Background and purpose
After the advent of drug-carrying devices, the concept of “vessel preparation” has been paid more attention, and good vascular preparation can improve the effectiveness of stents/DCB. Professor Shigemitsu Shirai’s team at the Department of Cardiology, Saiseikai Yokohamashi Tobu Hospital, Yokohama, Japan, conducted a retrospective study to compare the effects of a restrained balloon versus a conventional balloon on vessel preparation for femoral-popliteal artery angioplasty.

Research method
The center retrospective study included 111 patients with femoral-popliteal artery disease who were treated with DCB and had a pre-dilated balloon diameter ratio of 1:1 between February 2020 and August 2021. According to the types of predilation balloon, they were divided into the constraint balloon group (n=48) and the ordinary balloon group (n=63). The primary endpoint was the incidence of severe dissection after predilection. Secondary endpoints were the rate of residual lumen stenosis after predilation, the rate of remedial stent implantation, the rate of primary patency 6 months after surgery, and the rate of revascularization free from target lesions.

Research result
1. There were no significant differences in baseline data and lesion characteristics.
2. Surgical and angiographic features:
There was no significant difference in balloon diameter between the restrained balloon group and the ordinary balloon group, and the balloon length was 90±37 mm and 148±95 mm, respectively (P=0.004). The expansion pressures were 11±3 atm and 16±7atm respectively (P < 0.001).

3.Main evaluation index
the restrained balloon group: Incidence of severe dissection rate4.2%
the ordinary balloon group: Incidence of severe dissection rate25%
Remedial stent implantation rate
P value：0.003

4.Secondary evaluation index

Conclusion
The restrained balloon reduces the incidence of severe dissection while maintaining adequate dilation during the preparation of the drug-coated balloon for treating femoral-popliteal artery disease.

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