Long-Term Outcomes in Patients With Three-Vessel Disease

Sponsor

The First Affiliated Hospital of Dalian Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT05007054

Collaborator

(none)

4,300

Enrollment

Location

3.2

Actual Duration (Months)

1349.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Three Vessel Coronary Disease	Procedure: PCI or CABG

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 Design

Study Type:

Observational

Actual Enrollment :

4300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Aug 1, 2021

Actual Study Completion Date :

Aug 6, 2021

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

Percutaneous coronary intervention

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

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.