Results:

The trial included 131 participants with only de novo ISR of the femoral or popliteal arteries treated with paclitaxel-coated drug-coated balloon during the interventional (index) procedure. All participants had intermittent claudication or rest pain due to angiographically demonstrated femoropopliteal occlusion or stenosis. Mean participant age was 67.8 years. The study was completed by 125 participants; a total of 149 lesions were treated, including lesions along the full length of the superficial femoral artery or popliteal artery. Mean lesion length was 17.17 cm. Lesion types included total occlusions (34%), calcified lesions (59.1%), and severely calcified lesions (8.3%). Results were analyzed on an intent-to-treat basis. The primary effectiveness endpoint (primary patency at 12 months) was 88.7%. Freedom from clinically driven target lesion revascularization at 12 months was 92.9%. The primary safety endpoints demonstrated that 1) no mortality occurred related to device or procedure through 30 days, 2) no major target limb amputations occurred through 12 months, and 3) freedom from target lesions revascularization within 12 months post-index procedure was 92.7%. Secondary endpoints included incidence of major adverse events, change in Rutherford clinical category, change in ankle-brachial index (ABI), and level of walking impairment. Incidence of major adverse events was 0% acutely, 0% at 30 days, and 8.9% at 12 months. One case of thrombus at the target lesion occurred by 12 months. The change in Rutherford clinical category was statistically significant at p < 0.001. At baseline, 9.2% were Rutherford clinical category 4-5, and 90.8% were category 2-3. At 12 months, 3.3% were category 4-5, 20.0% were category 2-3, and 76.7% were category 0-1. Mean change in ABI from baseline was 0.241 (p < 0.001). Mean ABI was 0.667 at baseline and 0.909 at 12 months. Mean Walking Impairment Questionnaire score was 36.8% at baseline and 76.7% at 12 months (p < 0.001). Mean change in Walking Impairment Questionnaire score from baseline was 40.7 (p < 0.001). Compared with previous clinical studies of other treatment modalities for de novo ISR in femoropopliteal arteries (including drug-eluting stents, vascular stent grafts, cutting balloon angioplasty, brachytherapy, and various types of atherectomy or thrombectomy procedures), the IN.PACT paclitaxel coated balloon had superior primary patency and superior freedom from target lesion revascularization at 12 months. However, the authors acknowledge that direct comparisons to other studies cannot be made because the De Novo In-stent Restenosis Imaging Cohort study did not include an active comparison or control group.