Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation A Multicenter Prospective Cohort Study

SSPE Investigators; CanVECTOR Investigators

doi:10.7326/M21-2981

Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation A Multicenter Prospective Cohort Study

SSPE Investigators, CanVECTOR Investigators

Medicine

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

49 Citas (Scopus)

Resumen

Background: The incidence of pulmonary embolism has been increasing, but its case-fatality rate is decreasing, suggesting a lesser severity of illness. The clinical importance of patients with pulmonary embolism isolated to the subsegmental vessels is unknown. Objective: To determine the rate of recurrent venous thromboembolism in patients with subsegmental pulmonary embolism managed without anticoagulation. Design: Multicenter prospective cohort study. (ClinicalTrials. gov: NCT01455818) Setting: Eighteen sites between February 2011 and February 2021. Patients: Patients with isolated subsegmental pulmonary embolism. Intervention: At diagnosis, patients underwent bilateral lower-extremity venous ultrasonography, which was repeated 1 week later if results were negative. Patients without deep venous thrombosis did not receive anticoagulant therapy. Measurements: The primary outcome was recurrent venous thromboembolism during the 90-day follow-up period. Results: Recruitment was stopped prematurely because the predefined stopping rule was met after 292 of a projected 300 patients were enrolled. Of the 266 patients included in the primary analysis, the primary outcome occurred in 8 patients, for a cumulative incidence of 3.1% (95% CI, 1.6% to 6.1%) over the 90-day follow-up. The incidence of recurrent venous thromboembolism was 2.1% (CI, 0.8% to 5.5%) and 5.7% (CI, 2.2% to 14.4%) over the 90-day follow-up in patients with single and multiple isolated subsegmental pulmonary embolism, respectively. No patients had a fatal recurrent pulmonary embolism. Limitation: The study was restricted to patients with low-risk subsegmental pulmonary embolism. Conclusion: Overall, patients with subsegmental pulmonary embolism who did not have proximal deep venous thrombosis had a higher-than-expected rate of recurrent venous thromboembolism.

Idioma original	English
Páginas (desde-hasta)	29-35
Número de páginas	7
Publicación	Annals of Internal Medicine
Volumen	175
N.º	1
DOI	https://doi.org/10.7326/M21-2981
Estado	Published - ene. 1 2022

Nota bibliográfica

Funding Information:
Note: Dr. Le Gal holds a Clinical Chair on Diagnosis of Venous Thromboembolism from the Department of Medicine, University of Ottawa, and a Clinician-Scientist Award from the Heart and Stroke Foundation of Canada. Dr. Carrier holds a Clinical Chair on Cancer and Thrombosis, University of Ottawa.

Funding Information:
Primary Funding Source: Heart and Stroke Foundation of Canada and French Ministry of Health Programme Hospitalier de Recherche Clinique.

Funding Information:
The SubSegmental Pulmonary Embolism (SSPE) study (ClinicalTrials.gov: NCT01455818) was a prospective management cohort study assessing clinical outcomes among patients with single and multiple isolated subsegmental pulmonary embolism managed without anticoagulation. The members of the steering committee had final responsibility for the trial design, clinical protocol, and study oversight. The institutional review boards at each of the 18 participating sites from the Investigation Network on Venous Thromboembolism (INNOVTE), the Dutch Thrombosis Network, and the Canadian Venous Thromboembolism Research Network (CanVECTOR) approved the protocol (see the Supplement, available at Annals.org). Data were collected at the sites and entered in an online database managed by the Methods Centre of The Ottawa Hospital Research Institute (Canada and the Netherlands) and by the Direction de la Recherche et de l’Innovation at Brest University Hospital (France and Switzerland). A central adjudication committee reviewed all suspected outcome events. An independent data and safety monitoring board (see the Appendix, available at Annals.org) periodically reviewed all suspected outcome events and all deaths. The trial was sponsored by Brest University Hospital (France), the Ottawa Hospital Research Institute (Canada), Leiden University Medical Center (the Netherlands), and Geneva University Hospital (Switzerland).

Funding Information:
Financial Support: This work was sponsored by Brest University Hospital, the Ottawa Hospital Research Institute, Leiden University Medical Center, and Geneva University Hospital, with funding from the Heart and Stroke Foundation of Canada and the French Ministry of Health Programme Hospitalier de Recherche Clinique. Drs. Carrier, Le Gal, Shivakumar, Rodger, Hirsch, Wells, Schulman, Yeo, Wu, and Kovacs are investigators in the CanVECTOR Network, which receives grant funding from the Canadian Institutes of Health Research (funding reference: CDT-142654).

Publisher Copyright:
© 2021 American College of Physicians.

