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Rivaroxaban strategy safer than warfarin strategy in PCI for AF regardless of INR stability
Among patients with atrial fibrillation undergoing PCI, a rivaroxaban-based antithrombotic strategy was linked to reduced bleeding risk compared with a warfarin-based strategy regardless of INR, according to new data from the PIONEER AF-PCI study.
As Cardiology Today’s Intervention previously reported, in the main findings of the PIONEER AF-PCI study of 2,124 patients, compared with patients assigned warfarin plus dual antiplatelet therapy, patients assigned rivaroxaban (Xarelto, Janssen/Bayer) 15 mg once daily plus a P2Y12 inhibitor but no aspirin and patients assigned rivaroxaban 2.5 mg twice daily plus DAPT had reduced risk for clinically significant bleeding, with no difference in ischemic events.
For the present analysis, Mathieu Kerneis, MD, from the division of cardiovascular medicine at Beth Israel Deaconess Medical Center, and colleagues stratified the warfarin group by the percentage of time in which patients spent in therapeutic range as determined by INR (mean, 65%).
“It is known that there is an increased risk associated with vitamin K antagonist (VKA) therapies, when target INR is outside of the therapeutic window of 2-3,” C. Michael Gibson, MS, MD, professor of medicine at Harvard Medical School, interventional cardiologist at Beth Israel Deaconess Medical Center and director of Baim/PERFUSE Research Institutes, said in an interview. “This led to two questions. First, whether rivaroxaban-based strategies still significantly reduce the risk of bleeding compared to VKA-based strategies for participants who demonstrated INR stability, meaning they remained in the therapeutic INR window. Second, whether rivaroxaban-based strategies still reduced bleeding when compared to subjects administered VKA based on time spent during the study with an INR greater then 3, which increases the risk of bleeding. This analysis aimed to answer both of those questions.”
Compared with the warfarin group, both rivaroxaban groups had less clinically significant bleeding, regardless of time spent in therapeutic range (HR ranges for rivaroxaban 15 mg vs. warfarin = 0.53-0.71; HR ranges for rivaroxaban 2.5 mg vs. warfarin = 0.57-0.76; P < .05 for all), according to the researchers.
In addition, compared with the warfarin group, both rivaroxaban groups had less clinically significant bleeding no matter how much time patients spent with an INR more than 3 (HR ranges for rivaroxaban 15 mg vs. warfarin = 0.59-0.67; HR ranges for rivaroxaban 2.5 mg vs. warfarin = 0.42-0.69; P < .05 for all), Kerneis and colleagues wrote.
“Both rivaroxaban strategies still significantly reduced bleeding compared to the VKA strategy regardless of the time spent with an INR > 3,” Gibson said in an interview. “This indicates that even among subjects who never had their INR > 3, subjects on rivaroxaban-based strategies were still bleeding significantly less.”
Gibson noted that the researchers performed sensitivity analyses of different therapeutic ranges.
“Results remained the same when using [time in therapeutic range] of 1.5-2.5,” he said. “However, when VKA subjects were split based on time spent in a narrow INR range of 2-2.5 (< 60%, ≥ 60%), bleeding rates were similar between subjects on rivaroxaban strategies and VKA subjects who spent ≥ 60% of their time with an INR between 2-2.5. However, it is important to note that it is difficult to maintain such a narrow therapeutic range and it may not be feasible in clinical practice.” – by Erik Swain
Disclosures: The study was funded by Bayer and Janssen Scientific Affairs. Gibson reports he received consultant fees from Boston Scientific Research Institute, Eli Lilly, Gilead Sciences, Novo Nordisk, Pfizer, The Medicines Company and WebMD and grant support from Angel Medical, Bayer, CSL Behring, Ikaria, Janssen, Johnson & Johnson, Portola Pharmaceuticals, Stealth Peptides and St Jude Medical. Kerneis reports receiving research grants from Institut Servier and consultant fees from Bayer. Please see the study for the other authors’ relevant financial disclosures.