An indirect comparison, via enoxaparin, of rivaroxaban with dabigatran in the prevention of venous thromboembolism after hip or knee replacement

Figures & data

Table 1.  Summary of clinical trials included in the analyses.

Study reference	Study intervention	Patient number/characteristics	Dose and duration of intervention	Primary endpoint(s)
THR studies
Eriksson et al. 20079 RECORD1	Rivaroxaban	4541 patients randomized. Mean age = 63.2 years, 45.5% male	10 mg, 6–8 hours postoperatively then daily for 35 days	Total VTE (composite of any DVT or non-fatal PE) and all-cause mortality
Eriksson et al. 200714 RE-NOVATE	Dabigatran	3494 patients. Mean age = 64 years, 43.7% male	150 mg or 220 mg with half dose 1–4 hours after surgery/full dose if day after surgery, followed by full dose daily for 28–35 days	Total VTE (composite of any DVT or symptomatic PE) and all-cause mortality
TKR studies
Lassen et al. 200811 RECORD3	Rivaroxaban	2531 patients randomized. Mean age = 67.6 years, 31.8% male	10 mg, 6–8 hours postoperatively then daily for 10–14 days	Total VTE (composite of any DVT or non-fatal PE) and all-cause mortality
Eriksson et al. 200713 RE-MODEL	Dabigatran	2076 patients. Mean age = 68 years, 34.0% male	150 or 220 mg with either half dose 1–4 hours after surgery/full dose if day after surgery, followed by full dose daily for 6–10 days	Total VTE (composite of any DVT or symptomatic PE) and all-cause mortality

DVT, deep vein thrombosis; PE, pulmonary embolism; THR, total hip replacement; TKR, total knee replacement; VTE, venous thromboembolism.

Table 2.  Indirect comparison of extended prophylaxis with rivaroxaban (10 mg od) versus extended prophylaxis with dabigatran (220 mg od) in total hip replacement.

Events	RECORD1		RE-NOVATE		Indirect comparison RR (95% CI)
	Rivaroxaban	Enoxaparin	Enoxaparin	Dabigatran
Total VTE*†	1.1 (0.7–1.8)	3.7 (2.8–4.8)	6.7 (5.1–8.3)	6.0 (4.5–7.6)	0.34 (0.18–0.64)
	18/1595	58/1558	60/897	53/880
RR (95% CI)	0.30 (0.18–0.51)		0.90 (0.63–1.29)
Symptomatic VTE‡$	0.3 (0.1–0.7)	0.7 (0.4–1.1)	0.4 (0.1–1.0)	1.1 (0.5–1.8)	0.19 (0.05–0.77)
	7/2193	15/2206	5/1142	12/1137
RR (95% CI)	0.47 (0.19–1.15)		2.41 (0.85–6.82)
Major bleeding including surgical site¶	1.8 (1.3–2.5)	1.5 (1.0–2.1)	1.6 (0.9–2.5)	2.0 (1.3–3.0)	0.95 (0.44–2.03)
	40/2209	33/2224	18/1154	23/1146
RR (95% CI)	1.22 (0.77–1.93)		1.29 (0.70–2.37)

Indirect comparison shows RR for rivaroxaban vs dabigatran. For differences that are statistically significant, the 95% CI for the RR excludes 1.0.

CI, confidence interval; mITT: modified intention-to-treat; od, once daily; RR, relative risk against enoxaparin; VTE, venous thromboembolism.

*Results shown as percent incidence (95% CI), number of patients with event/number of patients over the treatment duration period/number of patients.

†mITT population, evaluable for primary efficacy outcome.

‡Results shown as percent incidence (95% CI), number of patients with event/number of patients over the total study duration, including follow up/number of patients.

$Safety population who underwent surgery.

¶Safety population.

Table 3.  Indirect comparison of short-term prophylaxis with rivaroxaban (10 mg od) versus short-term prophylaxis with dabigatran (220 mg od) in total knee replacement.

Events	RECORD3		RE-MODEL		Indirect comparison RR (95% CI)
	Rivaroxaban	Enoxaparin	Enoxaparin	Dabigatran
Total VTE*†	9.6 (7.7–11.8)	18.9 (16.4–21.7)	37.7 (33.5–41.9)	36.4 (32.2–40.6)	0.53(0.39–0.71)
	79/824	166/878	193/512	183/503
RR (95% CI)	0.51 (0.39–0.65)		0.97 (0.82–1.13)
Symptomatic VTE‡$	1.08 (0.6–1.8)	2.2 (1.5–3.2)	1.31	0.59	1.08 (0.28–4.15)
	13/1201	27/1217	9/685	4/675
RR (95% CI)	0.49 (0.25–0.94)		0.45 (0.14–1.46)
Major bleeding including surgical site¶	1.7 (1.1–2.6)	1.4 (0.8–2.2)	1.3 (0.6–2.4)	1.5 (0.7–2.7)	1.10 (0.37–3.31)
	21/1220	17/1239	9/694	10/679
RR (95% CI)	1.25 (0.67–2.37)		1.14 (0.46–2.78)

Indirect comparison shows RR for rivaroxaban vs dabigatran. For differences that are statistically significant, the 95% CI for the RR excludes 1.0.

*Results shown as percent incidence (95% CI), number of patients with event/number of patients over the treatment duration period/number of patients.

†mITT population.

‡Including follow-up period.

$Safety population who underwent surgery.

¶Safety population.

CI, confidence interval; od, once daily; RR, relative risk against enoxaparin; VTE, venous thromboembolism.

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