ASJC Scopus Subject Areas

Internal Medicine

PubMed: MeSH publication types

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

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10.7326/M21-2981

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Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation A Multicenter Prospective Cohort Study. / SSPE Investigators; CanVECTOR Investigators.
En: Annals of Internal Medicine, Vol. 175, N.º 1, 01.01.2022, p. 29-35.

Producción científica: Contribución a una revista › Artículo › revisión exhaustiva

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title = "Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation A Multicenter Prospective Cohort Study",

abstract = "Background: The incidence of pulmonary embolism has been increasing, but its case-fatality rate is decreasing, suggesting a lesser severity of illness. The clinical importance of patients with pulmonary embolism isolated to the subsegmental vessels is unknown. Objective: To determine the rate of recurrent venous thromboembolism in patients with subsegmental pulmonary embolism managed without anticoagulation. Design: Multicenter prospective cohort study. (ClinicalTrials. gov: NCT01455818) Setting: Eighteen sites between February 2011 and February 2021. Patients: Patients with isolated subsegmental pulmonary embolism. Intervention: At diagnosis, patients underwent bilateral lower-extremity venous ultrasonography, which was repeated 1 week later if results were negative. Patients without deep venous thrombosis did not receive anticoagulant therapy. Measurements: The primary outcome was recurrent venous thromboembolism during the 90-day follow-up period. Results: Recruitment was stopped prematurely because the predefined stopping rule was met after 292 of a projected 300 patients were enrolled. Of the 266 patients included in the primary analysis, the primary outcome occurred in 8 patients, for a cumulative incidence of 3.1% (95% CI, 1.6% to 6.1%) over the 90-day follow-up. The incidence of recurrent venous thromboembolism was 2.1% (CI, 0.8% to 5.5%) and 5.7% (CI, 2.2% to 14.4%) over the 90-day follow-up in patients with single and multiple isolated subsegmental pulmonary embolism, respectively. No patients had a fatal recurrent pulmonary embolism. Limitation: The study was restricted to patients with low-risk subsegmental pulmonary embolism. Conclusion: Overall, patients with subsegmental pulmonary embolism who did not have proximal deep venous thrombosis had a higher-than-expected rate of recurrent venous thromboembolism.",

author = "{SSPE Investigators} and {CanVECTOR Investigators} and {Le Gal}, Gr{\'e}goire and Kovacs, {Michael J.} and Laurent Bertoletti and Francis Couturaud and Carole Dennie and Hirsch, {Andrew M.} and Huisman, {Menno V.} and Klok, {Frederikus A.} and No{\'e}mie Kraaijpoel and Ranjeeta Mallick and Amanda Pecarskie and Elena Pena and Penny Phillips and Isabelle Pichon and Tim Ramsay and Marc Righini and Rodger, {Marc A.} and Roy, {Pierre Marie} and Olivier Sanchez and Jeannot Schmidt and Sam Schulman and Sudeep Shivakumar and Albert Trinh-Duc and Rachel Verdet and Ulric Vinsonneau and Philip Wells and Cynthia Wu and Erik Yeo and Marc Carrier and Amin Zahrai and Aur{\'e}lien Delluc and Lisa Duffett and Lana Castellucci and Alan Karovitch and Cathy Code and Dimitri Scarvelis and Carol Gonsalves and Melissa Forgie and Esteban Gandara and Mark Blostein and Susan Kahn and Vicky Tagalakis and Maral Koolian and Bruce Ritchie and Sarah Takach-Lapner and Jeffery Patterson and Lori Rackel and Alejandro Lazo-Langner and Judith Kovacs and David Anderson",

