Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

Study Overview
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Brief Summary
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To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75 4.0mm).

Detailed Description
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Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.

Official Title
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A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions

Conditions
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Coronary Artery Disease, Drug-coated Balloon

Intervention / Treatment
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* Device: Drug-Coated Balloon
* Device: Sirolimus-Eluting Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years and ≤80 years, regardless of gender; De novo lesion in a native coronary artery; Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia; Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis ≥70% or ≥50% (with evidence of ischemia) and TIMI flow ≥1; The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting); The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up. Exclusion Criteria: Reference vessel diameter <2.75 mm or >4.0 mm; In stent restenosis; Left main lesion, chronic complete occlusion lesion; Ostial lesion ≤2mm from the LM, or bifurcation lesion with branch vessel diameter≥2.5mm; There is a large scale of thrombus in the target vessel, and the thrombus grade >3 after thrombolysis or aspiration; Severe heart failure (NYHA IV); Severe renal failure (GFR<30ml/min) or undergoing hemodialysis treatment; Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal); Patients with vein graft restenosis after bypass or severe heart valve disease; Pregnant or breastfeeding female patients; The life expectancy of the patient is less than 12 months; The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications; Anemia (women's hemoglobin <117g/L, or men's hemoglobin <134g/L), or thrombocytopenia detected before the intervention within 6 months (<100×10⁹/L); Planned to perform non-cardiac surgery within 12 months after index procedure; The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint; Heart transplant patients; Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel; The investigator judged that the patient had poor compliance and could not complete the study as required.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-coated balloon<br>Drug-coated balloon is used to treat coronary artery stenosis lesions and improve myocardial blood flow. | Device: Drug-Coated Balloon<br>* Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.<br>|
| Active Comparator: Sirolimus-Eluting Stent<br>Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions. | Device: Sirolimus-Eluting Stent<br>* Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is <20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization). | During the hospital stay, up to 7 days after PCI | 
| Target lesion failure | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 1 month, 6months follow-up | 
| Patient-oriented composite endpoint | A composite of all-cause mortality, myocardial infarction, and any revascularization | 1 month, 6months,12 months follow-up |