Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Summary
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
Timeline
- Start
- 2014-07-22
- Primary completion
- 2017-06-05
- Completion
- 2017-06-05
Outcome
Met primary endpoint
registry analysis (superiority test); Dabigatran Etexilate 110mg vs Warfarin; p <0.001; Hazard Ratio (HR) 0.52 (95% CI 0.42 to 0.63) NCT02164864 ↗
registry analysis (superiority test); Dabigatran Etexilate 150mg vs Warfarin (Excluding Elder Patients Outside USA); p = 0.0020; Hazard Ratio (HR) 0.72 (95% CI 0.58 to 0.88) NCT02164864 ↗
paper The incidence of the primary end point was 15.4% in the 110-mg dual-therapy group as compared with 26.9% in the triple-therapy group PMID 28844193 ↗
Publications
- Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.
- De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.
- Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.
- Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.
- Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.
- Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | — | — |
| Subject | Dabigatran etexilate | Unknown | 110 mg | — |
| Subject | Dabigatran etexilate | Unknown | 150 mg | — |
| Comparator | Warfarin | Small molecule | 1 mg | — |
| Comparator | Warfarin | Small molecule | 3 mg | — |
| Comparator | Warfarin | Small molecule | 5 mg | — |
| Background | Clopidogrel | Small molecule | — | — |
| Background | Ticagrelor | Small molecule | — | — |