Sean T Chen1, Anne S Hellkamp1, Richard C Becker2, Scott D Berkowitz3, Günter Breithardt4, Keith A A Fox5, Werner Hacke6, Jonathan L Halperin7, Graeme J Hankey8, Kenneth W Mahaffey9, Christopher C Nessel10, Jonathan P Piccini1, Daniel E Singer11, Manesh R Patel1, Chiara Melloni1. 1. Duke Clinical Research Institute, Department of Medicine, 2400 Pratt St, Durham, NC, USA. 2. Division of Cardiovascular Health and Diseases, University of Cincinnati College of Medicine, 3590 Lucille Drive Suite 2700, Cincinnati, OH, USA. 3. Thrombosis and Hemostasis Group, Bayer U.S. LLC, 11 Waterview Blvd., Parsippany, NJ, USA. 4. Department of Cardiovascular Medicine, University of Münster, Albert-Schweitzer-Campus 1, Münster, Germany. 5. Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, 51 Little France Cres, Edinburgh, UK. 6. Department of Neurology, Ruprecht-Karls-University, Im Neuenheimer Feld 672, Heidelberg, Germany. 7. Cardiovascular Institute, Mount Sinai Medical Center, 1190 Fifth Avenue - 1 West, New York, NY, USA. 8. The University of Western Australia, School of Medicine and Pharmacology, 35 Stirling Highway Perth WA, Australia. 9. Department of Cardiovascular Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Stanford, CA, USA. 10. Janssen Research and Development LLC, 1000 US-202, Raritan, NJ, USA. 11. Department of Medicine, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street, Boston, MA, USA.
Abstract
AIMS: The management of anticoagulation therapy in patients with atrial fibrillation (AF) and cancer is challenging due to increased thrombotic and bleeding risks. We sought to determine the safety and efficacy of rivaroxaban in patients with AF and a history of cancer. METHODS AND RESULTS: ROCKET AF randomized 14 264 patients with AF torivaroxaban or warfarin with a median follow-up of 1.9 years. Cox regression models were used to assess the association between cancer history and clinical outcomes, and the relative treatment effect of rivaroxaban vs. warfarin in these patients. A total of 640 patients enrolled in ROCKET AF had a history of cancer, with the most common types being prostate (28.6%), colorectal (16.1%), and breast (14.7%) cancer. Patients with a history of cancer were older, more frequently male, more likely to have prior vitamin K antagonist (VKA) use and had higher rates of overall bleeding [hazard ratio (HR) 1.30, 95% confidence interval (CI) 1.16-1.47; P < 0.0001] and non-cardiovascular death (HR 1.47, 95% CI 1.04-2.07; P = 0.031) compared with those with no cancer history. There were no significant associations between cancer history and stroke, venous thromboembolism, or myocardial infarction. The relative efficacy of rivaroxaban vs. warfarin for prevention of stroke/systemic embolism was similar in those with and without a history of cancer (interaction P-value = 0.21). CONCLUSION: In ROCKET AF, a history of cancer was associated with a higher risk of bleeding and non-cardiovascular death, but not ischaemic events. The relative efficacy and safety of rivaroxaban compared with warfarin were not significantly different in patients with and without a history of cancer. The results of this study are exploratory and should be taken in context of the study population, which may not be generalizable to those with advanced malignancy. Further investigation is needed to understand optimal anticoagulation strategies in patients with AF and cancer.Clinical trial registration: ClinicalTrials.gov: NCT00403767. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: The management of anticoagulation therapy in patients with atrial fibrillation (AF) and cancer is challenging due to increased thrombotic and bleeding risks. We sought to determine the safety and efficacy of rivaroxaban in patients with AF and a history of cancer. METHODS AND RESULTS: ROCKET AF randomized 14 264 patients with AF to rivaroxaban or warfarin with a median follow-up of 1.9 years. Cox regression models were used to assess the association between cancer history and clinical outcomes, and the relative treatment effect of rivaroxaban vs. warfarin in these patients. A total of 640 patients enrolled in ROCKET AF had a history of cancer, with the most common types being prostate (28.6%), colorectal (16.1%), and breast (14.7%) cancer. Patients with a history of cancer were older, more frequently male, more likely to have prior vitamin K antagonist (VKA) use and had higher rates of overall bleeding [hazard ratio (HR) 1.30, 95% confidence interval (CI) 1.16-1.47; P < 0.0001] and non-cardiovascular death (HR 1.47, 95% CI 1.04-2.07; P = 0.031) compared with those with no cancer history. There were no significant associations between cancer history and stroke, venous thromboembolism, or myocardial infarction. The relative efficacy of rivaroxaban vs. warfarin for prevention of stroke/systemic embolism was similar in those with and without a history of cancer (interaction P-value = 0.21). CONCLUSION: In ROCKET AF, a history of cancer was associated with a higher risk of bleeding and non-cardiovascular death, but not ischaemic events. The relative efficacy and safety of rivaroxaban compared with warfarin were not significantly different in patients with and without a history of cancer. The results of this study are exploratory and should be taken in context of the study population, which may not be generalizable to those with advanced malignancy. Further investigation is needed to understand optimal anticoagulation strategies in patients with AF and cancer.Clinical trial registration: ClinicalTrials.gov: NCT00403767. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Anne Gulbech Ording; Mette Søgaard; Flemming Skjøth; Erik Lerkevang Grove; Gregory Y H Lip; Torben Bjerregaard Larsen; Peter Brønnum Nielsen Journal: Cancer Med Date: 2021-06-11 Impact factor: 4.452
Authors: Alfonso J Tafur; Nathan P Clark; Alex C Spyropoulos; Na Li; Eric Kaplovitch; Kira MacDougall; Sam Schulman; Joseph A Caprini; James Douketis Journal: J Am Heart Assoc Date: 2020-09-24 Impact factor: 5.501