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NSAIDs and cardiovascular risk
Clinical question: Which NSAID confers the least cardiovascular risk?
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation by decreasing prostaglandin production through cyclo-oxygenase (COX) inhibition. However, the COX enzyme stimulates protective prostaglandins for the GI mucosa. The development of cyclo-oxygenase-2 (COX-2) inhibitors did reduce the gastrointestinal side effects of NSAIDs, but subsequent trials pointed to increased cardiovascular events and resulted in rofecoxib being removed from the market. Celecoxib remained on the market as the only COX-2 inhibitor, but the Food and Drug Administration required a cardiovascular safety trial.
Study design: Prospective randomized, double-blind noninferiority study.
Setting: International (926 centers in 13 countries).
Synopsis: The PRECISION trial enrolled 24,081 patients who required NSAIDs for arthritis pain and who either had established cardiovascular disease or an increased risk of CV disease. Patients were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day. Patients were allowed to continue taking low-dose aspirin (325 mg or less daily). The primary composite outcome was cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was major adverse CV events (the primary outcome plus coronary revascularization or hospitalization for unstable angina or transient ischemic attack) and significant gastrointestinal events.
The primary outcome occurred in 188 patients in the celecoxib group (2.3%), 201 in the naproxen group (2.5%), and 218 in the ibuprofen group (2.7%). Celecoxib, as compared with either naproxen or ibuprofen, met all four prespecified noninferiority requirements (P less than .01 for noninferiority in both comparisons. Ibuprofen, as compared with naproxen, just met the noninferiority criteria (P = .025).
Bottom line: The PRECISION trial provides statistically strong evidence that the cardiovascular risk associated with moderate doses of celecoxib is not greater than that associated with nonselective NSAIDs (ibuprofen and naproxen).
Citations: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.” N Engl J M. 2016;375(26):2519-2529.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: Which NSAID confers the least cardiovascular risk?
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation by decreasing prostaglandin production through cyclo-oxygenase (COX) inhibition. However, the COX enzyme stimulates protective prostaglandins for the GI mucosa. The development of cyclo-oxygenase-2 (COX-2) inhibitors did reduce the gastrointestinal side effects of NSAIDs, but subsequent trials pointed to increased cardiovascular events and resulted in rofecoxib being removed from the market. Celecoxib remained on the market as the only COX-2 inhibitor, but the Food and Drug Administration required a cardiovascular safety trial.
Study design: Prospective randomized, double-blind noninferiority study.
Setting: International (926 centers in 13 countries).
Synopsis: The PRECISION trial enrolled 24,081 patients who required NSAIDs for arthritis pain and who either had established cardiovascular disease or an increased risk of CV disease. Patients were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day. Patients were allowed to continue taking low-dose aspirin (325 mg or less daily). The primary composite outcome was cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was major adverse CV events (the primary outcome plus coronary revascularization or hospitalization for unstable angina or transient ischemic attack) and significant gastrointestinal events.
The primary outcome occurred in 188 patients in the celecoxib group (2.3%), 201 in the naproxen group (2.5%), and 218 in the ibuprofen group (2.7%). Celecoxib, as compared with either naproxen or ibuprofen, met all four prespecified noninferiority requirements (P less than .01 for noninferiority in both comparisons. Ibuprofen, as compared with naproxen, just met the noninferiority criteria (P = .025).
Bottom line: The PRECISION trial provides statistically strong evidence that the cardiovascular risk associated with moderate doses of celecoxib is not greater than that associated with nonselective NSAIDs (ibuprofen and naproxen).
Citations: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.” N Engl J M. 2016;375(26):2519-2529.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: Which NSAID confers the least cardiovascular risk?
Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) reduce pain and inflammation by decreasing prostaglandin production through cyclo-oxygenase (COX) inhibition. However, the COX enzyme stimulates protective prostaglandins for the GI mucosa. The development of cyclo-oxygenase-2 (COX-2) inhibitors did reduce the gastrointestinal side effects of NSAIDs, but subsequent trials pointed to increased cardiovascular events and resulted in rofecoxib being removed from the market. Celecoxib remained on the market as the only COX-2 inhibitor, but the Food and Drug Administration required a cardiovascular safety trial.
