{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:22:42Z","timestamp":1791386562414,"version":"4.3.3"},"reference-count":17,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"6","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2012,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background\u2014<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and Results\u2014<\/jats:title>\n                    <jats:p>\n                      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\u00b15.3 and 6.6\u00b15.5cm 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 (\u22120.01mm [95% CI, \u22120.29; 0.26] versus 0.65mm [0.37; 0.93],\n                      <jats:italic>P<\/jats:italic>\n                      =0.001) and fewer binary restenoses (3 [8.6%] versus 11 [32.4%],\n                      <jats:italic>P<\/jats:italic>\n                      =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%],\n                      <jats:italic>P<\/jats:italic>\n                      &lt;0.01) as well as target lesion revascularizations (3 [7.1%] versus 12 [27.9%],\n                      <jats:italic>P<\/jats:italic>\n                      =0.02).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions\u2014<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial Registration\u2014<\/jats:title>\n                    <jats:p>\n                      URL\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      . Unique identifier: NCT01083030.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circinterventions.112.971630","type":"journal-article","created":{"date-parts":[[2012,11,28]],"date-time":"2012-11-28T20:46:57Z","timestamp":1354135617000},"page":"831-840","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":319,"title":["Paclitaxel-Coated Balloons Reduce Restenosis After Femoro-Popliteal Angioplasty"],"prefix":"10.1161","volume":"5","author":[{"given":"Michael","family":"Werk","sequence":"first","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Albrecht","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk-Roelfs","family":"Meyer","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammed Nabil","family":"Ahmed","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Behne","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Dietz","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00f6tz","family":"Eschenbach","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holger","family":"Hartmann","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Lange","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatrix","family":"Schnorr","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heiner","family":"Stiepani","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe Biondi","family":"Zoccai","sequence":"additional","affiliation":[{"name":"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 Charit\u00e9, Universit\u00e4tsmedizin Berlin, Berlin,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique Lopez","family":"H\u00e4nninen","sequence":"additional","affiliation":[{"name":"From the Department of Radiology and Nuclear Medicine, Martin-Luther-Hospital, Berlin, Germany (M.W., C.L., H.S., E.L.H.); 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