the Prevention of Clot in Orthopaedic Trauma (PREVENT CLOT) trial
정형외과적 외상(orthopedic trauma) 후에 정맥혈전색전증(venous thromboembolism)은 잘 알려진 치명적인 합병증이다.
수 많은 임상 지침에서 정형외과적 외상 후 정맥혈전색전증 예방을 위해 치료를 권장한다.
- Falck-Ytter Y, Francis CW, Johanson NA, et al. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:Suppl:e278S-e325S.
- Sagi HC, Ahn J, Ciesla D, et al. Venous thromboembolism prophylaxis in orthopedic trauma patients: a survey of OTA member practice patterns and OTA expert panel recommendations. J Orthop Trauma 2015;29(10):e355-e362.
- Rogers FB, Cipolle MD, Velmahos G, Rozycki G, Luchette FA. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma 2002;53:142-164.
- Guyatt GH, Akl EA, Crowther M, Gutterman DD, Schuünemann HJ. Executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012;141:Suppl:7S-47S.
최근의 trial과 메타 분석의 결과는 total joint arthroplasty을 받은 환자에서 아스피린이 보다 유리한 안전성 프로파일을 가지고 저분자 헤파린에 대한 효과적인 혈전 예방법의 대안이 될 수 있음을 시사한다.
- Anderson DR, Dunbar M, Murnaghan J, et al. Aspirin or rivaroxaban for VTE prophylaxis after hip or knee arthroplasty. N Engl J Med 2018;378:699-707.
- Anderson DR, Dunbar MJ, Bohm ER, et al. Aspirin versus low-molecular-weight heparin for extended venous thromboembolism prophylaxis after total hip arthroplasty: a randomized trial. Ann Intern Med 2013;158:800-806.
- Prevention of pulmonary embolism and deep vein thrombosis with low dose aspirin: Pulmonary Embolism Prevention (PEP) trial. Lancet 2000;355:1295-1302.
- Drescher FS, Sirovich BE, Lee A, Morrison DH, Chiang WH, Larson RJ. Aspirin versus anticoagulation for prevention of venous thromboembolism major lower extremity orthopedic surgery: a systematic review and meta-analysis. J Hosp Med 2014;9:579-585.
하지만 수술적으로 치료된 골절 환자에서 head to head를 비교한 증거는 제한적이다. 골절 환자에서 aspirin은 LMWH에 비해 낮은 비용과 경구 투여가 가능한 점을 고려할 때 혈전 예방 요법으로서 매력적이다.
the Prevention of Clot in Orthopaedic Trauma PREVENT CLOT) trial
👉 This pragmatic, randomized trial was designed from the perspective of a hospital thromboprophylaxis policy and aimed to assess whether aspirin would be noninferior to low-molecular-weight heparin with regard to throm-boembolic outcomes in patients with orthopedic trauma.
Randomization and Interventions
Patients were randomly assigned in a 1:1 ratio to receive aspirin or low-molecular-weight heparin for thromboprophylaxis.
LMWH: Patients in the low-molecular-weight–heparin group received subcutaneous enoxaparin at a pre-determined dose of 30 mg twice daily. Adjusted dose levels were permitted for patients with obesity or renal disease or as the result of other medical indications according to the protocols at each site.
Aspirin: Patients in the aspirin group received aspirin at a dose of 81 mg twice daily to balance the probability of adherence to a twice-daily intervention.
치료기간: The duration of thromboprophylaxis could end at hospital discharge or continue on the basis of the clinical protocols of each hospital, given the lack of consensus on the appropriate duration of treatment.
결과
We found that thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin for the prevention of death from any cause in patients with a pelvic or acetabular fracture treated with or without surgery or a fracture of the extremities treated operatively.
여러가지 한계에도 불구하고, 이번 연구 결과는 임상적으로 의미가 있다. 정형외과적 외상 환자들은 저분자량 헤파린보다 아스피린을 강하게 선호하는데, 이는 아스피린의 비용이 낮고 아스피린의 투여가 덜 부담스럽기 때문이다.(PO vs SC)
우리는 아스피린을 사용한 혈전증 예방이 정형외과 외상 환자의 치명적인 사건을 예방하기 위해 저분자량의 헤파린에 뒤지지 않는다는 것을 발견했고, 90일 이후 any cause - DVT, PE, 사망의 낮은 빈도와 관련이 있다는 것을 발견했다. 이 발견은 폐색전증과 치명적이지 않은 폐색전증과 관련된 사망 결과에서 일치했다. 또한, 우리는 실험 모집단에서 아스피린 혈전증 예방과 관련된 추가적인 안전 위험(safey risk)의 증거를 발견하지 못했다.
reference:
1) Major Extremity Trauma Research Consortium (METRC). "Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis after a Fracture." New England Journal of Medicine 388.3 (2023): 203-213.
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