Vascular thromboembolic events following COVID‐19 hospital discharge: Incidence and risk factors

Spyropoulos, Alex C.; Giannis, Dimitrios; Goldin, Mark

doi:10.1002/rth2.12547

Cited by 3 publications

(7 citation statements)

References 7 publications

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“…A recent meta-analysis reported a pooled VTE rate of 14.7% and 23.2% among those admitted to the hospital and intensive care units, respectively. 1 Additionally, emerging randomized clinical trials [2][3][4] have shown the benefit-risk of anticoagulation for patients with COVID-19 at different stages of the disease, and clinical societies have recommended initiating routine antithrombotic therapy during hospital admission. 5 In contrast, fewer clinical interventions have been implemented to prevent VTE among ambulatory patients with SARS-CoV-2 infection, partially because of conflicting findings on the association between the infection and VTE occurrence, with cohort studies showing no elevated risk 6 but self-controlled case series studies consistently showing a substantial increase of short-term risk.…”

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confidence: 99%

“…11,12 These collectively suggest that prophylaxis, including timing and dosing regimens, requires further refinement, particularly in the outpatient setting. [2][3][4]13,14 Moreover, 15 a lack of insight into the association of clinical, socioeconomic, and genetic risk factors with infection-related VTE persists. This study aimed to (1) quantify the magnitude of short-term VTE risk associated with SARS-CoV-2 infection identified in ambulatory settings and (2) investigate the clinical and genetic risk factors for VTE after SARS-CoV-2 infection.…”

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confidence: 99%

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Clinical and Genetic Risk Factors for Acute Incident Venous Thromboembolism in Ambulatory Patients With COVID-19

et al. 2022

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Key Points Question What is the 30-day acute risk of venous thromboembolism (VTE) among ambulatory patients with COVID-19, and what are the clinical and genetic risk factors predisposing them to developing post–COVID-19 VTE? Findings In this retrospective cohort study of 18 818 outpatients with COVID-19 and 93 179 propensity score–matched noninfected participants, a higher VTE incidence was observed in the former (hazard ratio, 21.42); however, this risk was considerably attenuated among the fully vaccinated, after breakthrough infection. Older age, male sex, obesity, no vaccination or partial vaccination, and inherited thrombophilia were independent risk factors for COVID-19–associated VTE. Meaning The results of this study suggest that ambulatory patients with COVID-19, either vaccinated or not, present a clinically relevant increased risk of incident VTE during the acute phase, with the risk pronounced by factors of older age, male sex, obesity, incomplete vaccination, and factor V Leiden thrombophilia.

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confidence: 99%

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confidence: 99%

Clinical and Genetic Risk Factors for Acute Incident Venous Thromboembolism in Ambulatory Patients With COVID-19

et al. 2022

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“…The rate of major bleeding in our study was low irrespective of the anticoagulation dose regimen, and similar to that reported in previously published RCTs. [11][12][13][14][15][16][17] To minimize the bleeding risk, we did not include patients with severe kidney failure (entangled as an independent risk factor for bleeding in critically ill patients) 39 or at the extreme ends of body weight (<40 kg or >100 kg, for whom low-molecular-weight heparin dosage has not been assessed). Although the limited sample size does not allow for definitive conclusions regarding the bleeding profile of the 3 anticoagulation regimens, our study provides additional evidence for the safety of escalating anticoagulant dose to prevent macrovascular thrombosis in patients with a low baseline bleeding risk.…”

Section: Bleeding and Net Benefitmentioning

confidence: 99%

“…17 In the INSPIRATION trial, 11 HD-PA use did not improve the primary composite outcome of thrombosis, indication for extracorporeal membrane oxygenation, or mortality within 30 days compared with SD-PA use. Similarly, a recent meta-analysis of 3220 noncritically ill patients reported that TA use compared with mixed PA [13][14][15] (SD-PA/ HD-PA per local practice, BMI, or creatinine clearance) or SD-PA use, had no significant effect on all-cause death or progression to invasive mechanical ventilation. 37 Our study results together with those of previous RCTs support the premise that the role of microvascular thrombosis in worsening organ dysfunction may be narrower than estimated.…”

Section: Microvascular Thrombosis and Organ Failurementioning

confidence: 99%

“…11,12 However, to our knowledge, no published trials have compared the efficacy of the 3 strategies (SD-PA, HD-PA, TA) in separate groups. In the most recent RCTs that tested TA, the control group consisted of a combination of patients receiving both SD-PA and HD-PA. [13][14][15][16][17][18][19] Microvascular thrombosis is another important issue among patients with COVID-19. 20 Prompted by endotheliitis and coagulopathy, microvascular thrombosis may lead to respiratory distress and other organ dysfunctions.…”

