According to a post-hoc analysis of the PIONEER AF-PCI trial that was recently published in the Journal of American College of Cardiology, there was no impact of complex coronary lesions, stent characteristics, or vascular approach on efficacy or safety outcomes among stented atrial fibrillation (AF) patients who received either rivaroxaban or Vitamin K Antagonists (VKA)-based dual or triple therapy.
The PIONEER AF-PCI was an open-label, randomized, controlled, multicenter study comparing rivaroxaban-based regimens to dose-adjusted oral VKAs triple therapy in patients with AF undergoing Percutaneous Coronary Intervention (PCI). The study revealed that in patients with AF undergoing PCI with stent placement, the administration of rivaroxaban based therapy reduced clinically significant bleeding compared to VKA-based triple therapy. However, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes had not been previously explored. Therefore, Dr. Kerneis and his colleagues conducted an analysis to compare the occurrence of Major Adverse Cardiovascular Events (MACE) and clinically significant bleeding between treatment arms, stratified by subgroups of procedure type and lesion characteristics.
[perfectpullquote align=”full” bordertop=”false” cite=”” link=”” color=”” class=”” size=””]“There is no good reason and no evidence to put a patient on VKA triple therapy after a PCI.”- Dr. Mathieu Kerneis[/perfectpullquote]
In this analysis, rivaroxaban-based strategies remained superior on bleeding outcomes compared to VKA triple therapy even in patients with characteristics associated with a decreased risk of bleeding such as radial access or use of a closure device. Moreover, the treatment effect of rivaroxaban on MACE did not vary when stratified by ischemia-driven revascularization, the urgency of revascularization, the location of the culprit lesion, presence of bifurcation lesion, the presence of thrombus, type and length of stent, or number of stents. In response to these findings, Dr. Mathieu Kerneis, an Interventional Cardiologist at Pitié-Salpêtrière Hospital in Paris stated, “It is not so surprising when you look at the primary results of the pivotal trial that demonstrate an important reduction of bleeding events with rivaroxaban-based therapy that cannot be explained by a selective effect.” While these findings suggest that rivaroxaban regimens were similar to VKA triple therapy on ischemic outcomes among patients with a complex procedure, the PIONEER AF-PCI trial was not powered to adequately assess efficacy outcomes. Dr. Kerneis has stated that the PIONEER AF-PCI trial has already had a substantial impact on clinical practice. In light of the recent evidence from PIONEER AF-PCI, “There is no good reason and no evidence to support putting a patient with atrial fibrillation on VKA triple therapy after a PCI.”