Comparing Drug-Coated Balloon and Drug-Eluting Stent for Treating Acute ST-Elevation Myocardial Infarction STEMI in a Randomized Multicenter Trial

What this Trial Is About

Researchers are evaluating the use of drug-coated balloons DCB compared to drug-eluting stents DES in percutaneous coronary intervention PCI for patients experiencing ST-elevation myocardial infarction STEMI. The study aims to compare these two treatments following successful preparation of the blocked artery and confirmation that all entry criteria are met. This randomized controlled trial is conducted internationally and sponsored by the Institute of Cardiovascular Diseases, Vojvodina. Patients will be randomly assigned to receive either a paclitaxel-coated balloon delivering 3.0-3.5 micrograms per square millimeter or a second-generation drug-eluting stent. The DCB group may receive a stent as a backup if the balloon treatment result is unsatisfactory. Standard implantation techniques will be used for the DES group. Randomization occurs after confirming the artery is suitable for treatment. Participants will be followed for up to two years to assess a device-oriented composite endpoint DoCE and other outcomes including bleeding complications, target vessel revascularization, and vessel failure. Evaluations will occur at one year and two years after treatment. The study does not use blinding, and participants will be monitored for safety and treatment effectiveness during this period.

Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial