The largest prospective, independently-adjudicated study of drug coated balloons (DCBs) in a broad range of lesions in real-world patients confirms the safety and performance of the IN.PACT Admiral DCB (Medtronic) in the treatment of femoropopliteal artery disease. This is the conclusion presented by Gunnar Tepe, professor of Radiology at the Academic Hospital RoMed in Rosenheim, Germany, during the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual meeting (22–25 September 2018, Lisbon, Portugal).
This three-year real-world data shows that freedom from clinically-driven target lesion revascularisation (CD-TLR) was achieved in 76.9% of patients, indicating that this global trial continues to confirm the safety of the IN.PACT Admiral DCB for treatment of femoropopliteal artery disease.
IN.PACT Global was a prospective, multicentre, single arm study conducted at 64 international sites. A total of 1,535 patients, with 1,773 lesions between them, were enrolled in this trial. A wide variety of lesions were included in this study, including: bilateral disease, multiple lesions, TASC (Trans-Atlantic Inter-Society Consensus Document), de novo in-stent stenosis, long lesions (≥150mm), and chronic total occlusions (≥50mm).
The primary safety endpoint that was measured at 12-months showed that no major adverse events were attributed to the DCB itself. Additionally, major limb amputation only occurred in 10 patients out of the entire cohort.
Tepe pointed towards the importance of subgroups to validate findings. For example, the data showed that diabetics (comprising 39.9% of patients in the study) treated within the IN.PACT trial demonstrated “consistent and durable results” through three years, with freedom from CD-TLR at 74.7%, similar to the rate of non-diabetics (78.4%).
The majority of patients in this study (67.8%) were male, and the mean age was 68.6±10.1 years. The mean lesion length was 12.09±9.54cm, including 18% in-stent stenosis, 35.5% total occlusions, and 68.7% calcified lesions.
Back in January 2019, data presented at the Leipzig Interventional Course (LINC; 20 January–2 February, Leipzig, Germany) demonstrated the durability and consistency in clinical outcomes of the IN.PACT Admiral drug-coated balloon. Thus was the result of the two-year MDT-2113 study (IN.PACT SFA Japan), as well as data from a critical limb ischaemia subgroup analysis of the IN.PACT Global study.
In Germany earlier this year, vascular surgeon Michel Reijnen (Rignstate Hospital, the Netherlands) presented the one year results from the critical limb ischaemia subset of the IN.PACT Global study: data showed comparable effectiveness with a freedom from CD-TLR based on Kaplan-Meier Estimate of 86.6% (Rutherford category four), and 85.5% in Rutherford category five (p<0.001).
This present data is an extension of the IN.PACT Global study, and corroborates the earlier findings of the subgroup analysis presented at LINC. Tepe maintained that the data presented so far greatly “reflects the clinical reality,” and noted that follow-up is due to continue for a further two years; allowing for five-year outcomes to be measured.