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PIONEER AF-PCI

"Rivaroxaban with or without Aspirin in Patients with Recent PCI and Atrial Fibrillation".The New England Journal of Medicine. 2016. 375(21):2033-2044.PubMed•Full text•PDFContents
1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
6.4Baseline Medications
7Interventions
8Outcomes
8.1Primary Outcomes
8.2Secondary Outcomes
9Criticisms
10Funding
11Further Reading

Clinical Question

In patients with nonvalvular atrial fibrillation who have undergone PCI with stent placement, does anticoagulation with rivaroxaban reduce the risk of clinically significant bleeding compared to standard therapy with a vitamin K antagonist plus dual antiplatelet therapy (DAPT)?

Bottom Line

For patients with atrial fibrillation undergoing PCI with stent placement, rivaroxaban in combination with a P2Y12 inhibitor for 12 months, or in combination with very-low-dose rivaroxaban plus DAPT for 1, 6, or 12 months, resulted in a lower rate of clinically significant bleeding compared to standard therapy with a vitamin K antagonist plus DAPT.

Major Points

In atrial fibrillation patients who underwent PCI with stenting, treatment with low-dose or very-low-dose rivaroxaban in combination with antiplatelet agents showed a lower risk of bleeding events than traditional therapy with a vitamin K antagonist and DAPT. Efficacy for major cardiovascular events was similar among the groups, although confidence intervals were broad, limiting definite conclusions regarding efficacy.

Guidelines

Currently, no guidelines reflect the results of this trial.

Design

- International, multicenter, randomized, open-label trial
- N=2,124 patients
- Group 1 (n=709): Low-dose rivaroxaban (15 mg once daily) plus P2Y12 inhibitor for 12 months
- Group 2 (n=709): Very-low-dose rivaroxaban (2.5 mg twice daily) plus DAPT for prespecified duration (1, 6, or 12 months)
- Group 3 (n=706): Standard therapy with vitamin K antagonist once daily plus DAPT for prespecified duration (1, 6, or 12 months)
- Enrollment: May 2013 to July 2015
- Mean follow-up: 12 months
- Analysis: Modified intention-to-treat
- Primary outcome: Clinically significant bleeding

Population

Inclusion Criteria
- Patients ≥18 years old
- Paroxysmal, persistent, or permanent nonvalvular atrial fibrillation
- Underwent PCI with stent placement

Exclusion Criteria
- Stroke or transient ischemic attack history
- Significant gastrointestinal bleeding within 12 months
- Creatinine clearance <30 ml/min
- Anemia or other conditions increasing bleeding risk

Baseline Characteristics
- Predominantly white men
- <10% enrolled in North America
- Majority intended to use clopidogrel as P2Y12 inhibitor

Baseline Medications
- Warfarin provided unless contraindicated or part of standard local therapy

Interventions

- Rivaroxaban dosing adjusted based on renal function and stratified by intended DAPT duration and P2Y12 inhibitor type

Outcomes

Primary Outcomes
- Clinically significant bleeding was lower in groups receiving rivaroxaban than in standard therapy group (16.8% in Group 1, 18.0% in Group 2, 26.7% in Group 3)

Secondary Outcomes
- Rates of major adverse cardiovascular events were similar across all groups
- Low stent thrombosis rates with no significant differences among groups

Criticisms

- Not powered to definitively establish superiority or noninferiority for efficacy outcomes
- Certain rivaroxaban doses not approved for management of acute coronary syndrome or atrial fibrillation
- Underpowered for individual efficacy end points and subgroups, limiting conclusions on efficacy

Funding

- Janssen Scientific Affairs and Bayer Pharmaceuticals