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Article ; Online: Extended Thromboprophylaxis in Hospitalized Patients with Heart Failure: A Post Hoc Analysis of the MAGELLAN Study.

Spyropoulos, Alex C / Raskob, Gary E / Spiro, Theodore E / Lu, Wentao / De Sanctis, Yoriko / Albanese, John / Mebazaa, Alexandre / Barnathan, Elliot S

TH open : companion journal to thrombosis and haemostasis

2022 Volume 6, Issue 4, Page(s) e304–e308

Abstract: This post hoc subgroup analysis examined efficacy and safety outcomes with extended thromboprophylaxis rivaroxaban compared with in-hospital enoxaparin in 2,078 patients from the MAGELLAN study who had a hospitalization for heart failure or a history of ... ...

Abstract	This post hoc subgroup analysis examined efficacy and safety outcomes with extended thromboprophylaxis rivaroxaban compared with in-hospital enoxaparin in 2,078 patients from the MAGELLAN study who had a hospitalization for heart failure or a history of heart failure and a lower risk of bleeding. A significant 36% reduction in the composite endpoint of asymptomatic proximal deep vein thrombosis (DVT) in the lower extremity, symptomatic DVT in the lower extremity (proximal or distal), symptomatic nonfatal pulmonary embolism, and venous thromboembolism-related death was observed with rivaroxaban. Major bleeding was low in both groups and not significantly increased with rivaroxaban.
Language	English
Publishing date	2022-10-07
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2901738-5
ISSN	2512-9465 ; 2567-3459
ISSN (online)	2512-9465
ISSN	2567-3459
DOI	10.1055/a-1926-2489
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Article ; Online: Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER.

Raskob, Gary E / Spyropoulos, Alex C / Spiro, Theodore E / Lu, Wentao / Yuan, Zhong / Levitan, Bennett / Suh, Eunyoung / Barnathan, Elliot S

Journal of the American Heart Association

2021 Volume 10, Issue 22, Page(s) e021579

Abstract: 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 ... ...

Abstract	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],
MeSH term(s)	Aftercare ; Anticoagulants/adverse effects ; Enoxaparin ; Hemorrhage/chemically induced ; Hospitalization ; Humans ; Patient Discharge ; Risk Factors ; Rivaroxaban/adverse effects ; Venous Thromboembolism/epidemiology ; Venous Thromboembolism/prevention & control
Chemical Substances	Anticoagulants ; Enoxaparin ; Rivaroxaban (9NDF7JZ4M3)
Language	English
Publishing date	2021-11-10
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2653953-6
ISSN	2047-9980 ; 2047-9980
ISSN (online)	2047-9980
ISSN	2047-9980
DOI	10.1161/JAHA.121.021579
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Cost-Effectiveness of Combination of Baricitinib and Remdesivir in Hospitalized Patients with COVID-19 in the United States: A Modelling Study.

Kelton, Kari / Klein, Tim / Murphy, Dan / Belger, Mark / Hille, Erik / McCollam, Patrick L / Spiro, Theodore / Burge, Russel

Advances in therapy

2021 Volume 39, Issue 1, Page(s) 562–582

Abstract: Introduction: Baricitinib-remdesivir (BARI-REM) combination is superior to remdesivir (REM) in reducing recovery time and accelerating clinical improvement among hospitalized patients with coronavirus disease 2019 (COVID-19), specifically those ... ...

