Performance of clinical decision rules in patients presenting with suspected recurrent venous thromboembolism: a multicenter prospective cohort study

Vicky Mai; Emily S L Martens; Marc Righini; Sam Schulman; Venkatesh Thiruganasambandamoorthy; Susan R Kahn; Amanda Pecarskie; Michael J Kovacs; Shaun Visser; Sudeep Shivakumar; Melanie Tan; Clive Kearon; Marc Rodger; Dimitrios Scarvelis; Aurélien Delluc; Philippe Girard; Menno V Huisman; Philip S Wells; Frederikus A Klok; Grégoire Le Gal; PREDICTORS study group

doi:10.1016/j.jtha.2025.06.019

Performance of clinical decision rules in patients presenting with suspected recurrent venous thromboembolism: a multicenter prospective cohort study

J Thromb Haemost. 2025 Jun 25:S1538-7836(25)00408-8. doi: 10.1016/j.jtha.2025.06.019. Online ahead of print.

Authors

Vicky Mai¹, Emily S L Martens², Marc Righini³, Sam Schulman⁴, Venkatesh Thiruganasambandamoorthy⁵, Susan R Kahn⁶, Amanda Pecarskie¹, Michael J Kovacs⁷, Shaun Visser⁸, Sudeep Shivakumar⁹, Melanie Tan¹⁰, Clive Kearon⁴, Marc Rodger¹¹, Dimitrios Scarvelis¹, Aurélien Delluc¹, Philippe Girard¹², Menno V Huisman², Philip S Wells¹, Frederikus A Klok², Grégoire Le Gal¹³; PREDICTORS study group

Affiliations

¹ Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada.
² Department of Medicine - Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
³ Division of Angiology and Hemostasis, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
⁴ Department of Medicine, Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Ontario, Canada.
⁵ University of Ottawa, Department of Emergency Medicine, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
⁶ Division of Internal Medicine, Department of Medicine, McGill University, Montreal, Québec, Canada.
⁷ Division of Hematology, Department of Medicine, University of Western Ontario, London, Ontario, Canada.
⁸ Department of Emergency Medicine, Hôpital Montfort, Ottawa, Ontario, Canada.
⁹ Department of Medicine, Dalhousie University, Nova Scotia Health, Halifax, Nova Scotia, Canada.
¹⁰ Amsterdam University Medical Center, Amsterdam, Netherlands.
¹¹ Department of Medicine, McMaster University, Hamilton, Ontario, Canada. Department of Medicine, McGill University, McGill University Health Center, Montreal, Quebec, Canada.
¹² Département de Pneumologie, Institut Mutualiste Montsouris, Paris, France; F-CRIN INNOVTE Network, Saint-Etienne, France.
¹³ Department of Medicine, Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Canada. Electronic address: glegal@toh.ca.

PMID: 40578691
DOI: 10.1016/j.jtha.2025.06.019

Abstract

Background: Diagnosing venous thromboembolism (VTE) in patients with prior VTE is challenging. Only ≈15% of these patients have a VTE recurrence ruled out without imaging, as compared with >30% in patients with a suspected first episode. Clinical decision rules (CDRs) are not well studied in this population. The aim was to assess the performance of existing CDRs (Wells, Geneva scores) in these patients.

Methods: This international prospective multicenter observational cohort study of outpatients with suspected VTE recurrence was conducted in eight sites (11/2014-01/2019) (ClinicalTrials.gov: NCT02297373). The primary outcome was the performance of CDRs. Secondary outcome included the diagnostic yield of D-dimers. Suspected recurrent VTE were adjudicated. Follow-up was 3 months.

Results: 723 patients were included. Amongst patients with suspected isolated deep venous thrombosis (DVT), 4/67 patients (6.0%), 39/186 patients (21.0%), and 65/148 patients (43.9%) had recurrent VTE in the low, moderate, and high probability groups, respectively. Amongst patients with suspected isolated pulmonary embolism (PE), 11/83 patients (13.3%), 56/160 patients (35.0%) and 12/25 patients (48.0%) had VTE recurrence in the low, moderate, and high probability groups (Wells), respectively. In patients with suspected isolated DVT and negative D-dimers, 2/65 patients, 3.1% (95%CI 0.4%-10.7%) in the low and moderate probability groups had recurrent VTE at enrollment. In patients with suspected PE±DVT and negative D-dimers, no recurrent VTE was diagnosed: 0/82, 0.0% (95%CI 0.0%-4.4%).

Conclusion: CDRs were able to characterize patients with increasing VTE prevalence. The efficiency and safety in ruling out recurrent VTE without imaging were lower than for suspected first VTE.

Keywords: clinical decision rules; deep venous thrombosis; prediction; pulmonary embolism; venous thromboembolism.

Associated data

ClinicalTrials.gov/NCT02297373