Blood advancesPub Date : 2025-05-13DOI: 10.1182/bloodadvances.2024015307
Thuy Linh Dang, Thibaut Moulin, Gonzalo de Luna, Sihem Iles, Anaïs Lamadieu, David Calvet, Geneviève Derumeaux, Pablo Bartolucci, Nicolas Lellouche, Thomas d'Humières
{"title":"Key role of long-duration cardiac rhythm monitoring in patients with sickle cell disease with atrial hyperexcitability.","authors":"Thuy Linh Dang, Thibaut Moulin, Gonzalo de Luna, Sihem Iles, Anaïs Lamadieu, David Calvet, Geneviève Derumeaux, Pablo Bartolucci, Nicolas Lellouche, Thomas d'Humières","doi":"10.1182/bloodadvances.2024015307","DOIUrl":"https://doi.org/10.1182/bloodadvances.2024015307","url":null,"abstract":"","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":"9 9","pages":"2261-2265"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-13DOI: 10.1182/bloodadvances.2024015176
Athalia R Pyzer, Laura W Dillon, Elad Sharon, Theodore G Karrison, Yuanyuan Zha, Noreen Fulton, Gege Gui, Georgia Andrew, Howard Streicher, Kendra Sweet, George Yaghmour, Jane Jijun Liu, Brian A Jonas, Aaron D Schimmer, Steven Grant, Amer M Zeidan, Gerhard C Hildebrandt, Christopher H Lowrey, Ryan J Mattison, Neil Palmisiano, Amandeep Salhotra, Dimitrios Tzachanis, Maria R Baer, Tara L Lin, Prapti Patel, Helen Chen, Walter M Stadler, Olatoyosi Odenike, Richard A Larson, Thomas F Gajewski, Christopher S Hourigan, Wendy Stock, Hongtao Liu
{"title":"Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia.","authors":"Athalia R Pyzer, Laura W Dillon, Elad Sharon, Theodore G Karrison, Yuanyuan Zha, Noreen Fulton, Gege Gui, Georgia Andrew, Howard Streicher, Kendra Sweet, George Yaghmour, Jane Jijun Liu, Brian A Jonas, Aaron D Schimmer, Steven Grant, Amer M Zeidan, Gerhard C Hildebrandt, Christopher H Lowrey, Ryan J Mattison, Neil Palmisiano, Amandeep Salhotra, Dimitrios Tzachanis, Maria R Baer, Tara L Lin, Prapti Patel, Helen Chen, Walter M Stadler, Olatoyosi Odenike, Richard A Larson, Thomas F Gajewski, Christopher S Hourigan, Wendy Stock, Hongtao Liu","doi":"10.1182/bloodadvances.2024015176","DOIUrl":"10.1182/bloodadvances.2024015176","url":null,"abstract":"<p><strong>Abstract: </strong>We conducted a multicenter, open-label, randomized phase 2 study to assess the efficacy of nivolumab (Nivo) as maintenance therapy for patients with acute myeloid leukemia (AML) in first complete remission (CR) or CR with incomplete hematologic recovery who were not candidates for stem cell transplant. Patients were stratified and randomized to observation (Obs) or Nivo (3 mg/kg IV every 2 weeks for 46 doses). The primary end point was progression-free survival (PFS) defined as time to disease relapse or death due to any reason. Secondary end points included overall survival (OS), and evaluation of adverse events (AEs) after Nivo administration. Eighty patients were enrolled with median duration of follow-up of 24 months (33 months among survivors). PFS was 13.2 months in the Nivo arm and 10.9 months in the Obs arm. Overall PFS curves were not statistically significantly different. The median OS was 53.9 months in the Nivo arm and 30.9 months in the Obs arm. There were more AEs of any type (regardless of attribution) on the Nivo arm; 27 patients (71%) on the Nivo arm had a grade ≥3 AE compared with 5 patients (12%) on the Obs arm (P < .001). Nivo maintenance after AML chemotherapy failed to improve the PFS and OS in this randomized phase 2 study. There were increased AEs and serious AEs (SAEs) with Nivo, but these AEs and SAEs were expected and manageable. This trial was registered at www.ClinicalTrials.gov as #NCT02275533.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":"2144-2152"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12051614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-13DOI: 10.1182/bloodadvances.2024015072
Luke Wang, Eliza Chung, Cameron Wellard, Allison Barraclough, Belinda A Campbell, Geoffrey Chong, Pietro R Di Ciaccio, Gareth P Gregory, Greg Hapgood, Anna M Johnston, Constantine Tam, Stephen Opat, Erica M Wood, Zoe K McQuilten, Eliza A Hawkes
