Current Literature

Article Examines Anti-Factor Xa Monitoring of Enoxaparin in Emergency General Surgery

Pokrzywa CJ, Biesboer EA, Figueroa J, et al. Anti-factor Xa Monitoring of Enoxaparin Thromboembolism Prophylaxis in Emergency General Surgery Patients. J Am Coll Surg. 2023, in press.

Postoperative venous thromboembolism (VTE) is an important cause of mortality and morbidity following general surgery procedures; the risk of VTE approaches 1% for elective general surgery patients, and available data show that this risk doubles for urgent and emergency operations.

Effective protection against VTE is provided by heparin prophylaxis, and studies have shown that the level of protection is increased when low molecular weight heparin (enoxaparin) is used. Monitoring of enoxaparin is not possible by direct measurement of drug levels but can be accomplished, indirectly, using serial assessments of anti-factor Xa. Agreement on the most effective monitoring protocol is a matter of debate, especially for patients undergoing urgent and emergent procedures.

This article reports results of a study of anti-factor Xa levels obtained during the early postoperative interval following an emergency general surgical procedure. 81 patients were included in the study. The data analysis showed that 87% of patients had anti-factor Xa levels below the desired level at the time of the first assessment and 82% remained low after dose adjustment. The authors concluded that carefully designed and tested monitoring protocols are needed to ensure adequate protection against VTE after urgent and emergent procedures.

Editorial

Ross SW. A Step in The Right Direction: Anti-factor Xa Monitoring of Enoxaparin in Emergency General Surgery. J Am Coll Surg. 2023, in press.

In the editorial that accompanied the article, Samuel W. Ross, MD, MPH, FACS, noted that the study results provided valuable information regarding the shortcomings of current monitoring efforts and highlighted the need for protocols supported by strong evidence. Dr. Ross stressed the facts that the study did not report rates of VTE, and that post-discharge monitoring data were not reported. Anti-factor Xa monitoring of enoxaparin has potential value but requires further study.

Database Analyses Show Similar Accuracy, Clinical Relevance to Randomized Clinical Trials

Wang SV, Schneeweiss S, Initiative R-D, et al. Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials. JAMA 2023;329(16):1376-85. doi: 10.1001/jama.2023.4221

Prospective, randomized trials are recognized as the best source of information to support clinical decision-making and the provision of safe, effective patient care. However, limitations of randomized studies, including a lack of similarity of study subjects with patients encountered in practice and restricted or sharply focused use of therapeutic interventions in study patients, often reduce the value of these data.

“Real-world data” that are also applicable to healthcare professionals’ daily practice may be obtained from carefully selected observational studies such as clinical database analyses. Shirley V. Wang, PhD, ScD, and coauthors reported a comparison of randomized trials and “real-world” database studies to determine whether observed outcomes were similar in the comparison groups. The two comparison groups consisted of 32 studies in each. The data analysis showed that when the characteristics of the study patients, the study interventions, and the chosen outcomes were well matched, the clinical guidance offered by the data from the database analyses was equivalent in accuracy and clinical relevance in nearly 90% of comparisons with data from randomized trials.

The authors concluded that real-world research studies can provide evidence of similar validity compared with randomized trials data when study design, measurements, and outcomes are closely matched.

Editorial

Sheldrick RC. Randomized Trials vs Real-World Evidence: How Can Both Inform Decision-Making? JAMA 2023;329(16):1352-53. doi: 10.1001/jama.2023.4855

In the editorial that accompanied the article, R. Christopher Sheldrick, PhD, noted that observational studies are not a substitute for randomized trials, but carefully matched comparisons can offer insights into the validity and clinical value of data from real-world observational studies.

Current Literature

Article Examines Anti-Factor Xa Monitoring of Enoxaparin in Emergency General Surgery

Database Analyses Show Similar Accuracy, Clinical Relevance to Randomized Clinical Trials

In This Issue

US COVID-19 Public Health Emergency Will End on May 11

Dr. Steven Stain, ACS Regent, Is the New ASA President

Hundreds of Surgeons Learned to Lead and Advocate at 2023 Summit

Submit Applications for Mentorship Program by May 12

View Webinar on Emergency Gastrointestinal Surgery in Resource-Constrained Settings

ACS 2023 Health Policy Scholars Are Announced

Foster a Supportive Mental Health Culture with Well-Being Resources

Enroll in ACS SSR Practice Improvement Initiative to Assess and Put Your Personal Data to Work

Check Out Webinar on Matching into Residency and Other Medical Student Resources

Apply for the ACS Gerald B. Healy, MD, FACS, Traveling Mentorship Fellowship

Surgeons Discuss Surgical Nursing Labor Costs, Sustainable Healthcare Finances