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Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis
Yaseen M Arabi1, Fahad Al-Hameed1, Karen E A Burns1
1From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.
Background:
Whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis would result in a lower incidence of deep-vein thrombosis than pharmacologic thromboprophylaxis alone is uncertain.
Methods:
We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group). The primary outcome was incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first.
Results:
A total of 2003 patients underwent randomization - 991 were assigned to the pneumatic compression group and 1012 to the control group. Intermittent pneumatic compression was applied for a median of 22 hours (interquartile range, 21 to 23) daily for a median of 7 days (interquartile range, 4 to 13). The primary outcome occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P = 0.74). Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13).
Conclusions:
Among critically ill patients who were receiving pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression did not result in a significantly lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone. (Funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center; PREVENT ClinicalTrials.gov number, NCT02040103; Current Controlled Trials number, ISRCTN44653506.).
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