Drug Eluting Balloon – A Single Center Study

Introduction: Drug eluting balloon (DEB) is indicated for the treatment of in-stent restenosis (ISR) and selected cases of de-novo coronary lesions. DEBs differ from drug-eluting stents (DES) with their potential of immediate and homogeneous drug release in the arterial wall, absence of implanted foreign materials that can induce chronic inflammation and the need of dual antiplatelet therapy for a shorter period of time.

Aims: This retrospective, observational all-comers registry assessed the safety and efficacy of DEB strategy in patients with coronary lesions.

Materials and Methods: This study was conducted as a national, single center registry, enrolling patients with de-novo CAD and patients with ISR. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) within 12 months. Secondary endpoints were defined as cardiac re-hospitalizations and death. Demographic, clinical and procedural data was collected from the Patient Medical Records and processed using uni- and multivariate analysis.

Results: A total of 442 patients with a mean age of 62.0±12.2 years who underwent percutaneous coronary intervention (PCI) with DEB between 2012-2017 at our institution were enrolled. The majority of treated lesions were de-novo (315 patients; 71.3%), followed by ISR (127 patients; 28.7%). The TLR rate was lower in the de-novo group when compared to ISR (7.0% vs. 13.4% respectively; P=0.032). Patient who needed TLR had more cardiac hospitalizations during the first year from primary PCI (P<0.001). Bailout stent implantation was required in 17.3% patients with de-novo lesion and only in 4.7% of patients with ISR (P<0.001).

Conclusions: To the best of our knowledge, this is the largest study made in Israel and the second largest made worldwide. At present, DEBs can be considered as an acceptable alternative for treatment of ISR or de-novo lesions especially when clinical and angiographic conditions suggest refraining from stent implantation.