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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02634086

Collaborator

(none)

10,000

Enrollment

Location

176

Duration (Months)

56.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Stenosis Myocardial Ischemia

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Apr 1, 2004

Anticipated Primary Completion Date :

Apr 1, 2016

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

All-cause mortality [Through study completion, an average of 5 year]
The mortality due to any cause

Secondary Outcome Measures

Major adverse cardiac and cerebrovascular event [Through study completion, an average of 5 year]
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
Myocardial infarction [Through study completion, an average of 5 year]
The Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction
Stroke [Through study completion, an average of 5 year]
The incidence rate of stroke, including cerebral infarction and hemorrhage
Repeat revascularization [Through study completion, an average of 5 year]
The incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.