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

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.

Inclusion criteria

• Patient-related:

• Patient must be ≥ 18 years of age
• 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
• (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)]
• Patient with lesions suitable for PCI with a DCB (and/or DES) according to the Instructions for Use
• 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:

• 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
• 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:

• Intolerance or allergy to Paclitaxel and/or the delivery matrix (main ingredient: Iopromide)
• Severe allergy to contrast media
• Recent STEMI (ongoing or < 48 hours after primary PCI and/or has sign of thrombus in lesion(s) to treat)
• NSTEMI hemodynamically unstable
• Known left ventricular ejection fraction of <30%
• Inability to take dual antiplatelet therapy or anticoagulation, or single antiplatelet therapy for at least six months
• 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)
• Patient with concomitant medical illnesses that require cytostatic, radiation therapy or renal replacement therapy
• 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
• Pregnancy or lactation
• Patient under administrative or judicial custody
• Lesion-related:

• Small vessel disease, defined as <3.0 mm of reference vessel diameter by visual estimation
• In-stent restenosis lesions for study lesions
• 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
• Lesions which are untreatable with PCI or other interventional techniques and coronary artery spasm in the absence of a significant stenosis
• Left main disease or aorta-ostial lesion requiring revascularization
• Severely calcified or tortuous vessels precluding DCB or DES application
• Prior Coronary Artery Bypass Graft (CABG)