Abstract	Introduction: Baricitinib-remdesivir (BARI-REM) combination is superior to remdesivir (REM) in reducing recovery time and accelerating clinical improvement among hospitalized patients with coronavirus disease 2019 (COVID-19), specifically those receiving high-flow oxygen/noninvasive ventilation. Here we assessed the cost-effectiveness of BARI-REM versus REM in hospitalized patients with COVID-19 in the USA. Methods: A three-state model was developed addressing costs and patient utility associated with COVID-19 hospitalization, immediate post hospital care, and subsequent lifetime medical care. Analysis was performed from the perspective of a payer and a hospital. Both perspectives evaluated two subgroups: all patients and patients who required oxygen. The primary measures of benefit in the model were patient quality-adjusted life years (QALYs) accrued during and after hospitalization, cost per life years gained, cost per death avoided, and cost per use of mechanical ventilation avoided. Results: In the base-case payer perspective with a lifetime horizon, treatment with BARI-REM versus REM resulted in an incremental total cost of $7962, a gain of 0.446 life years and gain of 0.3565 QALYs over REM. The incremental cost-effectiveness ratios of using BARI-REM were estimated as $22,334 per QALY and $17,858 per life year. The base-case and sensitivity analyses showed that the total incremental cost per QALY falls within the reduced willingness-to-pay threshold of $50,000/QALY applied under health emergencies. In all hospitalized patients, treatment with BARI-REM versus REM reduced total hospital expenditures per patient by $1778 and total reimbursement payments by $1526, resulting in a $252 reduction in net costs per patient; it also resulted in a net gain of 0.0018 QALYs and increased survival of COVID-19 hospitalizations by 2.7%. Conclusion: Our study showed that BARI-REM is cost-effective compared to using REM for hospitalized patients with COVID-19. The base-case results of this cost-effectiveness model were most sensitive to average annual medical costs for recovered patients.
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; Azetidines ; COVID-19/drug therapy ; Cost-Benefit Analysis ; Humans ; Purines ; Pyrazoles ; Quality-Adjusted Life Years ; SARS-CoV-2 ; Sulfonamides ; United States
Chemical Substances	Azetidines ; Purines ; Pyrazoles ; Sulfonamides ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; baricitinib (ISP4442I3Y) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-11-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	632651-1
ISSN	1865-8652 ; 0741-238X
ISSN (online)	1865-8652
ISSN	0741-238X
DOI	10.1007/s12325-021-01982-6
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Article ; Online: Cost-Effectiveness of Baricitinib Compared With Standard of Care: A Modeling Study in Hospitalized Patients With COVID-19 in the United States.

Ohsfeldt, Robert / Kelton, Kari / Klein, Tim / Belger, Mark / Mc Collam, Patrick L / Spiro, Theodore / Burge, Russel / Ahuja, Neera

Clinical therapeutics

2021 Volume 43, Issue 11, Page(s) 1877–1893.e4

Abstract: Purpose: In the Phase III COV-BARRIER (Efficacy and Safety of Baricitinib for the Treatment of Hospitalised Adults With COVID-19) trial, treatment with baricitinib, an oral selective Janus kinase 1/2 inhibitor, in addition to standard of care (SOC), was ...

Abstract	Purpose: In the Phase III COV-BARRIER (Efficacy and Safety of Baricitinib for the Treatment of Hospitalised Adults With COVID-19) trial, treatment with baricitinib, an oral selective Janus kinase 1/2 inhibitor, in addition to standard of care (SOC), was associated with significantly reduced mortality over 28 days in hospitalized patients with coronavirus disease-2019 (COVID-19), with a safety profile similar to that of SOC alone. This study assessed the cost-effectiveness of baricitinib + SOC versus SOC alone (which included systemic corticosteroids and remdesivir) in hospitalized patients with COVID-19 in the United States. Methods: An economic model was developed to simulate inpatients' stay, discharge to postacute care, and recovery. Costs modeled included payor costs, hospital costs, and indirect costs. Benefits modeled included life-years (LYs) gained, quality-adjusted life-years (QALYs) gained, deaths avoided, and use of mechanical ventilation avoided. The primary analysis was performed from a payor perspective over a lifetime horizon; a secondary analysis was performed from a hospital perspective. The base-case analysis modeled the numeric differences in treatment effectiveness observed in the COV-BARRIER trial. Scenario analyses were also performed in which the clinical benefit of baricitinib was limited to the statistically significant reduction in mortality demonstrated in the trial. Findings: In the base-case payor perspective model, an incremental total cost of 17,276 US dollars (USD), total QALYs gained of 0.6703, and total LYs gained of 0.837 were found with baricitinib + SOC compared with SOC alone. With the addition of baricitinib, survival was increased by 5.1% and the use of mechanical ventilation was reduced by 1.6%. The base-case incremental cost-effectiveness ratios were 25,774 USD/QALY gained and 20,638 USD/LY gained; a "mortality-only" scenario analysis yielded similar results of 26,862 USD/QALY gained and 21,433 USD/LY gained. From the hospital perspective, combination treatment with baricitinib + SOC was more effective and less costly than was SOC alone in the base case, with an incremental cost of 38,964 USD per death avoided in the mortality-only scenario. Implications: In hospitalized patients with COVID-19 in the United States, the addition of baricitinib to SOC was cost-effective. Cost-effectiveness was demonstrated from both the payor and the hospital perspectives. These findings were robust to sensitivity analysis and to conservative assumptions limiting the clinical benefits of baricitinib to the statistically significant reduction in mortality demonstrated in the COV-BARRIER trial.
MeSH term(s)	Adult ; Azetidines ; Cost-Benefit Analysis ; Humans ; Purines ; Pyrazoles ; Quality-Adjusted Life Years ; SARS-CoV-2 ; Standard of Care ; Sulfonamides ; United States ; COVID-19 Drug Treatment
Chemical Substances	Azetidines ; Purines ; Pyrazoles ; Sulfonamides ; baricitinib (ISP4442I3Y)
Language	English
Publishing date	2021-10-04
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	603113-4
ISSN	1879-114X ; 0149-2918
ISSN (online)	1879-114X
ISSN	0149-2918
DOI	10.1016/j.clinthera.2021.09.016
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Article: Extended Thromboprophylaxis in Hospitalized Patients with Heart Failure: A Post Hoc Analysis of the MAGELLAN Study

