Intermediate-Term (24-Month) Results of the TRANSCEND Study: Comparing a Next-Generation Paclitaxel Drug-Coated Balloon (SurVeil DCB) to IN.PACT Admiral DCB in the Treatment of Femoropopliteal Artery Disease

In this session from Tuesday afternoon, Peter A. Schneider, MD, Marianne Brodmann, MD, William Gray, MD, and Kenneth Rosenfield, MD reported 24-month results from the TRANSCEND study, which compared the SurVeil drug-coated balloon (DCB) to the IN.PACT Admiral DCB.

TRANSCEND was a prospective, multicenter, international, randomized, single-blind trial comparing the SurVeil drug-coated balloon (DCB) to the IN.PACT Admiral DCB. There were 446 patients randomized to each arm, SurVeil (n = 222) and IN.PACT (n = 224), with a 5-year follow-up. The intent for the next generation SurVeil DCB is higher efficacy that improves the therapeutic window but with fewer complications and a lower dose, more uniform drug distribution, better efficiency of drug transfer, and fewer downstream emboli.

To be eligible for TRANSCEND, patients had a target limb Rutherford Class 2-4, de novo or non-stented restenotic lesion, a lesion ≤180 mm in length and ≥4mm; ≤7mm in diameter, and stenosis ≥70% by visual estimate. The primary safety endpoint was freedom from device and procedure-related death, freedom from major target limb amputation, and clinically driven target vessel revascularization through 12 months post-index procedure. The primary efficacy endpoint was freedom from clinically-driven target lesion revascularization (CD-TLR) and binary restenosis through 12 months.

At 12 months, SurVeil met the primary safety endpoint with no amputations and low CD-TLR, and showed comparable effectiveness at a significantly lower dose. At 24 months, 88.5% of SurVeil and 89.3% of IN.PACT patients improved by ≥1 grade in the Rutherford class. There was also sustained improvement in both groups for ankle brachial index, walking impairment questionnaire, a 6-minute walk test, and the peripheral artery questionnaire summary score.

Study results concluded similar safety and efficacy results with the lower dose SurVeil DCB when compared with the IN.PACT Admiral DCB.