An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin k antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI)

Abstract

The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications.

O PIONEERs!

“…7 The secondary end point of cardiovascular death, myocardial infarction, or stroke was similar in all 3 arms. 7 Thus, from the PIONEER data to date, significant benefits can be realized from abandoning the strategy of full-dose triple therapy, with no apparent downside.…”

Evaluación de la anticoagulación con rivaroxaban, en pacientes con fibrilación auricular no valvular de reciente diagnóstico

“…Es probable que la generación de una superficie procoagulante sobre las plaquetas activadas y expresión de factor tisular, sobrepasa la capacidad de rivaroxaban de inhibir localmente la generación de trombina. Estos resultados están de acuerdo a lo reportado por Perzbron y cols., que sugieren, incluso, que la adición de un inhibidor de la activación de las plaquetas podría incrementar la capacidad antitrombótica de la droga, lo cual es un elemento a considerar en pacientes que han requerido implante reciente de stents por síndrome coronario agudo y tienen además FA 16,17 . A diferencia de los inhibidores indirectos del FXa, rivaroxaban no precisa de antitrombina para alcanzar su efecto e inhibe tanto el FXa libre como el unido a la fibrina, así como el FXa en el complejo de protrombinasa 11,18 , lo que se corrobora con la ausencia de efecto de la droga sobre niveles de TAT encontrado en nuestro estudio.…”

The Nonvitamin K Antagonist Oral Anticoagulants and Atrial Fibrillation: Challenges and Considerations

“…The PIONEER AF-PCI (Study Exploring Two Strategies of Rivaroxaban and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention; clinicaltrials.gov NCT01830543) is an exploratory, open-label, randomized trial assessing the safety of 2 rivaroxaban dual-antiplatelet treatment regimens compared with a triple-antiplatelet treatment regimen including VKA in NVAF patients with ischemic heart disease who have undergone PCI with stent placement (bare metal or drug-eluting stent). [65] The primary endpoint is a composite of the rate of major bleeding, bleeding requiring medical attention, and minor bleeding at 12 months. [65] Similarly, REDUAL-PCI (Randomized Evaluation of Dual Therapy with Dabigatran vs Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting; clinicaltrials.…”

“…[65] The primary endpoint is a composite of the rate of major bleeding, bleeding requiring medical attention, and minor bleeding at 12 months. [65] Similarly, REDUAL-PCI (Randomized Evaluation of Dual Therapy with Dabigatran vs Triple Therapy Strategy with Warfarin in Patients with NVAF that have undergone PCI with Stenting; clinicaltrials. gov NCT02164864) is assessing the safety of 2 dabigatran dualantiplatelet treatment regimens compared with a triple antiplatelet treatment regimen including VKA in patients with NVAF and ischemic heart disease who have undergone stent placement (bare metal or drug-eluting stents).…”