Study design: Prospective randomized, double-blind noninferiority study.
Setting: International (926 centers in 13 countries).
Synopsis: The PRECISION trial enrolled 24,081 patients who required NSAIDs for arthritis pain and who either had established cardiovascular disease or an increased risk of CV disease. Patients were randomized to celecoxib 100 mg twice a day, ibuprofen 600 mg three times a day, or naproxen 375 mg twice a day. Patients were allowed to continue taking low-dose aspirin (325 mg or less daily). The primary composite outcome was cardiovascular death (including hemorrhagic death), nonfatal myocardial infarction, or nonfatal stroke. A secondary composite outcome was major adverse CV events (the primary outcome plus coronary revascularization or hospitalization for unstable angina or transient ischemic attack) and significant gastrointestinal events.
The primary outcome occurred in 188 patients in the celecoxib group (2.3%), 201 in the naproxen group (2.5%), and 218 in the ibuprofen group (2.7%). Celecoxib, as compared with either naproxen or ibuprofen, met all four prespecified noninferiority requirements (P less than .01 for noninferiority in both comparisons. Ibuprofen, as compared with naproxen, just met the noninferiority criteria (P = .025).
Bottom line: The PRECISION trial provides statistically strong evidence that the cardiovascular risk associated with moderate doses of celecoxib is not greater than that associated with nonselective NSAIDs (ibuprofen and naproxen).
Citations: Nissen SE, Yeomans ND, Solomon DH, et al. Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis.” N Engl J M. 2016;375(26):2519-2529.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Palliative care: a systematic review for patients and their caregivers
Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?
Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.
Study design: Systematic review and meta-analysis of 43 randomized controlled trials.
Setting: Not applicable
Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30). 
When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06-0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was no longer statistically significant (standardized mean difference, −0.21; 95% CI, −0.42-0.00; ESAS mean difference, −3.28). Caregiver outcomes were mixed but with limited quality of evidence.
Bottom line: Although there was no significant association between palliative care and survival, palliative interventions were associated with improved patient QOL, patient and caregiver satisfaction, lower health care utilization, and symptom burden.
Citations: Kavalieratos D, Corbelli J, Zhang D, et al. Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA. 2016;316(20):2104-2114. doi: 10.1001/jama.2016.16840
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?
Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.
Study design: Systematic review and meta-analysis of 43 randomized controlled trials.
Setting: Not applicable
Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).
When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06-0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was no longer statistically significant (standardized mean difference, −0.21; 95% CI, −0.42-0.00; ESAS mean difference, −3.28). Caregiver outcomes were mixed but with limited quality of evidence.
Bottom line: Although there was no significant association between palliative care and survival, palliative interventions were associated with improved patient QOL, patient and caregiver satisfaction, lower health care utilization, and symptom burden.
Citations: Kavalieratos D, Corbelli J, Zhang D, et al. Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA. 2016;316(20):2104-2114. doi: 10.1001/jama.2016.16840
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?
Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.
Study design: Systematic review and meta-analysis of 43 randomized controlled trials.
Setting: Not applicable
Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).
When analyses were limited to trials at low risk of bias (n = 5), the association between palliative care and QOL was attenuated but remained statistically significant (standardized mean difference, 0.20; 95% CI, 0.06-0.34; FACIT-Pal mean difference, 4.94), whereas the association with symptom burden was no longer statistically significant (standardized mean difference, −0.21; 95% CI, −0.42-0.00; ESAS mean difference, −3.28). Caregiver outcomes were mixed but with limited quality of evidence.
Bottom line: Although there was no significant association between palliative care and survival, palliative interventions were associated with improved patient QOL, patient and caregiver satisfaction, lower health care utilization, and symptom burden.
Citations: Kavalieratos D, Corbelli J, Zhang D, et al. Association between palliative care and patient and caregiver outcomes: A systematic review and meta-analysis. JAMA. 2016;316(20):2104-2114. doi: 10.1001/jama.2016.16840
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
The cost of misdiagnosing cellulitis
Clinical question: What are the national health care costs of misdiagnosing cellulitis?
