Warfarina y anticoagulantes orales directos. Revisión sistemática y metanálisis sobre estudios de no inferioridad en fibrilación auricular y trombosis venosa profunda. / Warfarin and direct oral anticoagulants: a systematic review on non-inferiority studies in atrial fibrillation and deep venous thrombosis.
Resumen
Resumen.
Los anticoagulantes orales directos (ACODs), se han convertido en una alternativa de anticoagulación en fibrilación auricular (FA) y en trombosis venosa profunda (TVP). Los estudios de no inferioridad entre los ACODs y la warfarina, están diseñados para demostrar que los primeros mantienen al menos la misma eficacia y mejor seguridad que la warfarina. Se realizó una revisión sistemática y metanálisis de ensayos aleatorios controlados en FA (4 estudios) y TVP (6 estudios). El evento primario fue el ictus isquémico y embolismo sistémico) en FA y la trombosis venosa recurrente para TVP, y la hemorragia mayor para seguridad en ambas patologías. En FA, el análisis mostró equivalencia entre los ACODs y la warfarina, el resultado combinado evidenció una reducción significativa del riesgo de 24% [RR (IC95%)=0,76 (0,69-0,84), p<0,0001]. En el análisis de seguridad, en todos los estudios no hubo diferencias con warfarina y el resultado combinado mostró una reducción no significativa del riesgo del 14% [RR (IC95%)=0,86 (0,76- 1,01), p=0,058]. Para TVP recurrente, todos los estudios mostraron criterios de no inferioridad respecto a la warfarina pero sin uniformidad; el resultado combinado no obtuvo significación estadística [RR (IC95%)=0,93 (0,79-1,08), p=0,372]. El análisis de seguridad indicó que los ACODs fueron superiores a la warfarina, con una reducción significativa del riesgo de hemorragia (42%) [RR (IC95%)=0,58 (0,42- 0,79), p<0,0001]. En conclusión, estos resultados señalan que los ACODs son una buena alternativa para el uso terapéutico en FA y TVP, con una eficacia similar a la warfarina pero una ligera ventaja en la reducción del riesgo hemorrágico.
Abstract.
New oral anticoagulants (NOACs) have become an alternative for patients receiving long-term anticoagulation in atrial fibrillation (AF) and deep vein thrombosis (DVT). Studies of non-inferiority between NOACs and warfarin are designed to demonstrate that the former maintain at least the same efficacy and better safety in hemorrhagic events than warfarin. A systematic review and meta-analysis of randomized controlled trials was conducted in atrial fibrillation (AF) and deep vein thrombosis (DVT). The primary event was stroke (ischemic stroke and systemic embolism) for AF, recurrent venous thrombosis for DVT and the safety event was major bleeding for both pathologies. In AF, the analysis showed equivalence and significant reduction of NOACs compared to warfarin, with a 24% reduction in the relative risk [RR (IC95%)=0.76 (0.69-0.84), p<0.001]. In the safety analysis, all studies did not reveal differences with warfarin and the overall result showed a non-significant risk reduction of 14% [RR (IC95%)=0.86 (0.76-1.01), p=0.058]. For DVT, all studies showed non-inferiority criteria in comparison with warfarin [RR (IC95%) = 0.93 (0.79-1.08), p=0,372]. The safety analysis indicated superiority of NOACs over warfarin in all studies. The combined result revealed that there was a significant reduction of the risk of bleeding (42%) in favor of NOACs compared to warfarin [RR (IC95%) = 0.58 (0.42-0.79), p<0.0001]. In conclusion, these results showed that NOACs are a good alternative for therapeutic use in AF and DVT, with similar efficacy on warfarin but with a slight advantage in the reduction of hemorrhagic risk.
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