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.