Spyropoulos, Alex C. / Raskob, Gary E. / Spiro, Theodore E. / Lu, Wentao / De Sanctis, Yoriko / Albanese, John / Mebazaa, Alexandre / Barnathan, Elliot S.

TH Open

2022 Volume 06, Issue 04, Page(s) e304–e308

Abstract	This post hoc subgroup analysis examined efficacy and safety outcomes with extended thromboprophylaxis rivaroxaban compared with in-hospital enoxaparin in 2,078 patients from the MAGELLAN study who had a hospitalization for heart failure or a history of heart failure and a lower risk of bleeding. A significant 36% reduction in the composite endpoint of asymptomatic proximal deep vein thrombosis (DVT) in the lower extremity, symptomatic DVT in the lower extremity (proximal or distal), symptomatic nonfatal pulmonary embolism, and venous thromboembolism-related death was observed with rivaroxaban. Major bleeding was low in both groups and not significantly increased with rivaroxaban.
Keywords	heart failure ; thrombosis ; rivaroxaban ; direct oral anticoagulants ; venous thromboembolism ; medically ill
Language	English
Publishing date	2022-08-17
Publisher	Georg Thieme Verlag KG
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	2901738-5
ISSN	2512-9465 ; 2567-3459
ISSN (online)	2512-9465
ISSN	2567-3459
DOI	10.1055/a-1926-2489
Database	Thieme publisher's database

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Article ; Online: Modified IMPROVE VTE Risk Score and Elevated D-Dimer Identify a High Venous Thromboembolism Risk in Acutely Ill Medical Population for Extended Thromboprophylaxis.

Spyropoulos, Alex C / Lipardi, Concetta / Xu, Jianfeng / Peluso, Colleen / Spiro, Theodore E / De Sanctis, Yoriko / Barnathan, Elliot S / Raskob, Gary E

TH open : companion journal to thrombosis and haemostasis

2020 Volume 4, Issue 1, Page(s) e59–e65

Abstract: An individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical ... ...