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Effects of Standard-Dose Prophylactic, High-Dose Prophylactic, and Therapeutic Anticoagulation in Patients With Hypoxemic COVID-19 Pneumonia

et al. 2023

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ImportanceGiven the high risk of thrombosis and anticoagulation-related bleeding in patients with hypoxemic COVID-19 pneumonia, identifying the lowest effective dose of anticoagulation therapy for these patients is imperative.ObjectivesTo determine whether therapeutic anticoagulation (TA) or high-dose prophylactic anticoagulation (HD-PA) decreases mortality and/or disease duration compared with standard-dose prophylactic anticoagulation (SD-PA), and whether TA outperforms HD-PA; and to compare the net clinical outcomes among the 3 strategies.Design, Settings, and ParticipantsThe ANTICOVID randomized clinical open-label trial included patients with hypoxemic COVID-19 pneumonia requiring supplemental oxygen and having no initial thrombosis on chest computer tomography with pulmonary angiogram at 23 health centers in France from April 14 to December 13, 2021. Of 339 patients randomized, 334 were included in the primary analysis—114 patients in the SD-PA group, 110 in the HD-PA, and 110 in the TA. At randomization, 90% of the patients were in the intensive care unit. Data analyses were performed from April 13, 2022, to January 3, 2023.InterventionsPatients were randomly assigned (1:1:1) to receive either SD-PA, HD-PA, or TA with low-molecular-weight or unfractionated heparin for 14 days.Main Outcomes and MeasuresA hierarchical criterion of all-cause mortality followed by time to clinical improvement at day 28. Main secondary outcome was net clinical outcome at day 28 (composite of thrombosis, major bleeding, and all-cause death).ResultsAmong the study population of 334 individuals (mean [SD] age, 58.3 [13.0] years; 226 [67.7%] men and 108 [32.3%] women), use of HD-PA and SD-PA had similar probabilities of favorable outcome (47.3% [95% CI, 39.9% to 54.8%] vs 52.7% [95% CI, 45.2% to 60.1%]; P = .48), as did TA compared with SD-PA (50.9% [95% CI, 43.4% to 58.3%] vs 49.1% [95% CI, 41.7% to 56.6%]; P = .82) and TA compared with HD-PA (53.5% [95% CI 45.8% to 60.9%] vs 46.5% [95% CI, 39.1% to 54.2%]; P = .37). Net clinical outcome was met in 29.8% of patients receiving SD-PA (20.2% thrombosis, 2.6% bleeding, 14.0% death), 16.4% receiving HD-PA (5.5% thrombosis, 3.6% bleeding, 11.8% death), and 20.0% receiving TA (5.5% thrombosis, 3.6% bleeding, 12.7% death). Moreover, HD-PA and TA use significantly reduced thrombosis compared with SD-PA (absolute difference, −14.7 [95% CI −6.2 to −23.2] and −14.7 [95% CI −6.2 to −23.2], respectively). Use of HD-PA significantly reduced net clinical outcome compared with SD-PA (absolute difference, −13.5; 95% CI −2.6 to −24.3).Conclusions and RelevanceThis randomized clinical trial found that compared with SD-PA, neither HD-PA nor TA use improved the primary hierarchical outcome of all-cause mortality or time to clinical improvement in patients with hypoxemic COVID-19 pneumonia; however, HD-PA resulted in significantly better net clinical outcome by decreasing the risk of de novo thrombosis.Trial RegistrationClinicalTrials.gov Identifier: NCT04808882

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Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER

Raskob

Spyropoulos

Spiro

et al. 2021

JAHA

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Background Thromboprophylaxis extended after hospital discharge in medically ill patients currently is not recommended by practice guidelines because of uncertainty about the benefit for preventing major or fatal thromboembolic events, and the risk of bleeding. Methods and Results We assessed the benefit and risk of thromboprophylaxis with rivaroxaban 10 mg once daily extended for 25 to 45 days after hospitalization for preventing major thromboembolism in medically ill patients using the pooled data in 16 496 patients from 2 randomized trials, MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post‐Discharge Venous Thrombo‐Embolism Risk) and MAGELLAN (Multicenter, randomized, parallel‐group efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically ill patients comparing rivaroxaban with enoxaparin). The data from the MARINER trial were pooled with the data from the MAGELLAN trial in patients who were free of thrombotic or bleeding events up to the last dose of enoxaparin/placebo and who continued in the outpatient phase of thromboprophylaxis. The composite outcome of major thromboembolic events (symptomatic deep vein thrombosis, nonfatal pulmonary embolism, myocardial infarction, and nonhemorrhagic stroke) and all‐cause mortality was used to assess benefit and was compared with the risk of the composite of fatal and critical site bleeding. The incidence of the composite efficacy outcome was 1.80% (148 of 8222 patients) in the rivaroxaban group, compared with 2.31% (191 of 8274 patients in the placebo group) (HR, 0.78 [95% CI, 0.63–0.97], P =0.024). Fatal or critical site bleeding events were infrequent and occurred in <0.1% of patients in both groups (rivaroxaban 0.09%; placebo 0.04%; HR, 2.36; P =0.214). Conclusions The results suggest a benefit for reducing major thromboembolic outcomes (number needed to treat: 197), with a favorable trade‐off to fatal or critical site bleeding (number needed to harm: 2045). Registration URL: https://www.clinicaltrials.gov ; Unique identifiers: NCT00571649 and NCT02111564.

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Vascular thromboembolic events following COVID‐19 hospital discharge: Incidence and risk factors

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri butio n-NonCo mmerc ial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Cited by 3 publications

References 7 publications

Clinical and Genetic Risk Factors for Acute Incident Venous Thromboembolism in Ambulatory Patients With COVID-19

Clinical and Genetic Risk Factors for Acute Incident Venous Thromboembolism in Ambulatory Patients With COVID-19

Effects of Standard-Dose Prophylactic, High-Dose Prophylactic, and Therapeutic Anticoagulation in Patients With Hypoxemic COVID-19 Pneumonia

Benefit–Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER

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