viernes, 11 de abril de 2014

Troboprofilaxis/ Thromboprophylaxis

Heparina de bajo peso molecular y mortalidad en pacientes agudos


Low-molecular-weight heparin and mortality in acutely ill medical patients.
Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF; LIFENOX Investigators. Collaborators (383)
N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.
Abstract
BACKGROUND: Although thromboprophylaxis reduces the incidence of venous thromboembolism in acutely ill medical patients, an associated reduction in the rate of death from any cause has not been shown. METHODS: We conducted a double-blind, placebo-controlled, randomized trial to assess the effect of subcutaneous enoxaparin (40 mg daily) as compared with placebo--both administered for 10±4 days in patients who were wearing elastic stockings with graduated compression--on the rate of death from any cause among hospitalized, acutely ill medical patients at participating sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia. Inclusion criteria were an age of at least 40 years and hospitalization for acute decompensated heart failure, severe systemic infection with at least one risk factor for venous thromboembolism, or active cancer. The primary efficacy outcome was the rate of death from any cause at 30 days after randomization. The primary safety outcome was the rate of major bleeding during and up to 48 hours after the treatment period. RESULTS:
A total of 8307 patients were randomly assigned to receive enoxaparin plus elastic stockings with graduated compression (4171 patients) or placebo plus elastic stockings with graduated compression (4136 patients) and were included in the intention-to-treat population. The rate of death from any cause at day 30 was 4.9% in the enoxaparin group as compared with 4.8% in the placebo group (risk ratio, 1.0; 95% confidence interval [CI], 0.8 to 1.2; P=0.83). The rate of major bleeding was 0.4% in the enoxaparin group and 0.3% in the placebo group (risk ratio, 1.4; 95% CI, 0.7 to 3.1; P=0.35). CONCLUSIONS:The use of enoxaparin plus elastic stockings with graduated compression, as compared with elastic stockings with graduated compression alone, was not associated with a reduction in the rate of death from any cause among hospitalized, acutely ill medical patients. (Funded by Sanofi; LIFENOX ClinicalTrials.gov number, NCT00622648.).
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1111288



Apixaban vs. enoxaparina para tromboprofilaxis en pacientes de tipo médico

Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Collaborators (371)
N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13Author information
Abstract
BACKGROUND:The efficacy and safety of prolonging prophylaxis for venous thromboembolism in medically ill patients beyond hospital discharge remain uncertain. We hypothesized that extended prophylaxis with apixaban would be safe and more effective than short-term prophylaxis with enoxaparin.METHODS:In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2.5 mg twice daily for 30 days, or enoxaparin, administered subcutaneously at a dose of 40 mg once daily for 6 to 14 days. The primary efficacy outcome was the 30-day composite of death related to venous thromboembolism, pulmonary embolism, symptomatic deep-vein thrombosis, or asymptomatic proximal-leg deep-vein thrombosis, as detected with the use of systematic bilateral compression ultrasonography on day 30. The primary safety outcome was bleeding. All efficacy and safety outcomes were independently adjudicated.RESULTS: A total of 6528 subjects underwent randomization, 4495 of whom could be evaluated for the primary efficacy outcome--2211 in the apixaban group and 2284 in the enoxaparin group. Among the patients who could be evaluated, 2.71% in the apixaban group (60 patients) and 3.06% in the enoxaparin group (70 patients) met the criteria for the primary efficacy outcome (relative risk with apixaban, 0.87; 95% confidence interval [CI], 0.62 to 1.23; P=0.44). By day 30, major bleeding had occurred in 0.47% of the patients in the apixaban group (15 of 3184 patients) and in 0.19% of the patients in the enoxaparin group (6 of 3217 patients) (relative risk, 2.58; 95% CI, 1.02 to 7.24; P=0.04). CONCLUSIONS:
In medically ill patients, an extended course of thromboprophylaxis with apixaban was not superior to a shorter course with enoxaparin. Apixaban was associated with significantly more major bleeding events than was enoxaparin. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00457002.).

http://www.nejm.org/doi/pdf/10.1056/NEJMoa1110899


Incidencia y prevención de tromboembolismo en chinos viejos agudos hospitalizados
Incidence and prevention of venous thromboembolism in acutely ill hospitalized elderly Chinese.
Li XY, Fan J, Cheng YQ, Wang Y, Yao C, Zhong NS.
Chin Med J (Engl). 2011 Feb;124(3):335-40.
Abstract
BACKGROUND: As the third most frequent cardiovascular disease, venous thromboembolism (VTE) remains a major cause of morbidity and mortalityin hospitalized patients. The aim of this study was to determine the incidence of VTE and steps for its prevention in acutely ill hospitalized elderly Chinese patients. METHODS: A prospective multi-center study was conducted from June 2006 to November 2007. A total of 607 patients from 40 research centers in China were enrolled. Data of the patients' baseline characteristics, VTE events and prophylaxis/therapy methods were collected. RESULTS: Fifty-nine patients (9.7%) had an objectively confirmed VTE during the 90-day follow-up, of which, 59.3% occurred during the first week and 75% within 14 days. Forty-one patients died (6.6%) during the follow-up, 36.6% died within three weeks. We also found that medical disorders including respiratory failure (16.4%), acute brain infarction (15.6%), acute infectious diseases (14.3%), acute coronary artery syndrome (8.7%) and heart failure (7.6%) play a role in provoking VTE. Only 13.0% of the elderly patients with high risk of VTE used low dose unfractionated heparin, 7.1% used low molecular weight heparin, 5.4% used warfarin, 0.3% used graduated compression stockings and none of them used intermittent pneumatic compression. CONCLUSIONS:
Our study showed similar results between our study and western countries in the VTE incidence by day 90 in elderly hospitalizedpatients with acute medical illness. Great caution must be applied in the care of acutely ill elderly hospitalized patients to deal with the complications of VTE. Application of safe and effective prophylaxes against embolism remains a critical challenge.

http://www.cmj.org/ch/reader/view_abstract.aspx?volume=124&issue=3&start_page=335


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