Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion

Major adverse cardiac events at 12 months

Primary endpoint is major adverse cardiac events (MACE is a composite of cardiac death, non-fatal myocardial infarction, target-vessel revascularization and major bleeding \[BARC type 3 to 5\]) at 12 months. 1. Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. 2. Target vessel Revascularization: TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel.

Angiographic and clinical outcomes

* MACE at 12, 24, 36 months * The single components of the primary endpoint after 12, 24, 36 months. Bleeding Academic Research Consortium (BARC) type 2 to 5 bleeding after 12, 24, 36 months.1 (All events will be adjudicated by an independent Critical Events Committee). * Possible, probable, and definite stent thrombosis defined according to the ARC criteria after 12, 24, 36 months. * Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation * Cost-effectiveness of DCB vs. DES after 12, 24, 36 months. * All-cause death ⑥ Stroke (ischemic and hemorrhagic) * Angina severity measured with Seattle Angina Questionnaires at 12, 24 months * Total procedure time, fluoroscopy time, contrast volume, number of stents used ⑨ DAPT duration ⑩ Periprocedural MI rate ⑪ Sex difference in MACE between DCB vs. DES ⑫ Comparison of MACE between DCB vs. DES in DM patients