Warfarin Triple Therapy Research Articles

Dual antithrombotic therapy with dabigatran in patients with atrial fibrillation after percutaneous coronary intervention for ST-segment elevation myocardial infarction: a post hoc analysis of the randomised RE-DUAL PCI trial.

Little is known about the optimal antithrombotic therapy in patients with atrial fibrillation undergoing PCI for ST-elevation myocardial infarction (STEMI). The aim of this study was to investigate the safety and efficacy of dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) versus warfarin triple therapy in patients with atrial fibrillation and STEMI. In the RE-DUAL PCI trial, 305 patients with STEMI were randomised to dabigatran 110 mg (n=113 versus 106 warfarin) or 150 mg (n=86 versus 84 warfarin). The primary endpoint was the time to first major/clinically relevant non-major bleeding event (MBE/CRNMBE). The thrombotic endpoint was a composite of death, thromboembolic events, or unplanned revascularisation. In STEMI patients, dabigatran 110 mg (HR 0.39, 95% CI: 0.20-0.74) and 150 mg (0.43, 0.21-0.89) dual therapy reduced the risk of MBE/CRNMBE versus warfarin triple therapy (p for interaction vs all other patients=0.31 and 0.16). The risk of thrombotic events for dabigatran 110 mg (HR 1.61, 95% CI: 0.85-3.08) and 150 mg (0.56, 0.20-1.51) had p interactions of 0.20 and 0.33, respectively. For net clinical benefit, the HRs were 0.74 (95% CI: 0.46-1.17) and 0.49 (0.27-0.91) for dabigatran 110 and 150 mg (p for interaction=0.80 and 0.12), respectively. After PCI for STEMI, patients on dabigatran dual therapy had lower risks of bleeding events versus warfarin triple therapy with similar risks of thromboembolic events, supporting dabigatran dual therapy even in patients with high thrombotic risk.

The effect of sex on the efficacy and safety of dual antithrombotic therapy with dabigatran versus triple therapy with warfarin after PCI in patients with atrial fibrillation (a RE-DUAL PCI subgroup analysis and comparison to other dual antithrombotic therapy trials).

BackgroundThe RE‐DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI.HypothesisThe reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males.MethodsThe primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non‐major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint.ResultsA total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47–1.01, males: HR 0.46, 95% CI 0.37–0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48–1.16, males HR 0.71, 95% CI 0.56–0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively).ConclusionsConsistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.

Evaluation of Dual Versus Triple Therapy by Landmark Analysis in the RE-DUAL PCITrial.

The aim of this study was to explore the early versus late benefits and risks of dabigatran dual therapy versus warfarin triple therapy in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial. Patients with atrial fibrillation who undergo percutaneous coronary intervention are at increased risk for both bleeding and thrombotic events. A total of 2,725 patients with atrial fibrillation underwent percutaneous coronary intervention and were randomized to receive dabigatran 110 mg, or dabigatran 150 mg plus a P2Y12 inhibitor (and no aspirin), or warfarin plus a P2Y12 inhibitor plus aspirin. Landmark analysis was performed at 30 and 90days. There was a consistent and large reduction in major or clinically relevant nonmajor bleeding in patients randomized to dual therapy during the first 30days (110mg: hazard ratio [HR]: 0.45; 95% confidence interval [CI]: 0.31 to 0.66; p<0.0001; 150mg: HR: 0.46; 95%CI: 0.30 to 0.72; p=0.0006) compared with warfarin triple therapy. There was early net clinical benefit in both dabigatran groups versus warfarin (110mg: HR: 0.65; 95%CI: 0.47 to 0.88; p=0.0062; 150mg: HR: 0.54; 95%CI: 0.37 to 0.79; p=0.0015), due to larger reductions in bleeding than increased thrombotic events for dabigatran 110mg and bleeding reduction without increased thrombotic risk for dabigatran 150mg dual therapy versus warfarin triple therapy. After the removal of aspirin in the warfarin group, bleeding remained lower with dabigatran 110mg and was similar with dabigatran 150mg versus warfarin. In RE-DUAL PCI, in which patients in the dual-therapy arms were treated with aspirin for an averageofonly 1.6days, there was early net clinical benefit with both doses of dabigatran dual therapy, without an increase inthrombotic events with dabigatran 150mg. This could be helpful in the subset of patients with elevated riskforbothbleeding and thrombotic events.

Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI

BackgroundBody mass index (BMI) affects drug levels of nonvitamin K antagonist oral anticoagulants. We sought to assess whether BMI affected outcomes in the RE-DUAL PCI trial. MethodsRE-DUAL PCI (NCT02164864) evaluated the safety and efficacy of a dual-antithrombotic-therapy regimen using dabigatran (110 mg or 150 mg twice daily and a P2Y12 platelet antagonist) in comparison with triple therapy of warfarin, aspirin, and a P2Y12 platelet inhibitor in 2725 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI). We compared the risk of first International Society on Thrombosis and Haemostasis (ISTH)-defined major or clinically relevant nonmajor bleeding events (primary endpoint) and the composite of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization (main efficacy endpoint) in relation to baseline BMI. ResultsMedian (range) BMI was 28.1 (14-66) kg/m2. Dabigatran dual therapy versus warfarin triple therapy had relevantly and similarly lower rates of bleeding at both 110 mg and 150 mg twice-daily doses, irrespective of BMI. Thromboembolic event rates appeared consistent across categories of BMI, including those <25 and ≥35 kg/m2 (P for interaction: 0.806 and 0.279, respectively). ConclusionsThe reduction in bleeding with dabigatran dual therapy compared with warfarin triple therapy in patients here evaluated appears consistent across BMI categories.

Looking into the next decade of antithrombotic therapy for patients with atrial fibrillation and percutaneous coronary intervention.

Patients with atrial fibrillation who undergo percutaneous coronary intervention are at increased risk for both coronary and cerebral thrombotic events. As a result, antithrombotic therapy for this patientpopulationcontinues to pose a significant challenge. In this review, we discuss the development of warfarin triple therapy as the standard of carein the last century, the transition to dual therapy with warfarin and a P2Y12 inhibitor, the advent of NOACs, recent clinical trials, and new regimens with a NOAC and a P2Y12 inhibitor. We also discuss our current clinical practice, based on the available data.

P34 The effect of sex on the efficacy and safety of dabigatran dual therapy in atrial fibrillation after PCI: a subgroup analysis from the RE-DUAL PCI trial

Abstract Funding Acknowledgements Boehringer Ingelheim International GmbH On Behalf The Re-DUAL PCI Investigators Background The RE-DUAL PCI study (NCT02164864) compared dabigatran dual antithrombotic therapy (D-DAT) with warfarin triple antithrombotic therapy (W-TAT) in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). As previously reported D-DAT reduced bleeding compared with W-TAT and was non-inferior with regard to thromboembolic events. Aim The aim of this subgroup analysis of RE-DUAL was to assess the relationship between sex and treatment effects of D-DAT and W-TAT on bleeding and thromboembolic outcomes. Methods Patients were randomized to receive W-TAT (warfarin, clopidogrel or ticagrelor, and aspirin) or D-DAT (dabigatran 110 or 150 mg twice daily with clopidogrel or ticagrelor; D110- or D150-DAT). Younger patients (aged &amp;lt; 80 yrs. [&amp;lt; 70 yrs. in Japan]) and US patients irrespective of age received D110-DAT, D150-DAT or W-TAT; older patients (aged ≥ 80 yrs. in non-US countries [≥ 70 yrs. in Japan]) received only D110-DAT or W-TAT. Bleeding and thromboembolic outcomes were assessed according to treatment group and by sex (female vs. male). Results A total of 2725 patients were randomized; 2070 patients were male (76.0%) and 655 (24.0%) were female. Overall females were older at time of PCI than males (73.2 ± 7.9 vs. 70.0 ± 8.8 years). The mean CHA2DS2-VASc and modified HAS-BLED scores were higher in women at 4.5 and 2.8, respectively, than in men at 3.3 and 2.7, respectively. For the primary endpoint of major bleeding events or clinically relevant non-major bleeding events, treatment effects of D110-DAT vs. W-TAT were consistent for female and male patients (females: HR 0.69, 95% CI 0.47-1.01, males HR 0.46, 95%CI 0.37-0.59, interaction p-value 0.084). Similarly, consistent treatment effects were seen for the primary endpoint with D150-DAT vs W-TAT in female and male patients (females HR 0.74, 95% CI 0.48-1.16, males HR 0.71, 95% CI 0.56-0.90, interaction p value 0.83). No interaction between sex and treatment was observed for D110- or D150-DAT vs W-TAT with regard to the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization (interaction p values 0.73 and 0.72, respectively) (figure). Conclusion The treatment effect of dabigatran 110 mg and 150 mg dual therapy vs warfarin triple therapy was consistent across sex groups. This suggests that female and male patients with AF undergoing PCI should be treated equally in terms of the dosage of dabigatran selected for dual therapy strategies. Abstract P34 Figure. Re-DUAL sex subgroup analysis

