Impact of Chocolate percutaneous transluminal angioplasty balloon on vessel preparation in drug-coated balloon angioplasty for femoropopliteal lesion

Shigemitsu Shirai; Shinsuke Mori; Kohei Yamaguchi; Masafumi Mizusawa; Toshiki Chishiki; Kenji Makino; Yohsuke Honda; Masakazu Tsutsumi; Mana Hiraishi; Norihiro Kobayashi; Masahiro Yamawaki; Yoshiaki Ito

doi:10.1186/s42155-022-00324-z

Impact of Chocolate percutaneous transluminal angioplasty balloon on vessel preparation in drug-coated balloon angioplasty for femoropopliteal lesion

CVIR Endovasc. 2022 Sep 1;5(1):46. doi: 10.1186/s42155-022-00324-z.

Affiliations

¹ Department of Cardiovascular Medicine, Department of Cardiology, Saiseikai Yokohamashi Tobu Hospital, Yokohama, 230-8765, Japan. s0611617@yahoo.co.jp.
² Department of Cardiovascular Medicine, Department of Cardiology, Saiseikai Yokohamashi Tobu Hospital, Yokohama, 230-8765, Japan.

Abstract

Purpose: To compare the impact of Chocolate and conventional balloons on vessel preparation in percutaneous transluminal angioplasty.

Materials and methods: This single-center retrospective study included 111 endovascular therapy consecutive cases of femoropopliteal lesions using drug-coated balloon strategy with a 1:1 pre-dilation balloon diameter between February 2020 and August 2021, divided into the Chocolate percutaneous transluminal angioplasty (n = 48) and conventional (n = 63) groups. Before the availability of Chocolate balloons in Japan (December 2020), a standard semi-compliant or non-compliant balloon was used for vessel preparation. The primary endpoint was rate of severe dissection after pre-dilatation. Secondary endpoints were angiographic percent diameter stenosis, bailout stent rate, primary patency rate, and freedom from target-lesion-revascularization rate at six months.

Results: There was no significant difference in patient and lesion characteristics. The procedural characteristics comprised balloon length 90 ± 37 and 149 ± 95 mm (P = 0.004) and inflation pressure 11 ± 3 and 16 ± 7 atm (P < 0.001) in the Chocolate and conventional groups, respectively. Regarding primary endpoint, rates of severe dissection were 4.2% and 25% (P = 0.003); regarding secondary endpoints, percent diameter stenosis was 18 ± 15% and 20 ± 17% (P = 0.409), and the rate of bailout stenting was 2.1% and 15.9% (P = 0.016) in the Chocolate and conventional groups, respectively. The primary patency rates at six months were 89.1% and 85.2% (P = 0.670), and freedom from target-lesion-revascularization rate at six months was 100% and 92.8% (P = 0.691) in the Chocolate and conventional groups, respectively.

Conclusion: Chocolate percutaneous transluminal angioplasty balloons reduce the rate of severe dissection while maintaining a sufficient dilatation effect during drug-coated balloon vessel preparation.

Keywords: Drug-coated balloon; Endovascular procedures; Femoral artery; Peripheral artery disease; Popliteal artery.