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Clinical Trial2017 Dec;354(6):553-560

JOURNAL：Am J Med Sci. Article Link

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

Gobić D, Tomulić V, Lulić D et al. Keywords: Angioplasty; Balloon dilation; Coronary; Drug-eluting stents; Myocardial infarction; Percutaneous coronary intervention

ABSTRACT


BACKGROUND - 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 a DCB-only strategy has a similar safety profile and equal angiographic and clinical outcomes to DES implantation in primary percutaneous coronary intervention (pPCI).


MATERIALS AND METHODS - Seventy-five patients with acute myocardial infarction with ST elevation were randomized into DES and DCB groups of 37 and 38 patients, respectively. The study end-points were major adverse cardiac events and late lumen loss during the 6 months following the pPCI.


RESULTS - 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 ± 0.19mm and -0.09 ± 0.09mm in the DCB group (P < 0.05).


CONCLUSIONS - A DCB-only strategy is safe and feasible in the pPCI setting and showed good clinical and angiographic outcomes in a 6-month follow-up period.


Copyright © 2017 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.


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