Early Clinical Experience with Drug Coated Balloon Angioplasty
Suzanne S. Kool, M.D., Mounir J. Haurani, M.D., Hosam F. El Sayed, M.D., Jean E. Starr, M.D..
Ohio State University, Division of Vascular Surgery and Diseases, Columbus, OH, USA.
Objective: Industry-sponsored randomized trials have demonstrated that drug coated balloon angioplasty (DCBA) has improved patency over standard balloon angioplasty. Our study aimed to characterize real-world use and examine early clinical results of DCBA.
Method: A retrospective chart review of all consecutive patients at our center who underwent lower extremity DCBA between April 2015 and May 2016 was completed. Patient demographics, indications, procedural details, and clinical outcomes were reviewed. The primary efficacy end points were clinically driven target lesion revascularization (CD-TLR) and ipsilateral amputation.
Results: 86 patients underwent DCBA. Average patient age was 61.8 years and 52 (60.5%) patients were male. The indication for intervention was claudication in 46 (53.5%), rest pain in 10 (11.6%), and tissue loss in 29 (33.7%). The distribution of the lesions treated was femoropopliteal in 79 (91.9%), previous bypass grafts in 4 (4.6%), tibial in 3 (3.5%), and common femoral in 3 (3.5%). The specialist performing the procedure included vascular surgeons (53.5%), interventional cardiologists (41.9%), and other (4.7%). 25 patients had TASC A lesions, 30 had TASC B lesions, 15 had TASC C lesions and 14 had TASC D lesions. 35 (40.7%) had chronic total occlusions (CTO) and 21 (24.4%) had in-stent restenosis. Concurrent treatment of other lesions was performed in 24 (27.9%) patients. Atherectomy was performed prior to DCBA in 27 (31.5%) patients.
9 patients were lost to follow up. Of the remaining 77 patients, the mean follow up was 7.8 +/- 4.0 months (range 1.3-17.2). There were 2 deaths unrelated to DCBA. 8 (10.3%) patients required CD-TLR (5 open, 3 endovascular). 9 (11.6%) patients required minor amputations, however, 8 were planned prior to DCBA. 5 (6.5%) patients required major ipsilateral amputation; all had presented initially with critical limb ischemia (CLI). Overall 67 of 77 (87.0%) patients were free of CD-TLR or unplanned amputation.
Conclusions: This study illustrates real-world use of DCBA. While CD-TLR rates were higher compared to industry sponsored trials, this is likely due to the higher percentage of patients with CLI, CTO, in-stent restenosis and complex lesions. Results seem to be better compared historically to standard balloon angioplasty. Longer follow up and greater clinical experience should help to define the optimal patient population for DCBA.
Back to 2017 Karmody Posters
