Objectives: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Background: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. Methods: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization 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. Results: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization 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 clinically driven target lesion revascularization by 24 months. Conclusions: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons 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. (IN.PACT Global Clinical Study; NCT01609296)
Micari, A., Brodmann, M., Keirse, K., Peeters, P., Tepe, G., Frost, M., Wang, H., Zeller, T., Zeller, T., Torsello, G., Tepe, G., Peeters, P., Scheinert, D., Bosiers, M., Maene, L., Micari, A., Do, D. -., Hendriks, J., Keirse, K., Brodmann, M., Merkely, B., Lardenoije, J. -., Ruzsa, Z., Vogel, B., Veroux, P., Albuquerque E Castro, J., Periard, D., Ludyga, T., Midy, D., Choi, D., Lansink, W., Ketelsen, D., Dubenec, S., Banyai, M., Chakfe, N., Roithinger, F. X., Trani, C., Mansour, H., Rha, S. -., Vermassen, F., Belenky, A., Spak, L., Chalmers, N., Benko, A., Seerangan, K., Won, J. H., Vozar, M., Tan, K. T., Labib, M., De Borst, G. -., Do, Y. -., Teijink, J., Gomez, J. F., Falkowski, A., Ferreira, L., Matela, J., Lee, S. -., Verhoeven, B., Mannheim, D., Nessi, F., Vulev, I., De Vries, J. -., Maly, R., Kavteladze, Z., Turner, D., Mendiz, O., Kolvenbach, R., Karnabatidis, D., Cuellar, C., Venermo, M., Velicka, L., Lundberg, G., Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study, <<JACC: CARDIOVASCULAR INTERVENTIONS>>, 2018; 11 (10): 945-953. [doi:10.1016/j.jcin.2018.02.019] [http://hdl.handle.net/10807/157339]
Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study
Trani, Carlo;Seerangan, Kumar;
2018
Abstract
Objectives: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. Background: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. Methods: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization 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. Results: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization 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 clinically driven target lesion revascularization by 24 months. Conclusions: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons 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. (IN.PACT Global Clinical Study; NCT01609296)File | Dimensione | Formato | |
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