Reply: The ROTA-CUT randomised trial: push the button harder

We thank Novelli and colleagues for pointing out important aspects regarding the primary results of the ROTA-CUT trial1. We fully respect the authors and are aware of their great work and experience treating patients with severely calcified lesions. With respect to the points raised in their letter, we have the following answers:

1) With respect to the inflation pressure for the cutting balloon strategy, the ROTA-CUT investigators are very well aware of the data supporting the benefits of higher inflation pressures2. As mentioned in the discussion section of our manuscript3, the ROTA-CUT trial was conducted under U.S. Food and Drug Administration (FDA) investigational device exemption (IDE# G210030). It is important to note that compliance with the manufacturer’s instructions for use (IFU) was mandated and an inflation pressure of 12 atm was not to be exceeded. Therefore, we could not change that parameter without failing to meet compliance requirements according to the device label in the USA. To what extent the latter may have impacted the outcomes of ROTA-CUT and contributed to the discrepant results compared with the results...