Abstract	An individualized approach to identify acutely ill medical patients at increased risk of venous thromboembolism (VTE) and a low risk of bleeding to optimize the benefit and risk of extended thromboprophylaxis (ET) is needed. The International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) VTE risk score has undergone extensive external validation in medically ill patients for in-hospital use and a modified model was used in the MARINER trial of ET also incorporating an elevated D-dimer. The MAGELLAN study demonstrated efficacy with rivaroxaban but had excess bleeding. This retrospective analysis investigated whether the modified IMPROVE VTE model with an elevated D-dimer could identify a high VTE risk subgroup of patients for ET from a subpopulation of the MAGELLAN study, which was previously identified as having a lower risk of bleeding. We incorporated the modified IMPROVE VTE score using a cutoff score of 4 or more or 2 and 3 with an elevated D-dimer (>2 times the upper limit of normal) to the MAGELLAN subpopulation. In total, 56% of the patients met the high-risk criteria. In the placebo group, the total VTE event rate at Day 35 was 7.94% in the high-risk group and 2.83% for patients in the lower-risk group. A reduction in VTE was observed with rivaroxaban in the high-risk group (relative risk [RR]: 0.68, 95% confidence interval [CI]: 0.51-0.91,
Language	English
Publishing date	2020-03-13
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2901738-5
ISSN	2512-9465 ; 2567-3459
ISSN (online)	2512-9465
ISSN	2567-3459
DOI	10.1055/s-0040-1705137
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Article ; Online: Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness.

Raskob, Gary E / Ageno, Walter / Albers, Gregory / Elliott, C Gregory / Halperin, Jonathan / Maynard, Gregory / Steg, Philippe Gabriel / Weitz, Jeffrey I / Albanese, John / Yuan, Zhong / Levitan, Bennett / Lu, Wentao / Suh, Eun Young / Spiro, Theodore / Lipardi, Concetta / Barnathan, Elliot S / Spyropoulos, Alex C

Journal of the American Heart Association

2022 Volume 11, Issue 20, Page(s) e026229

Abstract: Background Venous thromboembolism (VTE) often occurs after hospitalization in medically ill patients, but the population benefit-risk of extended thromboprophylaxis remains uncertain. Methods and Results The MARINER (Medically Ill Patient Assessment of ... ...

Abstract	Background Venous thromboembolism (VTE) often occurs after hospitalization in medically ill patients, but the population benefit-risk of extended thromboprophylaxis remains uncertain. Methods and Results The MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) study (NCT02111564) was a randomized double-blind trial that compared thromboprophylaxis with rivaroxaban 10 mg daily versus placebo for 45 days after hospital discharge in medically ill patients with a creatinine clearance ≥50 mL/min. The benefit-risk balance in this population was quantified by calculating the between-treatment rate differences in efficacy and safety end points per 10 000 patients treated. Clinical characteristics of the study population were consistent with a hospitalized medical population at risk for VTE. Treating 10 000 patients with rivaroxaban resulted in 32.5 fewer symptomatic VTE and VTE-related deaths but was associated with 8 additional major bleeding events. The treatment benefit was driven by the prevention of nonfatal symptomatic VTE (26 fewer events). There was no between-treatment difference in the composite of critical site or fatal bleeding. Conclusions Extending thromboprophylaxis with rivaroxaban for 45 days after hospitalization provides a positive benefit-risk balance in medically ill patients at risk for VTE who are not at high risk for bleeding. Registration URL: https://clinicaltrials.gov/; Unique identifier: NCT02111564.
MeSH term(s)	Humans ; Rivaroxaban/adverse effects ; Venous Thromboembolism/epidemiology ; Anticoagulants/therapeutic use ; Aftercare ; Creatinine ; Patient Discharge ; Hospitalization ; Hemorrhage/chemically induced ; Risk Assessment
Chemical Substances	Rivaroxaban (9NDF7JZ4M3) ; Anticoagulants ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2022-10-07
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2653953-6
ISSN	2047-9980 ; 2047-9980
ISSN (online)	2047-9980
ISSN	2047-9980
DOI	10.1161/JAHA.122.026229
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Article ; Online: Rivaroxaban Plus Aspirin for Extended Thromboprophylaxis in Acutely Ill Medical Patients: Insights from the MARINER Trial.

Spyropoulos, Alex C / Goldin, Mark / Ageno, Walter / Albers, Gregory W / Elliott, C Gregory / Hiatt, William R / Halperin, Jonathan L / Maynard, Gregory / Steg, P Gabriel / Weitz, Jeffrey I / Spiro, Theodore E / Lu, Wentao / Marsigliano, Jessica / Raskob, Gary E / Barnathan, Elliot S

TH open : companion journal to thrombosis and haemostasis

2022 Volume 6, Issue 3, Page(s) e177–e183

Abstract: ... ...

