Paclitaxel eluting balloon plus spot bare metal stenting for diffuse and very long coronary disease. (PEB-long pilot study)

Abstract

Background

Albeit DES might be considered as a breakthrough against neointimal hyperplasia, concerns on stent thrombosis and increase incidence of in-stent restenosis after multiple DES implantations in complex, long lesions still exist. Hereby, we tried to test efficacy and safety of using PEB in long lesions followed by focal BMS implantation in a pilot multicenter study.

Methods

This study enrolled 16 patients with long lesions (> 30 mm) that were treated with PEB angioplasty followed by focal stenting with BMS. IVUS was performed before, after PEB and post stenting. Clinical and angiographic follow-up was done at 6 months. The primary end-point was angiographic late lumen loss.

Results

Patient age was 64.6 ± 8.1 years, 15 (93.7%) were males, and 7 (43.7%) diabetics. Target vessels were most commonly the left anterior descending (6 [31.6%]) and the right coronary artery (6 [31.6%]). PEB diameter was 2.8 ± 0.4 mm with a 31.3 ± 8.9 mm length. Stents per patient were 2.1 ± 0.8. No overlapping stents were deployed. Angiographic success was achieved in 100% of patients. Peri-procedural myocardial infarction occurred in 4 patients (25%). At 6 months follow-up angiography, MLD was 1.55 ± 0.53 mm with a late loss of 0.48 ± 0.52 mm, a binary re-stenosis rate of 2 (12.5%).

Conclusion

Using PEB with focal stenting by BMS proved to be a feasible, safe, and promising strategy in long coronary lesions. However larger study are needed to confirm these data.