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DEB followed by BMS implantation not superior to BMS alone in patients with STEMI
In patients with STEMI, researchers concluded that the use of drug-eluting balloon followed by bare metal stent implantation in primary percutaneous intervention did not show angiographic superiority to bare metal stent only.
In a randomized, international, two-center, single blind, three-arm study, researchers compared 6-month angiographic, intravascular imaging, functional parameters and clinical outcomes of 150 patients with STEMI treated with a drug-eluting balloon (DEB) plus bare metal stent, BMS alone or drug-eluting stent after successful thrombus aspiration.
In these patients, late luminal loss was 0.74 mm for the BMS group, 0.64 mm for the DEB plus BMS group and 0.21 mm for the DES group (P<.01). Results also indicated that binary restenosis was 26.2%, 28.6% and 4.7%, respectively (P=.01), and rates of major adverse CV events were 23.5%, 20% and 4.1%, respectively (P=.02).
Treatment with DEB showed significantly more combined uncovered and malapposed struts per lesion compared with BMS (average percentage, 2.84% vs. 0%). However, treatment with DEB showed less combined uncovered and malapposed struts when compared with patients treated with DES (2.84% vs. 5.21%).
“Local drug delivery with a DEB to the culprit plaque of a STEMI at the moment of highest inflammation remains an attractive treatment opportunity. Nevertheless, the DIOR DEB (Eurocor, Bonn, Germany) in combination with BMS failed to show angiographic superiority to BMS alone, and with more evident morphological and functional changes on optical coherence tomography (OCT) and acetylcholine testing, respectively. These morphological changes suggest a drug effect, however, one that is insufficient to result in superior angiographic results. Finally, the angiographic results of DES were superior to both BMS and DEB; however, DES induced delayed healing and endothelial dysfunction,” study researcher Anouar Belkacemi, MD, of the department of cardiology, University Medical Center Utrecht in the Netherlands, and colleagues wrote.
Disclosure: 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 researchers report no relevant financial disclosures.