Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty Evidence From the Randomized PACIFIER Trial

• Published in: Circulation. Cardiovascular interventions Vol. 5; no. 6; pp. 831 - 840
• Main Authors: Werk, Michael, Albrecht, Thomas, Meyer, Dirk-Roelfs, Ahmed, Mohammed Nabil, Behne, Andrea, Dietz, Ulrich, Eschenbach, Götz, Hartmann, Holger, Lange, Christian, Schnorr, Beatrix, Stiepani, Heiner, Zoccai, Giuseppe Biondi, Hänninen, Enrique Lopez
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.12.2012
• Subjects: Aged; Aged, 80 and over; Amputation; Angioplasty, Balloon - adverse effects; Angioplasty, Balloon - instrumentation; Angioplasty, Balloon - mortality; Arterial Occlusive Diseases - diagnostic imaging; Arterial Occlusive Diseases - mortality; Arterial Occlusive Diseases - therapy; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular Agents - administration & dosage; Cardiovascular system; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Diseases of the cardiovascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Drug Carriers; Equipment Design; Female; Femoral Artery - diagnostic imaging; Germany; Humans; Investigative techniques, diagnostic techniques (general aspects); Kaplan-Meier Estimate; Likelihood Functions; Linear Models; Male; Medical sciences; Middle Aged; Paclitaxel - administration & dosage; Popliteal Artery - diagnostic imaging; Proportional Hazards Models; Radiography; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Secondary Prevention; Time Factors; Treatment Outcome; Ultrasonic investigative techniques; Vascular Access Devices; Claudication; Relapse; Angiography; Aneurysmal bone cyst; Diseases of the osteoarticular system; Cuffed tube; Cardiovascular disease; Popliteal artery; peripheral vascular disease; Percutaneous route; Vascular disease; Optical microscopy; Amputation; Atherosclerosis; Paclitaxel; Complication; Blood pressure; Dog; Revascularization; angioplasty; Human; Fissipedia; Endoprosthesis; Carnivora; drug-eluting balloon; Instrumental dilatation; Restenosis; Vertebrata; Mammalia; Surveillance; Carotid; Risk factor; Coating; Comparative study
• ISSN: 1941-7640; 1941-7632; 1941-7632
• DOI: 10.1161/CIRCINTERVENTIONS.112.971630

Peripheral percutaneous transluminal angioplasty is fraught with a substantial risk of restenosis and reintervention. A drug-eluting balloon (DEB) based on a novel coating was compared with uncoated balloons in patients undergoing femoro-popliteal percutaneous transluminal angioplasty. Patients with symptomatic femoro-popliteal atherosclerotic disease undergoing percutaneous transluminal angioplasty were randomized to paclitaxel-coated IN.PACT Pacific or uncoated Pacific balloons. The primary end point was late lumen loss at 6 months assessed by blinded angiographic corelab quantitative analyses. Secondary end points were binary restenosis and Rutherford class change at 6 months, and target lesion revascularization plus major adverse clinical events (major adverse events=death, target limb amputation, or target lesion revascularization) at 6 and 12 months. Eighty-five patients (91 cases=interventional procedures) were randomized in 3 hospitals (44 to DEB and 47 to uncoated balloons). Average lesion length was 7.0 ± 5.3 and 6.6 ± 5.5 cm for DEB and control arm, respectively. Procedural success was obtained in all cases. Six-month quantitative angiography showed that DEB were associated with significantly lower late lumen loss (-0.01 mm [95% CI, -0.29; 0.26] versus 0.65 mm [0.37; 0.93], P=0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%], P=0.01). This translated into a clinically relevant benefit with significantly fewer major adverse events for DEB versus uncoated balloons up to 12 months (3 [7.1%] versus 15 [34.9%], P<0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%], P=0.02). Use of IN.PACT Pacific DEB is associated with significant reductions in late lumen loss and restenoses at 6 months, and reinterventions after femoro-popliteal percutaneous transluminal angioplasty up to 1 year of follow-up. URL http://www.clinicaltrials.gov. Unique identifier: NCT01083030.