Coronary artery treatment with an urea-based paclitaxel-coated balloon: The European wide Falcon all comers DCB Registry (FALCON-Registry).

AIMS: To investigate the use of drug-coated balloon (DCB) in daily clinical practice and provide further evidence for safety and efficacy of paclitaxel-coated balloon treatment using urea as inert excipient.

METHODS AND RESULTS: Between December 2013 and December 2015, 757 patients treated for coronary lesions with the IN.PACT Falcon balloon were enrolled in this prospective real-world all comers registry. Primary outcome was clinically driven target lesion revascularization (TLR) rate at 12 months. Secondary outcome was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction, TLR and target vessel revascularization (TVR). 43.1% out of 805 lesions were de novo, 53.2% drug-eluting stent (DES) or bare-metal stent (BMS) in-stent restenosis (ISR). TLR at 12 months was 6.2% and TVR 8.3%. MACE occurred in 9.7% of patients with a composite of cardiac death in 0.8% and myocardial infarction in 2.7% plus TLR/TVR. Subgroup analysis confirmed a TLR rate of 7.5% for ISR (2.1 % BMS and 9.5% DES) and 4.9% for de novo lesions.

CONCLUSIONS: The IN.PACT Falcon urea-based paclitaxel-coated balloon is safe and efficient in de novo and ISR lesions with low TLR/TVR. The high proportion of treatment of de novo lesions, indicates that DCB only strategy is nowadays common.