Real-World Predictor Factors and Clinical Outcomes in Patients With Major Depressive Disorder Undergoing Percutaneous Coronary Intervention: Rationale and Study Protocol for the PCI CODE Study

Abstract The predictors and clinical outcomes of Percutaneous Coronary Intervention in patients with suspected coronary heart disease with COmorbid major DEpressive disorder (PCI CODE) study employs a prospective, multidisciplinary, observational design to evaluate clinical outcomes post-percutaneous coronary intervention (PCI) between coronary heart disease (CHD) patients with or without major depressive disorder (MDD). This study is registered with ClinicalTrials.gov (NCT03852082). During enrollment, all consecutive individuals aged ≥18 years who are clinically suspected of CHD and scheduled for coronary angiography at Nanjing First Hospital are our observational cohort. After completing the self-rated Patient Health Questionnaire, undergoing a clinical MDD diagnosis by a psychiatrist when indicated, and having CHD confirmed by interventional cardiologists, participants in the PCI arm are stratified into 2 groups: CHD patients with MDD and CHD patients without MDD. The primary composite endpoint is the 1-year and 5-year incidence of major adverse cardiac events including all-cause death, non-fatal myocardial infarction, and any coronary revascularization. The secondary endpoints comprise individual events, including all-cause death, cardiovascular death, non-fatal myocardial infarction, any coronary revascularization, stent thrombosis, in-stent restenosis, cardiac-related rehospitalization, non-cardiac-related rehospitalization, or stroke. The PCI CODE study, which hypothesizes that certain biomarker combinations may correlate with a higher incidence of major adverse cardiac events at 1 and 5 years post-PCI, seeks to identify the key determinants that lead to poorer prognoses following PCI in patients with CHD and comorbid MDD compared to those without MDD.