Background: Clinical studies demonstrated the safety and effectiveness of drugcoated balloon (DCB) in various clinical scenarios and support the use of paclitaxeleluting balloon for the treatment of in-stent restenosis, of small coronary arteries and bifurcation lesions. We analyzed and compared the safety, focused on the rates of late coronary thrombosis (LT), after DCB in de-novo lesions without additional stenting - the so called "Drug-eluting balloon only" strategy - in four current studies with the outcome in a clinical setting. Methods: A retrospective review was done of 191 consecutive patients who underwent percutaneous coronary intervention procedure with the paclitaxel eluting balloon SeQuentTM Please at a high-volume Heart Center in Potsdam. DCB was used for the treatment of de-novo lesions in 85 patients (male n=61, age 67.1 +/- 10.9 years) in 102 interventions. The primary evaluation was LT. Mean clinical follow-up was 16.3 +/- 5.5 months. Duration of dual antiplatelet therapy was 5.4 +/- 4.1 months. Results: DCB without additional stenting was used in different clinical and interventional settings. During follow-up none of the 85 patients (0%) had suffered from late coronary thrombosis in the clinical setting. This is remarkable since DCB were mostly used in complex interventions. Three patients died due to renal failure, one of them after elective cardiac surgery and one patient died due to non-cardiovascular disease. Four DCB trials used the "Drug-eluting balloon only" strategy in de-novo lesions: PEPCAD I SVD, PEPCAD V (side branch), PICCOLETO and DEBUIT. Summarizing the rates of LT after 6 to 12 months LT was reported in none of the 179 patients (0%). Conclusions: The use of DCB in de-novo coronary artery disease is not associated with a higher rate of LT. Beside the proven efficacy the possible reduction in the duration of DAPT to one month may represent additional advantages regarding safety, patient compliance and costs for the Drug-eluting balloon only strategy. Further larger scale studies are needed before DCB can be recommended for routine initial use in all cases as an alternative approach.
Weichert, T., Fengler, A., Steen, P., & Bonaventura, K. (2013). TCT-459 Incidence of late thrombosis after paclitaxel-coated balloon angioplasty in de-novo coronary artery disease. Journal of the American College of Cardiology, 62(18), B141. https://doi.org/10.1016/j.jacc.2013.08.1202