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

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT02634086

2010CB732601

Details and patient eligibility

About

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).

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has coronary angiography confirmed triple-vessel disease.
2. Subject is ≥ 18 years of age at the time of inclusion.
3. 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

1. Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
2. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
3. Subjects with no way contact by telephone for follow-up.

Trial design

10,000 participants in 3 patient groups

Percutaneous coronary intervention

Description:

Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention.

Coronary artery bypass graft

Description:

Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft.

Optimal medication therapy

Description:

Patients with triple-vessel coronary artery disease underwent optimal medication therapy only.