Abstract 377: The China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of Percutaneous Coronary Intervention: Study Design

Abstract

Background: The volume of percutaneous coronary intervention (PCI) in China has increased more than 20-fold over the last decade. Consequently, there is a need for national-level information to characterize indications for PCI and its long-term outcomes, including health status improvement, which is the principal goal of PCI in stable patients. Objectives: To conduct a nationwide prospective study of patients receiving PCI and follow them to 1) measure long-term clinical outcomes, patient-reported outcomes (PROs), risk factor control and adherence to medications for secondary prevention; 2) determine patient- and hospital-level factors associated with these outcomes; and 3) assess indications for and appropriateness of the PCI procedures performed. Methods: The China PEACE Prospective Study of PCI, conducted from December 2012 to December 2014, has recruited 5000 consecutive patients undergoing PCI for any indication from 36 representative hospitals across China and followed them for 1-year. The follow-up rate at 12 months was 94%. After obtaining informed consent from each patient, we abstracted details of their medical history, treatments, and in-hospital outcomes from medical charts. We conducted baseline interviews to characterize patient demographics, risk factors, clinical presentation, and healthcare utilization. In addition, we used several validated instruments to measure PROs describing quality of life, symptoms, mood and sleep. The primary outcome, a composite measure of death, myocardial infarction and/or revascularization, was assessed at follow-up interviews conducted at 1-, 6- and 12-months after discharge. In addition, we measured PROs, medication adherence and risk factor control at these interviews. Blood and urine samples were collected at the 1- and 12-month interviews and stored for future analysis. To establish the appropriateness of PCI, the angiograms of 2000 randomly selected patients were reviewed by independent “core” labs in China and the United States. To complement these patient-level data, we surveyed participating hospitals to characterize their facilities, processes and organizational learning culture. Conclusion: This study will generate novel, high-quality, and comprehensive national data characterizing the patient experience after PCI in China.