Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients

A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study

Rajesh Malhotra, Sushrut Babhulkar, Kumar Behera Sanjib, Andreas Clemens, Akhil Dadi, Rajagopalan Iyer, Surendra Kamath, Bharat Mody, Satish Mutha, Gurava Reddy, Vikram Shah, Vrajesh Shah, Naresh Shetty, Sachin Tapasvi, Manuj Wadhwa

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)145-151
Number of pages7
JournalAsian Journal of Surgery
Volume40
Issue number2
DOIs
Publication statusPublished - 01-04-2017
Externally publishedYes

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Venous Thromboembolism
Arthroplasty
Enoxaparin
Hip
Mortality
Safety
Dabigatran
Double-Blind Method
Population
Compliance
Odds Ratio
Placebos
Outcome Assessment (Health Care)
Confidence Intervals
Hemorrhage
Incidence
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Surgery

Cite this

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. / Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients : A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study. In: Asian Journal of Surgery. 2017 ; Vol. 40, No. 2. pp. 145-151.
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title = "Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients: A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study",
abstract = "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.",
author = "Rajesh Malhotra and Sushrut Babhulkar and Sanjib, {Kumar Behera} and Andreas Clemens and Akhil Dadi and Rajagopalan Iyer and Surendra Kamath and Bharat Mody and Satish Mutha and Gurava Reddy and Vikram Shah and Vrajesh Shah and Naresh Shetty and Sachin Tapasvi and Manuj Wadhwa",
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Malhotra, R, Babhulkar, S, Sanjib, KB, Clemens, A, Dadi, A, Iyer, R, Kamath, S, Mody, B, Mutha, S, Reddy, G, Shah, V, Shah, V, Shetty, N, Tapasvi, S & Wadhwa, M 2017, 'Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients: A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study', Asian Journal of Surgery, vol. 40, no. 2, pp. 145-151. https://doi.org/10.1016/j.asjsur.2015.10.007

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

In: Asian Journal of Surgery, Vol. 40, No. 2, 01.04.2017, p. 145-151.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Thromboprophylaxis with dabigatran after total hip arthroplasty in Indian patients

T2 - A subanalysis of a double-blind, double-dummy, randomized RE-NOVATE II study

AU - Malhotra, Rajesh

AU - Babhulkar, Sushrut

AU - Sanjib, Kumar Behera

AU - Clemens, Andreas

AU - Dadi, Akhil

AU - Iyer, Rajagopalan

AU - Kamath, Surendra

AU - Mody, Bharat

AU - Mutha, Satish

AU - Reddy, Gurava

AU - Shah, Vikram

AU - Shah, Vrajesh

AU - Shetty, Naresh

AU - Tapasvi, Sachin

AU - Wadhwa, Manuj

PY - 2017/4/1

Y1 - 2017/4/1

N2 - 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.

AB - 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.

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DO - 10.1016/j.asjsur.2015.10.007

M3 - Article

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EP - 151

JO - Asian Journal of Surgery

JF - Asian Journal of Surgery

SN - 1015-9584

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