Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)

Patients with ACS and indications for percutaneous coronary intervention were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a Zotarolimus-Eluting Coronary Stent(ZES) . 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, 12 months, and 24 months after discharge, and coronary angiography and FFR measurements will be carried out at 9 months.The primary objective is to show non-inferiority of DCB versus drug-eluting stent(DES) regarding the functional assessment of target lesion by FFR at 9 months.

Inclusion criteria

• Age≥18 Years and <80 years;
• ACS patients eligible for percutaneous coronary intervention;
• Successful preparation is defined as ≤ 30% residual stenosis with Thrombolysis in Myocardial Infarction (TIMI) Grade III flow and not evidence of type C-F dissection;
• Vessel diameter from 2.25mm-4.0 mm ;
• Lesion length ≤ 28 mm;
• A single culprit lesion or 1 lesion in each of two vessels ;
• Eligible for enrollment and provide written informed consent.

Exclusion criteria

Clinical Exclusion Criteria：

• Stable angina or asymptomatic myocardial ischemia;
• Cardiogenic shock or requiring mechanical support for breathing and circulation;
• Hemodynamically unstable tachyarrhythmia or bradyarrhythmia;
• Plan to perform cardiac surgery or non-cardiac surgery within 24 months of percutaneous coronary intervention;
• A history of stroke within 6 months;
• History of severe renal insufficiency;
• Life expectancy < 12 months;
• Pregnant women;
• Allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, and paclitaxel, patients with systemic lupus erythematosus or other systemic immune diseases;
• Patients not suitable for enrollment considered by researcher;
• Currently participating in another trial before reaching the primary endpoint;
• Inability to provide informed consent. Image Exclusion Criteria

• Chronic total occlusion (CTO); 2. Left main lesion; 3. Bifurcation lesions treated with double stents; 4. Moderate to severe distortion, angulation or severe calcification lesions; 5. Coronary artery graft stenosis; 6. In-stent restenosis; 7. To be re-hospitalized for the other scheduled PCI treatment; 8. Myocardial bridge at the target lesion.