{"title":"Definitions and use of tumor bulk in phase 3 lymphoma trials: a comprehensive literature review.","authors":"Luke Wang, Eliza Chung, Cameron Wellard, Allison Barraclough, Belinda A Campbell, Geoffrey Chong, Pietro R Di Ciaccio, Gareth P Gregory, Greg Hapgood, Anna M Johnston, Constantine Tam, Stephen Opat, Erica M Wood, Zoe K McQuilten, Eliza A Hawkes","doi":"10.1182/bloodadvances.2024015072","DOIUrl":"10.1182/bloodadvances.2024015072","url":null,"abstract":"<p><strong>Abstract: </strong>Tumor \"bulk\" has historically been considered an important prognostic marker and a clinical tool to guide treatment in patients with lymphoma. However, its use and definitions in trial designs vary significantly, and it is unclear how this has influenced the relevance of bulk in contemporary practice. This comprehensive literature review evaluated the definitions, applications, and prognostic impact of bulk in phase 3 randomized trials in 4 major lymphoma subtypes. Overall, 87 studies were identified across follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL), and Hodgkin lymphoma (HL) with a wide range of bulk thresholds used (5 cm, 6 cm, 7 cm, 7.5 cm, 10 cm, and >1/3 mediastinal mass ratio [MMR]). The most common threshold was as follows: FL, 7 cm (58%); DLBCL, 7.5 cm and 10 cm (44% each); PTCL, 7.5 cm (66%); and HL, one-third MMR (91%). Bulk threshold was used by trials to determine eligibility (66%), stratification (24%), as a prognostic risk factor (37%), and as a decision tool for risk-adapted treatment, for example, radiotherapy (29%); however, bulk definitions used for these varied both between, and within, lymphoma subtypes and even within single trials in 25%. Furthermore, 32 studies incorporated bulk in prognostic analyses with only 5 showing significance for differential survival outcomes. Our analysis demonstrates high inconsistency in thresholds defining tumor bulk and use of bulk in phase 3 lymphoma trials across eligibility, stratification, therapeutic risk adaptation, and prognostication. This highlights an urgent need for international consensus on definitions of bulk within trials to improve its prognostic and predictive values and refine its application in clinical practice.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":"2275-2284"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143000482","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-13DOI: 10.1182/bloodadvances.2024015648
Bhavesh Mohan Lal, Marah Alzubi, Jawad Alrawabdeh, John D Shaughnessy, Fenghuang Zhan, Eric R Siegel, Carolina Schinke, Sharmilan Thanendrarajan, Maurizio Zangari, Frits van Rhee, Samer Al Hadidi
{"title":"Prior exposure to belantamab mafodotin influences outcomes with idecabtagene vicleucel in patients with multiple myeloma.","authors":"Bhavesh Mohan Lal, Marah Alzubi, Jawad Alrawabdeh, John D Shaughnessy, Fenghuang Zhan, Eric R Siegel, Carolina Schinke, Sharmilan Thanendrarajan, Maurizio Zangari, Frits van Rhee, Samer Al Hadidi","doi":"10.1182/bloodadvances.2024015648","DOIUrl":"10.1182/bloodadvances.2024015648","url":null,"abstract":"","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":"2155-2158"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12051553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143405750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-13DOI: 10.1182/bloodadvances.2024013744
Adriano Venditti, Raffaele Palmieri, Luca Maurillo, Christoph Röllig, Agnieszka Wierzbowska, David de Leeuw, Fabio Efficace, Antonio Curti, Lok Lam Ngai, Jesse Tettero, Lionel Adès, Antonio Almeida, Lars Bullinger, Mike Dennis, Jordi Esteve, Felicetto Ferrara, Michael Heuser, Gerwin Huls, Michael Lübbert, Priyanka Mehta, Pau Montesinos, Thomas Pabst, Christian Récher, Giuseppe Rossi, Nigel Russell, Jorge Sierra, Reinhard Stauder, Norbert Vey, Roland B Walter, Eunice Wang, Samantha Nier, Carolina Garcez Martins, Gert Ossenkoppele
