{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T03:53:35Z","timestamp":1793332415268,"version":"4.5.0"},"reference-count":24,"publisher":"BMJ","license":[{"start":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T00:00:00Z","timestamp":1740355200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"accepted":{"date-parts":[[2025,1,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To determine which primary endovascular revascularisation strategy represents the most clinically effective treatment for patients with chronic limb threatening ischaemia who require endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Three arm, open label, pragmatic, multicentre, randomised, phase 3 superiority trial (BASIL-3).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>35 UK NHS vascular units.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Patients with chronic limb threatening ischaemia who required endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Participants were randomly assigned (1:1:1) to femoro-popliteal plain balloon angioplasty with or without bare metal stenting (PBA\u00b1BMS), drug coated balloon angioplasty with or without bare metal stenting (DCBA\u00b1BMS), or drug eluting stenting (DES) as their first revascularisation strategy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The primary outcome was amputation free survival defined as time to first major amputation or death from any cause. Secondary outcomes included the composite components of the primary outcome, major adverse limb events, major adverse cardiac events, and other prespecified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days after the first revascularisation procedure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 29 January 2016 and 31 August 2021, 481 participants were randomised (167 (35%) women, mean age 71.8 years (standard deviation 10.8)). Major amputation or death occurred in 106 of 160 (66%) participants in the PBA\u00b1BMS group, 97 of 161 (60%) in the DCBA\u00b1BMS group, and 93 of 159 (58%) in the DES group (adjusted hazard ratios: PBA\u00b1BMS\n                      <jats:italic>v<\/jats:italic>\n                      DCBA\u00b1BMS: 0.84, 97.5% confidence interval 0.61 to 1.16, P=0.22; PBA\u00b1BMS\n                      <jats:italic>v<\/jats:italic>\n                      DES: 0.83, 0.60 to 1.15, P=0.20). No differences in serious adverse events were reported between the groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Neither DCBA\u00b1BMS nor DES conferred significant clinical benefit over PBA\u00b1BMS in the femoro-popliteal segment in patients with chronic limb threatening ischaemia undergoing endovascular femoro-popliteal, with or without infra-popliteal, revascularisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ISRCTN registry ISRCTN14469736<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmj-2024-080881","type":"journal-article","created":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T06:35:12Z","timestamp":1740378912000},"page":"e080881","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":43,"title":["Plain versus drug balloon and stenting\u00a0in severe ischaemia of the leg (BASIL-3): open label, three arm, randomised, multicentre, phase 3 trial"],"prefix":"10.1136","volume":"388","clinical-trial-number":[{"clinical-trial-number":"isrctn14469736","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0530-9667","authenticated-orcid":false,"given":"Andrew W","family":"Bradbury","sequence":"first","affiliation":[{"name":"University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3016-7624","authenticated-orcid":false,"given":"Jack A","family":"Hall","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, School of Health Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6239-4039","authenticated-orcid":false,"given":"Matthew A","family":"Popplewell","sequence":"additional","affiliation":[{"name":"Black Country Vascular Network, Dudley, UK"},{"name":"Department of Applied Health Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4698-7333","authenticated-orcid":false,"given":"Lewis","family":"Meecham","sequence":"additional","affiliation":[{"name":"University Hospital of Wales, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3084-070X","authenticated-orcid":false,"given":"Gareth R","family":"Bate","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0105-1967","authenticated-orcid":false,"given":"Lisa","family":"Kelly","sequence":"additional","affiliation":[{"name":"University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8850-1971","authenticated-orcid":false,"given":"Jon J","family":"Deeks","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, School of Health Sciences, University of Birmingham, Birmingham, UK"},{"name":"Department of Applied Health Sciences, University of Birmingham, Birmingham, UK"},{"name":"NIHR Birmingham Biomedical Research Centre, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0473-0532","authenticated-orcid":false,"given":"Catherine A","family":"Moakes","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, School of Health Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,2,24]]},"reference":[{"key":"2025110102511188000_388.feb24_1.e080881.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejvs.2019.05.006"},{"key":"2025110102511188000_388.feb24_1.e080881.2","doi-asserted-by":"publisher","DOI":"10.3310\/hta14220"},{"key":"2025110102511188000_388.feb24_1.e080881.3","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa2207899"},{"key":"2025110102511188000_388.feb24_1.e080881.4","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)00462-2"},{"key":"2025110102511188000_388.feb24_1.e080881.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jvs.2018.01.071"},{"key":"2025110102511188000_388.feb24_1.e080881.6","unstructured":"National Institute of Health and Care Excellence. 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