Behandlung der pulmonalen Thromboembolie

Behandlung der pulmonalen Thromboembolie

Behandlung der pulmonalen Thromboembolie Antikoagulation Behandlung der pulmonalen Thromboembolie


Behandlung der pulmonalen Thromboembolie Oral Rivaroxaban for Symptomatic Venous Thromboembolism — NEJM

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Behandlung der pulmonalen Thromboembolie

N Engl J Med ; Rivaroxaban, an oral factor Xa inhibitor, may provide a simple, Behandlung der pulmonalen Thromboembolie, fixed-dose regimen for treating acute deep-vein thrombosis DVT and for continued treatment, without the need for laboratory monitoring.

Full Text of Background We conducted an open-label, randomized, event-driven, noninferiority study that compared oral rivaroxaban alone 15 mg twice daily for 3 weeks, followed by 20 mg once daily with subcutaneous enoxaparin followed by a vitamin K antagonist either warfarin or acenocoumarol for 3, 6, or 12 months in patients with acute, symptomatic DVT.

In parallel, we carried out a double-blind, randomized, event-driven superiority study that compared rivaroxaban alone 20 mg once daily with placebo for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism. The primary efficacy outcome for both studies was recurrent venous thromboembolism. The principal safety outcome was major bleeding or clinically relevant nonmajor bleeding in the initial-treatment study and major bleeding in the continued-treatment study.

Full Text of Methods The study of rivaroxaban for acute DVT included patients: Rivaroxaban had noninferior efficacy with respect to the primary outcome 36 events [2. The principal safety outcome occurred in 8. In the continued-treatment study, which included patients in the rivaroxaban group and in the placebo group, rivaroxaban had superior efficacy 8 events [1. Four patients in the rivaroxaban group had nonfatal major bleeding 0. Full Text mit Krampfadern ein Friseur zu sein Results Rivaroxaban offers a simple, single-drug approach to the short-term and continued treatment of venous thrombosis that Behandlung der pulmonalen Thromboembolie improve the benefit-to-risk profile of anticoagulation.

Full Text of Discussion Acute venous thromboembolism i. Standard treatment for acute venous thromboembolism is limited by the need for parenteral heparin initially, with overlapping administration of a vitamin K antagonist.

This presents a challenge to outpatient management, 6 since treatment with a vitamin K antagonist requires laboratory monitoring and dose adjustment and may be complicated by drug and food interactions. A simple solution to some of these issues could be administration of an oral anticoagulant that does not require laboratory monitoring yet is effective as a single agent for the treatment of acute venous thromboembolism and for continued treatment.

Rivaroxaban, an orally active, direct factor Xa inhibitor, is effective in the prevention of venous thromboembolism after orthopedic surgery.

It does not require laboratory monitoring and has no food interactions and only a few drug interactions. In two dose-finding studies, we established the feasibility of single-agent therapy with rivaroxaban in patients with DVT. We report the results of the first and third trials; the second trial is ongoing. The Acute DVT Study was a randomized, open-label study that compared the efficacy and safety of rivaroxaban with standard therapy consisting of enoxaparin and a vitamin K antagonist in patients with acute, symptomatic DVT.

The Continued Treatment Study EINSTEIN—Extension was a double-blind study in which patients with confirmed symptomatic DVT or pulmonary embolism who had been treated Behandlung der pulmonalen Thromboembolie 6 or 12 months with a vitamin K Behandlung der pulmonalen Thromboembolie or rivaroxaban Varizen in jungen randomly assigned to receive continued treatment with rivaroxaban or placebo.

The trials were conducted in accordance with the protocol available with the full text of this article at NEJM. The steering committee had final responsibility for the study designs, clinical protocols, study oversight, and verification and analyses of the data.

The protocols were approved by the institutional review board at each center, and written informed consent was obtained from all patients. The data were collected and maintained by the sponsor. All suspected outcome events were classified by a central adjudication committee whose members were unaware of the treatment assignments. An independent data and safety monitoring board periodically reviewed outcomes.

The writing committee wrote the manuscript and vouches for the accuracy and completeness of the reported data and analyses and the fidelity of the study to the protocol. For the Acute DVT Study, patients were eligible if they were of legal age for consent and had acute, symptomatic, objectively confirmed proximal DVT, Behandlung der pulmonalen Thromboembolie, without symptomatic pulmonary embolism.

