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Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing Pci
Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing Pci
Gibson CM, Mehran R, Bode C, et al. N Engl J Med. 2016;375:2423-2434.
Study Question: How does the risk of bleeding for two different rivaroxaban regimens compare to standard therapy in patients with previous atrial fibrillation (AF) who underwent PCI?
Study Description: The PIONEER AF-PCI study was a multi-center, randomized, open-label trial that included patients who had non-valvular AF and had undergone PCI with stent placement. Patients were stratified by duration of dual antiplatelet therapy (DAPT [1, 6, 12 months]) in a 1:1:1 fashion to group 1, 2, or 3. Group 1 (n = 709) received rivaroxaban 15 mg plus single agent P2Y12 inhibitor for 12 months. Groups 2 (n = 709) and 3 (n = 706) received rivaroxaban 2.5 mg twice daily or dose adjusted vitamin K antagonist (VKA [INR 2 – 3]) plus DAPT, respectively, for 1, 6, or 12 months; patients receiving 1 or 6 months subsequently received rivaroxaban 15 mg or VKA plus aspirin for the remainder of the 12 months. The primary end point was occurrence of significant bleeding (composite of major or minor TIMI criteria bleeding or bleeding that required medical attention).
Results: The primary outcome occurred in 16.8%, 18.0%, and 26.7% for groups 1, 2 and 3, respectively (HR group 1 vs. 3, 0.59 [95% CI 0.47 - 0.76, p < 0.001]; HR group 2 vs. 3, 0.63 [95% CI 0.5 – 0.8, p < 0.001]).
Conclusion(s): Both rivaroxaban regimens result in lower rates of bleeding compared to standard therapy.
Perspective: This was the first study to investigate the safety of rivaroxaban during PCI in patients with a history of AF. Although there were lower rates of bleeding observed in the rivaroxaban regimens, the overall clinical efficacy is unknown as the study was underpowered to detect differences. Furthermore, the primary outcome was driven by bleeding that required medical attention, however, no further details were provided on the degree of medical attention. Other limitations include the lack of pertinent groups for comparisons (standard rivaroxaban 20 mg, rivaroxaban plus DAPT, and VKA plus a single agent P2Y12 inhibitor) and the variable durations of therapy. Future investigations should seek to address efficacy and bleeding outcomes with standardized durations in these groups.