title: 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.
abstract: OBJECTIVE
  The goal of this study was to compare angiographic, intravascular imaging, and functional parameters, as well as the clinical outcomes of patients treated with drug-eluting balloon (DEB) plus bare-metal stent (BMS) versus BMS versus drug-eluting stent (DES) for ST-segment elevated acute myocardial infarction (STEMI).
  
  
  BACKGROUND
  Concerns remain regarding the long-term safety of DES in STEMI. DEB could provide an attractive alternative in order to achieve potentially similar effectiveness but limiting the long-term hazards related to late-acquired stent malapposition and thus stent thrombosis.
  
  
  METHODS
  In this randomized, international, 2-center, single-blinded, 3-arm study, STEMI patients were randomly assigned to group A: BMS; group B: DEB plus BMS; or group C: DES after successful thrombus aspiration. The primary endpoint was 6-month angiographic in-stent late-luminal loss. Secondary endpoints were in-stent binary restenosis, major adverse cardiac events (MACE: cardiac death, myocardial infarction, target vessel revascularization). In a subgroup of patients, stent (mal)apposition (by optical coherence tomography) and endothelial function (by acetylcholine infusion) was assessed.
  
  
  RESULTS
  Overall, 150 patients were randomized. Procedural success was achieved in 96.7%. In groups A, B, and C, respectively, late-luminal loss was 0.74 ± 0.57 mm, 0.64 ± 0.56 mm, and 0.21 ± 0.32 mm (p < 0.01); binary restenosis was 26.2%, 28.6%, and 4.7% (p = 0.01); and MACE rates were 23.5%, 20.0%, and 4.1% (p = 0.02), respectively. The median percentage [25th to 75th interquartile range] of uncovered and malapposed stent struts per lesion was 0 [0 to 0.35], 2.84 [0 to 6.63], and 5.21 [3.25 to 14.5] (p < 0.01). Significant paradoxical vasoconstriction was seen in groups B and C.
  
  
  CONCLUSIONS
  In STEMI patients, DEB followed by BMS implantation failed to show angiographic superiority to BMS only. Angiographic results of DES were superior to both BMS and DEB. Moreover, DEB before implantation induced more uncovered and malapposed stent struts than BMS, but less than after DES. (Drug-Eluting Balloon in Acute Myocardial Infarction [DEB-AMI]; NCT00856765).
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, the Netherlands.
authors.forename: Anouar
authors.initials: A
authors.lastname: Belkacemi
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Agostoni
authors.forename: Hendrik M
authors.initials: HM
authors.lastname: Nathoe
authors.forename: Michiel
authors.initials: M
authors.lastname: Voskuil
authors.forename: ChunLai
authors.initials: C
authors.lastname: Shao
authors.forename: Eric
authors.initials: E
authors.lastname: Van Belle
authors.forename: Thierry
authors.initials: T
authors.lastname: Wildbergh
authors.forename: Luigi
authors.initials: L
authors.lastname: Politi
authors.forename: Pieter A
authors.initials: PA
authors.lastname: Doevendans
authors.forename: Giuseppe M
authors.initials: GM
authors.lastname: Sangiorgi
authors.forename: Pieter R
authors.initials: PR
authors.lastname: Stella
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D002857:Chromium; D003035:Cobalt; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006329:Heart Conduction System / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D017239:Paclitaxel; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002857:Chromium; D003035:Cobalt; D017239:Paclitaxel