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Oral anticoagulant therapy with rivaroxaban is a safe alternative to Vitamin K antagonist (VKA) therapy in patients with atrial fibrillation who are undergoing elective cardioversion to restore a normal heart rhythm, according to results presented today at ESC Congress 2014.
BARCELONA, Spain – Tuesday 2 September 2014: Oral anticoagulant therapy with rivaroxaban is a safe alternative to Vitamin K antagonist (VKA) therapy in patients with atrial fibrillation who are undergoing elective cardioversion to restore a normal heart rhythm, according to results presented today at ESC Congress 2014.In addition, rivaroxaban may potentially have one important advantage over VKAs, the study suggests.Findings from the X-VeRT (eXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in patients with nonvalvular aTrial fibrillation scheduled for cardioversion) trial were presented in a congress Hot Line session.
“The practical advantage of rivaroxaban was demonstrated by the short time to cardioversion compared to patients treated with VKAs,” said the study’s co-principal investigator Riccardo Cappato, MD, from the University of Milan, in Milan, Italy. However, since time to cardioversion was not a prespecificed outcome of the study, this finding should be interpreted with caution, he added.
While the use of VKAs before and after cardioversion to reduce the risk of clotting is the current standard of care, endorsed by guidelines from the ESC as well as the American Heart Association, American College of Cardiology, and Heart Rhythm Society, a major obstacle to this practice is that at least 3 weeks of treatment is required to achieve adequate anticoagulation,” noted co-principal investigator Michael Ezekowitz MD , PhD, from the Sidney Kimmel Medical School at the Thomas Jefferson University in Philadelphia Pennsylvania.The pharmacological characteristics of rivaroxaban are particularly useful in the setting of elective cardioversion because it has a rapid onset of action, within 2–4 hours, which can expedite cardioversion, he explained.X-Vert is the first prospective, randomised trial to examine the safety and efficacy of rivaroxaban compared to VKA therapy in patients undergoing elective cardioversion for the treatment of atrial fibrillation. It included 1 504 patients from 141 centres and 16 countries, who were scheduled to undergo either electrical (97.6%) or pharmacological (2.4%) cardioversion. Overall, 1 002 patients were randomised to oral rivaroxaban 20 mg once daily and 502 patients to VKA (warfarin or another VKA at the investigator’s discretion, based on local standard of care). Using established guidelines, patients were assigned to either early (58%) or delayed (42%) cardioversion. Cardioversion in the delayed group was allowed if at least 3 consecutive weeks of adequate anticoagulation was documented prior to cardioversion. VKA anticoagulation was considered adequate if the international normalised ratio (INR) was maintained in the range of 2.0–3.0 for that time period, while anticoagulation with rivaroxaban was considered adequate by drug compliance of at least 80% for that time period. Cardioversion in the early group was performed within a target range of one to five days after randomisation, while patients in the delayed cardioversion group had it performed between 21 and 25 days after randomisation. The study found that compared to patients taking a VKA, patients treated with rivaroxaban had a similar of risk of the primary composite outcome of stroke or transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. This composite outcome occurred in 0.5% of the rivaroxaban group versus 1.02% of the VKA group, a difference that was not considered statistically significant. In the early cardioversion group, the primary composite occurred in 0.71% of rivaroxaban-treated patients and 1.08% of VKA-treated patients, whereas in the delayed cardioversion group it occurred in 0.24% and 0.93% patients in the rivaroxaban and VKA groups, respectively.
“Although the study was not powered for statistical significance, the Steering Committee felt that a descriptive comparison of 1500 patients would give clinically meaningful information,” explained Professor Cappato.
For the primary safety outcome of major bleeding, there was no difference between the rivaroxaban and VKA groups (0.61% vs 0.80%, respectively; RR 0.76). No clinically important differences in the overall cumulative incidence of adverse events and serious adverse events by treatment assignment or by cardioversion strategy were observed. In the early cardioversion group, the time between randomisation and cardioversion was similar in both treatment arms (median 1 day), but in the delayed group, patients treated with rivaroxaban had a significantly shorter wait for cardioversion compared to the VKA-treated patients (median 22 vs 30 days, P < 0.001) “because of the inability to achieve adequate anticoagulation prior to cardioversion in the VKA group,” noted Professor Cappato. Professor Ezekowitz added that “X-VeRT illustrates the ease of using rivaroxaban in the setting of cardioversion by capitalising on its rapid onset of action.” In conclusion, Professor Cappato noted
“these data are preliminary; however, they offer the first evidence that oral rivaroxaban can be safely used as a possible alternative to VKA therapy for preventing thromboembolic events in patients undergoing elective cardioversion.”
