Background: Although stents form the backbone of PCI, they may not be ideal for all lesions, especially; in-stent restenosis (ISR) and diffuse disease in small vessels. Drug-eluting balloons (DEB) are emerging as an alternative treatment in such situations and their use is escalating. DEBs have been studied in randomized trials and registry studies with favourable outcomes. Despite these studies, data from real-world population is lacking. We report a single-center experience of DEB in the treatment of ISR and de novo coronary artery disease from a large cohort of patient. Methods: We retrospectively evaluated all patients treated with the drug-eluting balloon (In.Pact FalconTM, Medtronic Inc., Minneapolis, MN, USA) between January 2009 and December 2011. The measured endpoints were cardiac death, MI, target lesion revascularization (TLR), target vessel revascularization (TVR) and major adverse cardiac events (MACE) defined as combination of cardiac death, MI and TVR. Results: A total of 7622-PCI procedures were carried out at our centre during the study period. Drug-eluting balloons were used in 275-lesions (184-patients) (3.6%). The predominant indication for DEB use was ISR (n=170, 62%), with de novo lesions accounting for the remainder (n=105, 38%). The mean age of patients treated with DEB was 66.2±9.6 years and 87% were male. Bailout stenting was required in 31.6% of lesions; 24% for angiographic optimization and 7.3% for dissection caused by balloon injury. The median clinical follow-up was 14.6 months (IQR 12-23) and a minimum of 6-months follow-up was achieved in all patients. The rates of cardiac death, MI, TLR, TVR and MACE were: 3.8%, 1.6%, 16.8%, 17.9% and 21.7% respectively. The overall rate of stent thrombosis was 0.5% (n=1). Further subanalysis revealed that the benefits of DEB use were more pronounced in BMS-ISR than DES-ISR (TLR: 11% vs. 17.7%, TVR: 11% vs. 22%, MACE: 15% vs. 28%) respectively. Conclusions: Our results suggests that DEB can be considered in lesions where the use of stents are not desirable especially restenotic lesions and diffuse small vessel disease. Further long-term follow-up of these patients, will provide us more insights on the long-term outcomes.
CITATION STYLE
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
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