TRANSCEND: Head-to-Head SurVeil DCB vs IN.PACT Admiral DCB

The TRANSCEND trial tested the 3^rd generation SurVeil drug-coated balloon (DCB) (Surmodics), designed to achieve a similar outcome as existing DCB devices but with a lower dose of paclitaxel and utilizing greater efficiency of drug distribution, delivery, and transfer, according to presenter Kenneth Rosenfield, MD, from Massachusetts General Hospital.

First presented as a late breaker at the LINC symposium, Dr. Rosenfeld presented some extra data fleshing out details to the ISET 2021 crowd.

Using a noninferiority design, TRANSCEND prospectively enrolled 446 patients at 52 US sites and 13 clinical sites outside the US. Participants were randomly assigned to either SurVeil or IN.PACT ADMIRAL DCB (Medtronic) and followed for 60 months.

Enrollment was started in November 2017, “right in the middle of the paclitaxel debate,” noted Rosenfield, and slowed somewhat by COVID-19.

At 12 months, the primary safety composite (freedom from device- and procedure-related death through 30 days, freedom from major amputation [above ankle], and freedom from clinically-driven target vessel revascularization [CD-TVR] through 12 months) was 91.7% for SurVeil and 89.6% for IN.PACT, with a p-value for noninferiority of less than 0.001.

“So, they are equal, confirmed by a Kaplan Meier analysis where you can see the two curves are superimposable,” said Rosenfield.

Regarding the primary composite efficacy outcome, defined as primary patency through 12 months, (a composite of freedom from clinically-driven target lesion revascularization [CD-TLR], freedom from binary restenosis [peak systolic velocity ratio ≥2.4 or ≥50% stenosis), there was also no difference seen between devices (81.7% and 85.9%, respectively; p=0.003 for noninferiority).

There are visibly evident differences between the DCB technologies on the market, reported Rosenfield with the SurVeil DCB having “a more even coating than its counterparts that were generation 2 devices.” (See slide below).

“We believe that this might effectively broaden the therapeutic window, enabling, for example, more devices potentially to be used, although the IDE trial did not study that,” said Rosenfield.

He concluded that, in this first head-to-head comparison of next generation DCBs, the SurVeil DCB was non-inferior to the market leading IN.PACT DCB with respect to composite patency, including CD-TLR and binary restenosis. “And comparative effectiveness was achieved at a substantially lower dose of drug.”