In STEMI patients, DEB plus BMS failed to show angiographic superiority to BMS only for 6-month late-luminal loss (0.64 vs 0.74 mm), while DES was superior to both (0.21 mm, P<0.01).
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?
In STEMI patients, DEB followed by BMS failed to show angiographic superiority to BMS alone, while DES remained superior to both strategies.
Absolute Event Rate: 0.64% vs 0.74%
p-value: p=<0.01
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).
“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.”
Belkacemi et al. (Thu,) conducted a 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). In STEMI patients, DEB plus BMS failed to show angiographic superiority to BMS only for 6-month late-luminal loss (0.64 vs 0.74 mm), while DES was superior to both (0.21 mm, P<0.01).