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EFFICACY AND SAFETY OF EDOXABAN IN PATIENTS WITH ATRIAL FIBRILLATION AND ACTIVE MALIGNANCY: AN ANALYSIS OF ENGAGE AF – TIMI 48 RANDOMIZED CLINICAL TRIAL
325 JACC March 21, 2017 Volume 69, Issue 11
Arrhythmias and Clinical EP EFFICACY AND SAFETY OF EDOXABAN IN PATIENTS WITH ATRIAL FIBRILLATION AND ACTIVE MALIGNANCY: AN ANALYSIS OF ENGAGE AF - TIMI 48 RANDOMIZED CLINICAL TRIAL Moderated Poster Contributions Arrhythmias and Clinical EP Moderated Poster Theater, Poster Hall, Hall C Saturday, March 18, 2017, 12:30 p.m.-12:40 p.m. Session Title: Stroke and AF: Thinking About the Heart Abstract Category: 6. Arrhythmias and Clinical EP: Other Presentation Number: 1223M-03 Authors: Christina Fanola, Christian Ruff, Sabina Murphy, James Jin, Anil Duggal, Michele Mercuri, Elliott Antman, Eugene Braunwald, Robert Giugliano, TIMI Study Group, Brigham and Women’s Hospital, Boston, MA, USA, Harvard Medical School, Boston, MA, USA
Background: Anticoagulation in cancer pts with AF is a challenge due to the prothrombotic state and potential for bleeding associated with malignancy. Data on NOACs in cancer are sparse. Our aim is to evaluate the efficacy and safety of edoxaban in AF pts with active malignancy.
Methods: ENGAGE AF - TIMI 48 randomized 21,105 pts with AF on edoxaban or warfarin. Pts with active malignancy, defined as a post-randomization new diagnosis or recurrence of remote cancer, were followed for clinical events over a median 2.8 yrs. Kaplan-Meier analyses assessed rates of endpoints at 3 yrs by malignancy status, and Cox proportional hazard models evaluated safety and efficacy of edoxaban vs. warfarin.
Results: Overall 1,153 (5.5%) pts developed cancer, with the most common sites being GI (n=179, 15.6%), prostate (n=157, 13.6%), and lung (n=127, 11.0%). Compared to those without, pts with active malignancy had increased death (12.0%/yr vs. 3.6%/yr; univariate HR 3.3, 95% CI 3.0-3.7) and major bleeding (7.4%/yr vs. 2.5%/yr; HR 2.9, CI 2.4-3.4), but not stroke/SEE (HR 0.8, CI 0.6-1.2). In pts with cancer, edoxaban was effective in the prevention of stroke/SEE vs. warfarin, and had a similar risk of major bleeding (Figure 1) and death. No significant treatment interaction was observed by malignancy status for efficacy and safety endpoints. Conclusions: In pts with AF and active malignancy, edoxaban was a safe and efficacious alternative to warfarin. An ongoing need exists for randomized clinical trials of NOACs in AF and cancer.
Arrhythmias and Clinical EP EFFICACY AND SAFETY OF EDOXABAN IN PATIENTS WITH ATRIAL FIBRILLATION AND ACTIVE MALIGNANCY: AN ANALYSIS OF ENGAGE AF - TIMI 48 RANDOMIZED CLINICAL TRIAL Moderated Poster Contributions Arrhythmias and Clinical EP Moderated Poster Theater, Poster Hall, Hall C Saturday, March 18, 2017, 12:30 p.m.-12:40 p.m. Session Title: Stroke and AF: Thinking About the Heart Abstract Category: 6. Arrhythmias and Clinical EP: Other Presentation Number: 1223M-03 Authors: Christina Fanola, Christian Ruff, Sabina Murphy, James Jin, Anil Duggal, Michele Mercuri, Elliott Antman, Eugene Braunwald, Robert Giugliano, TIMI Study Group, Brigham and Women’s Hospital, Boston, MA, USA, Harvard Medical School, Boston, MA, USA
Background: Anticoagulation in cancer pts with AF is a challenge due to the prothrombotic state and potential for bleeding associated with malignancy. Data on NOACs in cancer are sparse. Our aim is to evaluate the efficacy and safety of edoxaban in AF pts with active malignancy.
Methods: ENGAGE AF - TIMI 48 randomized 21,105 pts with AF on edoxaban or warfarin. Pts with active malignancy, defined as a post-randomization new diagnosis or recurrence of remote cancer, were followed for clinical events over a median 2.8 yrs. Kaplan-Meier analyses assessed rates of endpoints at 3 yrs by malignancy status, and Cox proportional hazard models evaluated safety and efficacy of edoxaban vs. warfarin.
Results: Overall 1,153 (5.5%) pts developed cancer, with the most common sites being GI (n=179, 15.6%), prostate (n=157, 13.6%), and lung (n=127, 11.0%). Compared to those without, pts with active malignancy had increased death (12.0%/yr vs. 3.6%/yr; univariate HR 3.3, 95% CI 3.0-3.7) and major bleeding (7.4%/yr vs. 2.5%/yr; HR 2.9, CI 2.4-3.4), but not stroke/SEE (HR 0.8, CI 0.6-1.2). In pts with cancer, edoxaban was effective in the prevention of stroke/SEE vs. warfarin, and had a similar risk of major bleeding (Figure 1) and death. No significant treatment interaction was observed by malignancy status for efficacy and safety endpoints. Conclusions: In pts with AF and active malignancy, edoxaban was a safe and efficacious alternative to warfarin. An ongoing need exists for randomized clinical trials of NOACs in AF and cancer.