RECORD1 is a phase 3 multinational RCT (n=4541) comparing oral rivaroxaban 10 mg once daily versus subcutaneous enoxaparin 40 mg once daily for 35 days after total hip arthroplasty. It tests whether a once-daily oral direct factor Xa inhibitor can outperform the LMWH standard of care for extended VTE prophylaxis. Rivaroxaban was started postoperatively; enoxaparin was started the evening before surgery.
Before RECORD1, extended VTE prophylaxis after total hip arthroplasty meant 5 weeks of subcutaneous LMWH injections — effective but burdensome, with cost-effectiveness dependent on patient self-injection ability. Warfarin was the main oral alternative, but its unpredictable pharmacology, food interactions, and monitoring requirements made it difficult to manage.
This trial is why rivaroxaban became the preferred oral agent for post-THA thromboprophylaxis. When you discharge a THA patient, rivaroxaban 10 mg daily for 35 days gives superior VTE protection compared to enoxaparin, without increasing major bleeding or wound complications.
For patients who cannot self-inject or tolerate subcutaneous medications, this data provides strong justification for an oral regimen. The 88% relative reduction in major VTE (proximal DVT and PE) is the number worth remembering.
One caveat: exclude patients with creatinine clearance below 30 mL/min, significant liver disease, or concurrent HIV protease inhibitor use. These were the key contraindications in the trial.
RECORD1 is a phase 3 multinational RCT (n=4541) comparing oral rivaroxaban 10 mg once daily versus subcutaneous enoxaparin 40 mg once daily for 35 days after total hip arthroplasty. It tests whether a once-daily oral direct factor Xa inhibitor can outperform the LMWH standard of care for extended VTE prophylaxis. Rivaroxaban was started postoperatively; enoxaparin was started the evening before surgery.
Before RECORD1, extended VTE prophylaxis after total hip arthroplasty meant 5 weeks of subcutaneous LMWH injections — effective but burdensome, with cost-effectiveness dependent on patient self-injection ability. Warfarin was the main oral alternative, but its unpredictable pharmacology, food interactions, and monitoring requirements made it difficult to manage.
This trial is why rivaroxaban became the preferred oral agent for post-THA thromboprophylaxis. When you discharge a THA patient, rivaroxaban 10 mg daily for 35 days gives superior VTE protection compared to enoxaparin, without increasing major bleeding or wound complications.
For patients who cannot self-inject or tolerate subcutaneous medications, this data provides strong justification for an oral regimen. The 88% relative reduction in major VTE (proximal DVT and PE) is the number worth remembering.
One caveat: exclude patients with creatinine clearance below 30 mL/min, significant liver disease, or concurrent HIV protease inhibitor use. These were the key contraindications in the trial.