Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients: A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study

• Published in: Asian journal of surgery Vol. 40; no. 2; pp. 145 - 151
• Main Authors: Malhotra, Rajesh, Babhulkar, Sushrut, Sanjib, Kumar Behera, Clemens, Andreas, Dadi, Akhil, Iyer, Rajagopalan, Kamath, Surendra, Mody, Bharat, Mutha, Satish, Reddy, Gurava, Shah, Vikram, Shah, Vrajesh, Shetty, Naresh, Tapasvi, Sachin, Wadhwa, Manuj
• Format: Journal Article
• Language: English
• Published: China Elsevier Taiwan 01.03.2017; Elsevier
• Subjects: Administration, Oral; Aged; Arthroplasty, Replacement, Hip - adverse effects; Arthroplasty, Replacement, Hip - methods; Confidence Intervals; Dabigatran - administration & dosage; dabigatran etexilate; Double-Blind Method; enoxaparin; Enoxaparin - administration & dosage; Female; Follow-Up Studies; Humans; Incidence; India; Injections, Subcutaneous; Male; Middle Aged; Odds Ratio; Postoperative Complications - physiopathology; Postoperative Complications - prevention & control; Primary Prevention - methods; Prospective Studies; Risk Assessment; Surgery; total hip arthroplasty; Treatment Outcome; venous thromboembolism; Venous Thromboembolism - epidemiology; Venous Thromboembolism - prevention & control; dabigatran etexilate; total hip arthroplasty; enoxaparin; venous thromboembolism
• ISSN: 1015-9584; 0219-3108
• DOI: 10.1016/j.asjsur.2015.10.007

Summary Objective In the Re-NOVATE II study, oral dabigatran provided thromboprophylaxis after total hip arthroplasty and improved compliance postdischarge in a global population. This article aims to identify trends (if any) in the Indian population. Methods In this prospective, double-blind, double-dummy study, patients scheduled for primary, unilateral, elective total hip arthroplasty were randomized to 220 mg oral dabigatran once daily, starting with a 110 mg half-dose, 1–4 hours after surgery, or subcutaneous enoxaparin 40 mg once daily, starting the evening before surgery. Each group received a placebo of the other study drug. The primary efficacy outcome was the composite of total venous thromboembolism (VTE) and all-cause mortality. Secondary outcome measures were composite of major VTE and VTE-related mortality during the treatment period. The major safety outcome was incidence of bleeding events. Results Of the 179 Indian patients randomized, 91 received oral dabigatran and 88 received subcutaneous enoxaparin for 28–35 days. Total VTE and all-cause mortality occurred in 18.7% of patients in the dabigatran group and 13.7% in the enoxaparin group [odds ratio = 1.4 (95% confidence interval 0.6, 3.5)]. Major VTE and VTE-related mortality was numerically lower in the dabigatran group (7.9%) compared with the enoxaparin group (9.9%). Safety outcomes were comparable between both groups. Conclusion Dabigatran is an effective oral alternative to enoxaparin for thromboprophylaxis as demonstrated by the RE-NOVATE II study global results. Data analyzed in Indian patients indicate comparable effects of dabigatran etexilate for major efficacy and safety outcomes.