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

Aihara et al recently published a paper aiming at comparing 3 different drug-coated balloons (DCBs) in a rabbit hindlimb arteries model and concluded that the 2 paclitaxel DCBs (PCBs) were associated with higher efficacy and lower distal toxicity as compared to the MagicTouch sirolimus DCB (SCB) (Concept Medical)1. The findings of this study are intriguing but highly debatable and should be put into the context of the available literature. In fact, although distal embolisation is a well-known concern after PCB implantation, as seen in several preclinical and clinical studies and case reports, this complication has never been demonstrated with any of the 3 available SCBs2.

We would also like to point out that a rabbit is not a commonly used model to evaluate DCBs, and rabbit data are not the preferred model for coronary safety assessment by most government regulatory bodies. On the other hand, the porcine model is much preferred because of its similarities to humans in terms of anatomy and local reactivity to the devices/drugs used. Thus, if the aim is to predict the safety and efficacy...