Publications by authors named "Marc A Rodger"

Venous thromboembolism (VTE) is a frequent (annual incidence of 1-2 per 1,000) and potentially life-threatening (case-fatality rate up to 10%) disease. VTE is associated with serious short-term and long-term complications, including a recurrence rate approaching 20% within five years. Anticoagulant therapy, the mainstay of VTE treatment, drastically reduces the risk of early VTE recurrence, but it exposes patients to a substantial risk of bleeding.

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Background: Guidelines recommend extended anticoagulation after a first unprovoked venous thromboembolism (VTE) for individuals at low risk of bleeding. However, racial disparities in bleeding risks during extended treatment remain understudied.

Objectives: To compare risks of anticoagulant-associated bleeding and performance of a risk assessment model by racial group during extended VTE treatment.

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Background: There is a need to better understand barriers to recruitment and participation in randomized controlled trials evaluating postpartum thromboprophylaxis, as previous trials had low recruitment and were not feasible.

Objectives: In a qualitative interview study of a feasibility trial of low-dose aspirin vs placebo for 6 weeks postpartum (pilot PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) trial), we explored the facilitators and barriers to trial involvement.

Methods: Patients eligible for the pilot PARTUM trial, including those who declined to join the trial, were invited to participate in a qualitative study.

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Background: Despite the morbidity and mortality of venous thromboembolism, there is little evidence to guide postpartum thromboprophylaxis in patients at moderate risk. We aimed to assess the feasibility of conducting a double-blind, randomised trial of aspirin versus placebo in postpartum individuals with two or more venous thromboembolism risk factors, mild-to-moderate thrombophilia, or both.

Methods: The pilot PARTUM trial, a multi-national, randomised, double-blind, placebo-controlled trial, was conducted in seven centres across Canada, France, Ireland, and the Netherlands.

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Venous thromboembolism (VT) is a frequent (annual incidence of 1 to 2 per 1,000) and potentially life-threatening (case-fatality rate up to 10%) disease. VT is associated with serious short-term and long-term complications including a recurrence rate of approximately 20% within five years. Anticoagulant therapy, the mainstay of VT treatment, drastically reduces the risk of early VT recurrence, but it exposes patients to a substantial risk of bleeding.

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Background: Clinical practice guidelines recommend indefinite anticoagulation for a first unprovoked venous thromboembolism (VTE).

Objective: To estimate the benefit-harm tradeoffs of indefinite anticoagulation in patients with a first unprovoked VTE.

Design: Markov modeling study.

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Objectives Clinical discoveries are heralded by observing unique and unusual clinical cases. The effort of identifying such cases rests on the shoulders of busy clinicians. We assess the feasibility and applicability of an augmented intelligence framework to accelerate the rate of clinical discovery in preeclampsia and hypertensive disorders of pregnancy-an area that has seen little change in its clinical management.

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Objective:  The SOX-PTS, Amin, and Méan models are three different clinical prediction scores stratifying the risk for postthrombotic syndrome (PTS) development in patients with acute deep vein thrombosis (DVT) of the lower limbs. Herein, we aimed to assess and compare these scores in the same cohort of patients.

Methods:  We retrospectively applied the three scores in a cohort of 181 patients (196 limbs) who participated in the SAVER pilot trial for an acute DVT.

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We aimed to assess the relationship between residual pulmonary vascular obstruction (RPVO) on planar lung scan after completion of at least 3 months of anticoagulant therapy for acute pulmonary embolism (PE) and the risk of recurrent venous thromboembolism (VTE) or death due to PE one year after treatment discontinuation. The systematic review was registered with the International Prospective Registry of Systematic Reviews (PROSPERO: CRD42017081080). The primary outcome measure was to generate a pooled estimate of the rate of recurrent VTE at one year in patient with RPVO diagnosed on planar lung scan after discontinuation of at least 3 months of anticoagulant treatment for an acute PE.

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Background: Thrombophilia predisposes to venous thromboembolism (VTE) because of acquired or hereditary factors. Among them, it has been suggested that gene mutations of the factor V Leiden (FVL) or prothrombin G20210A mutation (PGM) might reduce the risk of bleeding, but little data exist for patients treated using anticoagulants.

Objectives: To assess whether thrombophilia is protective against bleeding.

