Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: Outcomes of the Randomised TRANSCEND Study Through 24 Months

Objective: The aim of the TRANSCEND study was to compare the safety and efficacy of the next generation SurVeil PCB with the IN.PACT Admiral PCB in patients with femoropopliteal arterial disease. SurVeil is a lower dose PCB (2.0 μg/mm²vs. 3.5 μg/mm² for IN.PACT Admiral) with a uniform microcrystalline coating intending to enhance durability and maximise drug delivery.

Methods: TRANSCEND is a prospective, single blind, randomised controlled, multicentre, non-inferiority clinical study. Patients with femoropopliteal artery disease in Rutherford stages 2 - 4 were randomised 1:1 to the SurVeil or the IN.PACT Admiral PCB. A sample size of 446 patients was calculated to prove non-inferiority of the SurVeil compared to the IN.PACT Admiral PCB for primary safety and efficacy endpoints at twelve months. Primary safety was defined as a composite of freedom from device and procedure related death through 30 days, and freedom from major target limb amputation and clinically driven (CD) target vessel revascularisation at twelve months. Primary efficacy was defined primary patency at twelve months as a composite of freedom from binary restenosis and freedom from CD target lesion revascularisation. Secondary outcomes were reported up to twenty four months.

Results: A total of 446 subjects were randomised, 222 to treatment with the SurVeil and 224 to the IN.PACT Admiral PCB. Primary safety was 91.8% for the SurVeil vs. 89.8% for the IN.PACT Admiral group (p_{non-inferiority} < .001), and primary efficacy was 82.2% vs. 85.9% (p_{non-inferiority} = .003). Primary patency through 24 months was 65.4% with the SurVeil and 66.9% with the IN.PACT Admiral PCB (p_{non-inferiority} = .005).

Conclusion: The next generation low dose SurVeil PCB demonstrated excellent safety and efficacy up to twenty four months and was non-inferior to the IN.PACT Admiral PCB. (ClinicalTrials registration ID: NCT03241459).