Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Assessment of Efficacy and Safety of Drug Eluting Stents

Conditions
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Coronary Heart Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary heart disease, Percutaneous Coronary Intervention, Drug Eluting Stents