Biological differences of three paclitaxel- and sirolimus-coated balloons on coronary lesions in a rabbit model.

BACKGROUND: Drug-coated balloons (DCBs) are important treatment options for coronary artery disease; however, randomised controlled trials comparing various DCB technologies are sparse, and further investigations are needed. AIMS: This preclinical study aimed to histologically and biologically compare the drug effects and safety of a low-dose paclitaxel-coated DCB (PCB; AGENT), a regular-dose PCB (SeQuent Please NEO) and a sirolimus-coated DCB (SCB; MagicTouch). METHODS: The DCBs were inflated in the healthy iliac arteries of 18 rabbits, which were euthanised after 28 days. The treated iliac arteries and distal skeletal muscles were histopathologically evaluated, and drug concentrations were measured. RESULTS: In the histopathological evaluation, the medial smooth muscle cell loss score regarding depth, an indicator of drug efficacy, was significantly higher with AGENT and SeQuent Please NEO than with MagicTouch (4.0 [3.6-4.0] vs 3.7 [3.7-4.0] vs 2.2 [2.0-2.4]), with significant differences in comparisons between AGENT and MagicTouch (p<0.01) and between SeQuent Please NEO and MagicTouch (p<0.01). AGENT and SeQuent Please NEO showed comparable drug concentrations in the treated artery (p=0.61). In contrast, the drug concentrations in distal skeletal muscles were the highest for MagicTouch, followed by SeQuent Please NEO and AGENT (28.07 [13.19-52.46] ng/mg vs 0.66 [0.22-3.76] ng/mg vs 0.25 [0.04-3.23] ng/mg, respectively). CONCLUSIONS: This study demonstrated that PCBs might have higher efficacy and lower drug concentrations in distal skeletal muscles than the MagicTouch SCB. The efficacy of the AGENT low-dose PCB and the SeQuent Please NEO regular-dose PCB was comparable.

A novel lesion crossing technique: Balloon deployment using FORcible Manner (BADFORM) technique.

OBJECTIVES: We evaluated the efficacy and safety of a novel endovascular technique for crossing arterial lesions: The BAlloon Deployment using FORcible Manner (BADFORM) technique. BACKGROUND: Endovascular treatment (EVT) for peripheral artery disease has been widely adopted, and developments in device technology and techniques have resulted in acceptable success rates. However, it may be difficult to deliver devices even after wire externalization, especially in the presence of an extremely long chronic total occlusion or severely calcified lesion. The BADFORM technique might be useful in these cases. METHODS: We retrospectively reviewed ten consecutive EVT cases using the BADFORM technique performed at our institution between April 2015 and September 2016. In all cases, wire externalization was established with the rendezvous technique. The BADFORM technique was performed when antegrade passage of any device was impossible after wire externalization. Physicians positioned a low-profile balloon or microcatheter just proximal to the calcified lesion and attached the device to the externalized wire using a torque device at the proximal catheter exit port. The externalized wire was then pulled retrogradely. RESULTS: All patients were receiving hemodialysis and had critical limb ischemia. All lesions were severely calcified, and 90% were chronic total occlusions. The technical success and procedure success rates were 90% and 70%, respectively. Delivered devices included five balloon catheters and four microcatheters. One procedure-related vessel injury occurred at the distal puncture site (digital artery), however, this was controlled by external manual compression. CONCLUSIONS: The efficacy and safety of the BADFORM technique might be acceptable. © 2017 Wiley Periodicals, Inc.