrovascular events (MACCE; a composite of all-cause mortality, MI, stroke, and transient ischemic attack [TIA]) at 30 days for statin loading vs. placebo, was 13.9% vs. 14.9% (p = 0.562).

Secondary outcomes for statin-loading vs. placebo:

  • Stroke at 30 days: 1.7% vs. 0.9% (p = 0.045)
  • Major adverse cardiac events (MACE; composite of cardiac death and MI) at 30 days: 12.1% vs. 13.5%  (p = 0.30)
  • Repeat revascularization at 30 days: 1.5% vs. 1.7%  (p = 0.8)
  • Postoperative atrial fibrillation: 23.3% vs. 25.9%  (p = 0.12)
  • All-cause mortality at 12 months: 3.1% vs. 2.9%  (p = 0.83)

Interpretation:

Additional statin loading prior to isolated CABG for CAD did not reduce 30-day MACCE compared to usual care among patients already on chronic statin therapy. Prespecified subgroup analyses, including by choice of statin, on- vs. off-pump surgery, etc., were similarly not significant. Given the negative primary outcome, the clinical significance of increased stroke incidence in the statin-loading group is unclear.

The ARMYDA-RECAPTURE trial previously demonstrated benefit to statin reloading in patients on chronic statin therapy undergoing percutaneous coronary intervention (PCI). Similarly, the ARMYDA-9 CAROTID trial showed a benefit of reloading with statin prior to carotid stenting. The current trial’s findings do not support a similar approach in patients instead undergoing CABG. It is unclear if more potent statins, especially rosuvastatin, would show a benefit here. Also, CABG is much more invasive in its nature due to direct surgical trauma of the heart, the use of cardiopulmonary bypass, and cardioplegic cardiac arrest. These and other factors may result in greater global myocardial injury and inflammation compared with PCI where regional ischemia is frequently caused by atherosclerotic plaque embolization.

References:

Liakopoulos OJ, Kuhn EW, Hellmich M, et al., for the StaRT-CABG Investigators. Statin loading before coronary artery bypass grafting: a randomized trial. Eur Heart J 2023;Apr 22:[Epub ahead of print].

Clinical Topics: Acute Coronary Syndromes, Arrhythmias and Clinical EP, Cardiac Surgery, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Interventions and ACS, Interventions and Coronary Artery Disease

Keywords: Acute Coronary Syndrome, Atrial Fibrillation, Cardiac Surgical Procedures, Coronary Artery Bypass, Coronary Artery Bypass, Off-Pump, Coronary Artery Disease, Dyslipidemias, Fluvastatin, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Ischemic Attack, Transient, Lipoproteins, LDL, Myocardial Infarction, Myocardial Ischemia, Pravastatin, Primary Prevention, Simvastatin, Stroke


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