Relationship of stroke and bleeding risk profiles to efficacy and safety of dabigatran dual therapy versus warfarin triple therapy in atrial fibrillation after percutaneous coronary intervention: An ancillary analysis from the RE-DUAL PCI trial.

Abstract

BACKGROUND:

In the RE-DUAL PCI trial of patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI), dabigatran dual therapy (110 or 150 mg bid, plus clopidogrel or ticagrelor) reduced International Society on Thrombosis and Haemostasis bleeding events compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. This analysis assessed outcomes in relation to patient bleeding and stroke risk profiles, based on the modified HAS-BLED and CHA2DS2-VASc scores.

METHODS:

The primary endpoint, major bleeding event (MBE) or clinically relevant nonmajor bleeding event (CRNMBE), was compared across study arms in patients categorized by modified HAS-BLED score 0-2 or ≥3. The composite endpoint of death, thromboembolic event, and unplanned revascularization rates was compared in patients categorized by CHA2DS2-VASc score 0-1, 2, or ≥3.

RESULTS:

Risk of MBE or CRNMBE was lower with dabigatran dual therapy (both doses) versus warfarin triple therapy, irrespective of modified HAS-BLED category (treatment-by-subgroup interaction P-value 0.584 and 0.273 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Risk of the composite thromboembolic endpoint was similar across CHA2DS2-VASc categories and consistent with overall study results (interaction P-value 0.739 and 0.075 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Higher HAS-BLED scores were associated with higher risks of bleeding in AF patients after PCI in a treatment-independent analysis.

CONCLUSION:

Dabigatran dual therapy reduced bleeding events irrespective of bleeding risk category and demonstrated similar efficacy regardless of stroke risk category when compared with warfarin triple therapy.

• Authors: Gregory Y H Lip, Laura Mauri, Gilles Montalescot, Mick Ozkor, Panagiotis Vardas, Philippe Gabriel Steg, Deepak L Bhatt, Stefan H Hohnloser, Corinna Miede, Matias Nordaby, Martina Brueckmann, Joerg Kreuzer, Takeshi Kimura, Jonas Oldgren, Jurrien M Ten Berg, Christopher P Cannon
• Journal: American heart journal (Am Heart J) Vol. 212 Pg. 13-22 (06 2019) ISSN: 1097-6744 [Electronic] United States
• PMID: 30928824 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Elsevier Inc. All rights reserved.

Chemical References

• Anticoagulants
• Warfarin
• Clopidogrel
• Ticagrelor
• Dabigatran

Topics

• Aged
• Anticoagulants (adverse effects, therapeutic use)
• Atrial Fibrillation (prevention & control)
• Clopidogrel (adverse effects, therapeutic use)
• Coronary Artery Disease (complications, surgery)
• Dabigatran (adverse effects, therapeutic use)
• Drug Therapy, Combination
• Equivalence Trials as Topic
• Female
• Hemorrhage (chemically induced)
• Humans
• Male
• Middle Aged
• Percutaneous Coronary Intervention
• Risk Assessment
• Stroke (chemically induced)
• Thromboembolism (prevention & control)
• Ticagrelor (adverse effects, therapeutic use)
• Warfarin (adverse effects, therapeutic use)