Three Vessel Coronary DiseaseNCT05007054
Long-Term Outcomes in Patients With Three-Vessel Disease
An observational study of Three Vessel Coronary Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Three Vessel Coronary Disease
- What is being tested?
- PCI or CABG
- Type of treatment
- Surgery or procedure
- How many people
- 4,300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 6 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with three-vessel coronary disease.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
About this study
Official title: 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.
Read the 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.
- Conditions
- Three Vessel Coronary Disease
- Being tested
- PCI or CABG
- Keywords
- three-vessel coronary disease, percutaneous coronary intervention, coronary artery bypass grafting, medical therapy, clincial outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI or CABGProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PCI or CABG | |
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events (MACCE)
MACCEs were a composite of all-cause death, myocardial infarction (MI), repeat revascularization, or stroke.
Measured: The median follow-up time was 2.4 years.
Secondary outcomes (1)
Cardiac death, MI, repeat revascularization, stroke, or hospitalization for angina pectoris or heart failure
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.
Measured: The median follow-up time was 2.4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 May 2021
- Primary completion1 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Three Vessel Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Guo, MD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007054
- Sponsor's protocol ID
- YJ-KY-FB-2021-10
- Status last verified
- Aug 2021
- First submitted
- 9 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Escaned J, Collet C, Ryan N, De Maria GL, Walsh S, Sabate M, Davies J, Lesiak M, Moreno R, Cruz-Gonzalez I, Hoole SP, Ej West N, Piek JJ, Zaman A, Fath-Ordoubadi F, Stables RH, Appleby C, van Mieghem N, van Geuns RJ, Uren N, Zueco J, Buszman P, Iniguez A, Goicolea J, Hildick-Smith D, Ochala A, Dudek D, Hanratty C, Cavalcante R, Kappetein AP, Taggart DP, van Es GA, Morel MA, de Vries T, Onuma Y, Farooq V, Serruys PW, Banning AP. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. Eur Heart J. 2017 Nov 7;38(42):3124-3134. doi: 10.1093/eurheartj/ehx512.
PubMed 29020367Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet. 2013 Feb 23;381(9867):629-38. doi: 10.1016/S0140-6736(13)60141-5.
PubMed 23439102Head SJ, Davierwala PM, Serruys PW, Redwood SR, Colombo A, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Stahle E, Underwood P, Dawkins KD, Kappetein AP, Mohr FW. Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. Eur Heart J. 2014 Oct 21;35(40):2821-30. doi: 10.1093/eurheartj/ehu213. Epub 2014 May 21.
PubMed 24849105Shiomi H, Morimoto T, Furukawa Y, Nakagawa Y, Tazaki J, Sakata R, Okabayashi H, Hanyu M, Shimamoto M, Nishiwaki N, Komiya T, Kimura T; CREDO-Kyoto PCI/CABG Registry Cohort-2 Investigators. Comparison of Five-Year Outcome of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Triple-Vessel Coronary Artery Disease (from the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2). Am J Cardiol. 2015 Jul 1;116(1):59-65. doi: 10.1016/j.amjcard.2015.03.040. Epub 2015 Apr 7.
PubMed 25956622Xu JJ, Zhang Y, Jiang L, Tian J, Song L, Gao Z, Feng XX, Zhao XY, Zhao YY, Wang D, Sun K, Xu LJ, Liu R, Gao RL, Xu B, Song L, Yuan JQ. Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study. Chin Med J (Engl). 2018 Jan 5;131(1):1-9. doi: 10.4103/0366-6999.221273.
PubMed 29271373Zhao X, Xu L, Jiang L, Tian J, Zhang Y, Wang D, Sun K, Xu B, Zhao W, Hui R, Gao R, Song L, Yuan J. Real-world outcomes of different treatment strategies in patients with diabetes and three-vessel coronary disease: a mean follow-up 6.3 years study from China. Cardiovasc Diabetol. 2021 Jan 11;20(1):16. doi: 10.1186/s12933-020-01193-3.
PubMed 33430864Tsuneyoshi H, Komiya T, Kadota K, Shimamoto T, Sakai J, Hiraoka T, Wada K, Kaneko H, Fujimoto Y, Furuichi Y, Hata R, Jinno T, Tominaga O. Coronary artery bypass surgery is superior to second generation drug-eluting stents in three-vessel coronary artery disease: a propensity score matched analysis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):462-468. doi: 10.1093/ejcts/ezx031.
