Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)

Study Overview
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Brief Summary
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The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).

Detailed Description
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About 10,000 participants will be enrolled into this retrospective study. Study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. Detailed procedural data will be obtained by the study coordinator and local principal investigator. These data will be entered into the electronic data capture system. Participants will have telephone follow-up interviews conducted by the centralized follow-up center at Fuwai Hospital.

Official Title
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Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)

Conditions
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Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has coronary angiography confirmed triple-vessel disease. Subject is ≥ 18 years of age at the time of inclusion. Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status). Exclusion Criteria: Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy. Subjects with no way contact by telephone for follow-up.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous coronary intervention<br>Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention. | |
| Coronary artery bypass graft<br>Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft. | |
| Optimal medication therapy<br>Patients with triple-vessel coronary artery disease underwent optimal medication therapy only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | The mortality due to any cause | Through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular event | The incidence rate of major adverse cardiac and cerebrovascular event (MACCE), which is a combination of all-cause death, myocardial infarction, stroke and repeat revascularization | Through study completion, an average of 5 year | 
| Myocardial infarction | The Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction | Through study completion, an average of 5 year | 
| Stroke | The incidence rate of stroke, including cerebral infarction and hemorrhage | Through study completion, an average of 5 year | 
| Repeat revascularization | The incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization | Through study completion, an average of 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Percutaneous coronary intervention, Coronary artery bypass graft, Medication therapy