CAVIAR phase II: Alirocumab + rosuvastatin for CAV after heart transplant

Results from the randomized, double-blind, multicenter, phase II CAVIAR study (NCT03537742), comparing alirocumab + rosuvastatin with placebo + rosuvastatin for the prevention of cardiac allograft vasculopathy (CAV) in heart transplant recipients (N = 114), were recently published in Circulation by Fearon et al. The primary endpoint was change in coronary artery plaque volume from baseline to 1 year. Secondary endpoints included differences in lipid particle values, such as low-density lipoprotein cholesterol (LDL-C); differences in coronary physiology (fractional flow reserve [FFR], coronary flow reserve [CFR], and index of microcirculatory resistance [IMR]); and differences in intravascular ultrasound with near-infrared spectroscopy (NIRS-IVUS) parameters. 

Key data: The primary endpoint was not met. The change in plaque volume from baseline to 1 year did not differ between groups (mean difference in differences, 1.01; 95% confidence interval [CI], 0.89–1.14; p = 0.86). LDL-C decreased from baseline to 1 year in the alirocumab arm (72.7 ± 31.7 to 31.5 ± 20.7 mg/dL; p < 0.001) and did not change with placebo (69.0 ± 22.4 to 69.2 ± 28.1 mg/dL; p = 0.92). There were no changes in FFR (p = 0.89), CFR (p = 0.68), or IMR (p = 1.00) in patients treated with alirocumab. Patients receiving placebo showed no changes in FFR (p = 0.22) or IMR (p = 0.41) but had increased CFR (p = 0.02). No significant treatment-related adverse events were reported with alirocumab.

Key learning: The addition of alirocumab to statin therapy early after heart transplantation lowered LDL-C but did not reduce coronary artery plaque progression after 1 year compared with rosuvastatin alone in patients with low baseline LDL-C levels.