Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications.

Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications. J Invasive Cardiol. 2020 Jul;32(7):243-248 Authors: Kobe DS, Jaff MR, Zeller T, Schneider PA, Shishehbor MH Abstract Drug-coated balloons (DCBs) have been shown to be superior to percutaneous transluminal angioplasty (PTA) for symptomatic femoropopliteal disease in randomized clinical trials; however, their clinical effectiveness and safety in more complex disease is less defined. The study sought to conduct a patient-level pooled analysis of all prospective randomized and single-arm studies evaluating the safety and efficacy of IN.PACT Admiral DCB (Medtronic) worldwide and in patients with complex disease. Subjects were treated with either IN.PACT Admiral DCB (n = 1837) or PTA (n = 143). The primary endpoint was freedom from clinically driven target-lesion revascularization (CD-TLR) within 12 months. The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months. Subsequently, we examined "real-life" complex lesions in a subgroup analysis, with standard use defined as simple, single de novo lesions (n = 712) and broader use defined as bilateral or multiple lesions (n = 1125). DCB when compared with PTA had significantly higher rates of freedom from CD-TLR through 12 months (93.8%...
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research