Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain

• DOI: 10.1016/j.jcin.2018.02.019
• Publication Date: 2018-05-21T18:38:32Z
• Authors: Antonio Micari; Marianne Brodmann; Koen Keirse; Patrick Peeters; Gunnar Tepe; Martin Frost; Hong Wang; Thomas Zeller; Thomas Zeller; Giovanni Torsello; Gunnar Tepe; Patrick Peeters; Dierk Scheinert; Marc Bosiers; Lieven Maene; Antonio Micari; Dai-Do Do; Jeroen Hendriks; Koen Keirse; Marianne Brodmann; Bela Merkely; Jan-Willem Larden...; Zoltan Ruzsa; Britta Vogel; Pierfrancesco Veroux; Joao Albuquerque ...; Daniel Periard; Tomasz Ludyga; Dominique Midy; Donghoon Choi; Wouter Lansink; Dominik Ketelsen; Steven Dubenec; Martin Banyai; Nabil Chakfe; Franz Xaver Roith...; Carlo Trani; Hossam Mansour; Seung-Woon Rha; Frank Vermassen; Alexander Belenky; Lubomir Spak; Nicholas Chalmers; Andrew Benko; Steven Kum; Je Hwan Won; Matej Vozar; Kong Teng Tan; Mamdouh Labib; Gert-Jan de Borst; Young-Soo Do; Joep Teijink; Juan Fernando Gomez; Aleksander Falkowski; Luis Ferreira; Jozef Matela; Seung-Whan Lee; Bart Verhoeven; Dalit Mannheim; Franco Nessi; Ivan Vulev; Jean-Paul de Vries; Radovan Maly; Zaza Kavteladze; Douglas Turner; Oscar Mendiz; Ralf Kolvenbach; Dimitrios Karnaba...; Cesar Cuellar; Maarit Venermo; Linas Velicka; Goran Lundberg
• Keywords: Male; angioplasty; drug-coated balloon; femoropopliteal artery; peripheral artery disease; target lesion revascularization; Aged; Angioplasty, Balloon; Cardiovascular Agents; Constriction, Pathologic; Female; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Recurrence; Time Factors; Treatment Outcome; Vascular Patency; Coated Materials, Biocompatible; Femoral Artery; Popliteal Artery; Vascular Access Devices; Time Factors; Paclitaxel; ELUTING BALLOON; drug-coated balloon; 610 Medicine & health; femoropopliteal artery; Constriction, Pathologic; SUPERFICIAL FEMORAL-ARTERY; SFA-LONG; PACLITAXEL; peripheral artery disease; 2705 Cardiology and Cardiovascular Medicine; Peripheral Arterial Disease; 03 medical and health sciences; 0302 clinical medicine; Coated Materials, Biocompatible; PERIPHERAL ARTERY-DISEASE; Ischemia; Recurrence; 615; Humans; Popliteal Artery; Prospective Studies; ANGIOPLASTY; Vascular Patency; Aged; 10031 Clinic for Angiology; angioplasty; drug-coated balloon; femoropopliteal artery; peripheral artery disease; target lesion revascularization; Cardiology and Cardiovascular Medicine; angioplasty; Cardiovascular Agents; Intermittent Claudication; Middle Aged; RANDOMIZED-TRIAL; 3. Good health; Femoral Artery; Treatment Outcome; REGISTRY; target lesion revascularization; REVASCULARIZATION; Female; RESTENOSIS; Cardiology and Cardiovascular Medicine; Angioplasty, Balloon; Vascular Access Devices

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.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.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.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.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).