The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design

Abstract

BackgroundThe number of percutaneous coronary interventions (PCI) in China has increased more than 20‐fold over the last decade. Consequently, there is a need for national‐level information to characterize PCI indications and long‐term patient outcomes, including health status, to understand and improve evolving practice patterns. Objectives: This nationwide prospective study of patients receiving PCI is to: (1) measure long‐term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient‐reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient‐ and hospital‐level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. Methods: The China Patient‐centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012–2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in‐hospital outcomes from medical charts, and conducted baseline, 1‐, 6‐, and 12‐month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12‐month follow‐up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. Conclusion: China PEACE Prospective Study of PCI will be the first study to generate novel, high‐quality, comprehensive national data on patients’ socio‐demographic, clinical, treatment, and metabolic/genetic factors, and importantly, their long‐term outcomes following PCI, including health status. This will build the foundation for PCI performance improvement efforts in China. © 2016 The Authors. Catheterization and Cardiovascular Interventions. Published by Wiley Periodicals, Inc.

Comparison of Physician Visual Assessment With Quantitative Coronary Angiography in Assessment of Stenosis Severity in China

“…The design of China PEACE-Prospective PCI Study has been described previously. 14 In brief, it is a national study to assess long-term clinical outcomes, cardiovascular risk factor control, and the appropriate use of PCI procedures. From 2012 to 2013, 4225 consecutive patients undergoing PCI for ischemic heart disease and requiring implantation of at least 1 coronary stent were enrolled at 40 hospitals in 18 provinces in China.…”

“…Specifically, we randomly selected coronary angiograms from patients participating in the China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective PCI Study. 14 Among those lesions treated with PCI, we compared QCA assessment that was performed independently by trained analysts in 2 core laboratories blinded to the clinical readings by site operating physicians.…”

Percutaneous Coronary Intervention in Patients Without Acute Myocardial Infarction in China

“…Details about the design of the China PEACE Prospective Study of PCI have been described previously. 10 In brief, the study consecutively enrolled 5038 patients undergoing PCI from 40 hospitals in 18 provinces in China from December 2012 to August 2014. Participants were eligible if they received PCI for any indication in a participating hospital.…”

Development of local clinical practice guidelines in the real world: an evolving scene in China

“…This recommendation, formulated by expert consensus, is based on the growing epidemic of coronary artery disease (CAD) and exponential increase in CAD mortality rates in China,21 which undoubtedly calls for greater efforts to monitor the overall quality and performance of the high volume of PCI procedures in the real world in order to further understand if clinical practice guidelines are being implemented. The ongoing China Patient-Centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of Percutaneous Coronary Intervention,22 part of the nationwide China PEACE Initiative, is a multicentre prospective cohort study involving 34 tertiary hospitals that aims to evaluate long-term clinical and patient-reported outcomes, adherence to medication for secondary prevention of CAD as well as risk factors in patients following PCI. Also worth highlighting is the nationwide China Acute Myocardial Infarction Registry,23 which was designed to incorporate the three-tier hospital infrastructure in China: province, prefecture and county.…”