Patients were ineligible if they had received therapeutic doses of low-molecular-weight heparin, Behandlung der pulmonalen Thromboembolie, fondaparinux, or unfractionated heparin for more than 48 hours or if they had received more than a single dose of a vitamin K antagonist before randomization; if they had been treated with thrombectomy, a vena cava filter, or a fibrinolytic agent for the current episode of thrombosis; or if they had any contraindication listed in the labeling of enoxaparin, warfarin, or acenocoumarol.

Exclusion criteria for both studies were another indication for a vitamin K antagonist; a creatinine clearance below 30 ml per minute; Behandlung der pulmonalen Thromboembolie significant liver disease e.

In both studies, patients were randomly assigned to a study group with the use of a computerized voice—response system, with stratification by country. The intended treatment duration was determined by the treating physician. In the Acute DVT Study, patients assigned to receive oral rivaroxaban were given 15 mg twice daily for the first 3 weeks, followed by 20 mg once daily for the intended 3, 6, or 12 months of treatment. Patients who were assigned to standard therapy received subcutaneous enoxaparin, 1.

Enoxaparin was discontinued when the international normalized ratio INR was 2. The dose of the vitamin K antagonist was adjusted to maintain an INR of 2. The INR was determined at least once per Behandlung der pulmonalen Thromboembolie. The time during which the INR was within the therapeutic range was calculated for each patient from the discontinuation of heparin until the end of treatment, including interruptions.

For the Continued Treatment Study, patients were assigned to either rivaroxaban, 20 mg once daily, or matching placebo for the intended treatment duration of 6 or 12 months. In both studies, the use of nonsteroidal antiinflammatory drugs and antiplatelet agents was discouraged. If indicated, aspirin up to mg per dayclopidogrel 75 mg per dayor both were allowed.

In both studies, patients were followed for the intended treatment duration and seen at fixed intervals that were identical for the rivaroxaban and comparison groups, Behandlung der pulmonalen Thromboembolie, at which time a checklist was used to elicit information on symptoms and signs of recurrent venous thromboembolism, bleeding, and adverse events. Patients were instructed to report to the study center immediately if any of these events occurred.

In cases of suspected venous thromboembolism, the protocol required objective testing. For both studies, the primary efficacy outcome was symptomatic, recurrent venous thromboembolism, defined as the composite of DVT or nonfatal or fatal pulmonary embolism, with the use of diagnostic criteria described previously 12 see the Supplementary Appendixavailable at NEJM.

Death was classified as due to pulmonary embolism, bleeding, or other established causes. Pulmonary embolism was considered the cause of death if there was objective documentation or if death could not be attributed to a documented cause and pulmonary embolism could not be confidently ruled out.

For the Acute DVT Study, the principal safety outcome was clinically relevant bleeding, defined as the composite of major or clinically relevant nonmajor bleeding, Behandlung der pulmonalen Thromboembolie. For the Continued Treatment Study, the principal safety outcome was major bleeding. Criteria for bleeding were described previously 12 see the Supplementary Appendix. Predefined secondary outcomes included all-cause mortality, vascular events acute coronary syndrome, ischemic stroke, transient ischemic attack, Behandlung der pulmonalen Thromboembolie, or systemic embolismand net clinical benefit defined as the composite of the primary efficacy outcome or major bleeding.

In addition, analyses of the treatment effects and bleeding were performed in prespecified subgroups in both studies. However, it was specified a priori that the steering committee would decide to stop enrollment when it was estimated that 88 events would be reached.

This decision was to be made without knowledge of the outcomes in the treatment groups. When enrollment was discontinued, patients completed their assigned treatment, except for patients in the month stratum who had completed at least 6 months of treatment. The Continued Treatment Study was an Behandlung der pulmonalen Thromboembolie, superiority study.

