Surmodics’ SurVeil DCB to Treat Femoropopliteal Artery Disease Evaluated at 24 Months in TRANSCEND Study

November 3, 2022—Intermediate-term (24-month) follow-up results from the TRANSCEND study continue to demonstrate similar outcomes for the SurVeil drug-coated balloon (DCB; Surmodics, Inc.) compared with a high-dose DCB (In.Pact Admiral; Medtronic) for the treatment of patients with symptomatic peripheral artery disease (PAD) caused by stenosis of the femoral and/or popliteal arteries. The data also demonstrated noninferiority of the SurVeil DCB compared to the In.Pact Admiral DCB.

The findings were presented by Kenneth Rosenfield, MD, in the first of three Late-Breaking Clinical Trials sessions at the VIVA Foundation’s VIVA22 conference held October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, the TRANSCEND study aims to demonstrate the safety and efficacy of the SurVeil DCB for the treatment of patients with symptomatic PAD caused by stenosis of the femoral and/or popliteal arteries, as well as demonstrate noninferiority to the In.Pact Admiral DCB.

The TRANSCEND study is a global, multicenter, pivotal investigational device exemption clinical trial that enrolled 446 patients with femoropopliteal disease and Rutherford class (RC) 2 to 4. Investigators randomized the patients to either the low-dose (2.0 µg/mm²) paclitaxel SurVeil DCB (n = 222) or the high-dose (3.5 µg/mm²) paclitaxel In.Pact DCB (n = 224).

Patient outcomes were collected at 1, 6, 12, 24, 36, 48, and 60 months. Intermediate-term (24-month) secondary outcomes included primary patency, target vessel patency, clinically driven target lesion revascularization (CD-TLR), major target limb amputation (TLA), thrombosis at the target lesion, and change in target limb RC.

A total of 362/384 (94.2%) patients completed their 24-month visit.

Dr. Rosenfield reported that Kaplan-Meier primary patency at 24 months was 70.8% for SurVeil DCB versus 70.4% for In.Pact Admiral DCB (log rank P = .991). CD-TLR was comparable (14.7% vs 11.8%; P = .453).

Secondary endpoints for SurVeil versus In.Pact were statistically comparable, including target vessel patency (63.0% vs 63.1%; P = 1.000), major TLA (0.0% vs 0.5%; P = 1.000), thrombosis at the target lesion (0.6% vs 0.0%; P = .470), change in ankle-brachial index (0.2 ± 0.2 for both groups; P = .345), and change in target limb RC (improvement by ≥ 1 category, 88.5% vs 89.3%; P = .104).

Additionally, there were comparable improvements between groups in quality-of-life measures including Peripheral Academic Research Consortium symptom classification, Walking Impairment Questionnaire, and Peripheral Artery Questionnaire.

The investigators concluded that the SurVeil DCB, which previously demonstrated noninferior primary safety and effectiveness outcomes through 12 months with a lower paclitaxel dose, continued to demonstrate similar outcomes at intermediate-term follow-up of 24 months compared with high-dose DCB in the treatment of femoropopliteal lesions, stated the VIVA Foundation press release.