NOACs Cut Bleeding vs Warfarin Following Acute VTE

Samuel Z. Goldhaber, MD


February 04, 2016

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Samuel Z. Goldhaber, MD: Hello. This is Dr Sam Goldhaber from the Clot Blog at on Medscape, speaking to you from the American Heart Association (AHA) 2015 Scientific Sessions in Orlando.

Today, I'm going to speak about bleeding complications from treating patients with acute [deep vein thrombosis] DVT or pulmonary embolism (PE), either with dabigatran [Pradaxa, Boehringer Ingelheim] or with low-molecular-weight heparin as a bridge to warfarin.

There seems to be a lot of concern among professionals and among the lay public about bleeding rates with the novel oral anticoagulants. There are many television commercials from lawyers suggesting that the bleeding rates on the novel oral anticoagulants are actually higher than those with warfarin.

But, in fact, this has been studied in carefully performed randomized controlled trials, and what is found in treating acute DVT and acute venous thromboembolism (VTE) is that, in fact, the bleeding rates with the novel oral anticoagulants are considerably lower than those with low-molecular-weight heparin as a bridge to warfarin. Fatal bleeds, major bleeds, and intracranial hemorrhage are reduced by the order of about 50% compared with low-molecular-weight heparin as a bridge to warfarin when treating acute PE or acute DVT.

What I'm going to do now is drill down on a specific study that was recently published, looking at the experience treating acute VTE either with dabigatran or with low-molecular-weight heparin as a bridge to warfarin [Dr Goldhaber is a coauthor].[1] This study did a meta-analysis of the RE-COVER I study[2] and the RE-COVER II study,[3] comprising about 5000 patients with acute DVT or acute PE. What was found is that the bleeding complication rate with dabigatran of any bleeding was about 40% lower than that with low-molecular-weight heparin as a bridge to warfarin.

In addition, there was a marked reduction in clinically relevant nonmajor bleeding events with dabigatran compared with warfarin. So, it turns out, in this specific trial of patients with acute venous thromboembolism, whether one looks at any bleeding or whether one looks at clinically relevant nonmajor bleeding, dabigatran had a much better safety profile than warfarin.

When one adds into the equation the added convenience of using a novel oral anticoagulant, which is given in fixed dose — where you don't have to worry about getting any laboratory coagulation values or any dose adjustment — dabigatran becomes an important option, just like the other novel oral anticoagulants, for treatment of acute DVT and pulmonary embolism. I think we could use these data to reassure our patients that the science and that the clinical trials supported a better safety profile for the novel oral anticoagulants than for warfarin — with respect to reduced bleeding with the novel oral anticoagulants — in the treatment of acute PE and acute DVT.

This is Dr Sam Goldhaber signing off for the Clot Blog.


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