BACKGROUND: Proprotein convertase subtilisin / Kexin type 9 (PCSK9) inhibitors are efficacious lipid-lowering agents. This drug is related to improving the prognosis of patients with cardiovascular disease (CVD). The purpose of this meta-analysis was to systematically analyze the safety and efficacy of PCSK9 inhibitors in all published randomized controlled trials (RCTs). METHODS: As of October 25, 2021, we searched PubMed, EMBASE, MEDLINE, Cochrane Library and web of science. RESULTS: From 684 articles, we included 11 trials for meta-analysis, including 52511 participants (26938 in the PCSK9 inhibitor group and 25573 in the control group). In terms of effectiveness, PCSK9 inhibitors reduced the risk of major adverse cardiovascular events(MACE) (OR=0.89, 95% Cl: 0.83-0.95, =0.0009), but did not significantly reduce the risk of cardiovascular death (OR=0.95, 95% Cl: 0.84-1.07, =0.38) or all-cause death (OR=0.93, 95% Cl: 0.85-1.03, =0.18); In terms of safety, PCSK9 did not increase the risk of treatment-emergent adverse events (TEAE)(OR=0.98, 95% Cl: 0.94-1.02, =0.28). CONCLUSION: PCSK9 inhibitors can significantly reduce the risk of MACE in patients with high cardiovascular risk, which is well tolerated, but the impact on the risk of death is unclear.