Long-Term Outcomes in Patients With Three-Vessel Disease
NCT ID: NCT05007054
Last Updated: 2021-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
4300 participants
OBSERVATIONAL
2021-05-01
2021-08-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)
NCT02634086
PEACE Prospective Study of Patients With Three-vessel Disease
NCT01617785
Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease
NCT01035034
China PEACE-Prospective 3-vessel Disease Study
NCT01625312
Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves
NCT07122050
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Dalian Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lei Guo, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Dalian Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Mohr 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.
Head 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.
Shiomi 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.
Xu 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.
Zhao 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.
Tsuneyoshi 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YJ-KY-FB-2021-10
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.