Comparison of the Effect of Age (< 75 Versus ≥ 75) on the Efficacy and Safety of Dual Therapy (Dabigatran + Clopidogrel or Ticagrelor) Versus Triple Therapy (Warfarin + Aspirin + Clopidogrel or Ticagrelor) in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the RE-DUAL PCI Trial)

The RE-DUAL PCI trial reported that dabigatran dual therapy (110/150 mg twice daily, plus clopidogrel or ticagrelor) reduced bleeding events versus warfarin triple therapy (warfarin plus aspirin and clopidogrel or ticagrelor) in patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events. In this prespecified analysis, risks of first major or clinically relevant nonmajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization were compared between dabigatran dual therapy and warfarin triple therapy in older (≥ 75 years) and younger (< 75 years) patients, using Cox proportional hazard regression. Of 2,725 patients randomized to treatment, 1,026 (37.7%) were categorized into older and 1,699 (62.3%) into younger age groups. Dabigatran 110 mg dual therapy lowered bleeding risk versus warfarin triple therapy in older (hazard ratio [HR] 0.67; 95% confidence interval [CI] 0.51 to 0.89) and younger patients (HR 0.40; 95% CI 0.30 to 0.54); interaction p value: 0.0125. Dabigatran 150 mg dual therapy lowered bleeding risk versus warfarin triple therapy in younger patients (HR 0.57; 95% CI 0.44 to 0.74), whereas no benefit could be observed in older patients (HR 1.21; 95% CI 0.83 to 1.77); interaction p value: 0.0013. For the thromboembolic end point, there was a trend for a higher risk with dabigatran 110 mg dual therapy in older patients, compared with warfarin triple therapy, whereas the risk was similar in younger patients. For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients. In conclusion, the benefits of dabigatran dual therapy differed in the 2 age groups, which may help dose selection when using dabigatran dual therapy.

Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post–PCI in Patients With Atrial Fibrillation and Diabetes

ObjectivesThe aim of this study was to evaluate dabigatran dual therapy versus warfarin triple therapy in patients with or without diabetes mellitus in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial. BackgroundIt is unclear whether dual therapy is as safe and efficacious as triple therapy in patients with atrial fibrillation with diabetes following percutaneous coronary intervention. MethodsIn RE-DUAL PCI, 2,725 patients with atrial fibrillation (993 with diabetes) who had undergone PCI were assigned to warfarin triple therapy (warfarin, clopidogrel or ticagrelor, and aspirin) or dabigatran dual therapy (dabigatran 110 mg or 150 mg twice daily and clopidogrel or ticagrelor). Median follow-up was 13 months. The primary outcome was the composite of major bleeding or clinically relevant nonmajor bleeding, and the main efficacy outcome was the composite of death, thromboembolic events, or unplanned revascularization. ResultsAmong patients with diabetes, the incidence of major bleeding or clinically relevant nonmajor bleeding was 15.2% in the dabigatran 110 mg dual therapy group versus 27.5% in the warfarin triple therapy group (hazard ratio [HR]: 0.48; 95% confidence interval [CI] 0.35 to 0.67) and 23.8% in the dabigatran 150 mg dual therapy group versus 25.1% in the warfarin triple therapy group (HR: 0.87; 95% CI: 0.62 to 1.22). Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83). Risk for the efficacy endpoint was comparable between treatment groups for both patients with and those without diabetes. No interaction between treatment and diabetes subgroup could be observed, either for bleeding or for composite efficacy endpoints. ConclusionsIn this subgroup analysis, dabigatran dual therapy had a lower risk for bleeding and a comparable rate of the efficacy endpoint compared with warfarin triple therapy in patients with atrial fibrillation with or without diabetes following percutaneous coronary intervention.

