Retrospective Analysis of the Effect of In-hospital Initiation of PCSK9i on Clinical Outcomes in Chinese ACS Patients

Yun Dai Chen10,000 enrolled

Overview

The objective of this study is to investigate the effectiveness of in-hospital initiation of alirocumab combined with statin ± ezetimibe on major cardiovascular events (MACE) in Chinese ACS patients. The main question it aims to answer is: whether early initiation PCKS9i in hospital could reduce recent cardiovascular event risk in Chinese ACS patients in real-world setting. Data from CCA Database-Chest Pain Center were screened for all ACS patients from 01-Jan 2021 to 31-Dec 2023. Patients diagnosed with STEMI, NSTEMI or UA at admission were identified at the first step. Then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the ACS hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the ACS hospitalization will be included. All enrolled patients were required to have at least one documented follow-up visit.

Study Type

OBSERVATIONAL

Enrollment

10,000

Conditions

Acute Coronary Syndrome

Interventions

alirocumab 75mg/2weekDRUG

patients continually prescribed or stopped alirocumab treatment during the follow-up visit, which depend on physician's clinical decision and patient preference

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with Acute Coronary Syndrome (ACS) upon hospital admission. * Patients aged 18 years or older. * Patients who received Alirocumab 75 mg in combination with statin therapy ± Ezetimibe as the intervention group, and those treated exclusively with statin therapy ± Ezetimibe as the control group, either during hospitalization or at discharge. * Patients with at least one follow-up record. Exclusion Criteria: * Patients who received Evolocumab treatment at any time. * Patients who received Inclisiran treatment at any time.

Outcomes

Primary Outcomes

The primary endpoint is the risk of MACE within 1 year of follow-up

MACE was defined as the composite of non-fatal myocardial infarction, non-fatal ischemic stroke, all-cause mortality, or any coronary revascularization. Coronary revascularization was limited to procedures occurring at least two weeks after the index date, including PCI and CABG

Time frame: 12 months

Secondary Outcomes

Percentage reduction of LDL-C levels at 1-month follow-up from baseline

Time frame: 1 month

Proportion of patient who achieved LDL-C goal (<1.4mmol/L) at 1-month follow-up

Proportion of patient who achieved LDL-C goal (\<1.4mmol/L) at 1-month follow-up