Drug-eluting balloon (DEB) for de-novo coronary artery disease and in-stent restenosis: immediate and intermediate term results from a prospective registry.

OBJECTIVES To study the safety and short and intermediate term efficacy of drug-eluting balloon (DEB) in the treatment of de-novo and in-stent restenotic coronary artery disease (CAD). METHODS Of the total 100 patients so far enrolled in a prospective DEB registry using a Paclitaxel-coated balloon at our hospital, 36 patients were studied for short and intermediate term i.e. 12 months outcomes. All patients with symptomatic coronary artery disease (CAD) including de-novo lesions or in-stent restenosis (ISR) requiring percutaneous intervention (PCI) with a DEB were included. Clinical follow-up was conducted at 3, 6 and 12 months. Primary outcome was a composite of major adverse cardiac events (MACE). RESULTS Procedural success was achieved in all (100%) patients. Mean age was 53.2 +/- 12 years, 61.1% presented with acute coronary syndrome (ACS) and 47.2% had triple vessel CAD. Sixty six percent were classified as having ACC/AHA B-2 or C type coronary arteries including 22.2% with bifurcation lesions. DEB intervention for de-novo CAD was done in 77.7% patients and 22.2% for ISR. All de-novo lesions required a bare- metal stent (BMS) after DEB dilatation. Mean DEB diameter was 2.73 +/- 0.06 mm and mean length was 19.58 +/- 0.81 mm. Coronary dissections occurred in 5 patients which were successfully treated with additional stents. At 3 (n=36), 6 (n=31) and 12 (n=31) months follow-up, no MACE was observed in any patient. CONCLUSION The short and intermediate term outcomes from this prospective DEB registry showed excellent results with 0% target lesion revascularization (TLR) for both de-novo and ISR lesions.