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Rivaroxaban vs enoxaparin for the Prevention of Venous Thromboembolism..

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Hi this is claude yancey here the 2011 american college of cardiology meeting delighted to bring to you trials and p is a very important segment on the heart org it gives us the opportunity to discuss with you and with the principal investigators here at the acc meeting the important late-breaking clinical trials so to start our discussion about the magellan trial

I’m delighted to introduce to you and dirk owen who is an investigator from great britain and has had a ton of experience in this field welcome thanks so much for being a thank you god i would love for you to start off by just setting up the premise why this study why another study you’ve got so much evidence already about rivaroxaban why this study well we did this

Study because about 60% of the attributable risk of venous thrombosis is in medical patients and not in surgical patients so we see about 25% of the attributable risk being related to surgery and about 60% related to non-surgical illnesses right so as you decided to recruit your patients i’m fascinated at how you collected them how did you identify the patients to

Role in this study well it’s it’s a fairly well-worn path there’s been a number of studies previous to this that myself and other investigators have been involved in in 1999 we published the mid nock study which looked at patients with heart failure respiratory failure infectious disease and inflammatory disease and then in 2004 we publish the prevent study which

Was the study using delta perrin and we looked at a similar group and in 2006 we published the artemis study with juice ponder paradox in this setting now we had a broader group of patients so we had patients not just with heart failure respiratory failure infectious disease and inflammatory disease we also had patients who had acute ischemic stroke and cancer so

We had a very broad acutely ill medical patient group so in addition to recruiting this very large patient population of 8,000 individuals with medical illnesses where they are clearly at risk it really intrigues me to think about your study protocol so can you share that with us for a moment certainly the protocol in wrong patients over the age of 40 who had been

Hospitalized and we’re going to be immobile for at least four days one of those days being in hospital and the patients were randomized into a double-blind double dummy multicenter multinational study the two arms of the study where the the rivaroxaban are sore where they received 35 days of oral rivaroxaban ten milligrams daily or the anoxic parinama where they

Received 40 milligrams of an oxy parent subcutaneously once daily and after the first 10 days they then received placebo so very intriguing design is certainly set up to answer the important question of what is the advantage potentially rivaroxaban in this setting so let’s just get right to it what did you find well we had two primary efficacy outcomes because we

Had two questions the question of whether rivaroxaban was as effective as an ox perrin in the first 10 days because that was a head-to-head comparison sure and our studies showed that they were equally effective in the first ten days so you could take an oral medication and have just as much effect as a subcutaneous medication and equally effective as determined by

Similar statistical assessments or by a defined non-inferiority boundaries defined non-inferiority roundtree’s the the relative risk reduction was slightly less than one favoring rivaroxaban but it was so close to one and easily achieved non-inferiority based on a margin of 1.5 yes so the second question was working second question was would extended rivaroxaban

For 35 days be superior to shorter term prophylaxis with an ox apparent for 10 days and it was we got a 22% relative risk reduction so as we wrap this up for the audience two questions i think are very important first the take-home message our messages from magellan large volume deep vein thrombosis and thromboembolic disease and then the second one is to take

Advantage of your experience and look at the overall profile of risk and benefit for rivaroxaban because our viewership is wondering will would be using this drug and what are the things about which we should be concerned in terms of benefits what kind of benefits should we anticipate so crisply and quickly tell us about the take-home from magellan first well

The take-home message from magellan ah is that we’re still analyzing the data because there was more bleeding in the rivaroxaban both the day 10 and a day 35 and as a result of that there was not a clear net clinical benefit so very important so now we integrate that statement into everything else we have been trying to understand about rivaroxaban and all the

Different scenarios after orthopedic surgery and a setting of the deep vein thrombosis and setting fibrillation and now in these with these new data for magellan what are the two or three messages about reefer rocks abanazar out now that we can leave with up your ship well i think that this is an unusual finding we showed clear net clinical benefit in our other

Studies so in atrial fibrillation with the rocket af in the einstein studies of dvt treatment and dvt and pe extended treatment we showed net clinical benefit and of course in the record studies we showed net clinical benefit i think that these patients in the magellan study are different they’re older this they’re sicker there was the mortality rate was 5% at

30 days which is you know very high and they had far worse renal function over 60% had an elevated or reduced creatinine clearance i should say i think that these patients are completely different from the patients that we enrolled in the atrial fibrillation and the deep and the dvt and the orthopedic studies and so the the findings of magellan don’t translate into

These other areas and so it sounds like if we were trying to convey a message to the viewership we would say look we have a new anticoagulant it has a different mechanism of action than the other identical wide ones that we’ve been considering it certainly we have to be sensitive to the risk of bleeding there at one time was a concern about a panel toxicity i think

That’s been reduced somewhat by all the studies we have that’s right we saw absolutely no epidote ethnicity and we looked in a cumulative sense at 90 days and the liver function was perfect throughout and then finally it is conceivable that the way this drug is coming forward we will at first use be able to deploy it in a number of different clinical scenarios

Potentially for the benefit of our patients yeah and i think that’s true i mean i should point out that when we looked at the other factors like cardiovascular mortality total mortality there were no differences and in the outcomes there are a number of lives saved from the prevention of pommery embolism and dvt now we can’t forget that that’s why we’re treating

Those deep veins now as we’re talking about rivaroxaban i want to be complete here because i know that early on there were questions about to paddle toxicity but some of those questions are much less concerned now but your thoughts on that well i think the arab less concern and certainly in this large study of sick patients the magellan study there were no changes

In liver function that made us concerned so that at least factors into the equation but as we talked about already the net clinical benefit in the gellin study was neutral we didn’t really see that with rivaroxaban and some of that has to be in consideration of the risk of bleeding so that we put the benefit on formosus with the risk of bleeding and understand

Where we are so a lot of work still needs to be done but thanks to you and others we’re getting the answers that we think you could reshape that they’ve no cat bubba thanks

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Rivaroxaban vs enoxaparin for the Prevention of Venous Thromboembolism.. By theheartorg