Two-Year Results Reported From IN.PACT Global Study of Medtronic's In.Pact Admiral DCB in Femoropopliteal Lesions
May 30, 2018—Two-year results from the IN.PACT Global study were published by Antonio Micari, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:945–953).
According to the investigators, the IN.PACT Global study is a prospective, multicenter, independently adjudicated trial evaluating the In.Pact Admiral paclitaxel drug-coated balloon (DCB; Medtronic) in patients with lifestyle-limiting claudication and/or ischemic rest pain caused by atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond those typically included in randomized controlled trials.
As summarized in JACC: Cardiovascular Interventions, the study enrolled 1,535 patients, of which 1,406 patients (1,773 lesions) were included in the predefined clinical cohort analysis. Freedom from clinically driven target lesion revascularization (CD-TLR) was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. Mean lesion length was 12.1 cm, 35.5% of lesions were total occlusions, and 18% had in-stent restenosis.
The investigators reported that freedom from CD-TLR at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for CD-TLR by 24 months.
This real-world study of femoropopliteal artery disease treatment with DCBs confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment, concluded the investigators in JACC: Cardiovascular Interventions.