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Evidence on safety, efficacy of newer oral anticoagulants in patients with VTE continues to mount

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HOLLYWOOD, Fla. — In patients with venous thromboembolism, treatment with non-vitamin K oral anticoagulants is safer than warfarin without compromising efficacy, according to a speaker at the International Symposium on Endovascular Therapy.

Compared with warfarin, the non-vitamin K oral anticoagulants have lower rates of major bleeding in patients with VTE, and are more convenient because treatment does not require routine monitoring, Ian Del Conde, MD, FACC, section head of vascular medicine at Miami Cardiac and Vascular Institute, said here.

“There is now plenty of evidence about what these drugs do and don’t do, and how patients behave on them,” he said.

Ian Del Conde

It has been demonstrated that dabigatran (Pradaxa, Boehringer Ingelheim) and edoxaban (Savaysa, Daiichi Sankyo) require a heparin or low-molecular-weight heparin bridge before use in patients with VTE, but rivaroxaban (Xarelto, Janssen Pharmaceuticals) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) do not. Moreover, the four oral anticoagulants are all noninferior to low-molecular-weight heparin/warfarin for efficacy.  

In previous meta-analyses, the non-vitamin K oral anticoagulants conferred a 57% risk reduction for intracranial hemorrhage, a 28% risk reduction for major bleeding and a 24% risk reduction for total bleeding compared with warfarin, according to information discussed by Del Conde.

In the HOKUSAI trial, a prespecified subanalysis of 938 patients with severe pulmonary embolism, edoxaban showed superiority compared with warfarin in risk for recurrent VTE (3.4% vs. 6.2%; HR = 0.52; 95% CI, 0.28-0.98). Thus, edoxaban may be the drug of choice for patients with submassive PE, Del Conde said.

Data suggest that before low-risk procedures, the non-vitamin K oral anticoagulants should be stopped 1 day in advance, and 2 days in advance of high-risk procedures. However, 1 or even 2 extra days of delay may be necessary for patients with advanced renal dysfunction or those who are undergoing a very high-risk procedure “in which bleeding would be absolutely unacceptable,” Del Conde said.

“All of the [non-vitamin K oral anticoagulants] are as effective as [warfarin] and safer,” he said. “There are no head-to-head comparisons among the [non-vitamin K oral anticoagulants] and none are expected. For the treatment of [VTE], [non-vitamin K oral anticoagulants] offer a very advantageous efficacy/safety profile.” – by Erik Swain

Reference:

Del Conde I. Focused Symposium VI: Fundamentals of Endovascular Therapy. Presented at: International Symposium on Endovascular Therapy; Feb. 4-8, 2017; Hollywood, Fla.

Disclosure: Del Conde reports consulting for Merck and New Haven Pharmaceuticals; serving on an advisory board for IC Sciences and Merck; and speaking for Bristol-Myers Squibb, Johnson & Johnson and Pfizer.