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Statin Loading Before Coronary Artery Bypass Grafting
Quick Takes
- An additional statin-loading therapy did not reduce the rate of MACCE or any of its components within 30 days of CABG.
- Of note, the additional statin dose was safe and well tolerated without a clinically relevant difference in safety outcomes.
- Future studies may want to assess whether a different statin-loading scheme would have generated any benefit, especially in those requiring urgent surgery for ACS.
Study Questions:
What is the efficacy of an additional statin-loading therapy on clinical outcomes in patients undergoing coronary artery bypass grafting (CABG)?
Methods:
The investigators initiated a randomized, double-blind, and placebo-controlled trial, which was conducted from November 2012 to April 2019 at 14 centers in Germany. Adult patients (n = 2,635) with a long-term statin treatment (≥30 days) who were scheduled for isolated CABG were randomly assigned to receive a statin-loading therapy or placebo at 12 and 2 hours prior to surgery using a web-based system. The primary outcome of major adverse cardiac and cerebrovascular events (MACCE) was a composite consisting of all-cause mortality, myocardial infarction (MI), and a cerebrovascular event occurring within 30 days after surgery. Key secondary endpoints included a composite of cardiac death and MI, myocardial injury, and death within 12 months. For 12-month all-cause mortality, Kaplan–Meier curves were computed and compared between groups by the log-rank test.
Results:
Nonstatistically relevant differences were found in the modified intention-to-treat analysis (2,406 patients; 1,203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.74-1.18; p = 0.562) or any of its individual components. Secondary endpoints including cardiac death and MI (12.1% vs. 13.5%; OR, 0.88; 95% CI, 0.69-1.12; p = 0.300), the area under the troponin T-release curve (median 0.398 vs. 0.394 ng/mL, p = 0.333), and death at 12 months (3.1% vs. 2.9%; p = 0.825) were comparable between treatment arms.
Conclusions:
The authors report that additional statin loading before CABG failed to reduce the rate of MACCE occurring within 30 days of surgery.
Perspective:
This study reports that an additional statin-loading therapy did not reduce the rate of MACCE or any of its components within 30 days of CABG. Furthermore, these results do not support the assumption that statin loading exhibits a relevant clinical benefit in high-risk patient subgroups for perioperative complications. Of note, the additional statin dose was safe and well tolerated without a clinically relevant difference in safety outcomes. There was, however, a higher stroke rate in statin-loaded patients that reached a borderline statistical difference, which may be related to a type-I error inflation due to multiple testing. Finally, future studies may want to assess whether a different statin-loading scheme would have generated any benefit and especially in those requiring urgent surgery for acute coronary syndrome (ACS).
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Cardiovascular Care Team, Diabetes and Cardiometabolic Disease, Dyslipidemia, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Nonstatins, Novel Agents, Statins, Interventions and ACS
Keywords: Acute Coronary Syndrome, Cardiac Surgical Procedures, Coronary Artery Bypass, Dyslipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Myocardial Infarction, Secondary Prevention, Stroke, Troponin T, Vascular Diseases
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