PIONEER AF-PCI (low-dose rivaroxaban)
Trial question
What is the role of 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 (369 female, 1046 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 low-dose rivaroxaban (rivaroxaban 15 mg/day plus P2Y12 inhibitor for 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
16.8%
26.7%
26.7 %
20.0 %
13.3 %
6.7 %
0.0 %
Low-dose
rivaroxaban
Standard
therapy
Significant
decrease ▼
NNT = 10
Significant decrease in clinically significant bleeding (16.8% vs. 26.7%; HR 0.59, 95% CI 0.47 to 0.76).
Secondary outcomes
No significant difference in major adverse cardiovascular event (6.5% vs. 6%; HR 1.08, 95% CI 0.69 to 1.68).
No significant difference in CV death (2.4% vs. 1.9%; HR 1.29, 95% CI 0.59 to 2.8).
No significant difference in stent thrombosis (0.8% vs. 0.7%; HR 1.2, 95% CI 0.32 to 4.45).
Conclusion
In patients with NVAF who had undergone PCI with stenting, 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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