"Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation".The New England Journal of Medicine. 2017. 377(16):1513-1524.PubMed•Full text•PDF

Contents

1Clinical Question
2Bottom Line
3Major Points
4Guidelines
5Design
6Population
6.1Inclusion Criteria
6.2Exclusion Criteria
6.3Baseline Characteristics
7Interventions
8Outcomes
8.1Primary Outcome
8.2Secondary Outcomes
9Criticisms
10Funding
11Further Reading

Clinical Question

In patients with atrial fibrillation who have undergone percutaneous coronary intervention (PCI), does dual antithrombotic therapy with dabigatran reduce the risk of bleeding compared to triple therapy with warfarin?

Bottom Line

Dual antithrombotic therapy with dabigatran plus a P2Y12 inhibitor (clopidogrel or ticagrelor) after PCI in patients with atrial fibrillation was associated with a lower risk of bleeding events compared to triple therapy with warfarin, a P2Y12 inhibitor, and aspirin. Dual therapy with dabigatran was also noninferior to triple therapy with warfarin with respect to risk of thromboembolic events.

Major Points

Guidelines

Design

- Multicenter, randomized, open-label trial.
- N=2,725 patients with atrial fibrillation who had undergone PCI.
- Intervention groups:
- Dual therapy: dabigatran (110 mg or 150 mg twice daily) + P2Y12 inhibitor (clopidogrel or ticagrelor).
- Triple therapy: warfarin + a P2Y12 inhibitor + aspirin (stopped after 1 to 3 months).
- Mean follow-up of 14 months.
- Primary efficacy analysis: intention-to-treat.

Population

Inclusion Criteria

- Adults ≥18 years with nonvalvular atrial fibrillation.
- Successful PCI with a bare-metal or drug-eluting stent within the previous 120 hours.

Exclusion Criteria

- Bioprosthetic or mechanical heart valves, severe renal insufficiency, major coexisting conditions.

Baseline Characteristics

- Mean age: 70.8 years.
- Acute coronary syndrome indication for 50.5% of patients.
- Drug-eluting stents used in 82.6%.

Interventions

- Randomization to dual therapy with dabigatran or triple therapy with warfarin.
- Duration of aspirin component in triple therapy: 1 month for bare-metal stent, 3 months for drug-eluting stent.

Outcomes

Primary Outcome

- Lower incidence of major or clinically relevant nonmajor bleeding with dual therapy (both dabigatran doses) compared to triple therapy.

Secondary Outcomes

- Dual therapy was noninferior to triple therapy regarding thromboembolic events, death, or unplanned revascularization.
- No significant difference in serious adverse events between the groups.

Criticisms

- The original protocol called for more patients than were enrolled, potentially limiting power to examine individual efficacy according to dabigatran dose.
- Noninferiority margin was based on previous atrial fibrillation studies for a dissimilar endpoint.
- Contributions of aspirin omission and oral anticoagulant type regarding outcome differences between dual and triple therapy could only be speculated.

Funding

Funded by Boehringer Ingelheim.

Further Reading

Please refer to the New England Journal of Medicine article and included references for more detailed information.