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N Engl J Med. 2011 Dec 29;365(26):2463-72. doi: 10.1056/NEJMoa1111288.

Low-molecular-weight heparin and mortality in acutely ill medical patients.

Collaborators (383)

Bergmann JF, Cimminiello C, Goldhaber SZ, Kakkar AK, Parakh R, Wang C, Arcelus J, DeMets D, Haas S, Mismetti P, Vicaut E, Bergmann JF, Cimminiello C, Goldhaber SZ, Kakkar AK, Li X, Liu W, Liu S, Wang G, Wang C, Dai H, Liu M, Yang X, Zhang F, Yao W, Zheng Y, Bai C, Sun Y, Ke Y, Zhou Y, Sun Y, Lu C, Jiang P, Wang Y, Ge G, Xu G, Jiang T, Wei L, Chen S, Qin B, Wang L, Yu K, Zhu H, Guo X, Chen X, Fang W, Han B, Wu S, Wu Z, Jin Y, Xu Y, Xu Q, Lu H, Bai C, Feng Q, Guo X, Sheng J, Zhou J, Wang Z, Ren Z, Wang Z, Huang M, Zhu X, Yu H, Jiang X, Wang L, Li W, Qian C, Liu Y, Dong Y, Chen X, Song Z, Yang H, Wu Y, Chen Z, Huang W, Dong Y, Li J, Ma S, Zhao L, Li Z, Wang C, Gao Y, Yu B, Qi W, Mao J, Liu X, Huang Z, Gu S, Zhu Q, Chen X, Zhou X, Wang F, Wu W, Zhang H, Chen P, Wu Y, Fan F, Zeng B, Zheng Y, Hua S, Liu B, Zhang J, Xiao Z, Zheng Z, Wang S, Wu Y, Kuang J, Hao Y, Yuan Y, Qi X, Han X, Xu Z, Chen J, Yang M, Xu D, Lin H, Liu C, Wu C, Jiang Y, Huang D, Cui L, Chen L, Cai Y, Liu X, Song Y, Xia S, Ge H, Hui F, Wu C, Jin Y, Wang D, Sun Q, Tian J, Liu A, Yan J, Zhuo A, Ma Z, Yang L, Gao Y, Zhang D, Liang Y, Li J, Xiong X, Wong RS, Cheng G, Lin SY, Patel T, Bankar D, Dosi V, Raju K, Chakrapani M, Zirpe K, Gupta R, Sircar M, Ravindra TS, Goyal A, Abhyankar N, Alexander KG, Moulick ND, John M, Talwar D, Jain M, Reddy PN, Hussain MH, Miryala S, Jadwani JP, Daga MK, Subuhani MS, Srinivasan R, D'Costa P, Kumar NS, Shah KK, Rajasekaran VN, Jog S, Dhanuka S, Mangrulkar S, Bhatter SK, Parale GP, Todi SK, Singh O, Rao AC, Singh HP, Khan ZA, Jindal R, Sharma SK, Agarwal DP, Memon MF, Alexander T, Agarwal A, Jain V, Puri S, Chakravarthy VK, Wander GS, Rodrigues L, Pandey AK, Singh DK, Mantri S, Kumar AK, Jabir A, Gupta R, Patil R, Gawarikar SB, Jain RK, Kamat P, Bhardwaj B, Balachandran V, Ramasubban S, Singh AK, Sahu S, Goel M, Subramanium V, Johri A, Kulkarni NS, Purnanand A, Raghupati P, Misra RR, Jaiswal SJ, Parakh R, Devarajan TV, Sundaram AL, Sarma PV, Balaji R, Vachaparambil JJ, Rajasekhar D, Somani M, Kasturi S, Oomman A, Rajadhayaksha G, Singh L, Vyas G, Rao MB, Raghu C, Sunder TS, Solanki B, Srinivas V, Matthew R, Shah PK, Vidyasagar S, Kumar TM, Saha A, Gupta H, Singh RM, Dogra P, Kaushal SS, Kashyap S, Phatak P, Bhupali A, Sharma K, Singh P, Agrawal RP, Gupta P, Basavana Gowdappa H, Chopda M, Salkar HR, Deshmukh JM, Parmar MC, Sujatha V, Chandwani P, Babu PR, Khandelwal B, Goyal NK, Sivakumar V, Manjunath R, Raju CS, Thasan RB, Khippal N, Phanikrishna B, Bhat GK, Kim HS, Yang SC, Hong SB, Lee SY, Hur GY, Park CG, Kang SM, Kim YK, Kim JY, Choi DJ, Kim DK, Lee C, Ahn TH, Kim MH, Lee WY, Kim JY, Lim SC, Ahn YK, Jin SW, Heo SH, Han MS, Kim SJ, Choi CW, Yoo JH, Park MS, Kim YS, Nah DY, Hwa YC, Ma WT, Najihah I, How SH, Abdul Razak AM, Law WC, Tie ST, Bharathan T, Monniaty M, Chandran A, Yew NY, Aziah AM, Wong I, Chuah CK, Rosemi S, Sia KK, Jeyaindran S, Leong CY, Rubio Guerra AF, Zamora Angulo LE, Valero Rodríguez JE, Rosas Guzmán J, Merino Rosillo JE, Aguirre Avalos G, Tamariz Becerra A, Peón Peralta G, Quesada Sánchez A, Estrada Gutiérrez A, Barajas Montoya Z, Miranda Liñero A, Mancillas Adame LG, Rodríguez González D, Hernández Labastida A, Vargas Flores AR, Zecua Hernández J, Rodríguez Marto C, Vázquez López MA, Secchi Nicolás NC, Llamas Esperón G, Ramírez Díaz SP, Jiménez Godínez AA, De Guia T, Bravo P, Wang A, Ang E, Rogelio G, Ramos G, Germar A, Naval S, Megdiche ML, Ghedira H, Ayoub A, Beji M, Cheikh R, Ben Kheder A, Tritar F, Chabbou A, Feki A, Ben Rhouma C, Helioui R, Cheikh K, El Kamel A, Rokbani L, Houman H, Mahjoub S, Othmani S, Louzir B, Charfi R, Bouacha H, Chakroun M, Khechrid C, Jerbi Z, Abroug F, Besbes M, Gamra H, Elatrousl S, Kammoun S, Maatouk F, Ben Jemaa M, Messaadi A, Ferjani M, Milla A, Dewez D, Brunet-Horion F, Domenger C, Deslandes B, Salette G.

Author information

  • 1Thrombosis Research Institute and University College London, London, United Kingdom. akkakkar@tri-london.ac.uk

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.).

Comment in

PMID:
22204723
[PubMed - indexed for MEDLINE]
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