note = "Funding Information: Note: Dr. Le Gal holds a Clinical Chair on Diagnosis of Venous Thromboembolism from the Department of Medicine, University of Ottawa, and a Clinician-Scientist Award from the Heart and Stroke Foundation of Canada. Dr. Carrier holds a Clinical Chair on Cancer and Thrombosis, University of Ottawa. Funding Information: Primary Funding Source: Heart and Stroke Foundation of Canada and French Ministry of Health Programme Hospitalier de Recherche Clinique. Funding Information: The SubSegmental Pulmonary Embolism (SSPE) study (ClinicalTrials.gov: NCT01455818) was a prospective management cohort study assessing clinical outcomes among patients with single and multiple isolated subsegmental pulmonary embolism managed without anticoagulation. The members of the steering committee had final responsibility for the trial design, clinical protocol, and study oversight. The institutional review boards at each of the 18 participating sites from the Investigation Network on Venous Thromboembolism (INNOVTE), the Dutch Thrombosis Network, and the Canadian Venous Thromboembolism Research Network (CanVECTOR) approved the protocol (see the Supplement, available at Annals.org). Data were collected at the sites and entered in an online database managed by the Methods Centre of The Ottawa Hospital Research Institute (Canada and the Netherlands) and by the Direction de la Recherche et de l{\textquoteright}Innovation at Brest University Hospital (France and Switzerland). A central adjudication committee reviewed all suspected outcome events. An independent data and safety monitoring board (see the Appendix, available at Annals.org) periodically reviewed all suspected outcome events and all deaths. The trial was sponsored by Brest University Hospital (France), the Ottawa Hospital Research Institute (Canada), Leiden University Medical Center (the Netherlands), and Geneva University Hospital (Switzerland). Funding Information: Financial Support: This work was sponsored by Brest University Hospital, the Ottawa Hospital Research Institute, Leiden University Medical Center, and Geneva University Hospital, with funding from the Heart and Stroke Foundation of Canada and the French Ministry of Health Programme Hospitalier de Recherche Clinique. Drs. Carrier, Le Gal, Shivakumar, Rodger, Hirsch, Wells, Schulman, Yeo, Wu, and Kovacs are investigators in the CanVECTOR Network, which receives grant funding from the Canadian Institutes of Health Research (funding reference: CDT-142654). Publisher Copyright: {\textcopyright} 2021 American College of Physicians.",

year = "2022",

month = jan,

day = "1",

doi = "10.7326/M21-2981",

language = "English",

volume = "175",

pages = "29--35",

journal = "Annals of Internal Medicine",

issn = "0003-4819",

publisher = "American College of Physicians",

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TY - JOUR

T1 - Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation A Multicenter Prospective Cohort Study

AU - SSPE Investigators

AU - CanVECTOR Investigators

AU - Le Gal, Grégoire

AU - Kovacs, Michael J.

AU - Bertoletti, Laurent

AU - Couturaud, Francis

AU - Dennie, Carole

AU - Hirsch, Andrew M.

AU - Huisman, Menno V.

AU - Klok, Frederikus A.

AU - Kraaijpoel, Noémie

AU - Mallick, Ranjeeta

AU - Pecarskie, Amanda

AU - Pena, Elena

AU - Phillips, Penny

AU - Pichon, Isabelle

AU - Ramsay, Tim

AU - Righini, Marc

AU - Rodger, Marc A.

AU - Roy, Pierre Marie

AU - Sanchez, Olivier

AU - Schmidt, Jeannot

AU - Schulman, Sam

AU - Shivakumar, Sudeep

AU - Trinh-Duc, Albert

AU - Verdet, Rachel

AU - Vinsonneau, Ulric

AU - Wells, Philip

AU - Wu, Cynthia

AU - Yeo, Erik

AU - Carrier, Marc

AU - Zahrai, Amin

AU - Delluc, Aurélien

AU - Duffett, Lisa

AU - Castellucci, Lana

AU - Karovitch, Alan

AU - Code, Cathy

AU - Scarvelis, Dimitri

AU - Gonsalves, Carol

AU - Forgie, Melissa

AU - Gandara, Esteban

AU - Blostein, Mark

AU - Kahn, Susan

AU - Tagalakis, Vicky

AU - Koolian, Maral

AU - Ritchie, Bruce

AU - Takach-Lapner, Sarah

AU - Patterson, Jeffery

AU - Rackel, Lori

AU - Lazo-Langner, Alejandro

AU - Kovacs, Judith

AU - Anderson, David

N1 - Funding Information: Note: Dr. Le Gal holds a Clinical Chair on Diagnosis of Venous Thromboembolism from the Department of Medicine, University of Ottawa, and a Clinician-Scientist Award from the Heart and Stroke Foundation of Canada. Dr. Carrier holds a Clinical Chair on Cancer and Thrombosis, University of Ottawa. Funding Information: Primary Funding Source: Heart and Stroke Foundation of Canada and French Ministry of Health Programme Hospitalier de Recherche Clinique. Funding Information: The SubSegmental Pulmonary Embolism (SSPE) study (ClinicalTrials.gov: NCT01455818) was a prospective management cohort study assessing clinical outcomes among patients with single and multiple isolated subsegmental pulmonary embolism managed without anticoagulation. The members of the steering committee had final responsibility for the trial design, clinical protocol, and study oversight. The institutional review boards at each of the 18 participating sites from the Investigation Network on Venous Thromboembolism (INNOVTE), the Dutch Thrombosis Network, and the Canadian Venous Thromboembolism Research Network (CanVECTOR) approved the protocol (see the Supplement, available at Annals.org). Data were collected at the sites and entered in an online database managed by the Methods Centre of The Ottawa Hospital Research Institute (Canada and the Netherlands) and by the Direction de la Recherche et de l’Innovation at Brest University Hospital (France and Switzerland). A central adjudication committee reviewed all suspected outcome events. An independent data and safety monitoring board (see the Appendix, available at Annals.org) periodically reviewed all suspected outcome events and all deaths. The trial was sponsored by Brest University Hospital (France), the Ottawa Hospital Research Institute (Canada), Leiden University Medical Center (the Netherlands), and Geneva University Hospital (Switzerland). Funding Information: Financial Support: This work was sponsored by Brest University Hospital, the Ottawa Hospital Research Institute, Leiden University Medical Center, and Geneva University Hospital, with funding from the Heart and Stroke Foundation of Canada and the French Ministry of Health Programme Hospitalier de Recherche Clinique. Drs. Carrier, Le Gal, Shivakumar, Rodger, Hirsch, Wells, Schulman, Yeo, Wu, and Kovacs are investigators in the CanVECTOR Network, which receives grant funding from the Canadian Institutes of Health Research (funding reference: CDT-142654). Publisher Copyright: © 2021 American College of Physicians.

