PIONEER AF-PCI (very low-dose rivaroxaban)
Trial question
What is the role of very low-dose rivaroxaban in patients with AF undergoing PCI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
26.0% female
74.0% male
N = 1415
1415 patients (362 female, 1053 male).
Inclusion criteria: patients with NVAF who had undergone PCI with stenting.
Key exclusion criteria: history of stroke or TIA; clinically significant gastrointestinal bleeding within 12 months; calculated CrCl < 30 mL/min; increased risk of bleeding.
Interventions
N=709 very low-dose rivaroxaban (rivaroxaban 2.5 mg BID plus dual antiplatelet therapy for 1, 6, or 12 months).
N=706 standard therapy (standard therapy with a dose-adjusted VKA once daily plus dual antiplatelet therapy for 1, 6, or 12 months).
Primary outcome
Clinically significant bleeding
18%
26.7%
26.7 %
20.0 %
13.3 %
6.7 %
0.0 %
Very low-dose
rivaroxaban
Standard
therapy
Significant
decrease ▼
NNT = 11
Significant decrease in clinically significant bleeding (18% vs. 26.7%; HR 0.63, 95% CI 0.5 to 0.8).
Secondary outcomes
No significant difference in major adverse cardiovascular event (5.6% vs. 6%; HR 0.93, 95% CI 0.59 to 1.48).
No significant difference in CV death (2.2% vs. 1.9%; HR 1.19, 95% CI 0.54 to 2.62).
No significant difference in stent thrombosis (0.9% vs. 0.7%; HR 1.44, 95% CI 0.4 to 5.09).
Conclusion
In patients with NVAF who had undergone PCI with stenting, very low-dose rivaroxaban was superior to standard therapy with respect to clinically significant bleeding.
Reference
C Michael Gibson, Roxana Mehran, Christoph Bode et al. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434.
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