YEARS Algorithm for Diagnosis of Suspected Pulmonary Embolism in Patients With Cancer: A Randomized Clinical Trial.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος:	YEARS Algorithm for Diagnosis of Suspected Pulmonary Embolism in Patients With Cancer: A Randomized Clinical Trial.
Συγγραφείς:	Akerboom B; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Martens ESL; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Stals MAM; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Brouwer RE; Department of Internal Medicine, Reinier de Graaf Gasthuis, Delft, the Netherlands., Coppens M; Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.; Pulmonary Hypertension & Critical Care, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands., Costantino G; Emergency Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy., Couturaud F; Department of Medicine and Pulmonology, CHU Brest, INSERM U1304-GETBO, Brest University, Brest, France., van Dooren YPA; Department of Pulmonology, Groene Hart Hospital, Gouda, the Netherlands., van der Griend R; Department of Medicine, Diakonessenhuis Utrecht, Utrecht, the Netherlands., Hugli O; Emergency Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland., Jiménez D; Respiratory Department, Ramón y Cajal Hospital (IRYCIS), Madrid, Spain.; Department of Medicine, Universidad de Alcalá (IRYCIS), Madrid, Spain.; CIBER de Enfermedades respiratorias (CIBERES), Madrid, Spain., Kamphuisen PW; Department of Vascular Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.; Pulmonary Hypertension & Critical Care, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.; Department of Medicine, Tergooi Medical Center, Hilversum, the Netherlands., El Kharbouchi O; Department of Pulmonology, Amphia Hospital, Breda, the Netherlands., Kroft LJM; Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands., Leentjens J; Department of Medicine, Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, the Netherlands., Maas ML; Department of Internal Medicine, Bernhoven Hospital, Uden, the Netherlands., van Mens TE; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Mahé I; Department of Internal Medicine, Paris Cité University, Assistance-Publique-Hôpitaux de Paris, Hôpital Louis-Mourier, Colombes, France., van Meer OA; Emergency Department, Leiden University Medical Center, Leiden, the Netherlands., Out M; Centrum Leefstijl en Gewicht (Center for Lifestyle and Weight), Kliniek Twente, Oldenzaal, the Netherlands., Pola R; Percorso Trombosi, Dipartimento di Scienze dell'Invecchiamento, Ortopediche e Reumatologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Raskin J; Department of Pulmonology and Thoracic Oncology, Antwerp University Hospital, Edegem, Belgium., Righini M; Division of Angiology and Hemostasis, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland., Sprenger RA; Department of Medicine, Maasstad Hospital, Rotterdam, the Netherlands., Kaptein FHJ; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Talerico R; Percorso Trombosi, Dipartimento di Scienze dell'Invecchiamento, Ortopediche e Reumatologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Tritschler T; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland., Ten Wolde M; Department of Internal Medicine, Flevo Hospital, Almere, the Netherlands., Klok FA; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands., Huisman MV; Department of Medicine-Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
Συλλογικό Έργο:	Hydra Study Investigators
Πηγή:	JAMA [JAMA] 2026 Jul 12. Date of Electronic Publication: 2026 Jul 12.