Background: Lower extremity cellulitis is primarily a clinical diagnosis but many mimickers such as venous stasis, lymphedema, gout, deep venous thrombosis, and contact dermatitis can lead to a misdiagnosis rate of 30%-90%. Between 14% and 17% of emergency department patients with cellulitis are admitted, accounting for 10% of all infectious disease-related hospitalizations. Overdiagnosis leads to antibiotic misuse and increased hospital utilization.
Study design: Retrospective cross-sectional study.
Setting: Emergency department of Massachusetts General Hospital.
Synopsis: Among 259 ED patients identified from all screened (840 patients total) from June 2010 to December 2012, 79 (30.5%) were incorrectly diagnosed with lower extremity cellulitis and 52 of these misdiagnosed patients were admitted primarily for their cellulitis, resulting in 92.3% of this group receiving unnecessary antibiotics and 84.6% unnecessarily hospitalized.
The authors used cost estimates and previously published data from the Medical Expenditure Panel Survey (MEPS) provided by the Agency for Healthcare Research and Quality (AHRQ) 2010 to project that cellulitis misdiagnosis leads to 50,000-130,000 unnecessary hospitalizations and $195-$515 million in avoidable health care expense annually. The estimates include over 44,000 pseudocellulitis patients being exposed to antibiotics annually with an associated 13% readmission rate and medication complications such as rash and gastrointestinal side effects and implications for resistance selection and antimicrobial stewardship efforts. Nationally, the unnecessary antibiotics and hospitalization associated with misdiagnosis were estimated to cause more than 9,000 nosocomial infections, 1,000 to 5,000 Clostridium difficile infections, and two to six cases of anaphylaxis annually.
Bottom line: Misdiagnosis of lower extremity cellulitis is common and leads to unnecessary patient exposures (antibiotics, hospitalization) and excessive health care spending.
Citations: Weng QY, Raff AB, Cohen JM, et al. Costs and consequences associated with misdiagnosed lower extremity cellulitis. JAMA Dermatol. 2016; doi: 10.1001/jamadermatol.2016.3816.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What are the national health care costs of misdiagnosing cellulitis?
Background: Lower extremity cellulitis is primarily a clinical diagnosis but many mimickers such as venous stasis, lymphedema, gout, deep venous thrombosis, and contact dermatitis can lead to a misdiagnosis rate of 30%-90%. Between 14% and 17% of emergency department patients with cellulitis are admitted, accounting for 10% of all infectious disease-related hospitalizations. Overdiagnosis leads to antibiotic misuse and increased hospital utilization.
Study design: Retrospective cross-sectional study.
Setting: Emergency department of Massachusetts General Hospital.
Synopsis: Among 259 ED patients identified from all screened (840 patients total) from June 2010 to December 2012, 79 (30.5%) were incorrectly diagnosed with lower extremity cellulitis and 52 of these misdiagnosed patients were admitted primarily for their cellulitis, resulting in 92.3% of this group receiving unnecessary antibiotics and 84.6% unnecessarily hospitalized.
The authors used cost estimates and previously published data from the Medical Expenditure Panel Survey (MEPS) provided by the Agency for Healthcare Research and Quality (AHRQ) 2010 to project that cellulitis misdiagnosis leads to 50,000-130,000 unnecessary hospitalizations and $195-$515 million in avoidable health care expense annually. The estimates include over 44,000 pseudocellulitis patients being exposed to antibiotics annually with an associated 13% readmission rate and medication complications such as rash and gastrointestinal side effects and implications for resistance selection and antimicrobial stewardship efforts. Nationally, the unnecessary antibiotics and hospitalization associated with misdiagnosis were estimated to cause more than 9,000 nosocomial infections, 1,000 to 5,000 Clostridium difficile infections, and two to six cases of anaphylaxis annually.
