Statin Therapy in Cardiac Surgery - STICS

Description:

The goal of the trial was to evaluate treatment with rosuvastatin compared with placebo among patients undergoing cardiac surgery. Numerous smaller trials have documented a benefit for statin therapy in reducing the incidence of postoperative atrial fibrillation.

Contribution to the Literature: The STICS trial failed to show that rosuvastatin decreased the incidence of postoperative atrial fibrillation or myocardial injury.

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients undergoing cardiac surgery were randomized to rosuvastatin 20 mg (n = 960) versus placebo (n = 962) for up to 8 days before and for 5 days after surgery. Use of preoperative statin therapy was stopped prior to study enrollment.

  • Total number of enrollees: 1,922
  • Duration of follow-up: 5 days
  • Mean patient age: 59 years
  • Percentage female: 20%
  • Percentage diabetics: 32%

Inclusion criteria:

  • Patients at least 18 years of age undergoing cardiac surgery, defined as coronary artery bypass grafting or aortic valve replacement
  • Sinus rhythm and not on antiarrhythmic medication

Exclusion criteria:

  • Moderate or severe mitral valve disease
  • Renal dysfunction (creatinine >2.3 mg/dl)
  • Contraindication to statin therapy

Other salient features/characteristics:

  • 33% were on preoperative statin therapy
  • 87% underwent coronary artery bypass grafting
  • 10% underwent aortic valve replacement alone

Principal Findings:

The first co-primary outcome, postoperative atrial fibrillation within 5 days (detected by continuous Holter electrocardiographic monitoring), occurred in 21% of the rosuvastatin group versus 20% of the placebo group (p = 0.72). This lack of effect was the same among all tested subgroups.

The second co-primary outcome, perioperative myocardial injury (area under the troponin-I release curve), was 102 ng x hr/ml in the rosuvastatin group versus 100 ng x hr/ml the placebo group (p = 0.80). This lack of effect was the same among all tested subgroups.

Secondary outcomes:

  • Acute kidney injury: 25% vs. 19% (p = 0.005), respectively for rosuvastatin versus placebo
  • Postoperative atrial fibrillation within 5 days (detected clinically by electrocardiography): 16% of the rosuvastatin group versus 12% of the placebo group (p = 0.03)

Interpretation:

Among individuals underdoing cardiac surgery, perioperative rosuvastatin therapy did not reduce the risk of postoperative atrial fibrillation or myocardial injury compared with placebo. Rosuvastatin was also associated with an increased risk of acute kidney injury compared with placebo.

References:

Zheng Z, Jayaram R, Jiang L, et al. Perioperative rosuvastatin in cardiac surgery. N Engl J Med 2016;374:1744-53.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Clinical Topic Collection: Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Nonstatins, Novel Agents, Statins

Keywords: Acute Kidney Injury, Arrhythmias, Cardiac, Atrial Fibrillation, Cardiac Surgical Procedures, Coronary Artery Bypass, Electrocardiography, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Incidence, Myocardial Reperfusion Injury, Primary Prevention, Transcatheter Aortic Valve Replacement, Troponin I


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