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.