On the basis of a frequency of the primary outcome of 3. However, the final sample size was determined as described for the Acute Behandlung der pulmonalen Thromboembolie Study, with a Behandlung der pulmonalen Thromboembolie treatment duration of 3 months. For both studies, the primary efficacy analysis was performed on an intention-to-treat basis with the use of a stratified intended-duration Cox proportional-hazards model, adjusted for the presence of a malignant condition at baseline in the Acute DVT Study and pretreatment in the Continued Treatment Study, Behandlung der pulmonalen Thromboembolie.

The safety analyses included all patients who received the assigned study drug. Bleeding events were included in the analyses if they occurred during treatment or within 2 days after discontinuation of the study drug.

From February through Marcha total of patients were enrolled in the Continued Treatment Study. Of these patients, For the Acute DVT Study, data on treatment with rivaroxaban or with enoxaparin combined with a vitamin K antagonist standard therapyas well as the main reasons for premature discontinuation of treatment, are shown in Table 2 Table 2 Characteristics of Treatment in Each Study.

In the standard-therapy group, the median duration of enoxaparin treatment was 8 days interquartile range, 6 to 11and the INR at the end of enoxaparin treatment was 2.

Overall, the INR was in the therapeutic range 2. The percentage of time within the therapeutic range varied from Because termination of the study was event-driven, the duration of treatment was shorter than intended for patients 5.

In the rivaroxaban group, 15 patients 0. For the Continued Treatment Study, data on treatment with either rivaroxaban or placebo and the reasons for premature discontinuation of treatment are shown in Table 2.

As a result of event-driven termination, the duration of treatment was shorter than intended for patients Follow-up for the primary efficacy outcome was complete for patients The primary efficacy outcome was suspected in patients in the rivaroxaban group and in patients in the standard-therapy group and was confirmed in 36 and 51 of these patients, Behandlung der pulmonalen Thromboembolie, respectively.

Hence, the primary efficacy outcome occurred in 2. VKA denotes vitamin K antagonist. By day 21 the end of twice-daily rivaroxaban dosingthe primary efficacy outcome had occurred in 21 patients 1. The results of the on-treatment and per-protocol analyses were similar to those of the intention-to-treat analysis data not shown. The principal safety outcome Behandlung der pulmonalen Thromboembolie first major or clinically relevant nonmajor bleeding — occurred in patients 8.

The outcome of a net clinical benefit occurred in 51 2. The relative efficacy and safety were consistent across Behandlung der pulmonalen Thromboembolie prespecified subgroups Figure 1 and Figure 2 in the Supplementary Appendix.

Vascular events during study treatment occurred in 12 patients 0. The combination Behandlung der pulmonalen Thromboembolie an alanine aminotransferase level exceeding three times the upper limit of the normal range and a bilirubin level exceeding twice the upper limit of the normal range was observed in 2 patients 0.

The primary efficacy outcome occurred in 8 patients 1. The time course for recurrent venous thromboembolism in the two groups is shown in Figure 2B.

The principal safety outcome of major bleeding occurred in 4 patients 0. The outcome of a net clinical benefit occurred in 12 patients 2.

The relative efficacy and safety were consistent across the prespecified subgroups Figure 3 and Figure 4 in the Supplementary Appendix. Vascular events occurred in 3 patients in the rivaroxaban group and 4 patients in the placebo group Table 3 in the Supplementary Appendix, Behandlung der pulmonalen Thromboembolie.

No patient in either group had the combination of an alanine aminotransferase level exceeding three times the upper limit of the normal range and a bilirubin level exceeding twice the upper limit of the normal range Table 4 in the Supplementary Appendix.

Our studies show that rivaroxaban alone is as effective as standard therapy, with similar safety, Behandlung der pulmonalen Thromboembolie, for the treatment of acute DVT and that when treatment is continued, rivaroxaban is very effective in preventing recurrences, as Behandlung der pulmonalen Thromboembolie with placebo, and has an acceptable risk of bleeding, Behandlung der pulmonalen Thromboembolie.

A unique aspect of the Acute Behandlung der pulmonalen Thromboembolie Study is the use of rivaroxaban as a single agent, replacing both low-molecular-weight heparin and a vitamin K antagonist in the treatment of DVT.

Accordingly, the great majority of patients in the rivaroxaban group either did not receive low-molecular-weight heparin or received a single dose. Nevertheless, efficacy during the first weeks of treatment was similar in the two study groups.


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