{"title":"Fitness assessment in acute myeloid leukemia: recommendations from an expert panel on behalf of the European LeukemiaNet.","authors":"Adriano Venditti, Raffaele Palmieri, Luca Maurillo, Christoph Röllig, Agnieszka Wierzbowska, David de Leeuw, Fabio Efficace, Antonio Curti, Lok Lam Ngai, Jesse Tettero, Lionel Adès, Antonio Almeida, Lars Bullinger, Mike Dennis, Jordi Esteve, Felicetto Ferrara, Michael Heuser, Gerwin Huls, Michael Lübbert, Priyanka Mehta, Pau Montesinos, Thomas Pabst, Christian Récher, Giuseppe Rossi, Nigel Russell, Jorge Sierra, Reinhard Stauder, Norbert Vey, Roland B Walter, Eunice Wang, Samantha Nier, Carolina Garcez Martins, Gert Ossenkoppele","doi":"10.1182/bloodadvances.2024013744","DOIUrl":"10.1182/bloodadvances.2024013744","url":null,"abstract":"<p><strong>Abstract: </strong>Fitness assessment in patients with acute myeloid leukemia (AML) is critical to deliver the right therapy to the right patient. Although several scoring systems are available to aid in determining fitness, the absence of validation studies has resulted in the lack of universally accepted assessment procedures. This limitation, combined with the increasing availability of novel agents expanding the spectrum of less-intensive options, has introduced additional complexity to the fitness assessment process. In this evolving context, fitness should reflect eligibility for a specific treatment among the several available, rather than a generic binary classification of eligibility for intensive chemotherapy. Moreover, the growing emphasis on patient-centered care, further highlights the importance of integrating quality of life, patient preferences, patient self-reported physical and social functioning status, social support, and early integration of palliative care into the assessment framework. A modern interpretation of fitness assessment should incorporate a comprehensive evaluation that extends beyond traditional clinical and biological disease characteristics. Thus, fitness assessment in patients with AML represents only 1 piece of a larger puzzle, encompassing the patient's overall capacity to sustain and benefit from a specific therapeutic program.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":"2207-2220"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-13DOI: 10.1182/bloodadvances.2025015912
Cecilia Anna Fidanza, Fabio Serpenti, Francesca Cavallaro, Kordelia Barbullushi, Nicolò Rampi, Francesca Gaia Rossi Dardanoni, Maria Goldaniga, Giorgia Natascia Saporiti, Francesco Passamonti
{"title":"GVHD in the era of checkpoint inhibition in Hodgkin lymphoma.","authors":"Cecilia Anna Fidanza, Fabio Serpenti, Francesca Cavallaro, Kordelia Barbullushi, Nicolò Rampi, Francesca Gaia Rossi Dardanoni, Maria Goldaniga, Giorgia Natascia Saporiti, Francesco Passamonti","doi":"10.1182/bloodadvances.2025015912","DOIUrl":"10.1182/bloodadvances.2025015912","url":null,"abstract":"","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":"2341-2343"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143363726","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Impacts of donor age and HLA mismatch on HCT outcomes differ according to the donor CMV serostatus in unrelated allo-HCT.","authors":"Shunto Kawamura, Daishi Nakagawa, Takashi Nagayama, Yuta Katayama, Noriko Doki, Wataru Takeda, Tetsuya Nishida, Ken-Ichi Matsuoka, Takashi Ikeda, Hiroyuki Ohigashi, Masashi Sawa, Kentaro Fukushima, Junya Kanda, Kentaro Serizawa, Makoto Onizuka, Takahiro Fukuda, Yoshiko Atsuta, Yoshinobu Kanda, Hideki Nakasone","doi":"10.1182/bloodadvances.2024014408","DOIUrl":"10.1182/bloodadvances.2024014408","url":null,"abstract":"<p><strong>Abstract: </strong>In unrelated allogeneic hematopoietic cell transplantation (allo-HCT), older and/or HLA-mismatched donors are known risk factors for survival outcomes. In healthy individuals, cytomegalovirus (CMV) seropositivity is associated with impaired adaptive immune systems. We assessed whether the adverse effects of donor risk factors are influenced by the donor CMV serostatus. We analyzed 5836 patients with CMV seropositivity who received unrelated allo-HCT. We divided the entire