Switching of Oral Anticoagulation Therapy After PCI in Patients With Atrial Fibrillation: The RE-DUAL PCI Trial Subanalysis

ObjectivesThe aim of this study was to assess if prior oral anticoagulant agent (OAC) use modifies the lower bleeding risk observed with dabigatran dual therapy (dabigatran twice daily plus a P2Y12 inhibitor) versus warfarin triple therapy (warfarin plus a P2Y12 inhibitor plus aspirin) in patients with atrial fibrillation who underwent percutaneous coronary intervention (PCI). BackgroundIn the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, the primary outcome of major bleeding or clinically relevant nonmajor bleeding was lower with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation who underwent PCI. MethodsA total of 2,725 patients were randomized to dual therapy with dabigatran (110 or 150 mg twice daily) plus clopidogrel or ticagrelor or triple therapy with warfarin plus aspirin and clopidogrel or ticagrelor. Subgroup analysis compared risk for major bleeding or clinically relevant nonmajor bleeding and a composite thromboembolic endpoint in patients with prior OAC use and in those who were OAC treatment naive. ResultsRisk for major bleeding or clinically relevant nonmajor bleeding was reduced with both dabigatran dual therapies compared with warfarin triple therapy in both the prior OAC use group (hazard ratios: 0.58 [95% confidence interval (CI): 0.42 to 0.81] and 0.61 [95% CI: 0.41 to 0.92] with 110 and 150 mg dabigatran, respectively) and the OAC-naive group (hazard ratios: 0.49 [95% CI: 0.38 to 0.63] and 0.76 [95% CI: 0.59 to 0.97] with 110 and 150 mg dabigatran) (p for interaction = 0.42 and 0.37, 110 and 150 mg dabigatran, respectively). The risk for thromboembolic events seemed similar with dabigatran dual therapy (both doses) and warfarin triple therapy across subgroups. ConclusionsBleeding risk was reduced with dabigatran dual therapy versus warfarin triple therapy in patients with atrial fibrillation after PCI, regardless of whether they were prior OAC users or OAC treatment naive. These results suggest that it is also safe to switch patients on OAC pre-PCI to dabigatran dual therapy post-PCI.

Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI

ObjectivesThe study sought to evaluate the effect of dabigatran dual therapy versus warfarin triple therapy across categories of renal function in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy with Dabigatran versus Triple Therapy with Warfarin in Patients with Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial. BackgroundThe RE-DUAL PCI (NCT02164864) trial of patients with atrial fibrillation undergoing percutaneous coronary intervention reported that dabigatran dual therapy (110 or 150 mg twice daily, plus clopidogrel or ticagrelor) reduced the primary endpoint of major bleeding events (MBE) or clinically relevant nonmajor bleeding events (CRNMBE) compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. MethodsRisk of a first MBE or CRNMBE and the composite of death or thromboembolic event (DTE) or unplanned revascularization were evaluated in 2,725 patients according to baseline creatinine clearance (CrCl) categories: 30 to <50, 50 to <80, and ≥80 ml/min. ResultsCompared with warfarin, dabigatran 110 mg dual therapy reduced risk of MBE or CRNMBE across all categories of CrCl (p for interaction = 0.19). Dabigatran 150 mg dual therapy reduced risk of MBE or CRNMBE regardless of the CrCl category (p for interaction = 0.31). Risk of DTE or unplanned revascularization was similar to warfarin triple therapy for dabigatran 110 mg dual therapy across all CrCl categories. Dabigatran 150 mg dual therapy versus warfarin triple therapy had similar risk for DTE or unplanned revascularization in patients with CrCl 30 to <80 ml/min and lower risk at CrCl ≥80 ml/min (p for interaction = 0.02). ConclusionsIn the RE-DUAL PCI trial, dabigatran dual therapy reduced bleeding events versus warfarin triple therapy irrespective of renal function, with overall similar risks of thromboembolic events but lower risks with dabigatran 150 mg in patients with normal CrCl.

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

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. 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. 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. 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.

Dabigatran dual therapy with ticagrelor or clopidogrel after percutaneous coronary intervention in atrial fibrillation patients with or without acute coronary syndrome: a subgroup analysis from the RE-DUAL PCI trial.

