Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

Completed

• Conditions: Coronary Heart Disease

• Registration Number: NCT02313038
• Lead Sponsor: China National Center for Cardiovascular Diseases

Brief Summary

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.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-05
• Study First Submitted QC: 2014-12-07
• Study First Posted: 2014-12-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-27
• Last Update Posted: 2015-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6023

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of major adverse cardiac events (MACE)	1 year	Composite of major adverse cardiac events (MACE) including death, myocardial infarction, and/or revascularization.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fuwai hospital; 🇨🇳 Beijing, Beijing, China