Study design and patients
This study was based on a real world, multicenter patient cohort. All the patients underwent PCI with very high risk of ASCVD in 32 hospitals were recruited between January to June 2019 in China, with 6 months follow up. A total of 453 patients treated with PCSK-9 inhibitors combined with statin and 2,610 patients treated with statins were included in current study.
Patients who met the following criteria are eligible for the study: age ≥ 18 years with very high risk of ASCVD which defined as had more than two severe ASCVD events or one severe ASCVD event combined with more than two high-risk factors [11]; underwent PCI during the study recruitment period; treated with statin w/wo other lipid-lowering drugs or initiated treated with PCSK-9 inhibitor evolocumab 140mg per 2 weeks or 420 mg per month after PCI. All patients received PCSK-9 inhibitor treatment for 1 month then changed to statin w/wo other lipid-lowering drugs. Patients who met any of the following criteria will not be eligible for this study: malignant tumor or disease of the blood system; severe hepatic and renal insufficiency; severe allergic reactions history; aspartate aminotransferase or alanine amino transferase more than three times the upper limit of normal (ULN); creatinine greater than three times ULN.
In this study, patients’ treatment of statin before and over 6 months after PCI was described. LDL-c control rate over 6 months after PCI in the real world was analyzed and compared between patients initiated with PCSK-9 inhibitors combined with statin and patients with statins agents. The impact of PCSK-9 inhibitors combined with statins or statins on incidence of cardiovascular events was also compared. An independent ethics committee had approved the protocol. Written informed consent for both participation and publication was obtained from all the participants.