Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty Evidence From the Randomized PACIFIER Trial
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...
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| Published in | Circulation. Cardiovascular interventions Vol. 5; no. 6; pp. 831 - 840 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hagerstown, MD
Lippincott Williams & Wilkins
01.12.2012
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1941-7640 1941-7632 1941-7632 |
| DOI | 10.1161/CIRCINTERVENTIONS.112.971630 |
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| Abstract | 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. |
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| AbstractList | 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.BACKGROUNDPeripheral 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).METHODS AND RESULTSPatients 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.CONCLUSIONSUse 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.CLINICAL TRIAL REGISTRATIONURL http://www.clinicaltrials.gov. Unique identifier: NCT01083030. 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. |
| Author | Albrecht, Thomas Ahmed, Mohammed Nabil Hartmann, Holger Lange, Christian Eschenbach, Götz Werk, Michael Meyer, Dirk-Roelfs Stiepani, Heiner Schnorr, Beatrix Hänninen, Enrique Lopez Zoccai, Giuseppe Biondi Dietz, Ulrich Behne, Andrea |
| Author_xml | – sequence: 1 givenname: Michael surname: Werk fullname: Werk, Michael organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 2 givenname: Thomas surname: Albrecht fullname: Albrecht, Thomas organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 3 givenname: Dirk-Roelfs surname: Meyer fullname: Meyer, Dirk-Roelfs organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 4 givenname: Mohammed Nabil surname: Ahmed fullname: Ahmed, Mohammed Nabil organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 5 givenname: Andrea surname: Behne fullname: Behne, Andrea organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 6 givenname: Ulrich surname: Dietz fullname: Dietz, Ulrich organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 7 givenname: Götz surname: Eschenbach fullname: Eschenbach, Götz organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 8 givenname: Holger surname: Hartmann fullname: Hartmann, Holger organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 9 givenname: Christian surname: Lange fullname: Lange, Christian organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 10 givenname: Beatrix surname: Schnorr fullname: Schnorr, Beatrix organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 11 givenname: Heiner surname: Stiepani fullname: Stiepani, Heiner organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 12 givenname: Giuseppe Biondi surname: Zoccai fullname: Zoccai, Giuseppe Biondi organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin – sequence: 13 givenname: Enrique Lopez surname: Hänninen fullname: Hänninen, Enrique Lopez organization: From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); Department of Radiology and Interventional Therapy, Vivantes Clinic, Berlin, Germany (T.A., M.N.A., A.B., G.E.); Department of Diagnostic and Interventional Radiology, Hubertus-Hospital, Berlin, Germany (D-R.M, H.H.); Department of Cardiology, German Diagnostic Clinic, Wiesbaden, Germany (U.D.); Department of Experimental Radiology Charité, Universitätsmedizin Berlin, Berlin |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26818844$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/23192918$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1002/ccd.22124 10.1016/j.jcin.2011.11.010 10.1016/j.jacc.2011.08.023 10.1055/s-0029-1246028 10.7326/0003-4819-134-8-200104170-00011 10.3174/ajnr.A2644 10.1056/NEJMoa051303 10.1161/circulationaha.110.936922 10.1583/11-3627.1 10.1016/j.jacc.2009.01.069 10.1093/eurheartj/ehn514 10.1002/clc.20066 10.1097/RLI.0b013e31820577df 10.1161/circulationaha.107.688341 10.1056/NEJMoa0706356 10.1002/ccd.21104 10.1161/circulationaha.107.735985 |
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| Keywords | 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 |
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| SubjectTerms | 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 |
| Subtitle | Evidence From the Randomized PACIFIER Trial |
| Title | Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty |
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