Statin loading before CABG showed no added benefit vs. placebo
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Key takeaways:
- Statin loading prior to coronary artery bypass grafting surgery showed no added benefit compared with placebo.
- Most patients were already on statin therapy for a year or more before surgery.
Statin-loading therapy at 12 and 2 hours before CABG — although safe and well tolerated — demonstrated no significant clinical benefit compared with placebo, researchers reported.
The results of the investigator-initiated, randomized, double-blind and placebo-controlled Statin Recapture Therapy Before Coronary Artery Bypass Grafting (StaRT-CABG) trial were published in the European Heart Journal.
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“Nowadays, over 80% of patients with CAD referred to CABG are already taking statins before surgery, and the effect of an additional statin-loading dose in these patients before surgery is uncertain,” Oliver J. Liakopoulos, MD, professor of cardiac surgery at University Hospital Cologne, Germany, and colleagues wrote. “Promising evidence from experimental studies and the Atorvastatin for Reduction of Myocardial Damage During Angioplasty trial (ARMYDA-RECAPTURE) suggest that statin-mediated cardioprotective actions exerted through the PI3K/Akt pathway wane over time, but can be reactivated by a high-dose statin-loading therapy given shortly before a planned and reversible myocardial ischemia-reperfusion sequence, as it commonly occurs in patients undergoing a PCI or CABG.”
Liakopoulos and colleagues designed the StaRT-CABG trial to evaluate the efficacy of statin-loading therapy compared with placebo on clinical outcomes among 2,635 adult patients with CAD and long-term statin treatment scheduled for CABG (mean age, 66 years; 15% women; 35% with diabetes). Statin-loading therapy or placebo was administered at 12 and 2 hours before surgery.
The primary outcome was a composite of major adverse CV and cerebrovascular events including all-cause mortality, MI and cerebrovascular events within 30 days after CABG. Secondary endpoints included a composite of cardiac death and MI, myocardial injury (area under the troponin T-release curve) and death within 12 months.
Within this cohort, 78.6% had three-vessel disease; 89.9% underwent elective CABG; and approximately 63% were already taking a statin for more than 1 year before surgery.
The researchers observed no significant differences between statin-loading therapy and placebo for the occurrence of the composite primary endpoint or any of its individual components withing 30 days after CABG (OR = 0.93; 95% CI, 0.74-1.18; P = .562).
Similarly, they observed no significant difference between secondary endpoints including cardiac death and MI (OR = 0.88; 95% CI, 0.69-1.12; P = .3), AUC of troponin T release (median for statin-loading therapy, 0.398 ng/mL; median for placebo, 0.394 ng/mL; P = .333) and death at 12 months (statin-loading therapy, 3.1%; placebo, 2.9%; P = .825), according to the study.
“Our results suggest that an additional statin treatment exerts only negligible or no clinical effect in patients undergoing CABG, that is much more invasive in its nature due to direct surgical trauma of the heart, the use of cardiopulmonary bypass and cardioplegic cardiac arrest, that altogether are factors associated with a greater global myocardial injury and inflammation compared with PCI where regional ischemia is frequently caused by atherosclerotic plaque embolization,” the researchers wrote. “The additional statin dose was safe and well tolerated by our patients with regard to adverse muscle effects and we found no clinically relevant difference in our safety outcomes.”
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