{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T22:43:41Z","timestamp":1790808221178,"version":"4.1.0"},"reference-count":28,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["JAHA"],"published-print":{"date-parts":[[2022,6,21]]},"abstract":"<jats:sec sec-type=\"background\" xml:lang=\"en\">\n            <jats:title>Background<\/jats:title>\n            <jats:p xml:lang=\"en\">Despite high female prevalence of peripheral artery disease (PAD), little is known about sex\u2010based outcomes after lower extremity revascularization (LER) for symptomatic PAD. The effects of rivaroxaban according to sex following LER have not been fully reported.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Methods and Results<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              In VOYAGER PAD (Vascular Outcomes Study of ASA [acetylsalicylic acid] Along with Rivaroxaban in Endovascular or Surgical Limb Revascularization for Peripheral Artery Disease), low\u2010dose rivaroxaban versus placebo on a background of aspirin reduced the composite primary efficacy outcome of cardiovascular and limb events in patients with PAD undergoing LER. Unplanned index limb revascularization was prespecified and prospectively ascertained. The primary safety outcome was Thrombolysis in Myocardial Infarction major bleeding. Analyses of outcomes and treatment effects by sex were performed using Cox proportional hazards models. Among 6564 randomly assigned patients followed for a median of 28\u2009months, 1704 (26.0%) were women. Among patients administered placebo, women were at similar risk for the primary efficacy outcome (hazard ratio [HR], 0.90; [95% CI, 0.74\u20131.09];\n              <jats:italic>P<\/jats:italic>\n              =0.29) as men, while female sex was associated with a trend toward higher risk of unplanned index limb revascularization (HR, 1.18; [95% CI, 1.00\u20131.40];\n              <jats:italic>P<\/jats:italic>\n              =0.0499). Irrespective of sex, effects of rivaroxaban were consistent for the primary efficacy outcome (\n              <jats:italic>P<\/jats:italic>\n              \u2010interaction=0.22), unplanned index limb revascularization (\n              <jats:italic>P<\/jats:italic>\n              \u2010interaction=0.64), and bleeding (\n              <jats:italic>P<\/jats:italic>\n              \u2010interaction=0.61). Women were more likely than men to discontinue study treatment (HR, 1.13; [95% CI, 1.03\u20131.25];\n              <jats:italic>P<\/jats:italic>\n              =0.0099).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p xml:lang=\"en\">Among &gt;1700 women with PAD undergoing LER, women and men were at similar risk for the primary outcome, but a trend for greater risk of unplanned index limb revascularization among women was observed. Effects of rivaroxaban were consistent by sex, though women more often discontinued treatment. Better understanding of sex\u2010based outcomes and treatment adherence following LER is needed.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec xml:lang=\"en\">\n            <jats:title>Registration<\/jats:title>\n            <jats:p xml:lang=\"en\">\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">http:\/\/clinicaltrials.gov<\/jats:ext-link>\n              ; Unique identifier: NCT02504216.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/jaha.121.024655","type":"journal-article","created":{"date-parts":[[2022,6,14]],"date-time":"2022-06-14T10:36:24Z","timestamp":1655202984000},"update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":16,"title":["Sex\u2010Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD"],"prefix":"10.1161","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5830-0511","authenticated-orcid":false,"given":"Connie N.","family":"Hess","sequence":"first","affiliation":[{"name":"Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO"},{"name":"CPC Clinical Research Aurora CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Iris","family":"Baumgartner","sequence":"additional","affiliation":[{"name":"Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital University of Bern Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3692-7441","authenticated-orcid":false,"given":"Sonia S.","family":"Anand","sequence":"additional","affiliation":[{"name":"Population Health Research Institute, Hamilton Health Sciences McMaster University Hamilton Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark R.","family":"Nehler","sequence":"additional","affiliation":[{"name":"CPC Clinical Research Aurora CO"},{"name":"Department of Surgery University of Colorado School of Medicine Aurora CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2393-0855","authenticated-orcid":false,"given":"Manesh R.","family":"Patel","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Duke Clinical Research Institute Duke University Medical Center Durham NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5664-6439","authenticated-orcid":false,"given":"E. Sebastian","family":"Debus","sequence":"additional","affiliation":[{"name":"Department of Vascular Medicine, Vascular Surgery \u2013 Angiology \u2013 Endovascular Therapy University of Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Szarek","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO"},{"name":"CPC Clinical Research Aurora CO"},{"name":"The State University of New York Downstate Health Sciences University Brooklyn NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Warren","family":"Capell","sequence":"additional","affiliation":[{"name":"CPC Clinical Research Aurora CO"},{"name":"Division of Endocrinology, Department of Medicine University of Colorado Anschutz Medical Campus Aurora 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M.","family":"Bauersachs","sequence":"additional","affiliation":[{"name":"CCB\u2010Cardiovascular Center Bethanien Frankfurt Germany"},{"name":"Center for Thrombosis and Hemostasis University of Mainz Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9860-3584","authenticated-orcid":false,"given":"Marc P.","family":"Bonaca","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO"},{"name":"CPC Clinical Research Aurora CO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3413-7836","authenticated-orcid":false,"given":"Judith","family":"Hsia","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Medicine University of Colorado School of Medicine Aurora CO"},{"name":"CPC Clinical Research Aurora 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