Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

Study Overview
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Brief Summary
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This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.

Official Title
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Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease

Conditions
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Coronary Artery Disease, Multi Vessel Coronary Artery Disease

Intervention / Treatment
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* Device: drug-coated balloon
* Device: drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 or older Multivessel coronary artery disease patients requiring coronary intervention Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm Capable of understanding the risks and benefits of participating in the study and providing informed consent Exclusion Criteria: Incapable of voluntarily providing informed consent Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents Cardiogenic shock or cardiac arrest patients Patients with severe left ventricular systolic dysfunction (ejection fraction <30%) Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention Patients with severe valvular heart disease requiring open heart surgery Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hybrid strategy<br>The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion. | Device: drug-coated balloon<br>* For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.<br>Device: drug-eluting stent<br>* When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.<br>|
| DES only<br>The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion. | Device: drug-eluting stent<br>* When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reclassification rate of the treatment strategy | The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease. | At the time of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy | Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy | At the time of procedure | 
| Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy | Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy | At the time of procedure | 
| Cardiovascular death | Cardiovascular death | 1 year | 
| All-cause death | All-cause death | 1 year | 
| Non-fatal myocardial infarction (MI) | Non-fatal myocardial infarction (MI) | 1 year | 
| Target vessel MI excluding periprocedural MI | Target vessel MI excluding periprocedural MI | 1 year | 
| Target vessel MI including periprocedural MI | Target vessel MI including periprocedural MI | 1 year | 
| Clinically indicated target lesion revascularization | Clinically indicated target lesion revascularization | 1 year | 
| Clinically indicated target vessel revascularization | Clinically indicated target vessel revascularization | 1 year | 
| Any revascularization | Any revascularization | 1 year | 
| Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition | Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition | 1 year | 
| Cardiovascular death or target vessel MI | Cardiovascular death or target vessel MI | 1 year | 
| All-cause death or non-fatal MI | All-cause death or non-fatal MI | 1 year | 
| Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization | Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization | 1 year | 
| Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization | Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization | 1 year | 
| Cardiovascular death, target vessel MI, or vessel or stent thrombosis | Cardiovascular death, target vessel MI, or vessel or stent thrombosis | 1 year | 
| All-cause death, non-fatal MI, or clinically indicated target vessel revascularization | All-cause death, non-fatal MI, or clinically indicated target vessel revascularization | 1 year | 
| Major bleeding events (BARC type 2, 3, or 5) | Major bleeding events (BARC type 2, 3, or 5) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Multivessel coronary artery disease, Percutaneous coronary intervention, Drug-coated balloon, Drug-eluting stent