Julian Daniel Widder1, MD; Bernardo Cortese2, MD; Sebastien Levesque3, MD; Dominik Berliner1, MD; Simon Eccleshall4, MD; Kristof Graf5, MD; Luc Doutrelant6, MD; Javed Ahmed7, MD; Erwan Bressollette8, MD; Dennis Zavalloni9, MD; Davide Piraino10, MD; Ariel Roguin11, MD, PhD; Bruno Scheller12, MD; Pieter R. Stella13, MD; Johann Bauersachs1, MD; on behalf of the FALCON Investigators
1. Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany; 2. Department of Cardiology, ASST Fatebenefratelli-Sacco, Milan, Italy; 3. Department of Cardiology, CHU Poitiers, Poitiers, France; 4. Department of Cardiology, Norfolk and Norwich University Hospital, Norwich, United Kingdom; 5. Department of Cardiology, Jüdisches Krankenhaus Berlin, Berlin, Germany; 6. Department of Cardiology, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France; 7. Department of Cardiology, Freeman Hospital, Newcastle upon Tyne, United Kingdom; 8. Department of Cardiology, Nouvelles Cliniques Nantaises, Nantes, France; 9. Department of Cardiology, Istituto Clinico Humanitas, Rozzano, Italy; 10. Interventional Cardiology, “P. Giaccone” University Hospital of Palermo, Palermo, Italy; 11. Interventional Cardiology, Rambam Medical Center, Haifa, Israel; 12. Clinical and Experimental Interventional Cardiology, University of Saarland, Homburg/Saar, Germany; 13. Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands
Aims: The aim of this study was to investigate the use of a drug-coated balloon (DCB) in daily clinical practice and provide further evidence on the safety and efficacy of paclitaxel-coated balloon treatment using urea as an 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. The primary outcome was the clinically driven target lesion revascularisation (TLR) rate at 12 months. The secondary outcome was major adverse cardiac events (MACE) defined as cardiac death, myocardial infarction, TLR and target vessel revascularisation (TVR). Out of 805 lesions, 43.1% were de novo, and 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 rates of TLR/TVR. The high proportion of treatment of de novo lesions indicates that a DCB-only strategy is nowadays common.