Dr. Sam Goldhaber discusses some of the important thrombosis-related trials set to be released at the 2018 European Society of Cardiology Congress in Munich, Germany.
Hello. I am Dr. Sam Goldhaber, President of NATF, and today on Clot Chronicles, I’m going to talk about two important thrombosis trials that are being presented at the European Society of Cardiology in Munich at the end of August 2018. The European Society of Cardiology, or ESC, is the largest cardiology meeting in the world and it attracts more than 30,000 to 40,000 cardiologists. At this meeting, there will be two trials that will be of interest to the NATF viewers.
The first one is called COMMANDER. It’s a trial of heart failure patients who have a reduced ejection fraction, that means reduced pumping capacity of their heart, and they also have coronary artery disease. They are going to be randomized either to a very low dose of rivaroxaban, sometimes called Xarelto, 2.5 mg twice a day. Now that dose is only 25% of the dose that is commonly used to prevent strokes in atrial fibrillation or to treat patients who’ve suffered from deep vein thrombosis (DVT) or pulmonary embolism (PE). Of course, in the COMMANDER trial, it is a randomized, double blind, placebo controlled trial, so half of the patients will be receiving a placebo for rivaroxaban after their episode of heart failure in the presence of coronary artery disease.
At the end of the study, unblinding will take place to determine whether rivaroxaban reduced all cause mortality, cardiovascular mortality, heart attack, or stroke. We all are waiting with baited breath to see what the answer to this will be. All of these patients in the COMMANDER trial have a normal sinus rhythm, not atrial fibrillation, at the time they are entered into the trial. Therefore, using anticoagulation at the moment in these heart failure patients is not the standard of care. We look forward to seeing the results.
The other trial being presented at the ESC meeting is called MARINER. This is a trial of rivaroxaban versus not receiving rivaroxaban for patients who have had medical illness and are just being discharged from the hospital. They will receive extended duration rivaroxaban or placebo for the month following hospital discharge to determine whether the prescription of rivaroxaban will reduce recurrent or initial pulmonary embolism, or DVT, or other cardiovascular endpoints.
Right now, the only anticoagulant that is approved for extended duration venous thromboembolism (VTE) prophylaxis after discharge from the hospital in medically ill patients is betrixaban. If MARINER is a positive study, then potentially after further regulatory review, there could be two anticoagulants that are available, rather than just betrixaban. And, of course, if MARINER is a negative trial, then betrixaban will stand alone as the only anticoagulant with FDA approval for extended duration prophylaxis against VTE in medically ill patients after they are discharged from the hospital.
This is Sam Goldhaber, MD, signing off for the Clot Chronicles.