Background: Drug-eluting balloons (DEB) are emerging as an alternative treatment for coronary stenoses when scaffolding is undesirable. We report a real world, single center experience of DEB usage over a 19-month period in the treatment of in-stent restenosis (ISR) and de novo coronary artery disease. Methods: Consecutive patients treated with the In.Pact FalconTM (Medtronic Inc., Minneapolis, MN, USA) paclitaxel eluting balloon as part of a coronary revascularization strategy between May 2009 and December 2010 were retrospectively studied. The primary outcome was a composite of all-cause death, myocardial infarction (MI) and target vessel revascularization (TVR) at a minimum of 6 months follow-up. Secondary outcomes were in-segment restenosis and the individual components of the primary composite. Results: A total of 122 lesions were successfully treated in 75 patients. The mean age was 66.6+/-9.3 years and 89.3% were male. The majority of patients (85.3%) had stable angina, and 62.7% had triple vessel CAD. The predominant indication for DEB use was ISR (62.7%), with diffuse disease (34.7%) and focal, small vessel disease (2.6%) accounting for the remainder. 77.3% of lesions were classified as ACC/AHA B2 or C, and 20.0% involved a bifurcation. A mean of 1.5+/-0.8 DEB were used per patient. Bailout stenting was required in 25.8% of lesions, 19.3% for angiographic optimization and 6.5% for dissection caused by balloon injury. The median clinical follow-up was 13 months (IQR 6-16 months). The primary composite endpoint occurred in 13.3% of patients, with the individual components of death, MI and TVR occurring in 0%, 2.7% and 12.0% respectively. Of the 78 lesions (63.9%) followed up angiographically at a median of 8 months (IQR 5-18 months), target lesion revascularization (TLR) occurred in 13.9%, and restenosis in 30.8%; 41.7% was focal and 37.5% was diffuse in character. Restenosis was significantly more common when DEB were used for drug-eluting stent ISR (DES-ISR) than for bare metal stent ISR (BMS-ISR) or de novo disease (47.5.% vs. 0% vs. 16.1%; p=0.003). Conclusion: DEB can be used safely to treat ISR and diffuse, small vessel CAD. However, their use in DES-ISR is associated with significantly higher rates of recurrent restenosis at 8 months than their use in BMS-ISR or de novo disease.
Basavarajaiah, S., Latib, A., Hasegawa, T., Sticchi, A., Bertoldi, L., Naganuma, T., … Colombo, A. (2013). TCT-465 Drug-Eluting Balloon in the Treatment of Instent Restenosis and Diffuse Coronary Artery Disease; Real World Experience from a Single Center Registry. Journal of the American College of Cardiology, 62(18), B142. https://doi.org/10.1016/j.jacc.2013.08.1208