Why the study?
Concerns remain regarding the long-term safety of DES in STEMI, and DEB could potentially provide similar effectiveness while limiting long-term hazards related to late-acquired stent malapposition and stent thrombosis.
Does a drug-eluting balloon plus bare-metal stent reduce 6-month angiographic in-stent late-luminal loss compared to bare-metal stent alone or drug-eluting stent in STEMI patients?
RCT (n=150)
single-blinded
randomly assigned
Yes
Does a drug-eluting balloon plus bare-metal stent reduce 6-month angiographic in-stent late-luminal loss compared to bare-metal stent alone or drug-eluting stent in STEMI patients?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The drug-eluting balloon and bare metal stent combination induces some morphological changes that are seen with [optical coherence tomography] and acetylcholine testing, but this is insufficient to result in superior angiographic results. The drug-eluting stent is better in all comparisons.”
“Results of the DEB-AMI trial indicate that drug-eluting stents induce more pronounced morphological changes (compared to drug-eluting balloons), resulting in superior angiographical and clinical outcomes with respect to bare metal stents and drug-eluting stents.”
“We really don't know what is the drug uptake, especially with high doses delivered in the setting of ruptured plaque and thrombotic burden, and the pharmacokinetic profile in their presence, and the potential for toxicity that exists, especially when you combine drug elution with a bare metal stent.”
In STEMI patients, DEB followed by BMS failed to show angiographic superiority to BMS alone, while DES remained superior to both strategies.
OBJECTIVES: 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).
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Belkacemi et al. (2012) conducted an RCT in ST-segment elevated acute myocardial infarction (STEMI) (n=150). Drug-eluting balloon (DEB) plus bare-metal stent (BMS) vs. Bare-metal stent (BMS) or drug-eluting stent (DES) was evaluated on 6-month angiographic in-stent late-luminal loss (p=<0.01).
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