Drug eluting balloon with BMS not superior to BMS alone – DEB-AMI Trial

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DEB-AMI Trial compared bare metal stents (BMS) with drug eluting stents (DES) and the combination of drug eluting balloon (DEB) with BMS in the setting of acute myocardial infarction and primary angioplasty [Belkacemi A et al. First Results of the DEB-AMI (Drug Eluting Balloon in Acute ST-Segment Elevation Myocardial Infarction) Trial. A Multicenter Randomized Comparison of Drug-Eluting Balloon Plus Bare-Metal Stent Versus Bare-Metal Stent Versus Drug-Eluting Stent in Primary Percutaneous Coronary Intervention With 6-Month Angiographic, Intravascular, Functional, and Clinical Outcomes. J Am Coll Cardiol, 2012; 59:2327-2337]. This was a randomized international trial involving two centers, with three arms and single-blinded allocation. Randomization was done after successful thrombus aspiration of STEMI (ST elevation myocardial infarction) patients. Six month angiographic in-stent lumen loss was the primary end point. Binary restenosis and major adverse cardiac events (MACE): cardiac death, myocardial infarction and target vessel revascularisation (TLR) were the secondary end points. A sub group of patients underwent optical coherence tomography (OCT) for assessment of stent apposition. Endothelial function was also assessed in a subgroup by acetyl choline infusion. Late lumen loss was most for BMS and least for DES. Though the late lumen loss was lesser than BMS for drug eluting balloon application followed by BMS implantation, the difference was not sufficient to demonstrate superiority. Uncovered and malapposed stent struts were most with DES and least with BMS and intermediate with drug eluting balloon inflation followed by BMS implantation.

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