Abstract	Background
Language	English
Publishing date	2022-07-11
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2901738-5
ISSN	2512-9465 ; 2567-3459
ISSN (online)	2512-9465
ISSN	2567-3459
DOI	10.1055/s-0042-1750379
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Article ; Online: Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials.

Spyropoulos, Alex C / Raskob, Gary E / Cohen, Alexander T / Ageno, Walter / Weitz, Jeffrey I / Spiro, Theodore E / Lu, Wentao / Lipardi, Concetta / Albers, Gregory W / Elliott, C Gregory / Halperin, Jonathan L / Hiatt, William R / Maynard, Gregory / Steg, P Gabriel / Sugarmann, Chiara / Barnathan, Elliot S

Circulation

2022 Volume 145, Issue 19, Page(s) 1471–1479

Abstract: Background: Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients because of bleeding concerns. The MAGELLAN (Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous ... ...

Abstract	Background: Extended thromboprophylaxis has not been widely implemented in acutely ill medical patients because of bleeding concerns. The MAGELLAN (Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin) and MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) trials evaluated whether rivaroxaban compared with enoxaparin or placebo could prevent venous thromboembolism without increased bleeding. We hypothesized that patients with major bleeding but not those with nonmajor clinically relevant bleeding would be at an increased risk of all-cause mortality (ACM). Methods: We evaluated all bleeding events in patients taking at least 1 dose of study drug and their association with ACM in 4 mutually exclusive groups: (1) no bleeding, or first event was (2) nonmajor clinically relevant bleeding, (3) major bleeding, or (4) trivial bleeding. Using a Cox proportional hazards model adjusted for differences in baseline characteristics associated with ACM, we assessed the risk of ACM after such events. Results: Compared with patients with no bleeding, the risk of ACM for patients with nonmajor clinically relevant bleeding was not increased in MARINER (hazard ratio, 0.43; Conclusions: Patients with major bleeding had an increased risk of ACM, whereas nonmajor clinically relevant bleeding was not consistently associated with an increased risk of death. These results inform the risk-benefit calculus of extended thromboprophylaxis in medically ill patients. Registration: URL: https://www. Clinicaltrials: gov; Unique identifier: MAGELLAN, NCT00571649. URL: https://www. Clinicaltrials: gov; Unique identifier: MARINER, NCT02111564.
MeSH term(s)	Aftercare ; Anticoagulants/adverse effects ; Enoxaparin/adverse effects ; Hemorrhage/chemically induced ; Hemorrhage/complications ; Humans ; Patient Discharge ; Rivaroxaban/adverse effects ; Venous Thromboembolism/epidemiology
Chemical Substances	Anticoagulants ; Enoxaparin ; Rivaroxaban (9NDF7JZ4M3)
Language	English
Publishing date	2022-04-07
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	80099-5
ISSN	1524-4539 ; 0009-7322 ; 0069-4193 ; 0065-8499
ISSN (online)	1524-4539
ISSN	0009-7322 ; 0069-4193 ; 0065-8499
DOI	10.1161/CIRCULATIONAHA.121.057847
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Article ; Online: Rivaroxaban for thromboprophylaxis in acutely ill medical patients.

Cohen, Alexander T / Spiro, Theodore E / Spyropoulos, Alex C

The New England journal of medicine

2013 Volume 368, Issue 20, Page(s) 1945–1946

MeSH term(s)	Anticoagulants/therapeutic use ; Enoxaparin/therapeutic use ; Factor Xa Inhibitors ; Female ; Hemorrhage/chemically induced ; Humans ; Male ; Morpholines/therapeutic use ; Thiophenes/therapeutic use ; Venous Thromboembolism/prevention & control
Chemical Substances	Anticoagulants ; Enoxaparin ; Factor Xa Inhibitors ; Morpholines ; Thiophenes
Language	English
Publishing date	2013-05-16
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc1303641
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