PY - 2022/1/1

Y1 - 2022/1/1

N2 - Background: The incidence of pulmonary embolism has been increasing, but its case-fatality rate is decreasing, suggesting a lesser severity of illness. The clinical importance of patients with pulmonary embolism isolated to the subsegmental vessels is unknown. Objective: To determine the rate of recurrent venous thromboembolism in patients with subsegmental pulmonary embolism managed without anticoagulation. Design: Multicenter prospective cohort study. (ClinicalTrials. gov: NCT01455818) Setting: Eighteen sites between February 2011 and February 2021. Patients: Patients with isolated subsegmental pulmonary embolism. Intervention: At diagnosis, patients underwent bilateral lower-extremity venous ultrasonography, which was repeated 1 week later if results were negative. Patients without deep venous thrombosis did not receive anticoagulant therapy. Measurements: The primary outcome was recurrent venous thromboembolism during the 90-day follow-up period. Results: Recruitment was stopped prematurely because the predefined stopping rule was met after 292 of a projected 300 patients were enrolled. Of the 266 patients included in the primary analysis, the primary outcome occurred in 8 patients, for a cumulative incidence of 3.1% (95% CI, 1.6% to 6.1%) over the 90-day follow-up. The incidence of recurrent venous thromboembolism was 2.1% (CI, 0.8% to 5.5%) and 5.7% (CI, 2.2% to 14.4%) over the 90-day follow-up in patients with single and multiple isolated subsegmental pulmonary embolism, respectively. No patients had a fatal recurrent pulmonary embolism. Limitation: The study was restricted to patients with low-risk subsegmental pulmonary embolism. Conclusion: Overall, patients with subsegmental pulmonary embolism who did not have proximal deep venous thrombosis had a higher-than-expected rate of recurrent venous thromboembolism.

AB - Background: The incidence of pulmonary embolism has been increasing, but its case-fatality rate is decreasing, suggesting a lesser severity of illness. The clinical importance of patients with pulmonary embolism isolated to the subsegmental vessels is unknown. Objective: To determine the rate of recurrent venous thromboembolism in patients with subsegmental pulmonary embolism managed without anticoagulation. Design: Multicenter prospective cohort study. (ClinicalTrials. gov: NCT01455818) Setting: Eighteen sites between February 2011 and February 2021. Patients: Patients with isolated subsegmental pulmonary embolism. Intervention: At diagnosis, patients underwent bilateral lower-extremity venous ultrasonography, which was repeated 1 week later if results were negative. Patients without deep venous thrombosis did not receive anticoagulant therapy. Measurements: The primary outcome was recurrent venous thromboembolism during the 90-day follow-up period. Results: Recruitment was stopped prematurely because the predefined stopping rule was met after 292 of a projected 300 patients were enrolled. Of the 266 patients included in the primary analysis, the primary outcome occurred in 8 patients, for a cumulative incidence of 3.1% (95% CI, 1.6% to 6.1%) over the 90-day follow-up. The incidence of recurrent venous thromboembolism was 2.1% (CI, 0.8% to 5.5%) and 5.7% (CI, 2.2% to 14.4%) over the 90-day follow-up in patients with single and multiple isolated subsegmental pulmonary embolism, respectively. No patients had a fatal recurrent pulmonary embolism. Limitation: The study was restricted to patients with low-risk subsegmental pulmonary embolism. Conclusion: Overall, patients with subsegmental pulmonary embolism who did not have proximal deep venous thrombosis had a higher-than-expected rate of recurrent venous thromboembolism.

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Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation A Multicenter Prospective Cohort Study

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ASJC Scopus Subject Areas

PubMed: MeSH publication types

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