Long-Term Outcomes in Patients With Three-Vessel Disease

August 9, 2021 updated by: The First Affiliated Hospital of Dalian Medical University

Long-Term Outcomes of Different Treatment Strategies in Patients With Three-Vessel Coronary Disease

The long-term outcome of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and medical therapy (MT) alone for triple-vessel disease (TVD) patients is controversial. The aim of this study is to evaluate the long-term outcome of TVD patients among these three treatment strategies, to find out the most appropriate treatment methods for these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study was a retrospective observational study. Patients who underwent diagnostic coronary angiography from January 2013 to December 2018 were eligible for this study if they had three-vessel disease, which was defined as more than 50% stenosis in three major epicardial coronary arteries, left anterior descending, left circumflex, and right coronary artery. There were no pre-specified exclusion criteria. The choice of PCI, CABG, or MT was mainly followed the guidelines and based on clinical and angiographic features, physical condition (comorbidities, malignant tumor, frailty, etc.), complexity, and was discussed by physicians and surgeons, combined with the choice of patients. The PCI strategy and stent type were left to the physician's discretion.

The primary endpoint were major adverse cardiac and cerebrovascular events (MACCE), which were a composite of all-cause death, myocardial infarction (MI), repeat revascularization, or stroke. Clinical information of in-hospital outcome was obtained by reviewing medical records. Follow-up was completed by survey via telephone, letter, or hospital visit. All patients had at least one follow-up visit.

Study Type

Observational

Enrollment (Actual)

4300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • The First Affiliated Hospital of Dalian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with three-vessel coronary disease.

Description

Inclusion Criteria:

  • Patients were diagnosed as having three-vessel disease (defined as angiographic stenosis of ≥ 50% in all three main epicardial coronary arteries, with or without left main artery involvement) and age >18 years.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Percutaneous coronary intervention
The PCI performed following current standard guidelines. All patients were pre-treated with aspirin and clopidogrel before catheterization. Thereafter, heparin (70-100 IU/kg) was administered before PCI, however, the use of glycoprotein IIb/IIIa inhibitors was at the physician's discretion. Dual-antiplatelet medication was administered to the patients after PCI for at least 12 months.
Procedure: PCI or CABG
The PCI performed following current standard guidelines. All patients were pre-treated with aspirin and clopidogrel before catheterization. Thereafter, heparin (70-100 IU/kg) was administered before PCI, however, the use of glycoprotein IIb/IIIa inhibitors was at the physician's discretion. Dual-antiplatelet medication was administered to the patients after PCI for at least 12 months. For CABG, the left internal mammary artery was routinely used to graft to the left anterior descending artery and completed by venous grafts to other coronary branches with standard bypass techniques. The procedure was performed by surgeons experienced in on-pump or of-pump surgery at the operator's discretion.
Coronary artery bypass grafting
The left internal mammary artery was routinely used to graft to the left anterior descending artery and completed by venous grafts to other coronary branches with standard bypass techniques. Te procedure was performed by surgeons experienced in onpump or of-pump surgery at the operator's discretion.
Procedure: PCI or CABG
The PCI performed following current standard guidelines. All patients were pre-treated with aspirin and clopidogrel before catheterization. Thereafter, heparin (70-100 IU/kg) was administered before PCI, however, the use of glycoprotein IIb/IIIa inhibitors was at the physician's discretion. Dual-antiplatelet medication was administered to the patients after PCI for at least 12 months. For CABG, the left internal mammary artery was routinely used to graft to the left anterior descending artery and completed by venous grafts to other coronary branches with standard bypass techniques. The procedure was performed by surgeons experienced in on-pump or of-pump surgery at the operator's discretion.
Medical therapy
Patients with neither PCI nor CABG treatment were allocated to the MT alone group. For medical therapy, antiplatelet medication, statins, renin-angiotensin system blockade, β-blockers, and nitrate were used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: The median follow-up time was 2.4 years.
MACCEs were a composite of all-cause death, myocardial infarction (MI), repeat revascularization, or stroke.
The median follow-up time was 2.4 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death, MI, repeat revascularization, stroke, or hospitalization for angina pectoris or heart failure
Time Frame: The median follow-up time was 2.4 years.
Cardiac death was considered to be of cardiac origin cause could be established. MI was defined as recurrent symptoms with new electrocardiographic changes compatible with MI or cardiac markers at least twice the upper limit of normal. Repeat revascularization was defined as either PCI or CABG in the vessel for any reasons. Stroke was defined as ischemic or hemorrhagic stroke either occurring during hospitalization or requiring hospitalization for symptoms. Hospitalization for angina pectoris or heart failure heart failure was defined as hospitalization because of worsening angina pectoris or heart failure requiring intravenous drug therapy.
The median follow-up time was 2.4 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Lei Guo, MD, The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 6, 2021

Study Registration Dates

First Submitted

August 9, 2021

First Submitted That Met QC Criteria

August 9, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJ-KY-FB-2021-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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