{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:54:11Z","timestamp":1793332451437,"version":"4.5.0"},"reference-count":36,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2024,2,1]],"date-time":"2024-02-01T00:00:00Z","timestamp":1706745600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Interventions"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND:<\/jats:title>\n            <jats:p>The treatment of complex infra-inguinal disease with drug-coated balloons (DCBs) is associated with a significant number of patients undergoing provisional stenting to treat a suboptimal result. To determine the potential long-term impact of DCB treatment with provisional bare metal stenting in complex lesions in real-world patients, a post hoc analysis was performed on data from the IN.PACT Global Study (The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and\/or Popliteal Artery Lesions Using the IN.PACT Admiral Drug-Eluting Balloon). Five-year outcomes were compared between participants who were stented after DCB treatment versus those treated with DCB alone.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS:<\/jats:title>\n            <jats:p>The IN.PACT Global Study enrolled 1535 participants with intermittent claudication and\/or ischemic rest pain caused by femoropopliteal lesions; 1397 patients were included in this subgroup analysis (353 stented and 1044 nonstented). Effectiveness was assessed as freedom from clinically driven target lesion revascularization through 60 months. The primary safety composite end point was defined as freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and clinically driven target vessel revascularization through 60 months.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS:<\/jats:title>\n            <jats:p>\n              Lesions in the stented group were longer (15.37 versus 10.98 cm;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              &lt;0.001) and had more total occlusions (54.7% versus 28.6%;\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              &lt;0.001) compared with the nonstented group. The 5-year Kaplan-Meier estimated freedom from clinically driven target lesion revascularization was similar between groups (66.8% stented versus 70.0% nonstented group, log-rank\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              =0.22). The safety composite end point was achieved in 64.5% stented versus 68.2% nonstented participants (log-rank\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              =0.19) as estimated by the Kaplan-Meier method. No significant difference was observed in the cumulative incidence of major adverse events (49.1% stented versus 45.0% nonstented; log-rank\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              =0.17), including all-cause death (19.6% stented versus 19.3% nonstented, log-rank\n              <jats:italic toggle=\"yes\">P<\/jats:italic>\n              =0.99).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSIONS:<\/jats:title>\n            <jats:p>In this real-world study, revascularization of complex femoropopliteal artery lesions with DCB angioplasty alone or DCB followed by provisional bare metal stenting in certain lesions achieved comparable long-term safety and clinical effectiveness.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>REGISTRATION:<\/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=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              ; Unique identifier: NCT01609296.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circinterventions.123.013084","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T10:01:14Z","timestamp":1707818474000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Five-Year Safety and Effectiveness of Paclitaxel Drug-Coated Balloons Alone or With Provisional Bare Metal Stenting for Real-World Femoropopliteal Lesions: IN.PACT Global Study Subgroup Analysis"],"prefix":"10.1161","volume":"17","clinical-trial-number":[{"clinical-trial-number":"nct01609296","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0612-4269","authenticated-orcid":true,"given":"Gary M.","family":"Ansel","sequence":"first","affiliation":[{"name":"Department of Medicine, University of Toledo, OH (G.M.A.)."},{"name":"Healthcare Insights, LLC, Boston, MA (G.M.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6493-3799","authenticated-orcid":true,"given":"Marianne","family":"Brodmann","sequence":"additional","affiliation":[{"name":"Division of Angiology, Medical University, Graz, Austria (M.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4261-6359","authenticated-orcid":true,"given":"Krishna J.","family":"Rocha-Singh","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Prairie Heart Institute, St. John\u2019s Hospital, Springfield, IL (K.J.R.-S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah S.","family":"Menk","sequence":"additional","affiliation":[{"name":"Peripheral Vascular Health, Medtronic, Minneapolis, MN (J.S.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2704-3871","authenticated-orcid":true,"given":"Thomas","family":"Zeller","sequence":"additional","affiliation":[{"name":"Universit\u00e4ts-Herzzentrum Freiburg, Kardiologie und Angiologie II, Bad Krozingen, Germany (T.Z.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the IN.PACT Global Study Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2019.01.080"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.07.023"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007702"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2021.01.041"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-022-03265-1"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2019.05.034"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.115.002730"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2014.12.004"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2004.11.026"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1177\/15266028211016441"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.117.005654"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1177\/1358863X18775593"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007730"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.02.019"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2018.12.004"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.67.4.723"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcin.2014.10.016"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.29777"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.116.004848"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.4244\/EIJ-D-21-01098"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00270-022-03214-y"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1002\/ccd.30441"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.016900"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.11.039"},{"key":"e_1_3_3_26_2","first-page":"207","article-title":"The \u201cDEBELLUM\u201d--lower limb multilevel treatment with drug eluting balloon--randomized trial: 1-year results.","volume":"55","author":"Fanelli F","year":"2014","unstructured":"Fanelli, F, Cannavale, A, Corona, M, Lucatelli, P, Wlderk, A, Salvatori, FM. 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