Drug Eluting Balloon - A Single Center Study

Gal Sella The Heart Institute, Kaplan Medical Center, Rehovot, Israel Gera Gandelman The Heart Institute, Kaplan Medical Center, Rehovot, Israel Nikolay Teodorovich The Heart Institute, Kaplan Medical Center, Rehovot, Israel Leon Poles The Heart Institute, Kaplan Medical Center, Rehovot, Israel Oscar H. Kracoff The Heart Institute, Kaplan Medical Center, Rehovot, Israel Michael Yonash The Heart Institute, Kaplan Medical Center, Rehovot, Israel Oded Ayzenberg The Heart Institute, Kaplan Medical Center, Rehovot, Israel Dan Haberman The Heart Institute, Kaplan Medical Center, Rehovot, Israel Igor Volodarski The Heart Institute, Kaplan Medical Center, Rehovot, Israel Sarah Shimoni The Heart Institute, Kaplan Medical Center, Rehovot, Israel Valery Meledin The Heart Institute, Kaplan Medical Center, Rehovot, Israel Ayala Shaniv The Heart Institute, Kaplan Medical Center, Rehovot, Israel Jacob George The Heart Institute, Kaplan Medical Center, Rehovot, Israel

Background: Drug eluting balloon (DEB) is typically used for treatment the in-stent restenosis (ISR) and the de-novo lesions. Main advantages of this approach over the use of DES include a more homogeneous drug distribution which does not require foreign material implantation.

Patients and Methods: A retrospective single center study. We identified 294 patients who underwent percutaneous coronary intervention (PCI) with DEB during 2012-2017 at our institution: 181 patients received DEB-treatment for de-novo lesions (de-novo group, 61.6%) and 113 for ISR (ISR group, 38.4%). Demographic, clinical and procedural data was collected from the Patient Medical Records and compared between the two groups using univariate analyses.

Results: The two groups had no significant differences in baseline clinical characteristics except incidence of female gender, dyslipidemia and renal failure in patients with ISR than in de-novo lesion patients (15.5% vs 28.3%, p=0.026 ;74.6% vs 85.8%, p=0.021 and 16.0% vs 24.8%, p=0.046, respectively). The mean reference vessel diameter was lower in patients with de-no lesion (2.49 mm±0.52 mm vs 3.00±0.59 mm, p<0.0001). The DEB’s length was similar in the two groups (22.8±6.0 mm in patients with de-novo lesion and 22.3±6.5 in patient with ISR). The majority of the treated lesion in the de-novo group had diameter ≤ 2.5 mm (70.7%. vs 29.2% in ISR group, p=0.0001). Bailout stent implantation was required in 18.2% patients with de-novo lesion and only in 3.5% of patients with ISR (p=0.001).

Conclusion: At present, DEBs should be considered as an acceptable alternative for treatment of ISR or de-novo lesions especially where clinical and angiographic conditions suggest refraining from stent implantation.

Gal Sella
Gal Sella
KAPLAN MEDICAL CENTER








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