Surmodics, Inc. announced that 36-month data from its TRANSCEND clinical trial was presented by Dr. Peter A. Schneider at the 50th Annual VEITH Symposium in New York, New York. The TRANSCEND trial is a prospective, multi-center, single-blind, randomized, controlled trial to assess the safety and efficacy of the SurVeil? drug coated balloon (DCB) versus the IN.PACT® Admiral® DCB for treatment of superficial femoral and proximal popliteal artery lesions.

A total of 446 patients were randomized to either the low-dose paclitaxel (2.0 µg/mm2) SurVeil DCB (n = 222) or the high-dose (3.5 µg/mm2) paclitaxel IN.PACT Admiral DCB (n = 224) at 65 sites in the United States, Australia, Austria, Belgium, Czech Republic, Germany, Italy, Latvia and New Zealand. The primary efficacy endpoint is 12-month primary patency, defined as freedom from binary restenosis or clinically driven target lesion revascularization (CD-TLR). Primary patency was comparable between the SurVeil DCB and IN.PACT Admiral (82.2% vs 85.9%).

The primary safety endpoint is freedom from device or procedure related death within 30 days and above-ankle amputation or CD-TVR within 12 months, which also demonstrated comparable outcomes between SurVeil DCB and IN.PACT Admiral DCB (91.8% vs 89.9%). Non-inferiority was tested using a multiple imputation approach at one-sided alpha 0.025. Data demonstrates the SurVeil DCB is non-inferior to the IN.PACT Admiral DCB with regards to both safety and efficacy, while delivering a substantially lower drug dose.

Both the SurVeil and IN.PACT Admiral DCBs utilize coatings with the anti-proliferative drug paclitaxel. However, the IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5 µg/mm2) than the SurVeil DCB, which has a 2.0 µg/mm² drug load. Patient outcomes are being collected at 1, 6, 12, 24, 36, 48, and 60 months.

Intermediate-term (36-month) secondary outcomes included clinically driven target lesion revascularization (CD-TLR), major target limb amputation (TLA), thrombosis at the target lesion, and historical major adverse events. A total of 352/363 (96.97%) patients completed their 36-month visit. The SurVeil DCB, which previously demonstrated noninferior primary safety and effectiveness outcomes through 12 months with a lower paclitaxel dose, continues to demonstrate similar outcomes at intermediate-term follow-up of 36 months compared with the high-dose IN.PACT Admiral DCB in the treatment of patients with symptomatic peripheral artery disease (PAD) caused by stenosis of the femoral and/or popliteal arteries.

Results at 36 months for SurVeil versus IN.PACT Admiral were statistically comparable, including CD-TLR (20.3% vs 19.5%; P =0.897), major TLA (0.0% vs 0.5%; P = 1.000), thrombosis at the target lesion (0.6% vs 0.0%; P = .475), and historical MAEs (28.6% vs 28.5%; P = 1.000).