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Background: Post-thrombotic syndrome (PTS) is the most frequent long-term complication of deep vein thrombosis. Apart from anticoagulation, there are no medications, procedures, devices, or lifestyle changes that effectively prevent PTS. There is a growing interest in the potential protective effects of statins for the prevention of PTS.

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Background: Peripartum management of women using low-molecular-weight heparin (LMWH) varies widely. Minimum time intervals are required between LMWH injection and neuraxial procedure, and they differ by dose.

Objectives: The objective of this study was to describe the onset of labor and use of analgesia in women using LMWH and to compare practices between intermediate-dose and low-dose LMWH.

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Background: Pregnancy-related venous thromboembolism is a leading cause of maternal morbidity and mortality, and thromboprophylaxis is indicated in pregnant and post-partum women with a history of venous thromboembolism. The optimal dose of low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy and the post-partum period is uncertain.

Methods: In this open-label, randomised, controlled trial (Highlow), pregnant women with a history of venous thromboembolism were recruited from 70 hospitals in nine countries (the Netherlands, France, Ireland, Belgium, Norway, Denmark, Canada, the USA, and Russia).

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The risk of recurrence after discontinuation of anticoagulation for a combined oral contraceptive (COC)-associated venous thromboembolism (VTE) is unclear. Therefore, we conducted a systematic review and meta-analysis to estimate the incidence of recurrent VTE among women with COC-associated VTE, unprovoked VTE and to compare the incidence of recurrent VTE between the two groups. The Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Embase Classic +Embase and Medline ALL to July 2020 and citations from included studies were searched.

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No clinical prediction model has been specifically developed or validated to identify patients with unprovoked venous thromboembolism (VTE) who are at high risk of major bleeding during extended anticoagulation. In a prospective multinational cohort study of patients with unprovoked VTE receiving extended anticoagulation after completing ≥3 months of initial treatment, we derived a new clinical prediction model using a multivariable Cox regression model based on 22 prespecified candidate predictors for the primary outcome of major bleeding. This model was then compared with modified versions of 5 existing clinical scores.

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Background: Post-thrombotic syndrome (PTS) is one of the most frequent complications of venous thromboembolism (VTE) leading to considerable morbidity and cost. Apart from appropriate anticoagulation, there is no drug or medical intervention that helps to prevent PTS. We conducted a multicenter randomized controlled trial to determine whether rosuvastatin can prevent PTS.

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Introduction:  The Villalta scale is the endorsed tool to diagnose and grade the severity of postthrombotic syndrome (PTS); however, assessing presence and severity of PTS is time-consuming and relies on both the clinician and patient's assessments. The patient-reported Villalta scale version 2 (PRV2) is a visually assisted form that enables patients to self-assess presence and severity of PTS. Herein, we report on external validation of this tool.

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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.

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Article Synopsis
  • - This study investigates the long-term risk of major bleeding in patients who stop taking anticoagulants after experiencing their first unprovoked venous thromboembolism (VTE).
  • - Researchers reviewed data from 20 studies, tracking 8,740 patients over 13,011 person-years to determine the incidence rates of major and fatal bleeding post-anticoagulation.
  • - Findings show a 5-year cumulative incidence of major bleeding at 1.0%, suggesting that while the risk is low, it is present and should inform clinical decisions regarding treatment duration for unprovoked VTE.
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Background: Statins may reduce the risk for recurrent venous thromboembolism (VTE); however, no randomized trials have explored this hypothesis. We performed a pilot randomized trial to determine feasibility of recruitment for a larger trial of secondary VTE prevention with rosuvastatin.

Methods: Patients with a newly diagnosed symptomatic proximal deep vein thrombosis and/or pulmonary embolism, receiving standard anticoagulation, were randomly allocated to adjuvant rosuvastatin 20 mg once daily for 180 days or no rosuvastatin for 6 months.

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Article Synopsis
  • The study aimed to assess the risk of major bleeding in patients undergoing long-term anticoagulant therapy (up to 5 years) for a first unprovoked venous thromboembolism (VTE).
  • Analysis included 14 randomized controlled trials and 13 cohort studies, revealing a higher incidence of major bleeding events in patients taking vitamin K antagonists (VKAs) compared to direct oral anticoagulants (DOACs).
  • Significant risk factors for bleeding included being over 65 years old, having poor kidney function, a history of bleeding, and low hemoglobin levels.
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