Bottom line: Misdiagnosis of lower extremity cellulitis is common and leads to unnecessary patient exposures (antibiotics, hospitalization) and excessive health care spending.
Citations: Weng QY, Raff AB, Cohen JM, et al. Costs and consequences associated with misdiagnosed lower extremity cellulitis. JAMA Dermatol. 2016; doi: 10.1001/jamadermatol.2016.3816.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: What are the national health care costs of misdiagnosing cellulitis?
Background: Lower extremity cellulitis is primarily a clinical diagnosis but many mimickers such as venous stasis, lymphedema, gout, deep venous thrombosis, and contact dermatitis can lead to a misdiagnosis rate of 30%-90%. Between 14% and 17% of emergency department patients with cellulitis are admitted, accounting for 10% of all infectious disease-related hospitalizations. Overdiagnosis leads to antibiotic misuse and increased hospital utilization.
Study design: Retrospective cross-sectional study.
Setting: Emergency department of Massachusetts General Hospital.
Synopsis: Among 259 ED patients identified from all screened (840 patients total) from June 2010 to December 2012, 79 (30.5%) were incorrectly diagnosed with lower extremity cellulitis and 52 of these misdiagnosed patients were admitted primarily for their cellulitis, resulting in 92.3% of this group receiving unnecessary antibiotics and 84.6% unnecessarily hospitalized.
The authors used cost estimates and previously published data from the Medical Expenditure Panel Survey (MEPS) provided by the Agency for Healthcare Research and Quality (AHRQ) 2010 to project that cellulitis misdiagnosis leads to 50,000-130,000 unnecessary hospitalizations and $195-$515 million in avoidable health care expense annually. The estimates include over 44,000 pseudocellulitis patients being exposed to antibiotics annually with an associated 13% readmission rate and medication complications such as rash and gastrointestinal side effects and implications for resistance selection and antimicrobial stewardship efforts. Nationally, the unnecessary antibiotics and hospitalization associated with misdiagnosis were estimated to cause more than 9,000 nosocomial infections, 1,000 to 5,000 Clostridium difficile infections, and two to six cases of anaphylaxis annually.
Bottom line: Misdiagnosis of lower extremity cellulitis is common and leads to unnecessary patient exposures (antibiotics, hospitalization) and excessive health care spending.
Citations: Weng QY, Raff AB, Cohen JM, et al. Costs and consequences associated with misdiagnosed lower extremity cellulitis. JAMA Dermatol. 2016; doi: 10.1001/jamadermatol.2016.3816.
Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
DVT prophylaxis not needed after casting
Clinical question: Is DVT prophylaxis necessary with lower leg casting or after knee arthroscopy?
Background: Patients who undergo immobilization from casting or knee arthroscopic surgery are thought to be at increased risk for venous thromboembolism (VTE). Most patients who undergo orthopedic procedures receive thromboprophylaxis but controversy exists surrounding its use in low limb casting or knee arthroscopic surgery. Prior studies did not establish consensus because of methodologic weaknesses.
Study design: Two parallel randomized-controlled, open-label trials with blinded outcome (POD-KAST for knee arthroscopy and POD-CAST for casting lower leg.
Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).
Synopsis: Patients were randomly assigned to receive either a prophylactic dose of low-molecular-weight heparin (either for the 8 days after arthroscopy or for the duration of casting-related immobilization) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism (VTE) and major bleeding within 3 months after the procedure. For the 1,543 patients undergoing knee arthroscopy, VTE occurred in 0.7% of the treatment group and 0.4% of the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4-6.8; absolute difference in risk, 0.3 percentage points; 95% CI, −0.6 to 1.2) and major bleeding was seen in 0.1% of both groups.
For the 1,519 patients undergoing knee arthroscopy, VTE occurred in 1.4% of the treatment group and 1.8% of the control group (relative risk, 0.8; 95% CI, 0.3-1.7; absolute difference in risk, −0.4 percentage points; 95% CI, −1.8 to 1.0) and no episodes of major bleeding were reported in either group.
Bottom line: VTE prophylaxis either after arthroscopy or during immobilization from casting did not prevent DVT.
