Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease (DCB-MVD)

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Device: drug-coated balloon; Device: drug-eluting stent

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Bon-Kwon Koo, MD, PhD; Phone Number: +82-2-2072-2062; Email: bkkoo@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Bon-Kwon Koo
    • Contact: Bon-Kwon Koo, MD, PhD; Phone Number: +82-2-2072-2062; Email: bkkoo@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with multivessel coronary artery disease who undergo coronary intervention

Description

Inclusion Criteria:

1. Age 19 or older

2. 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
3. Capable of understanding the risks and benefits of participating in the study and providing informed consent

Exclusion Criteria:

1. Incapable of voluntarily providing informed consent
2. Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
3. Cardiogenic shock or cardiac arrest patients
4. Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
5. Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
6. Patients with severe valvular heart disease requiring open heart surgery
7. Pregnant or lactating women

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hybrid strategy; 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; 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.; Device: drug-eluting stent; 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.
DES only; The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.	Device: drug-eluting stent; 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.

What is the study measuring?

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
Cardiovascular death	Cardiovascular death	1 year
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
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

Collaborators and Investigators

• Sponsor: Bon-Kwon Koo
• Collaborators: Seoul St. Mary's Hospital; Chonnam National University Hospital; Seoul National University Hospital; Ulsan University Hospital; Korea University Anam Hospital; Seoul National University Bundang Hospital; Gachon University Gil Medical Center; Ajou University School of Medicine; Daegu Catholic University Medical Center; Kyungpook National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Inje University; Gyeongsang National University Hospital; Yeungnam University Hospital; Gangnam Severance Hospital; Severance Hospital; Ewha Womans University Mokdong Hospital; Keimyung University Dongsan Medical Center; Kyung Hee University Hospital at Gangdong; Soonchunhyang University Hospital; St Vincent's Hospital; Hanyang University Seoul Hospital; Jeju National University Hospital; Wonju Severance Christian Hospital; Kyunghee University Medical Center; KangWon National University Hospital; Chosun University Hospital; Uijeongbu St. Mary Hospital; Inje University Ilsan Paik Hospital; Ulsan Medical Center; Chung-Ang University Gwangmyeong Hospital; Bucheon Sejong Hospital; Uijeongbu Eulji Medical Center, Eulji University
• Investigators: Study Chair: Bon-Kwon Koo, MD, PhD, +82-2-2072-2062

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease; Percutaneous coronary intervention; Drug-eluting stent; Drug-coated balloon; Multivessel coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2306-138-1440

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No