Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— REVERSE  

Official title:

Randomised Trial of Drug-Coated Balloon Versus Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05846893
• Other study ID #: AAG-G-H-2124
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: September 2028

Study information

• Verified date: May 2024
• Source: B. Braun Medical Industries Sdn. Bhd.
• Contact: Hooi Sian Eng, Ph.D
• Phone: +60-12-428-2880
• Email: hooi.eng[@]bbraun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

Description:

Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease.

Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation).

The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1436
• Est. completion date: September 2028
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient-related:

1. Patient must be = 18 years of age

2. Patient is able to verbally confirm understanding of the study aim, risks, benefits, and treatment alternatives of receiving DCB or DES and he/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure

3. (i) Clinical evidence of angina, and/or (ii) an abnormal functional study demonstrating myocardial ischemia due to the target lesion(s), or (iii) acute coronary syndrome [unstable angina or non-ST-elevation myocardial infarction (NSTEMI) or uneventful STEMI (= 48 hours after primary PCI and no sign of thrombus in lesion(s) to treat)]

4. Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use

5. Patient is able to comply with the study protocol and agrees to undergo the clinical follow-up of 30 days, 6 months, 12 months, 24 months, and 36 months

• Lesion-related:

1. Presence of significant de novo large vessel coronary artery disease (reference vessel diameter =3.0 mm by visual estimation) with either = 70% diameter stenosis or intermediate = 50% to <70% diameter stenosis with abnormal functional test or symptom of ischemia

2. Successful lesion preparation. For randomisation, the lesion must satisfy the following criteria after optimal balloon angioplasty: no flow-limiting dissection (TIMI=3), and residual stenosis is = 30%

• Multivessel disease with two or more vessels showing diameter stenosis of 50% or more is not an exclusion as long as it fulfills all study's eligibility criteria.

• In diffuse lesion, inclusion is possible if the proximal reference vessel diameter is 3.0 mm or more.

Exclusion Criteria:

• Patient-related:

1. Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient:

Iopromide)

2. Severe allergy to contrast media

3. Recent STEMI (ongoing or < 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)

4. NSTEMI hemodynamically unstable

5. Known left ventricular ejection fraction of <30%

6. Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months

7. Non-cardiac co-morbid conditions that may result in protocol non-compliance and inability of patient to complete the study (per the site investigator's medical judgment)

8. Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy

9. Patient who is currently/ planning to participate in another clinical trial when such participation could confound the treatment or outcomes of this study, except for observational registry

10. Pregnancy or lactation

11. Patient under administrative or judicial custody

• Lesion-related:

1. Small vessel disease, defined as <3.0 mm of reference vessel diameter by visual estimation

2. In-stent restenosis lesions for study lesions

3. Patient will be excluded if meet any of the following angiographic exclusion criteria after lesion preparation:

(i) Flow limiting dissection with TIMI flow < III (ii) Residual diameter stenosis >30%

• The case of persistent ischemic symptoms/signs is up to the operator's decision

4. Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis

5. Left main disease or aorta-ostial lesion requiring revascularization

6. Severely calcified or tortuous vessels precluding DCB or DES application

7. Prior Coronary Artery Bypass Graft (CABG)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• De Novo Stenosis
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• SeQuent® Please NEO drug-coated balloon catheter
Treatment of coronary artery disease with SeQuent® Please NEO for de novo lesions in native large coronary arteries
• Current-generation drug-eluting stent
Treatment of coronary artery disease with current-generation drug-eluting stent for de novo lesions in native large coronary arteries

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon	Gyeongsangnam-do
Korea, Republic of	Kangwon National University Hospital	Chuncheon	Gangwon-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Ulsan University Hospital	Donggu	Ulsan
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggi-do
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Malaysia	Sultan Idris Shah Serdang Hospital	Kajang	Selangor
Malaysia	Queen Elizabeth II Hospital	Kota Kinabalu	Sabah
Malaysia	Cardiac Vascular Sentral Kuala Lumpur	Kuala Lumpur
Malaysia	National Heart Institute Malaysia	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur
Malaysia	Sarawak Heart Center	Kuching	Sarawak
Singapore	Tan Tock Seng Hospital	Novena
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	National Heart Centre Singapore	Singapore
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (6)

Lead Sponsor	Collaborator
B. Braun Medical Industries Sdn. Bhd.	B. Braun Melsungen AG, European Cardiovascular Research Center, Seoul National University Hospital, Ulsan University Hospital, Universität des Saarlandes

Countries where clinical trial is conducted

Korea, Republic of,  Malaysia,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Late lumen loss (LLL)	LLL is defined as: the minimal lumen diameter (MLD) immediately after PCI minus the MLD at the follow-up.	At 9-12 months post-procedure
Other	Percentage of diameter stenosis		At 9-12 months post-procedure
Other	Minimal lumen diameter		At 9-12 months post-procedure
Other	Binary restenosis		At 9-12 months post-procedure
Other	Quality of life analysis	Quality of life analysis using EQ-5D-5L questionnaire	After 12, 24, and 36 months
Other	Incidence of angina		At baseline and 12 months
Other	Dual Antiplatelet Therapy (DAPT) duration		At 30 days, 6 months, and 12 months
Other	Comparison of NACE between DCB vs. DES in sex difference, diabetes mellitus, and multivessel disease patients		At 1 year
Primary	Net Adverse Clinical Event (NACE)	Net adverse clinical event (NACE): a composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, or major bleeding (BARC type 3 to 5)	At 1 year
Secondary	All-cause death		At 12, 24, and 36 months
Secondary	Non-fatal myocardial infarction		At 12, 24, and 36 months
Secondary	Clinically driven target vessel revascularization		At 12, 24, and 36 months
Secondary	Major bleeding (BARC type 3 to 5)		At 12, 24, and 36 months
Secondary	Cardiac death		At 12, 24, and 36 months
Secondary	Target vessel myocardial infarction		At 12, 24, and 36 months
Secondary	Periprocedural myocardial infarction		At 12, 24, and 36 months
Secondary	Target lesion revascularization		At 12, 24, and 36 months
Secondary	Stent/lesion thrombosis in treated lesion defined according to the Academic Research Consortium-2 (ARC-2) criteria		At 12, 24, and 36 months
Secondary	Rehospitalization related to study endpoints	Rate of hospitalization related to study endpoints	At 30 days, 12 months, 24 months, and 36 months
Secondary	Stroke (ischemic and hemorrhagic)	Number of participants with stroke (ischemic and hemorrhagic)	At 12, 24, and 36 months
Secondary	Total angioplasty procedure time		During the index procedure
Secondary	Fluoroscopy time of the angioplasty procedure		During the index procedure
Secondary	Contrast volume of the angioplasty procedure		During the index procedure
Secondary	Number of devices (DCB/ DES) used for PCI treatment		During the index procedure