Impact of depression and/or anxiety on patients with percutaneous coronary interventions after acute coronary syndrome: a protocol for a real-world prospective cohort study.

introductionAcute coronary syndrome (ACS) is one of the leading causes of death. Depression and/or anxiety after ACS is common. Studies from developed countries have reported that the occurrence of anxiety or depression after ACS might increase the risk of cardiovascular events and mortality. However, the results varied, and are limited in developing countries. Therefore, well designed large-scale real-world study is needed to make further clarification. The main objective of this study is to evaluate whether depression or anxiety could affect the prognosis of patients with percutaneous coronary intervention (PCI) post-ACS. METHOD AND ANALYSIS: The study is a prospective, multicentre, cohort study, which will be performed at 12 large hospitals in northwest China and led by the First Affiliated Hospital of Xi'an Jiaotong University. A total of 5000 patients with PCI post-ACS will be enrolled and followed up for 2 years. Their depression and anxiety status will be evaluated with the Patient Health Questionnaire-9 or Generalised Anxiety Disorder-7 Assessment scales during the follow-up. A Cox proportional hazard model will be used to determine if depression/anxiety after PCI increase the risk of cardiovascular events. The impact of antidepression or antianxiety treatment on the cardiac prognosis will be explored as well among the patients with ACS who received the treatment after PCI. ETHICS AND DISSEMINATION: This study has been approved by the ethics committee of the First Affiliated Hospital of Xi'an Jiaotong University (approval number: XJTU1AF2016LSL-036). The results will be published in research articles or conference papers. TRIAL REGISTRATION NUMBER: NCT03057691.