cohort into 2 cohorts according to the donor CMV serostatus: CMV positive (DP) and negative (DN). We also stratified each cohort into 4 groups based on donor age (aged ≥40 or <40 years) and HLA parity (8/8 or 7/8): Young88 and Old88, and Young78 and Old78, respectively. In the CMV-DP cohort, the Old88 (hazard ratio [HR], 1.20; P = .012), Young78 (HR, 1.35; P < .001), and Old78 (HR, 1.60; P < .001) groups were associated with inferior overall survival (OS) than the Young88 group. In contrast, in the CMV-DN cohort, neither donor age nor HLA disparity was associated with inferior OS. The adverse impact of donor age was different between the cohorts (CMV-DP: HR, 1.19; P = .001; CMV-DN: HR, 1.04; P = .53; P for interaction, .070), as was the impact of HLA (CMV-DP: HR, 1.34; P < .001; CMV-DN: HR, 1.08; P = .23; P for interaction, .012). The impacts of donor age and HLA mismatch on OS might differ according to the donor CMV serostatus. In unrelated allo-HCT from a CMV-seronegative donor, an HLA-mismatched older donor may be able to be selected without affecting OS.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":"2356-2365"},"PeriodicalIF":7.4,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142982800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-12DOI: 10.1182/bloodadvances.2024015777
Thalia Padilla Kelley, Hannah L King, Aditya Malhotra, Thomas G DeLoughery, Kylee L Martens, Joseph J Shatzel
{"title":"Advancements in Complement Inhibition for PNH and Primary Complement Mediated Thrombotic Microangiopathy.","authors":"Thalia Padilla Kelley, Hannah L King, Aditya Malhotra, Thomas G DeLoughery, Kylee L Martens, Joseph J Shatzel","doi":"10.1182/bloodadvances.2024015777","DOIUrl":"https://doi.org/10.1182/bloodadvances.2024015777","url":null,"abstract":"<p><p>Paroxysmal nocturnal hemoglobinuria (PNH) and primary complement-mediated thrombotic microangiopathy (CM-TMA), also known as atypical hemolytic uremic syndrome (aHUS), are hematologic disorders characterized by dysregulation of the complement system leading to hemolysis and other systemic and potentially lethal complications. The advent of C5 inhibition with agents such as eculizumab and ravulizumab has revolutionized the management of patients with these disorders, though some may still experience clinically significant breakthrough extravascular hemolysis. Over the past several years, novel therapies targeting upstream pathways of complement inhibition have been approved for the treatment of patients with PNH experiencing breakthrough hemolysis despite C5 inhibition. These agents currently include pegcetacoplan, a C3 inhibitor, iptacopan, an oral factor B inhibitor, danicopan, an oral factor D inhibitor, and crovalimab, an anti-C5 monoclonal antibody. This review highlights recent advances in complement-targeted therapies for PNH, including their indications and efficacy and safety data from key randomized trials. In addition, we review current data supporting the use of these novel agents for aHUS, for which only the terminal complement inhibitors eculizumab and ravulizumab are currently approved. Future research is crucial to establish the long-term efficacy and safety profiles of these novel therapies, ensuring the best treatment strategies for patients with PNH and aHUS.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-12DOI: 10.1182/bloodadvances.2024015417
John N Allan, Tao Ran, Zhijie Ding, Jinghua He, Alex Bokun, Zaina P Qureshi, Susan M O'Brien
