Study shows ability of new agent to prevent strokes in patients with atrial fibrillation
In the primary result from the largest double-blind study ever completed to assess a drug's effect in the prevention of stroke in patients with atrial fibrillation, a common heart rhythm abnormality, rivaroxaban, an anti-clotting drug, was shown to be an attractive alternative to warfarin, the current standard for treatment of atrial fibrillation.
The full intention-to-treat analysis, which includes patients who discontinued study drug, showed that rivaroxaban was noninferior to warfarin for the prevention of stroke or blood clots. Importantly, rivaroxaban use led to less intra-cranial and fatal bleeding.
The findings, co-authored by a research team from the Duke Clinical Research Institute, were published online today in the New England Journal of Medicine.
"Warfarin has been a standard treatment for decades, but requires a rigorous monitoring schedule to ensure therapeutic dosing levels, and is subject to the potential of food and drug interactions that present treatment obstacles for patients and doctors alike," said the study's lead author, Manesh R. Patel, MD assistant professor of medicine at Duke University School of Medicine.
"The results of this large global trial have convincingly shown rivaroxaban to be an alternative to warfarin in treating patients with atrial fibrillation and, importantly, with no increase in bleeding."
Atrial fibrillation is the most common abnormal heart rhythm disorder in the U.S. and is characterized by an unusual and dangerously fast heart beat. It can cause blood to pool in the heart resulting in the formation of clots that may become lodged in the artery to the brain resulting in a stroke, or in formation of non-central nervous system blood clots.
Approximately 2.2 million Americans suffer from atrial fibrillation, which increases a person's stroke risk by four to six times on average.
Warfarin has been documented over the years to reduce the rate of stroke for those who have atrial fibrillation by approximately one-half to two-thirds, at the cost of increased bleeding.
"In addition to addressing an important therapeutic need for patients with atrial fibrillation, ROCKET AF provides a model for how clinical trials of investigational therapies should be conducted to assess safety and efficacy prior to FDA submission," said Robert M. Califf, MD, the study's co-chair, who is vice chancellor for clinical research at Duke University School of Medicine, and director of the Duke Translational Medicine Institute.
"The sponsors of the study should be congratulated for taking this approach in which an international committee of leaders in the field designed the trial and provided independent oversight, including an independent analysis of the trial results," Califf added.
The ROCKET AF (Rivaroxaban once daily oral direct factor xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation) study included 14,264 patients with atrial fibrillation who had a history of stroke or additional independent risk factors for future stroke and were randomized to receive either rivaroxaban or warfarin. The trial included more than 1,100 centers in 45 countries.
In the analysis of the intent to treat population -- patients followed from the time of entry and throughout the full study duration, even if they discontinued study medication -- rivaroxaban was not inferior to warfarin (p< 0.001) and showed a nonsignificant trend toward benefit compared to warfarin (event rates = 2.12 vs. 2.42).
Rates of bleeding and adverse events were similar between treatment groups. Compared to warfarin, rivaroxaban showed similar rates for the principal safety measure of major and non-major clinically relevant bleeding events (event rates = 14.9 vs. 14.5, p=0.442). Rates of major bleeding were also comparable between rivaroxaban and warfarin (event rates = 3.6 vs. 3.4, p=0.576).
Patients treated with rivaroxaban had significantly fewer intracranial hemorrhages (event rates = 0.4 vs. 0.7), critical organ bleeds (event rates = 0.8 vs. 1.2) and bleeding-related deaths (event rates = 0.2 vs. 0.5) compared with warfarin, respectively. However, patients treated with rivaroxaban did show increased rates of hemoglobin/hematocrit drop (event rates = 2.8 vs. 2.3) and transfusions (event rates = 1.7 vs. 1.3), compared to warfarin.
"Atrial fibrillation is becoming increasingly prevalent and can be life-threatening if not properly managed. Stroke prevention is a key treatment goal in atrial fibrillation management," said Keith A. A. Fox, MB ChB, professor of cardiology at the University and Royal Infirmary of Edinburgh, Centre for Cardiovascular Science, in Edinburgh, UK, and one of the study's co-leaders "Rivaroxaban appears to be an attractive and well-tolerated clinical alternative to warfarin for patients with atrial fibrillation."
