Long-Term Outcomes in Patients With Three-Vessel Disease

Completed

• Conditions: Three Vessel Coronary Disease
• Interventions: Procedure: PCI or CABG

• Registration Number: NCT05007054
• Lead Sponsor: The First Affiliated Hospital of Dalian Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2021-05-01
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-06
• Study First Submitted: 2021-08-09
• Study First Submitted QC: 2021-08-09
• Last Update Submitted: 2021-08-09
• Study First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Percutaneous coronary intervention	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.
Coronary artery bypass grafting	PCI or 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. Te procedure was performed by surgeons experienced in onpump or of-pump surgery at the operator's discretion.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cardiac death, MI, repeat revascularization, stroke, or hospitalization for angina pectoris or heart failure	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Dalian Medical University; 🇨🇳 Dalian, Liaoning, China