Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCI Trial

Q: What does this research mean for the field?

In patients with atrial fibrillation undergoing percutaneous coronary intervention, dabigatran dual therapy provides an early net clinical benefit by significantly reducing bleeding without increasing thrombotic risk compared to warfarin triple therapy. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Benjamin E. Peterson; Deepak L. Bhatt; Philippe Gabríel Steg; Jonas Oldgren; Michael Mæng; Uwe Zeymer; Sigrun Halvorsen; Stefan H. Hohnloser; Gregory Y.H. Lip; Takeshi Kimura; Matias Nordaby; Corinna Miede; Eva Kleine; Jurriën M. ten Berg; Christopher P. Cannon

doi:10.1016/j.jcin.2021.02.022

April 1, 2021JACC: Cardiovascular InterventionsOpen Access

Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCI Trial

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Why the study?

Patients with AF undergoing PCI are at increased risk for bleeding and thrombotic events, prompting exploration of early versus late benefits and risks of dabigatran dual therapy versus warfarin triple therapy.

Does dabigatran dual therapy improve early net clinical benefit and reduce bleeding compared to warfarin triple therapy in patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention?

Key Points

To evaluate the early versus late benefits and risks of dabigatran dual antithrombotic therapy compared with warfarin triple therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention.
Conducted 30-day and 90-day landmark analyses using data from the randomized RE-DUAL PCI trial.
Compared dual therapy using dabigatran (110 mg or 150 mg) plus a P2Y12 inhibitor against triple therapy with warfarin, a P2Y12 inhibitor, and aspirin.
Major or clinically relevant nonmajor bleeding within the first 30 days was significantly lower with dual therapy versus warfarin triple therapy for dabigatran 110 mg (HR: 0.45; 95% CI: 0.31 to 0.66; p < 0.0001) and dabigatran 150 mg (HR: 0.46; 95% CI: 0.30 to 0.72; p = 0.0006).
Net clinical benefit during the early period favored dual therapy over warfarin for dabigatran 110 mg (HR: 0.65; 95% CI: 0.47 to 0.88; p = 0.0062) and dabigatran 150 mg (HR: 0.54; 95% CI: 0.37 to 0.79; p = 0.0015).
Following aspirin discontinuation in the warfarin arm, bleeding risk remained reduced with dabigatran 110 mg, while dabigatran 150 mg maintained bleeding reduction without an increase in thrombotic events.

Structured PICO

Does dabigatran dual therapy improve early net clinical benefit and reduce bleeding compared to warfarin triple therapy in patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention?

P

Population

Patients with nonvalvular atrial fibrillation undergoing percutaneous coronary intervention

I

Intervention

Dabigatran dual therapy (110 mg or 150 mg) (with aspirin for an average of only 1.6 days)

C

Comparator

Warfarin triple therapy (including aspirin)

O

Outcome

Major or clinically relevant nonmajor bleeding and net clinical benefit at 30 and 90 dayscomposite

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Implication

In patients with nonvalvular atrial fibrillation undergoing PCI, dabigatran dual therapy provides an early net clinical benefit and significant reduction in bleeding within the first 30 days compared to warfarin triple therapy.

Abstract

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Cite This Study

Peterson et al. (2021) studied this question.

synapsesocial.com/papers/6a1a9697382248a45185a102 https://doi.org/10.1016/j.jcin.2021.02.022

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Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCI Trial

Key Points

Structured PICO

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCI Trial

Key Points

Structured PICO

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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