Prospective Assessment of Efficacy and Safety of Drug Eluting Stents (PEACE-DES)

Coronary heart disease (CHD) pose a serious health threat to population. PCI using drug eluting stents (DES), as a well-proved and booming measure in CHD management, is invasive and of high cost, however the knowledge about the real-life DES use and the efficacy and safety in China is limited. By consecutively recruiting first-ever PCI patients in 30 geographically representative highest-rank hospitals, this study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease

Detailed Description

In this study, 6000 patients who underwent the first-ever drug eluting stents (DES) deployment during the index hospitalization will be consecutively recruited in 30 tertiary hospitals scattered all over China. At study entry, participants will be interviewed during their index hospitalization, to collect information about symptoms, functioning, quality of life, and medical care. Demographic characteristics, medical history, clinical features, diagnostic tests, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained professional abstractors. And CAG imaging will be reviewed by national and international expert panels. At 1 month, 6 month, and 12 month after discharge, participants will return to the clinic for follow up visits, a face-to-face interview will be conducted to get information about clinical events, symptoms, functioning, quality of life, and medical care during the recovery period. At 1-Month and 12-Month follow-up visit, blood and urine sample will be collected. Participants' blood samples will be stored for future biologic and genetic studies. This study will examine the prognosis in groups with different brands of DES, and various real-life factors, that may affect patients recovery after the procedure. Evidence for clinical practice and health resource allocation will be established based on the findings, to improve patients outcomes in future finally.

• Study Type: Observational
• Enrollment (Actual): 6023

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent the first-ever DES deployment during the index hospitalization were consecutively recruited.

Description

Inclusion Criteria:

• At least one DES is implanted successfully in the procedure
• Only one of the five major brands of DES is used in the procedure

Exclusion Criteria:

• Prior stent implantation history

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of major adverse cardiac events (MACE)	Composite of major adverse cardiac events (MACE) including death, myocardial infarction, and/or revascularization.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint	Safety endpoint: stent thrombosis	1 year
Efficacy composite endpoints	Efficacy composite endpoints, including cardiac death, myocardial infarction (not clearly attributable to a nontarget vessel), and/or target lesion revascularization	1 year
Status of general health	Status of general health (SF-12)	1 year
Quality of life	Quality of life (EQ-5D)	1 year
Symptoms status	Symptoms status (SAQ)	1 year
Cost-effectiveness	Cost-effectiveness ratio: marginal cost (direct and indirect) per QALY increase, with homebred DES as the reference group	1 year

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Harlan M Krumholz, MD, SM, Yale University; Principal Investigator: Lixin Jiang, MD, PhD, China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: December 7, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 27, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Coronary heart disease; Drug Eluting Stents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: MOST-2013BAI17B00