Efficacy and Safety of Rivaroxaban and Enoxaparin for Thromboprophylaxis Among Total Hip Arthroplasty Patients: A Systematic Review and Meta-Analysis

Abstract

Background Venous thromboembolism (VTE) is one of the major and potentially life-threatening complications following major orthopedic surgeries. Research evidence comparing the effectiveness of rivaroxaban and enoxaparin for thromboprophylaxis specific to total hip arthroplasty (THA) has been limited. Hence, this review was done to compare the efficacy and safety of rivaroxaban against enoxaparin for thromboprophylaxis after THA.

Materials and Methods We conducted a search in databases including Medline, EMBASE, ScienceDirect, Google Scholar, and Cochrane Library from inception until May 2021. Randomized controlled trials directly comparing the effectiveness of rivaroxaban and enoxaparin for thromboprophylaxis among patients undergoing THA were eligible for inclusion. Outcome parameters assessed were efficacy in terms of total VTE and all-cause mortality, major VTE, deep vein thrombosis, symptomatic VTE, and safety in terms of major bleeding events, clinically relevant nonmajor bleeding events, minor bleeding events, total bleeding events, drug-related adverse events, and wound infection. We performed a meta-analysis with a random effects model and reported a pooled risk ratio (RR) with a 95% confidence interval (CI).

Results Eleven studies, including 9057 participants, were analyzed. Amongst efficacy outcomes, VTE and all-cause mortality pooled an RR of 0.58 (95% CI: 0.34–0.99), major VTE pooled an RR of 0.37 (95% CI: 0.15–0.90), deep vein thrombosis pooled an RR of 0.57 (95% CI: 0.32–1.02), and symptomatic VTE pooled an RR of 0.51 (95% CI: 0.30–0.87). Amongst safety outcomes, major bleeding events pooled an RR of 1.18 (95% CI: 0.77–1.80), total bleeding events pooled an RR of 1.12 (95% CI: 0.93–1.34), drug-related adverse event pooled an RR of 0.99 (95% CI: 0.87–1.12), and wound infection pooled an RR of 1.11 (95% CI: 0.58–2.14).

Conclusion Rivaroxaban is a more efficacious drug in terms of VTE and all-cause mortality compared to enoxaparin following THA, and rivaroxaban was non-inferior in terms of safety profiles such as wound infection, bleeding, and drug-related adverse events.

Zusammenfassung

Hintergrund Venöse Thromboembolien (VTE) sind eine der wichtigsten und potenziell lebensbedrohlichen Komplikationen nach größeren orthopädischen Eingriffen. Die Forschungsergebnisse zum Vergleich der Wirksamkeit von Rivaroxaban und Enoxaparin für die Thromboseprophylaxe bei Hüftgelenkersatzoperationen (HTEP) waren bisher begrenzt. Daher wurde diese Übersichtsarbeit durchgeführt, um die Wirksamkeit und Sicherheit von Rivaroxaban und Enoxaparin bei der Thromboseprophylaxe nach HTEP zu vergleichen.

Materialien und Methoden Wir führten eine Suche in den Datenbanken Medline, EMBASE, ScienceDirect, Google Scholar und Cochrane Library von Anfang an bis Mai 2021 durch. Eingeschlossen wurden randomisierte kontrollierte Studien, die die Wirksamkeit von Rivaroxaban und Enoxaparin zur Thromboseprophylaxe bei Patienten, die sich einer HTEP unterziehen, direkt vergleichen. Als Ergebnisparameter wurden die Wirksamkeit in Bezug auf VTE-Gesamt- und Gesamtmortalität, schwere VTE, tiefe Venenthrombose, symptomatische VTE sowie die Sicherheit in Bezug auf schwere Blutungsereignisse, klinisch relevante nicht-schwere Blutungsereignisse, leichte Blutungsereignisse, Gesamtblutungsereignisse, arzneimittelbedingte unerwünschte Ereignisse und Wundinfektionen untersucht. Wir haben eine Meta-Analyse mit einem Modell mit zufälligen Effekten durchgeführt und ein gepooltes Risikoverhältnis (RR) mit einem 95%-Konfidenzintervall (KI) angegeben.

Ergebnisse Es wurden 11 Studien mit 9.057 Teilnehmern ausgewertet. Bei den Wirksamkeitsnachweisen ergab sich für VTE und Gesamtmortalität ein gepooltes RR von 0,58 (95%-KI: 0,34–0,99), für schwere VTE ein gepooltes RR von 0,37 (95%-KI: 0,15–0,90), für TVT ein gepooltes RR von 0,57 (95%-KI: 0,32–1,02) und für symptomatische VTE ein gepooltes RR von 0,51 (95%-KI: 0,30–0,87). Bei den Sicherheitsergebnissen hatten schwere Blutungen ein gepooltes RR von 1,18 (95%-KI: 0,77–1,80), Gesamtblutungen ein gepooltes RR von 1,12 (95%-KI: 0,93–1,34), arzneimittelbedingte unerwünschte Ereignisse ein gepooltes RR von 0,99 (95%-KI: 0,87–1,12) und Wundinfektionen ein gepooltes RR von 1,11 (95%-KI: 0,58–2,14).

Schlussfolgerung Rivaroxaban ist ein wirksameres Medikament in Bezug auf VTE und Gesamtmortalität im Vergleich zu Enoxaparin nach HTEP, und beide waren in Bezug auf Sicherheitsprofile wie Wundinfektion, Blutung und arzneimittelbedingte unerwünschte Ereignisse nicht unterlegen.

Keywords

Enoxaparin - Rivaroxaban - meta-analysis - total hip arthroplasty

Schlüsselwörter

Hüfttotalendoprothese - Rivaroxaban - Enoxaparin - Meta-Analyse

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