David Feinbloom, MD; Kenneth A. Bauer, MD
Does thromboprophylaxis with enoxaparin reduce mortality in acutely ill medical patients?
Randomized placebo-controlled trial (LIFENOX study). ClinicalTrials.gov NCT00622648.
Unclear allocation concealment.*
Blinded* (patients, investigators, safety and steering committees, and research personnel).
30 and 90 days.
193 hospitals in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia.
8323 patients ≥ 40 years of age (mean age 65 y, 63% men) who had been hospitalized in the past 48 hours for ≥ 1 of acute decompensation of heart failure, active cancer (excluding planned stays for chemotherapy), or severe systemic infection; had ≥ 1 of chronic pulmonary disease, body mass index ≥ 30, age ≥ 60 years, or history of venous thromboembolism (VTE); and had an expected stay ≥ 6 days and an American Society of Anesthesiologists health status score ≤ 3 out of 6 or an Eastern Cooperative Oncology Group performance status score ≤ 2 out of 5. Exclusion criteria included recent major surgery or trauma, recent stroke, severe renal failure, ventilator support with intubation, and active bleeding.
Subcutaneous enoxaparin, 40 mg/d (n = 4174), or placebo (0.9% saline) (n = 4145), for 6 to 14 days. All patients wore knee-high, elastic, graduated compression stockings.
Primary efficacy outcome was all-cause mortality at 30 days. Other outcomes included major bleeding events, all-cause mortality at 90 days, and cardiopulmonary mortality (sudden death or death due to acute myocardial infarction, heart failure, or pulmonary embolism) at 30 and 90 days. The study had 77% power to detect a 25% reduction from the 4.8% observed 30-day mortality rate in the placebo group (2-sided α = 0.05).
99% at 90 days (intention-to-treat analysis).
Enoxaparin and placebo did not differ for all-cause or cardiopulmonary mortality at 30 or 90 days (Table); groups also did not differ for major bleeding during or ≤ 14 days after treatment (n = 8307, 0.4% vs 0.3%, P = 0.35).
Thromboprophylaxis with enoxaparin did not reduce mortality or increase major bleeding events in acutely ill medical patients.
Enoxaparin vs placebo in acutely ill medical patients†
†Abbreviations defined in Glossary. RRI and CI calculated from event rates and relative risks in article; RRR and CI calculated from hazard ratios and control event rates in article.
Feinbloom D, Bauer KA. Enoxaparin thrombophylaxis did not reduce mortality in acutely ill medical patients. Ann Intern Med. ;156:JC4–6. doi: 10.7326/0003-4819-156-8-201204170-02006
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Published: Ann Intern Med. 2012;156(8):JC4-6.
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