Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (PCI)
Authors' conclusion
In participants with atrial fibrillation undergoing PCI with placement of stents, the administration of either low-dose rivaroxaban plus a P2Y12 inhibitor for 12 months or very-low-dose rivaroxaban plus DAPT for 1, 6, or 12 months was associated with a lower rate of clinically significant bleeding than was standard therapy with a vitamin K antagonist plus DAPT for 1, 6, or 12 months.
Study context
- Population
- Patients with nonvalvular AF who had undergone PCI with stenting
- Participants
- 2,124 patients
- Comparison
- Rivaroxaban plus one or two antiplatelet agents vs VKA plus dual antiplatelet therapy (DAPT)
- Primary endpoint
- Clinically significant bleeding (TIMI major or minor bleeding or bleeding requiring medical attention) (primary safety outcome)
Methodological details1:1:1 ratio
- 1:1:1 ratio
Primary result
As reported in the abstract
Clinically significant bleeding
Each group vs group 3Hazard ratio (95% CI)P value
Group 1
0.59(0.47–0.76)
P < 0.001Group 2
0.63(0.50–0.80)
P < 0.001Further findings
CV death, MI or stroke · Kaplan-Meier estimates
CV death, MI or stroke
- Similar in the three groups; P values for all comparisons nonsignificant
Original publication
Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. Published 14 November 2016. doi:10.
Summarised from the published abstract; every number is checked against it