About the European Society of CardiologyThe European Society of Cardiology (ESC) represents more than 80 000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe. About ESC Congress 2014The ESC Congress is currently the world's largest international congress in cardiovascular medicine. The spotlight of this year's event is “innovation and the heart”. ESC Congress 2014 takes place from 30 August to 3 September at the Fira Gran Via in Barcelona, Spain. For more information on ESC Congress 2014 contact the ESC Press Office.To access all the scientific resources from the sessions during the congress, visit ESC Congress 365. This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2014. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.SOURCES OF FUNDING: The trial was sponsored by Bayer HealthCare Pharmaceuticals, Germany, and Janssen Scientific Affairs LLC, USA. DISCLOSURES: Professor Cappato has received consultancy fees from Boston Scientific, Medtronic, St. Jude, Biosense Webster, ELA Sorin, Boehringer Ingelheim, Bayer HealthCare, and Abbott; Pfizer; speaker’s bureau fees from Boston Scientific, Medtronic, St. Jude, Biosense Webster, BARD, sanofi-aventis, Boehringer Ingelheim, Bayer HealthCare, and Abbott; investigator fees from Medtronic, Biosense Webster sanofi-aventis, Cameron Health, BARD, Bayer HealthCare, Abbott, and Pfizer; grants from Boston Scientific, Medtronic, St. Jude, Biosense Webster, BARD, and ELA Sorin; and holds equity and intellectual property rights with Cameron Health. The co-primary investigator, Dr. Michael Ezekowitz, is a consultant and speaker for Boehringer Ingelheim and a consultant for Pfizer, Sanofi- Aventis, Bristol-Myers Squibb, Portola, Bayer, Daichii Sankyo, Medtronic, Aegerion, Merck, Johnson & Johnson, Gilead, Janssen Scientific Affairs, Pozen Inc., and Coherex. Other co-authors report the following:A.L.K. has received honoraria from book publishers Elsevier and LWW. C.S.M. reports no relevant disclosures. A.J.C. has received personal fees from Sanofi-Aventis, Boehringer Ingelheim, Bayer, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, GlaxoSmithKline, Meda, and Servier. J.Y.L.H. has received consultancy fees from Sanofi-Aventis, Boehringer Ingelheim, Bayer, Bristol-Myers Squibb/Pfizer, Daiichi Sankyo, GlaxoSmithKline, Meda, and Servier. M.T. has received consultancy fees and research funding from Bayer, Boehringer Ingelheim, and Bristol-Myers Squibb. M.I.S. has received consultancy and lecture fees from Bayer, Bristol-Myers Squibb/Pfizer, Johnson & Johnson, St Jude Medical, and Boston Scientific. P.E.V. has received educational grants and consultancy fees from Servier, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Menarini, Respicardia, and Pfizer.P.K. has received consultancy fees and honoraria from 3M Medica, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cardiome, Daiichi Sankyo, MEDA Pharma, Medtronic, Merck, Otsuka, Pfizer, Sanofi-Aventis, Servier, Siemens, and Takeda; and research grants from 3M Medica, Cardiovascular Therapeutics, Daiichi Sankyo, MEDA Pharma, Medtronic, OMRON, and St Jude Medical. S.H.H. has received consultancy and lecture fees from Sanofi- Aventis, Boehringer Ingelheim, Bayer, Bristol-Myers Squibb/Pfizer, Johnson & Johnson, St Jude Medical, Cardiome, Gilead, Servier, Boston Scientific, and Medtronic. V.L., M.H., I.L.M., and M.vE. are employees of Bayer HealthCare; P.W. is an employee of Janssen Scientific Affairs, LLC and a shareholder in Johnson & Johnson.