Continuous Intravenous Heparin Compared with Intermittent Subcutaneous Heparin in the Initial Treatment of Proximal-Vein Thrombosis

Hull, Russell D.; Raskob, Gary E.; Hirsh, Jack; Jay, Richard; Leclerc, Jacques; Geerts, William; Rosenbloom, David; Sackett, David L.; Anderson, Christine; Harrison, Linda; Gent, Michael

doi:10.1056/nejm198610303151801

Cited by 716 publications

(344 citation statements)

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“…This decision was based on previous studies that observed an excess of recurrent venous thromboembolic events during a period of 3 months in patients with DVT who received either inadequate doses of initial heparin, or no initial heparin at all,10, 11, 12 and the short‐term effects of heparins on the occurrence of bleeding. Limiting the time window for bleeding to the actual duration of enoxaparin plus 2 days was not possible because patients receiving rivaroxaban did not receive placebo/enoxaparin.…”

Section: Discussionmentioning

confidence: 99%

“…Patients who do not reach therapeutic levels of anticoagulation within 48 hours of commencing heparin show an increased risk of recurrent VTE (relative risk of 4.5) 9. At 3 months, the incidence of recurrent VTE has been shown to range between 16 and 25% in patients not receiving initial heparin and those who receive inadequate heparin doses 9, 10, 11, 12, 13…”

mentioning

confidence: 99%

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Use of Prestudy Heparin Did Not Influence the Efficacy and Safety of Rivaroxaban in Patients Treated for Symptomatic Venous Thromboem‐bolism in the EINSTEIN DVT and EINSTEIN PE Studies

Prandoni

Prins

Cohen

et al. 2015

Academic Emergency Medicine

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ObjectivesIn the EINSTEIN DVT and EINSTEIN PE studies, the majority of patients received heparins to bridge the period during venous thromboembolism (VTE) diagnosis confirmation and the start of the study. In contrast to vitamin K antagonists (VKAs), rivaroxaban may not require initial heparin treatment.MethodsTo evaluate the effect of prestudy heparin on the efficacy and safety of rivaroxaban relative to enoxaparin/VKA, the 3‐month incidence of recurrent VTE, and the 14‐day incidence of major and nonmajor clinically relevant bleeding were compared in patients who did and did not receive prestudy heparin.ResultsOf the 8,281 patients randomized, 6,937 (83.8%) received prestudy heparin (mean ± SD duration = rivaroxaban: 1.04 [± 0.74] days; enoxaparin 1.03 [± 0.42] days), and 1,344 (16.2%) did not. In patients who did not receive prestudy heparin, the incidences of recurrent VTE were similar in rivaroxaban (15 of 649, 2.3%) and enoxaparin/VKA (13 of 695, 1.9%) patients (adjusted hazard ratio [HR] = 1.11; 95% confidence interval [CI] = 0.52 to 2.37). The incidences of recurrent VTE were also similar in rivaroxaban (54 of 3,501, 1.5%) and enoxaparin/VKA (69 of 3,436, 2.0%) patients who did receive prestudy heparin (adjusted HR = 0.74; 95% CI = 0.52 to 1.06; pinteraction = 0.32). The incidences of major or nonmajor clinically relevant bleeding with rivaroxaban were not significantly different from those with enoxaparin/VKA, either with (105 of 3,485, 3.0% vs. 104 of 3,428, 3.0%; adjusted HR = 0.98; 95% CI = 0.75 to 1.29) or without (24 of 645, 3.7% vs. 30 of 688, 4.4%; adjusted HR = 0.81; 95% CI = 0.46 to 1.40; pinteraction = 0.68) prestudy heparin.ConclusionsAlthough the majority of patients in the EINSTEIN studies received prestudy heparin, there were no notable differences in treatment effect of rivaroxaban versus enoxaparin/VKA in those who did and did not receive it.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Use of Prestudy Heparin Did Not Influence the Efficacy and Safety of Rivaroxaban in Patients Treated for Symptomatic Venous Thromboem‐bolism in the EINSTEIN DVT and EINSTEIN PE Studies

Prandoni

Prins

Cohen

et al. 2015

Academic Emergency Medicine

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“…A meta-analysis of the most important studies indicated that unfractionated SH administered subcutaneously twice daily is more effective and at least as safe as continuous intravenous SH administration [18]. This is in contrast to a trial performed by Hull et al in which subcutaneous SH resulted in a higher frequency of recurrent thrombosis [19].…”

Section: L Standard Unfractionated Heparin (Sh)mentioning

confidence: 92%

New developments in the treatment of deep venous thrombosis

Janssen¹,

Nováková²,

Verbruggen³

et al. 1997

The Netherlands Journal of Medicine

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An initial course of standard heparin (SH) or low-molecular-weight heparins (LMWH) is regarded as the treatment of choice for patients with deep venous thrombosis (DVT). LMWH have better bioavailability after subcutaneous administra tion, have a longer half-life, and show higher and more predictable anticoagulant activity. As a result they can be given subcutaneously and without laboratory control, using a dose that is determined by body weight. Because of these multiple advantages of LMWH they will replace SH in the future and subsequently home treatment with LMWH of selected patients seems feasible. The currently accepted approach is to start with SH or LMWH therapy combined with oral anticoagulant therapy (OAT) at the time of diagnosis. The course of SH or LMWH should continue for at least 5 days, provided that international normalized ratio (INR) is in the therapeutic range on 2 consecutive days. OAT should be continued for at least 3 months to prolong the prothrombin time to an INR of 2 -3 . When oral anticoagulants are either contraindicated or inconvenient, SH or LMWH can be used at the middosing interval. The role of anti-platelet treatment is not yet established 4 and should be compared with coumarin therapy in the future.

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“…All patients who fulfilled at least 1 of the diagnostic criteria for DVT or pulmonary embolism were considered to have confirmed venous thromboembolism on follow-up. The 3-month follow-up period was chosen because inadequate management of acute DVT results in a high rate of recurrent venous thromboembolic events during the subsequent 3 months (18)(19)(20).…”

Section: Long-term Follow-upmentioning

confidence: 99%

Negative d-dimer result to exclude recurrent deep venous thrombosis: A management trial

Rathburn¹,

Whitsett²,

Raskob³

2005

ACC Current Journal Review

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Continuous Intravenous Heparin Compared with Intermittent Subcutaneous Heparin in the Initial Treatment of Proximal-Vein Thrombosis

Cited by 716 publications

References 23 publications

Use of Prestudy Heparin Did Not Influence the Efficacy and Safety of Rivaroxaban in Patients Treated for Symptomatic Venous Thromboem‐bolism in the EINSTEIN DVT and EINSTEIN PE Studies

Use of Prestudy Heparin Did Not Influence the Efficacy and Safety of Rivaroxaban in Patients Treated for Symptomatic Venous Thromboem‐bolism in the EINSTEIN DVT and EINSTEIN PE Studies

New developments in the treatment of deep venous thrombosis

Negative d-dimer result to exclude recurrent deep venous thrombosis: A management trial

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