Publication Model:	Ahead of Print
Τύπος έκδοσης:	Journal Article
Γλώσσα:	English
Στοιχεία περιοδικού:	Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE
Imprint Name(s):	Original Publication: Chicago : American Medical Association, 1960-
Περίληψη:	Importance: Although the YEARS algorithm is a safe and efficient way to rule out acute pulmonary embolism (PE), robust evidence on its accuracy in patients with cancer is lacking, and current guidelines suggest proceeding directly to computed tomographic pulmonary angiography (CTPA). Objective: To compare the safety and efficiency of the YEARS algorithm with CTPA only to rule out acute PE in patients with active cancer. Design, Setting, and Participants: The Hydra study was an open-label, randomized, investigator-initiated, noninferiority trial with blinded central outcome adjudication conducted from August 22, 2019, to August 21, 2025, the date of final follow-up. Patients with active cancer and suspected acute PE were recruited from emergency departments or medical units in 21 hospitals in the Netherlands, Italy, Switzerland, Belgium, France, and Spain. Interventions: Patients were randomly assigned in a 1:1 ratio to receive diagnostic management by the YEARS algorithm (n = 352)-consisting of assessing YEARS items, D-dimer levels, and performing risk-dependent CTPA-or by CTPA only (n = 346). Main Outcomes and Measures: The primary outcome was centrally adjudicated symptomatic venous thromboembolism or (possible) PE-related death within 90 days after ruling out PE at baseline, assessed in a per-protocol noninferiority analysis with a 2.6% margin for the upper bound of a 1-sided 99.9% CI. The key secondary outcome was the proportion of negative CTPA results at baseline, assessed in a superiority analysis. Results: A total of 698 patients were randomized (median age, 65 years [IQR, 56-72 years], 422 female [60%]), and 104 patients (15%) had PE diagnosed at baseline. One patient was lost to follow-up. Of those in whom PE was considered excluded, 5 of 282 patients (1.8%) in the per-protocol YEARS group vs 15 of 273 patients (5.5%) in the per-protocol CTPA-only group had a primary outcome (absolute risk difference, -3.7%; 99.9% CI, -8.8% to 1.4%; P = 3.4 × 10-5 for noninferiority). In the intention-to-diagnosis analysis, the absolute risk difference between the YEARS algorithm and CTPA only was -2.6% (99.9% CI, -7.5% to 2.4%; P = 5.9 × 10-4 for noninferiority). Diagnostic management of PE was carried out for 77 of 352 patients (22%) in the YEARS group without CTPA. No difference in the proportion of negative CTPA (P = .93) was observed between the groups. Conclusions and Relevance: In patients with cancer and suspected PE, a diagnostic strategy using the YEARS diagnostic algorithm was as safe as using CTPA only, thus, obviating the need to perform CTPA in 22% of patients. Trial Registration: ccmo.nl Identifier: NL-OMON52383.
Contributed Indexing:	Investigator: JM Kwakkel; TS Lapperre; A Hufkens; W Spysschaert; IN Verhaegen; D Balemans; G Vermeulen; CC Stessels; G Le Gal; K Vrotniakaite-Barjerciene; R Verdet; P Stephan; P Bourgeois; P Dias; S Salami-Adjavon; M Chemouny; H Heffer; N Izrouel; S Hadim; L Plaisance; O Sanchez; L Bertoletti; C Cavallaro; A D'Errico; F Gianni; G Ramponi; B Appelman; S Middeldorp; VL Jansen; V Lanting; A Strijdhorst; MM Hovens; F Kleijwegt; LM Faber; C Bresser; ZS Jaderi Pour Minabi; AW Flikweert; BJM van Steen; C Peeters; BMC Maas; MAP Daalmans; MJJH Grootenbroers; DA van Rijssel; EM van der Weert; C Haazer; B van Prooijen; EB van Druten; K van Elst; KA van Assen; E Geraedts; M Nagtegaal; A Ten Heuvel; R Sluga; MJM de Vreede; YM Ende-Verhaar; IC van der Plas; S Jagernath; CMM de Jong; SFB van der Horst; D Luijten; JF Krommenhoek; RMA Mali; SNM Ter Haar; LJ Op de Hoek; PL den Exter; JWE Stenger; S Moll; M de Bruijn; EM Klappe; O Sir; ATW Wei; ALTM Sanders; BE Raap; HC Peters; M Deelen; A Aikema; H Zanders; JJC Drijkoningen; B Jones; LMG van Berkesteijn; W Briceño; R Morillo; C Rodriguez-Calle; C Baumgartner; D Pulver; S Maurer; N Koffi Malan Antoine; H Gerhard Donnet; MJ Brochu Vez
Entry Date(s):	Date Created: 20260712 Latest Revision: 20260726
Update Code:	20260726
PubMed Central ID:	PMC13358875
DOI:	10.1001/jama.2026.10676
PMID:	42437322
Βάση Δεδομένων:	MEDLINE

Περιγραφή
ISSN:	1538-3598
DOI:	10.1001/jama.2026.10676