PubMed 28874027
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Outcomes of Different Treatment Strategies in Patients With Three-Vessel Coronary Disease
- ClinicalTrials.gov ID
- NCT05007054
- Acronym / sponsor ID
- YJ-KY-FB-2021-10
- Conditions
- Three Vessel Coronary Disease
- Keywords
- three-vessel coronary disease, percutaneous coronary intervention, coronary artery bypass grafting, medical therapy, clincial outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,300 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Percutaneous coronary intervention | – | Procedure: PCI or CABGThe 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 | – | Procedure: PCI or CABGThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with three-vessel coronary disease.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI or CABGThe 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. | Procedure or surgery | Coronary artery bypass grafting, Percutaneous coronary intervention |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Results publication: PubMed 29020367Escaned J, Collet C, Ryan N, De Maria GL, Walsh S, Sabate M, Davies J, Lesiak M, Moreno R, Cruz-Gonzalez I, Hoole SP, Ej West N, Piek JJ, Zaman A, Fath-Ordoubadi F, Stables RH, Appleby C, van Mieghem N, van Geuns RJ, Uren N, Zueco J, Buszman P, Iniguez A, Goicolea J, Hildick-Smith D, Ochala A, Dudek D, Hanratty C, Cavalcante R, Kappetein AP, Taggart DP, van Es GA, Morel MA, de Vries T, Onuma Y, Farooq V, Serruys PW, Banning AP. Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. Eur Heart J. 2017 Nov 7;38(42):3124-3134. doi: 10.1093/eurheartj/ehx512.
- Results publication: PubMed 23439102Mohr FW, Morice MC, Kappetein AP, Feldman TE, Stahle E, Colombo A, Mack MJ, Holmes DR Jr, Morel MA, Van Dyck N, Houle VM, Dawkins KD, Serruys PW. Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. Lancet. 2013 Feb 23;381(9867):629-38. doi: 10.1016/S0140-6736(13)60141-5.
- Results publication: PubMed 24849105Head SJ, Davierwala PM, Serruys PW, Redwood SR, Colombo A, Mack MJ, Morice MC, Holmes DR Jr, Feldman TE, Stahle E, Underwood P, Dawkins KD, Kappetein AP, Mohr FW. Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. Eur Heart J. 2014 Oct 21;35(40):2821-30. doi: 10.1093/eurheartj/ehu213. Epub 2014 May 21.
- Results publication: PubMed 25956622Shiomi H, Morimoto T, Furukawa Y, Nakagawa Y, Tazaki J, Sakata R, Okabayashi H, Hanyu M, Shimamoto M, Nishiwaki N, Komiya T, Kimura T; CREDO-Kyoto PCI/CABG Registry Cohort-2 Investigators. Comparison of Five-Year Outcome of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Triple-Vessel Coronary Artery Disease (from the Coronary Revascularization Demonstrating Outcome Study in Kyoto PCI/CABG Registry Cohort-2). Am J Cardiol. 2015 Jul 1;116(1):59-65. doi: 10.1016/j.amjcard.2015.03.040. Epub 2015 Apr 7.
- Results publication: PubMed 29271373Xu JJ, Zhang Y, Jiang L, Tian J, Song L, Gao Z, Feng XX, Zhao XY, Zhao YY, Wang D, Sun K, Xu LJ, Liu R, Gao RL, Xu B, Song L, Yuan JQ. Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study. Chin Med J (Engl). 2018 Jan 5;131(1):1-9. doi: 10.4103/0366-6999.221273.
- Results publication: PubMed 33430864Zhao X, Xu L, Jiang L, Tian J, Zhang Y, Wang D, Sun K, Xu B, Zhao W, Hui R, Gao R, Song L, Yuan J. Real-world outcomes of different treatment strategies in patients with diabetes and three-vessel coronary disease: a mean follow-up 6.3 years study from China. Cardiovasc Diabetol. 2021 Jan 11;20(1):16. doi: 10.1186/s12933-020-01193-3.
- Results publication: PubMed 28874027Tsuneyoshi H, Komiya T, Kadota K, Shimamoto T, Sakai J, Hiraoka T, Wada K, Kaneko H, Fujimoto Y, Furuichi Y, Hata R, Jinno T, Tominaga O. Coronary artery bypass surgery is superior to second generation drug-eluting stents in three-vessel coronary artery disease: a propensity score matched analysis. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):462-468. doi: 10.1093/ejcts/ezx031.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Guo, MD principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Three Vessel Coronary Disease, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebrovascular events (MACCE) (time frame: The median follow-up time was 2.4 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007054, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.