New APERTO AVF RCT data show DCB reduces restenosis significantly more than high-pressure balloon alone
Matteo Tozzi (Varese, Italy) discusses new data from the APERTO AVF study, the first randomised trial in China to compare the safety and efficacy of the APERTO drug-coated balloon (DCB; Cardionovum) with a high-pressure balloon. The trial results for the treatment of failing haemodialysis arteriovenous shunts were presented by Qizhuang Jin (Beijing, China) at CX 2019.
At six months, data revealed that using an APERTO balloon resulted in greater freedom from restenosis (65.82%) than when a high-pressure balloon (37.8%) was used. This result was statistically significant (p<0.001).
While many DCBs are coated with paclitaxel, the excipient – which according to Tozzi is the “heart” of the balloon, makes the APERTO device unique as it minimises the “wash-off” of the drug during the navigation and manipulation of the device. “The APERTO DCB is specifically designed for treatment of AV stenosis,” Tozzi says.