{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T22:34:17Z","timestamp":1788474857982,"version":"build-2803163510"},"reference-count":23,"publisher":"European Respiratory Society (ERS)","issue":"4","license":[{"start":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T00:00:00Z","timestamp":1727308800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005646","name":"Actelion Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005646","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2024,7,25]]},"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>SELECT was the first global randomised controlled trial of selexipag with standard of care in patients with inoperable or persistent\/recurrent chronic thromboembolic pulmonary hypertension.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>SELECT was a multicentre, randomised, double-blind, placebo-controlled, parallel-group, group-sequential, phase 3 study (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/\">ClinicalTrials.gov<\/jats:ext-link>:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03689244\">NCT03689244<\/jats:ext-link>). Adults aged \u226485\u2005years in World Health Organization Functional Class I\u2013IV, with a 6-min walk distance of 100\u2013450\u2005m, were randomised (1:1) to receive selexipag (200\u20131600\u2005\u00b5g twice daily titration until individual maximum tolerated dose)+standard of care or placebo+standard of care. Patients were recruited into the haemodynamic set (first 91 randomised patients to undergo right heart catheterisation (RHC); week 20) or non-haemodynamic cohort (remaining patients, no RHC required). The primary end-point was percent of baseline pulmonary vascular resistance (PVR; week 20). Safety was also assessed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 321 patients screened, 128 were randomised (haemodynamic set n=91 (selexipag n=47; placebo n=44)). In the haemodynamic set, 29 (31.9%) patients had previous pulmonary endarterectomy (PEA), 20 (22.0%) balloon pulmonary angioplasty (BPA), and 14 (15.4%) both PEA and BPA; 28 (30.8%) were inoperable. The independent data monitoring committee recommended to stop the study for futility as no statistically significant difference was observed for the primary end-point (between-treatment geometric least squares mean ratio of PVR: 0.95, 95% CI 0.84\u20131.07; p=0.412). Adverse events were reported in 63 (98.4%) and 53 (82.8%) patients for selexipag and placebo, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>SELECT was discontinued for futility, as no treatment effect on the primary end-point (PVR) was observed. Safety data were consistent with the established safety profile of selexipag, with no new safety signals identified.<\/jats:p><\/jats:sec>","DOI":"10.1183\/13993003.00193-2024","type":"journal-article","created":{"date-parts":[[2024,9,26]],"date-time":"2024-09-26T15:42:22Z","timestamp":1727365342000},"page":"2400193","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":15,"title":["Efficacy and safety of selexipag in patients with inoperable or persistent\/recurrent CTEPH (SELECT randomised trial)"],"prefix":"10.1183","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4702-650X","authenticated-orcid":false,"given":"Nick H.","family":"Kim","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Channick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8394-9809","authenticated-orcid":false,"given":"Marion","family":"Delcroix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Madani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Pepke-Zaba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julian I.","family":"Borissoff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valerie","family":"Easton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Gesang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dominik","family":"Richard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2029-4419","authenticated-orcid":false,"given":"Hossein-Ardeschir","family":"Ghofrani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2024,9,26]]},"reference":[{"key":"2024112623040014000_64.4.2400193.1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehac237"},{"key":"2024112623040014000_64.4.2400193.2","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00879-2022"},{"key":"2024112623040014000_64.4.2400193.3","doi-asserted-by":"publisher","DOI":"10.1177\/2045894020977300"},{"key":"2024112623040014000_64.4.2400193.4","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00449-2023"},{"key":"2024112623040014000_64.4.2400193.5","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.016522"},{"key":"2024112623040014000_64.4.2400193.6","doi-asserted-by":"crossref","first-page":"106293","DOI":"10.1016\/j.rmed.2020.106293","article-title":"Interventional and pharmacological management of chronic thromboembolic pulmonary hypertension","volume":"177","author":"Ghofrani","year":"2021","journal-title":"Respir Med"},{"key":"2024112623040014000_64.4.2400193.7","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.110.015008"},{"key":"2024112623040014000_64.4.2400193.8","doi-asserted-by":"crossref","first-page":"S420","DOI":"10.1016\/j.healun.2023.02.1087","article-title":"(976) Assessment of clinical practices and unmet needs in chronic thromboembolic pulmonary hypertension (CTEPH) \u2013 a global cross-sectional scientific survey (CLARITY)","volume":"42","author":"Heresi","year":"2023","journal-title":"J Heart Lung Transplant"},{"key":"2024112623040014000_64.4.2400193.9","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00087114"},{"key":"2024112623040014000_64.4.2400193.10","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01694-2021"},{"key":"2024112623040014000_64.4.2400193.11","unstructured":"European Medicines Agency . 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