Citations: Van Adrichem RA, Nemeth B, Algra A, et al. Thromboprophylaxis after knee arthroscopy and low-leg casting. N Engl J Med. 2016 Dec 3. doi: 10.1056/NEJMoa1613303.
Dr. Cerceo is assistant professor in the division of hospital medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: Is DVT prophylaxis necessary with lower leg casting or after knee arthroscopy?
Background: Patients who undergo immobilization from casting or knee arthroscopic surgery are thought to be at increased risk for venous thromboembolism (VTE). Most patients who undergo orthopedic procedures receive thromboprophylaxis but controversy exists surrounding its use in low limb casting or knee arthroscopic surgery. Prior studies did not establish consensus because of methodologic weaknesses.
Study design: Two parallel randomized-controlled, open-label trials with blinded outcome (POD-KAST for knee arthroscopy and POD-CAST for casting lower leg.
Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).
Synopsis: Patients were randomly assigned to receive either a prophylactic dose of low-molecular-weight heparin (either for the 8 days after arthroscopy or for the duration of casting-related immobilization) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism (VTE) and major bleeding within 3 months after the procedure. For the 1,543 patients undergoing knee arthroscopy, VTE occurred in 0.7% of the treatment group and 0.4% of the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4-6.8; absolute difference in risk, 0.3 percentage points; 95% CI, −0.6 to 1.2) and major bleeding was seen in 0.1% of both groups.
For the 1,519 patients undergoing knee arthroscopy, VTE occurred in 1.4% of the treatment group and 1.8% of the control group (relative risk, 0.8; 95% CI, 0.3-1.7; absolute difference in risk, −0.4 percentage points; 95% CI, −1.8 to 1.0) and no episodes of major bleeding were reported in either group.
Bottom line: VTE prophylaxis either after arthroscopy or during immobilization from casting did not prevent DVT.
Citations: Van Adrichem RA, Nemeth B, Algra A, et al. Thromboprophylaxis after knee arthroscopy and low-leg casting. N Engl J Med. 2016 Dec 3. doi: 10.1056/NEJMoa1613303.
Dr. Cerceo is assistant professor in the division of hospital medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.
Clinical question: Is DVT prophylaxis necessary with lower leg casting or after knee arthroscopy?
Background: Patients who undergo immobilization from casting or knee arthroscopic surgery are thought to be at increased risk for venous thromboembolism (VTE). Most patients who undergo orthopedic procedures receive thromboprophylaxis but controversy exists surrounding its use in low limb casting or knee arthroscopic surgery. Prior studies did not establish consensus because of methodologic weaknesses.
Study design: Two parallel randomized-controlled, open-label trials with blinded outcome (POD-KAST for knee arthroscopy and POD-CAST for casting lower leg.
Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).
Synopsis: Patients were randomly assigned to receive either a prophylactic dose of low-molecular-weight heparin (either for the 8 days after arthroscopy or for the duration of casting-related immobilization) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism (VTE) and major bleeding within 3 months after the procedure. For the 1,543 patients undergoing knee arthroscopy, VTE occurred in 0.7% of the treatment group and 0.4% of the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4-6.8; absolute difference in risk, 0.3 percentage points; 95% CI, −0.6 to 1.2) and major bleeding was seen in 0.1% of both groups.
For the 1,519 patients undergoing knee arthroscopy, VTE occurred in 1.4% of the treatment group and 1.8% of the control group (relative risk, 0.8; 95% CI, 0.3-1.7; absolute difference in risk, −0.4 percentage points; 95% CI, −1.8 to 1.0) and no episodes of major bleeding were reported in either group.
Bottom line: VTE prophylaxis either after arthroscopy or during immobilization from casting did not prevent DVT.
Citations: Van Adrichem RA, Nemeth B, Algra A, et al. Thromboprophylaxis after knee arthroscopy and low-leg casting. N Engl J Med. 2016 Dec 3. doi: 10.1056/NEJMoa1613303.
Dr. Cerceo is assistant professor in the division of hospital medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.