Provided by Duke University Medical Center
- New agent to prevent strokes in patients with atrial fibrillation shown in major study Nov 16, 2010 | not rated yet | 0
- New anti-clotting drug added to recommendations for treating irregular heartbeat Feb 14, 2011 | not rated yet | 0
- Blood-Thinning Drug Linked to Increased Bleeding in Brain Sep 29, 2008 | not rated yet | 0
- Experimental blood thinner gets high marks Nov 17, 2010 | not rated yet | 0
- J&J wins US approval for new blood thinner Jul 02, 2011 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
The idea behind a reverse shock
4 hours ago So in a supernova explosion for example (5th slide) http://www.astro.princeton.edu/~burrows/classes/541/blastwavesChisari.pdf Ambient medium is...
Guass's Law for a charge distribution
4 hours ago First, this is not a homework question, just something I've been confused about for some time. I understand how to use Guass's law in many ways but...
5 hours ago Hello :) i'm new to this forum, so excuse me for my straightforwardness ;) I'm working on my bachelor work and i can't find a solution. I'm writing...
siphon and bernouli theorum
6 hours ago 1. I found this diagram on book but there weren't any description.can someone tell me, what its trying to tell specially by those two red lines...
Hot gas expansion rate into outer space
6 hours ago Good Morning Sirs, it seems to be surprisingly hard to get the numbers of a mystery: How fast expand hot rocket exhaust gases into empty space? ...
Magnetic field lines through copper
12 hours ago Hello. Assume an electron gun, as in CRT, made of plumbing copper instead of glass. Using magnetic scanning coils to move electron beam. Will the...
- More from Physics Forums - Classical Physics
More news stories
Heart failure accelerates the aging process and brings on early andropausal syndrome (AS), according to research presented today at the Heart Failure Congress 2013. AS, also referred to as male 'menopause', was four times ...
Cardiology 10 hours ago | not rated yet | 1
Mortality and length of stay are highest in heart failure patients admitted in January, on Friday, and overnight, according to research presented today at the Heart Failure Congress 2013. The analysis of nearly 1 million ...
Cardiology 10 hours ago | not rated yet | 0
Coenzyme Q10 decreases all cause mortality by half, according to the results of a multicentre randomised double blind trial presented today at Heart Failure 2013 congress. It is the first drug to improve heart failure mortality ...
Cardiology 10 hours ago | 5 / 5 (2) | 5
Transcatheter aortic valve implantation (TAVI) is effective and safe in Asian patients, according to early experience based on first results from a multicentre Asian registry reported at EuroPCR 2013.
Cardiology May 24, 2013 | not rated yet | 0
Routinely measuring fractional flow reserve (FFR) using pressure wire assessment during coronary angiography for diagnosis of chest pain leads to significant changes in the management of one in four patients, according to ...
Cardiology May 24, 2013 | not rated yet | 0
(HealthDay)—Animals make great companions for senior citizens, but elderly people who always drive with a pet in the car are far more likely to crash than those who never drive with a pet, researchers have ...
2 hours ago | not rated yet | 0
(AP)—Department of Justice lawyers have again asked a federal appeals court in New York to delay lifting age restrictions and prescription requirements on an emergency contraceptive popularly known as the morning-after ...
10 hours ago | not rated yet | 0
(Medical Xpress)—A research team, led by Jeremy Barr, a biology post-doctoral fellow, unveils a new immune system that protects humans and animals from infection.
May 20, 2013 | 4.8 / 5 (30) | 9 |
Until now, little was scientifically known about the human potential to cultivate compassion—the emotional state of caring for people who are suffering in a way that motivates altruistic behavior.
May 22, 2013 | 5 / 5 (4) | 6 |
Women at a particular stage in their monthly menstrual cycle may be more vulnerable to some of the psychological side-effects associated with stressful experiences, according to a study from UCL.
May 24, 2013 | 4 / 5 (4) | 4 |
Salamanders' immune systems are key to their remarkable ability to regrow limbs, and could also underpin their ability to regenerate spinal cords, brain tissue and even parts of their hearts, scientists have ...
May 20, 2013 | 4.9 / 5 (7) | 5 |