Germany: A German randomized trial showed that high-dose statin loading before CABG (coronary artery bypass grafting) surgery did not pan out as a strategy for preventing significant adverse cardiovascular events (MACE). The findings from the trial were published in the European Heart Journal.
The researchers state that additional statin loading before CABG failed to reduce the MACCE rate occurring within 30 days of surgery.
In the randomized clinical trial comprising 2406 CABG patients in the modified intention-to-treat analysis, the 30-day MACCE rate was 13.9% among patients in the statin loading group and 14.9% among patients in the statin loading group in the placebo group, which is a statistically non-significant difference (odds ratio 0.93).
Previous studies have suggested that high-dose statin loading before percutaneous coronary revascularization improves outcomes in patients receiving long-term statins. Therefore, Oliver J Liakopoulos, University of Giessen, Germany, and colleagues aimed to analyze the effects of such an additional statin therapy before surgical revascularization in an investigator-initiated, randomized, double-blind, and placebo-controlled trial.
The trial conducted at 14 centres in Germany from 2012 to 2019 included 2635 adult patients with a long-term statin treatment of more than 30 days, which were scheduled for isolated CABG. They were randomly allocated to receive a statin-loading therapy or placebo at 12 and 2 h before surgery through a web-based system.
The study's primary outcome was major adverse cardiac and cerebrovascular events (MACCE), a composite comprising myocardial infarction (MI), all-cause mortality, and a cerebrovascular event occurring within 30 days after surgery. Critical secondary endpoints included a composite of cardiac death and MI, death, and myocardial injury within 12 months.
The study revealed the following findings:
The researchers found non-statistically relevant differences in the modified intention-to-treat analysis (2406 patients; 1203 per group) between the statin (13.9%) and placebo groups (14.9%) for the primary outcome [odds ratio (OR) 0.93] or any of its components.
Secondary endpoints, including cardiac death and MI (12.1% versus 13.5%), the area under the troponin T-release curve (median 0.398 versus 0.394 ng/ml), and death at 12 months (3.1% versus 2.9%) were comparable between treatment arms.
To conclude, statin-loading therapy in patients before CABG does not reduce the rate of myocardial infarction, all-cause mortality, and cerebrovascular event at 30 days.
Reference:
Liakopoulos, O. J., Kuhn, E. W., Hellmich, M., Schlömicher, M., Strauch, J., Reents, W., Diegeler, A., Thielmann, M., Wendt, D., Börgermann, J., Gummert, J. F., Stoppe, C., Goetzenich, A., Martens, S., Reichenspurner, H., Wippermann, J., Reuter, H., Choi, Y., Wahlers, T., . . . Investigators, C. Statin loading before coronary artery bypass grafting: A randomized trial. European Heart Journal. https://doi.org/10.1093/eurheartj/ehad238