{"title":"Real-World Survival Outcomes in First-Line Ibrutinib-Treated Patients with High-Risk CLL/SLL.","authors":"John N Allan, Tao Ran, Zhijie Ding, Jinghua He, Alex Bokun, Zaina P Qureshi, Susan M O'Brien","doi":"10.1182/bloodadvances.2024015417","DOIUrl":"https://doi.org/10.1182/bloodadvances.2024015417","url":null,"abstract":"<p><p>In patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), high-risk cytogenetic features such as del(17p), del(11q), and unmutated immunoglobulin variable heavy chain (IGHV) may be associated with unfavorable outcomes. In this large retrospective cohort study, data from a nationwide electronic health record-derived deidentified database were analyzed to assess real-world overall survival (rwOS) among patients treated with first-line (IL) ibrutinib with and without high-risk cytogenetic features (i.e., del(17p), del(11q), unmutated IGHV). Inverse probability of treatment weighting was used to account for differences in patient characteristics between cohorts. Of the 1,242 patients included, 969 and 273 had high- and non-high-risk CLL/SLL, with a mean age of 70.0 and 70.8 years, and a median follow up of 32 and 31 months, respectively. Within the high-risk cohort, 32.9%, 36.7%, and 58.7% had the presence of del(17p), del(11q), and unmutated IGHV, respectively. Median rwOS was not reached for either cohort; the hazard ratio (HR; 95% confidence interval [CI]) comparing rwOS between the two cohorts was 1.09 (0.79, 1.51). In a sensitivity analysis where del(11q) was not part of the high-risk definition, similar results were found, with a HR (95% CI) of 1.19 (0.86, 1.64) and median rwOS not reached for either cohort. Similarly, among the subgroup of patients with Medicare coverage, the HR (95% CI) was 0.98 (0.63, 1.53), and median rwOS was not reached. In this real-world study using a large community healthcare dataset, there was no difference in rwOS between patients treated with 1L ibrutinib with and without high-risk cytogenetic features.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143965997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Blood advancesPub Date : 2025-05-12DOI: 10.1182/bloodadvances.2024015515
Kari A O Tikkinen, Deborah M Siegal, P J Devereaux, Sara V Tornberg, Flavia K Borges, Sandra Ofori, Jehonathan Pinthus, Bobby Shayegan, Lauri I Lavikainen, Gordon H Guyatt, Pavel S Roshanov
{"title":"The CLUE Post-Surgery VTE Risk Instrument for Abdominal and Pelvic Surgery: Validation of Patient Risk Factor Component.","authors":"Kari A O Tikkinen, Deborah M Siegal, P J Devereaux, Sara V Tornberg, Flavia K Borges, Sandra Ofori, Jehonathan Pinthus, Bobby Shayegan, Lauri I Lavikainen, Gordon H Guyatt, Pavel S Roshanov","doi":"10.1182/bloodadvances.2024015515","DOIUrl":"https://doi.org/10.1182/bloodadvances.2024015515","url":null,"abstract":"<p><p>Venous thromboembolism (VTE) remains a major postoperative risk. Systematic reviews have established procedure-specific VTE risk estimates, which form one component of the CLUE Post-Surgery VTE Risk Instrument. The instrument also incorporates patient-level factors-age (≥75 years), BMI (≥35 kg/m²), and prior VTE-to stratify overall risk. However, the patient risk factor component has not been formally validated. We therefore conducted the validation using data from the VISION study, a prospective, international cohort of 11,636 patients undergoing major general abdominal, urologic, or gynecologic surgery. Thirty-day postoperative VTE incidence was analyzed using modified Poisson regression. The instrument classified patients as low (72%), medium (25%), and high (4%) risk factor categories. VTE occurred in 97 patients (0.8%). Compared to the low-risk group, the relative risks of VTE was 1.56 (95% confidence interval, 1.01-2.43) for medium-risk and 3.60 (1.90-6.83) for high-risk patients. Among patients who did not receive antithrombotic medication, relative risks increased to 1.91 for medium-risk and 5.41 for high-risk patients. The CLUE Post-Surgery VTE Risk Instrument, using three widely available patient-level factors, accurately classifies patients into substantially different categories of relative VTE risk. This validated patient component complements procedure-specific absolute risk estimates derived from prior systematic reviews. To support evidence-based thromboprophylaxis decisions the instrument is now available through an interactive online platform.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":""},"PeriodicalIF":7.4,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975643","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}