Is VTE a Chronic Illness Requiring Long-term Anticoagulation?

Samuel Z. Goldhaber, MD


December 01, 2015

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PADIS-PE: Duration of Anticoagulation

Samuel Z. Goldhaber, MD: Hello. This is Dr Sam Goldhaber for the Clot Blog at at Medscape speaking to you from the European Society of Cardiology Congress in London. Today I'm going to speak about indefinite-duration anticoagulation for pulmonary embolism (PE) and deep vein thrombosis (DVT), and I'm going to highlight two important—in fact, I think, pivotal—clinical trials.

The first one called PADIS-PE[1] is a trial of about 370 PE patients who were randomly assigned either to standard-duration or to 18-month extended therapy with warfarin. We know that PE is a long-term illness and has a tendency to recur after anticoagulation is discontinued. In PADIS-PE, for the patients who received the extended-duration anticoagulation, there were virtually no recurrent venous thromboembolism (VTE) events while they were receiving warfarin.

As soon as warfarin was stopped, the event rate soared for recurrent VTE in patients who had received this additional year and a half of anticoagulation with warfarin. Extended-duration anticoagulation just postponed the recurrence until the time the warfarin was discontinued. Meanwhile, in the placebo group, who received placebo after the standard-duration anticoagulation, they had a very high recurrence rate from the start of the trial.

Bleeding Complications

In terms of bleeding complications, these patients were followed after warfarin was discontinued, and eventually the bleeding rates became—2 or 3 years down the road—pretty similar. During the 18-month period of the trial, where half the patients were receiving warfarin and the other half were receiving placebo, there was about a 2% major bleeding complication rate with warfarin.

In the same issue of JAMA, a meta-analysis[2] was done of 10 times as many patients (about 3700 patients) who received either extended-duration warfarin or short-term warfarin—3-6 months of warfarin—for treatment of acute DVT and PE. In the extended-duration group, the rate of recurrent VTE was reduced by 80% compared with the group that received short-term anticoagulation. The major bleeding complication rate in this meta-analysis was three times higher with warfarin compared with the group that had short-term anticoagulation.


We are now in the era of the novel oral anticoagulants (NOACs). What we find with the NOACs is that they have a markedly lower rate of major bleeding complications and of fatal bleeding complications and of intercranial hemorrhage compared with warfarin. It's quite possible that we've now entered the situation where the benefits of anticoagulation far outweigh the risks, and the benefit-to-risk ratio has really changed, with the risk dropping dramatically due to the lower bleeding rate with the NOACs.

I think what we're going to see in the future is more recognition that VTE is a chronic illness and more of a tendency for utilization of extended-duration anticoagulation.

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


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