International journal of surgery (London, England) · 2025
Apixaban versus enoxaparin for venous thromboembolism prophylaxis after total gastrectomy in patients with gastric cancer: a randomized controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Miratashi Yazdi Seyed Amir, Pezeshki Parmida Sadat, Zafarghandi Mohammad Reza
Аннотация
BACKGROUND: Patients undergoing total gastrectomy for gastric cancer are at high risk of venous thromboembolism (VTE), and enoxaparin is the current standard for prophylaxis. However, direct oral anticoagulants such as apixaban may improve adherence and patient satisfaction due to oral administration and ease of administration.
METHODS: In this single-center, open-label, randomized controlled trial, 57 patients receiving neoadjuvant FLOT chemotherapy and undergoing total gastrectomy for gastric cancer were assigned to receive either oral apixaban (2.5 mg twice daily) or subcutaneous enoxaparin (1 mg/kg once daily) for 28 days postoperatively. The primary outcome was treatment adherence, measured by the proportion of days covered (PDC). Secondary outcomes included VTE events, major bleeding, clinically relevant nonmajor bleeding, and patient satisfaction.
RESULTS: The mean PDC, as the primary outcome, was 93.5% (95% CI: 89.0%-98.0%) in the apixaban group and 89.9% (95% CI: 83.9%-96.0%) in the enoxaparin group ( P = 0.61). As for the secondary outcomes, no cases of VTE or major bleeding occurred in either group, and clinically relevant nonmajor bleeding occurred in two patients per group. Patient satisfaction was significantly higher in the apixaban group, with greater ease of use (86.2% vs. 35.7%, P < 0.001) and less pain associated with administration (3.5% vs. 50.0%, P < 0.001).
CONCLUSION: Apixaban demonstrated similar adherence, as measured by PDC, to enoxaparin, with no safety concerns identified in this pilot study. It also demonstrated greater patient satisfaction. While these results suggest apixaban might be a more patient-friendly alternative for postoperative VTE prophylaxis in gastric cancer patients undergoing total gastrectomy, larger studies are warranted to confirm its safety and efficacy as their primary outcome.
METHODS: In this single-center, open-label, randomized controlled trial, 57 patients receiving neoadjuvant FLOT chemotherapy and undergoing total gastrectomy for gastric cancer were assigned to receive either oral apixaban (2.5 mg twice daily) or subcutaneous enoxaparin (1 mg/kg once daily) for 28 days postoperatively. The primary outcome was treatment adherence, measured by the proportion of days covered (PDC). Secondary outcomes included VTE events, major bleeding, clinically relevant nonmajor bleeding, and patient satisfaction.
RESULTS: The mean PDC, as the primary outcome, was 93.5% (95% CI: 89.0%-98.0%) in the apixaban group and 89.9% (95% CI: 83.9%-96.0%) in the enoxaparin group ( P = 0.61). As for the secondary outcomes, no cases of VTE or major bleeding occurred in either group, and clinically relevant nonmajor bleeding occurred in two patients per group. Patient satisfaction was significantly higher in the apixaban group, with greater ease of use (86.2% vs. 35.7%, P < 0.001) and less pain associated with administration (3.5% vs. 50.0%, P < 0.001).
CONCLUSION: Apixaban demonstrated similar adherence, as measured by PDC, to enoxaparin, with no safety concerns identified in this pilot study. It also demonstrated greater patient satisfaction. While these results suggest apixaban might be a more patient-friendly alternative for postoperative VTE prophylaxis in gastric cancer patients undergoing total gastrectomy, larger studies are warranted to confirm its safety and efficacy as their primary outcome.