Author + information
- Received December 19, 2011
- Revision received February 6, 2012
- Accepted February 7, 2012
- Published online June 19, 2012.
- Anouar Belkacemi, MD⁎,
- Pierfrancesco Agostoni, MD, PhD⁎,
- Hendrik M. Nathoe, MD, PhD⁎,
- Michiel Voskuil, MD, PhD⁎,
- ChunLai Shao, MD⁎,
- Eric Van Belle, MD, PhD⁎,
- Thierry Wildbergh, MD⁎,
- Luigi Politi, MD†,
- Pieter A. Doevendans, MD, PhD⁎,
- Giuseppe M. Sangiorgi, MD† and
- Pieter R. Stella, MD, PhD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Dr. Pieter R. Stella, Department of Cardiology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, the Netherlands
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)
This study was funded by a research grant from Eurocor GmbH (Bonn, Germany). The DEB-AMI was a “physician-initiated study.” Eurocor GmbH gave a financial grant to support the research activities (development of the electronic case report form) and provided both centers with drug-eluting balloons. Dr. Stella is a member of the scientific advisory board of Eurocor GmbH. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Belkacemi and Agostoni contributed equally to this work.
- Received December 19, 2011.
- Revision received February 6, 2012.
- Accepted February 7, 2012.
- American College of Cardiology Foundation