AimsAfter percutaneous coronary intervention (PCI) in patients with atrial fibrillation, safety and efficacy with dabigatran dual therapy were evaluated in pre-specified subgroups of patients undergoing PCI due to acute coronary syndrome (ACS) or elective PCI, and those receiving ticagrelor or clopidogrel treatment.Methods and resultsIn the RE-DUAL PCI trial, 2725 patients were randomized to dabigatran 110 mg or 150 mg with P2Y12 inhibitor, or warfarin with P2Y12 inhibitor and aspirin. Mean follow-up was 14 months, 50.5% had ACS, and 12% received ticagrelor. The risk of the primary endpoint, major or clinically relevant non-major bleeding event, was reduced with both dabigatran dual therapies vs. warfarin triple therapy in patients with ACS [hazard ratio (95% confidence interval), 0.47 (0.35–0.63) for 110 mg and 0.67 (0.50–0.90) for 150 mg]; elective PCI [0.57 (0.43–0.76) for 110 mg and 0.76 (0.56–1.03) for 150 mg]; receiving ticagrelor [0.46 (0.28–0.76) for 110 mg and 0.59 (0.34–1.04) for 150 mg]; or clopidogrel [0.51 (0.41–0.64) for 110 mg and 0.73 (0.58–0.91) for 150 mg], all interaction P-values >0.10. Overall, dabigatran dual therapy was comparable to warfarin triple therapy for the composite endpoint of death, myocardial infarction, stroke, systemic embolism, or unplanned revascularization, with minor variations across the subgroups, all interaction P-values >0.10.ConclusionThe benefits of both dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy in reducing bleeding risks were consistent across subgroups of patients with or without ACS, and patients treated with ticagrelor or clopidogrel.

Dual Anti-Thrombotic Therapy With Dabigatran After Percutaneous Coronary Intervention in Atrial Fibrillation - Japanese and East-Asian Subgroup Analysis of the RE-DUAL PCI Trial.

In the RE-DUAL PCI trial, dual anti-thrombotic therapy with dabigatran and a P2Y12inhibitor had a lower risk of bleeding and similar risk reduction of thromboembolic events, compared with warfarin triple therapy, in patients with NVAF undergoing PCI. This subanalysis investigated whether the efficacy and safety of dabigatran dual therapy in Japanese and East-Asian patients enrolled in the RE-DUAL PCI trial were similar to those of the overall patient population of the trial. Methods and Results: RE-DUAL PCI was a multicenter, randomized trial. The primary endpoint was the time to first International Society on Thrombosis and Hemostasis major or clinically relevant non-major bleeding events. Of the East-Asian patients (n=240) enrolled in the RE-DUAL PCI trial, 111 were Japanese and received dabigatran 110 mg (n=50) or 150 mg (n=13) dual therapy, or warfarin triple therapy (n=48). The incidence of the primary endpoint in Japanese patients was 26.0% and 29.2% with dabigatran 110-mg dual therapy and the corresponding warfarin triple therapy, and 23.1% and 30.8% with dabigatran 150-mg dual therapy and the corresponding warfarin triple therapy, respectively. Similar results were observed in the East-Asian population. This subanalysis of the RE-DUAL PCI trial demonstrated that, like in the overall patient population, dabigatran dual therapy may offer physicians additional options for managing Japanese and East-Asian patients with NVAF receiving PCI.

P3180The effect of PCI complexity on the efficacy and safety of dabigatran dual therapy vs warfarin triple therapy in atrial fibrillation: a subgroup analysis from the RE-DUAL PCI trial

P3180The effect of PCI complexity on the efficacy and safety of dabigatran dual therapy vs warfarin triple therapy in atrial fibrillation: a subgroup analysis from the RE-DUAL PCI trial

DOES RENAL FUNCTION INFLUENCE THE BENEFIT OF DUAL ANTITHROMBOTIC THERAPY WITH DABIGATRAN IN PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING PERCUTANEOUS CORONARY INTERVENTION? RESULTS FROM RE-DUAL PCI

The RE-DUAL PCI trial evaluated the safety and efficacy of dabigatran dual vs. warfarin triple therapy. As∼85% of dabigatran is renally excreted, renal function as assessed by creatinine clearance (CrCl) could influence treatment effects of dabigatran. The RE-DUAL PCI trial ([NCT02164864][1])

IS IT SAFE TO SWITCH OAC IN PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING PERCUTANEOUS CORONARY INTERVENTION? RESULTS FROM A RE-DUAL PCI SUBANALYSIS

The RE-DUAL PCI trial showed that bleeding risk was lower with dabigatran dual vs. warfarin triple therapy in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). We studied whether this lower bleeding risk was also present in patients who were long