{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T08:40:26Z","timestamp":1782895226490,"version":"3.54.5"},"reference-count":19,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["13\/81\/02"],"award-info":[{"award-number":["13\/81\/02"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"<jats:sec id=\"abs1-1\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To determine which primary endovascular revascularisation strategy represents the most clinical and cost-effective treatment for patients with chronic limb threatening ischaemia who require an endovascular femoro-popliteal, with or without an infra-popliteal revascularisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-2\">\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Three-arm open-label pragmatic multicentre randomised phase 3 superiority trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-3\">\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Thirty-five UK NHS vascular units.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-4\">\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Patients with chronic limb threatening ischaemia who required an endovascular femoro-popliteal with or without an infra-popliteal revascularisation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-5\">\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Participants were randomly assigned (1\u2005:\u20051\u2005:\u20051) to either a femoro-popliteal plain balloon angioplasty with or without bare metal stenting (considered as control or reference), or a drug-coated balloon angioplasty with or without bare metal stenting, or a drug-eluting stenting first revascularisation strategy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-6\">\n                    <jats:title>Methods<\/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 overall survival, limb salvage, major adverse limb events, major adverse cardiac events and other pre-specified clinical and patient reported outcome measures. Serious adverse events were collected up to 30 days following the first revascularisation procedure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-7\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Between 29 January 2016 and 31 August 2021, 481 participants [167 (35%) women] of mean age 71.8 years (standard deviation 10.8) were randomised. Major amputation or death occurred in 106 of 160 (66%) participants in the plain balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting group, 97 of 161 (60%) participants in the drug-coated balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting, and 93 of 159 (58%) participants in the drug-eluting stenting group [adjusted hazard ratios: plain balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting vs. drug-coated balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting: 0.84 (97.5% confidence interval 0.61 to 1.16),\n                      <jats:italic>p<\/jats:italic>\n                      \u2005=\u20050.22; plain balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting vs. drug-eluting stenting: 0.83 (97.5% confidence interval 0.60 to 1.15),\n                      <jats:italic>p<\/jats:italic>\n                      \u2005=\u20050.20]. There were no differences in serious adverse events between the groups. There were no differences in mortality when drug technology arms were pooled versus plain balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting. When compared to plain balloon angioplasty, drug-eluting stenting was less costly [\u2212\u00a3724 (95% confidence interval \u2212\u00a34975 to \u00a32631)] and resulted in additional 0.048 quality-adjusted life-years (95% confidence interval \u22120.060 to 0.148). Drug-coated balloon angioplasty was unlikely to be a cost-effective option (probability 52% of being cost-effective at \u00a320,000 per quality-adjusted life-year) while drug-eluting stenting was potentially cost-effective (probability 76% of being cost-effective at \u00a320,000 per quality-adjusted life-year).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-8\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Neither drug-coated balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting, nor drug-eluting stenting, conferred significant clinical benefit over plain balloon angioplasty\u00a0\u00b1\u00a0bare metal stenting when used in the femoro-popliteal segment in patients undergoing femoro-popliteal\u00a0\u00b1\u00a0infra-popliteal endovascular revascularisation for chronic limb threatening ischaemia. Drug-eluting stenting and drug-coated balloon angioplasty in chronic limb threatening ischaemia patients were found to offer moderate benefits in health economic outcomes particularly when drug-eluting stenting was compared to plain balloon angioplasty.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"abs1-9\">\n                    <jats:title>Funding<\/jats:title>\n                    <jats:p>This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 13\/81\/02.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3310\/gjab0915","type":"journal-article","created":{"date-parts":[[2025,9,15]],"date-time":"2025-09-15T08:08:56Z","timestamp":1757923736000},"page":"1-18","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Plain balloon angioplasty +\/- bare metal stenting versus drug-coated balloon angioplasty +\/- bare metal stenting versus primary drug-eluting stenting in patients with chronic limb-threatening ischaemia: BASIL-3, an open-label, three-arm, randomised, multi-centre, phase 3 trial"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6239-4039","authenticated-orcid":true,"given":"Matthew A","family":"Popplewell","sequence":"first","affiliation":[{"name":"Department of Applied Health Sciences, Murray Learning Centre Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3016-7624","authenticated-orcid":true,"given":"Jack A","family":"Hall","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, Department of Applied Health Sciences, Public Health Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7608-4923","authenticated-orcid":true,"given":"Jesse","family":"Kigozi","sequence":"additional","affiliation":[{"name":"Health Economics Unit, Department of Applied Health Sciences, Public Health Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-5095-4231","authenticated-orcid":true,"given":"Mishal","family":"Javed","sequence":"additional","affiliation":[{"name":"Health Economics Unit, Department of Applied Health Sciences, Public Health Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4698-7333","authenticated-orcid":true,"given":"Lewis","family":"Meecham","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, University Hospital of Wales, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3084-070X","authenticated-orcid":true,"given":"Gareth R","family":"Bate","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, University Hospitals Birmingham NHS Foundation Trust, Heartlands Hospital, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0105-1967","authenticated-orcid":true,"given":"Lisa","family":"Kelly","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, University Hospitals Birmingham NHS Foundation Trust, Heartlands Hospital, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8850-1971","authenticated-orcid":true,"given":"Jonathan J","family":"Deeks","sequence":"additional","affiliation":[{"name":"Department of Applied Health Sciences, Murray Learning Centre Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0473-0532","authenticated-orcid":true,"given":"Catherine A","family":"Moakes","sequence":"additional","affiliation":[{"name":"Birmingham Clinical Trials Unit, Department of Applied Health Sciences, Public Health Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0530-9667","authenticated-orcid":true,"given":"Andrew W","family":"Bradbury","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, University of Birmingham, Public Health Building, University of Birmingham, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2026,6]]},"reference":[{"key":"key2026070112481500_ref1-bib1","doi-asserted-by":"crossref","first-page":"e080881","DOI":"10.1136\/bmj-2024-080881","article-title":"Plain 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