Drug-Coated Balloon Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention : A Feasibility Study

Drug-eluting stents (DES) represent a significant evolution in the treatment of patients with acute myocardial infarction with ST elevation. However, stent-related adverse events have led to an introduction of drug-coated balloons (DCB) applied particularly to bifurcation lesions, in-stent restenosis and small vessel disease. The aim of this study was to determine whether DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary percutaneous coronary intervention (pPCI). Seventy-five STEMI patients were randomized into DES and DCB groups of 37 and 38 patients, respectively. The study end-points were major adverse cardiac events and the late lumen loss during the 6 months following the pPCI. Reinfarction occurred in 5.4% of patients in the DES and 5.3% of patients in the DCB group after 1 month (risk ratio = 1.03, 95% CI [0.15-6.91], P = 0.98). After 6 months, major adverse cardiac events were reported in 5.4% of patients in the DES group and none in the DCB group (risk ratio = 5.13, 95% CI [0.25-103.42], P = 0.29). Late lumen loss in the DES group was 0.10 ± 0.19 mm and −0.09 ± 0.09 mm in the DCB group (P < 0.05). A DCB-only strategy is safe and feasible in the pPCI setting, and showed good clinical and angiographic outcomes in 6 months follow-up period