Dabigatran versus Enoxaparin in the prevention of venous thromboembolism after total knee arthroplasty: A randomized clinical trial

سال انتشار: 1393
نوع سند: مقاله ژورنالی
زبان: انگلیسی
مشاهده: 99

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شناسه ملی سند علمی:

JR_RYA-10-6_002

تاریخ نمایه سازی: 2 شهریور 1401

چکیده مقاله:

BACKGROUND: Venous thromboembolism (VTE) and deep vein thrombophlebitis (DVT) is a serious problem with high mortality and morbidity rates. This study was conducted to compare efficacy and safety results of the two types of VTE preventing in patients underwent total knee arthroplasty (TKA). METHODS: Having considered exclusion criteria, ۹۰ patients of ۱۳۶ ones were registered in the study. Our patients of TKA were split randomly in two groups. Totally, ۴۵ patients received enoxaparin, ۴۰ mg ۱۲ h before surgery and treated by ۴۰ mg daily up to ۱۵ days. The second group (۴۵ patients) were treated by dabigatran ۱۵۰ mg ۴ h after surgery and ۲۲۵ mg daily up to ۱۵ days. Efficacy was evaluated by Doppler sonography after ۱۵ days for the presence of DVT and safety was determined by ۳ months follow-up for all-cause mortality and any major or minor bleedings. RESULTS: Two groups were similar in baseline characteristics. The efficacy outcome events occurred in ۲.۲% (۲ of ۹۰) of the patients (۱ symptomatic VTE in dabigatran and ۱ in the enoxaparin group) without significant statistical difference between groups (P = ۰.۶۴). In terms of safety, ۳ patients (۶.۶%) in dabigatran and ۲ patients (۴.۴%) in enoxaparin group had major bleeding (P = ۰.۶۶) and ۸ patients (۱۷.۷%) in dabigatran and ۷ patients (۱۵.۷%) in enoxaparin group had non-major bleeding event (P = ۰.۸۱). There were no death, pulmonary emboli, and cardiac events during follow-up. CONCLUSION: Three months follow-up did not show statistical difference in efficacy and safety between dabigatran and enoxaparin. Future studies with mentioning to later outcomes for checking safety are warranted. 

نویسندگان

Ahmad Mirdamadi

Assistant Professor, Cardiologist, Fellowship of Echocardiography, School of Medicine, Islamic Azad University, Najafabad Branch, Isfahan, Iran

Solmaz Dashtkar

General Practitioner, Islamic Azad University, Najafabad Branch, Isfahan, Iran

Mahboobeh Kaji

Radiologist, Iranian Social Security Organization, Shariati Hospital, Isfahan, Iran

Farzad Pazhang

Orthopedic Surgeon, Iranian Social Security Organization, Shariati Hospital, Isfahan, Iran

Behnam Haghpanah

Orthopedic Surgeon, Iranian Social Security Organization, Shariati Hospital, Isfahan, Iran

Mojgan Gharipour

PhD Candidate, Isfahan Cardiovascular Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran