Rivaroxaban Gains Approval In Europe For ACS Indication Reply

Rivaroxaban (Xarelto, Bayer) has been approved in Europe for the prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) following an acute coronary syndrome (ACS). The drug was approved at a dose of 2.5 mg twice-daily and should be used in combination with standard antiplatelet therapy. Rivaroxaban is now the only oral anticoagulant to receive an ACS indication.

The approval is based on data from the pivotal ATLAS ACS 2-TIMI 51 trial. In the United States, where Xarelto is marketed by Johnson & Johnson, the FDA has twice rejected an ACS indication for rivaroxaban.

The new indication joins the already-approved indications for higher doses of rivaroxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery, for the treatment of, (and prevention of recurrent) DVT and PE, and for stroke prevention in patients with atrial fibrillation.

“We know that thrombin levels remain elevated long after an ACS event, leaving patients at risk. In the ATLAS ACS 2-TIMI 51 study, we’ve shown that treating these patients with a low dose of rivaroxaban in combination with standard antiplatelet therapy targets both pathways of clot formation providing more complete long-term protection, including significant reduction in mortality risk,” said C. Michael Gibson, the Principal Investigator of the ATLAS ACS2-TIMI 51 trial, in a Bayer press release. “This approval marks an important shift in the way we deliver protection to patients who are at risk of a secondary atherothrombotic event.”

 

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Expert Consensus Document Offers Advice On Troponin Tests Reply

A newly published document provides practical advice on the use of the popular and potent troponin tests. The Expert Consensus Document on Practical Clinical Considerations in the Interpretation of Troponin Elevations was developed by the American College of Cardiology Foundation in collaboration with several other societies to help address the many complex issues raised by the introduction of the tests in clinical practice.

Sanjay Kaul, a co-author of the document, said the document does not contain new information, but was written to respond to the request of clinicians “for help regarding the considerations for ordering, interpreting, and using troponin as a decision aid in the management of patients with ACS and non-ACS conditions.” The document provides “a roadmap for the proper use of troponin in the setting of appropriate clinical context. The hope is to avoid unnecessary testing and referral as well as inappropriate utilization of downstream diagnostic and therapeutic interventions.”

The document helps physicians understand when they should order troponin tests and how to interpret the results. The recommendations are designed to work in coordination with the recently updated universal definition of MI, and provide detailed information about the use of troponins in acute coronary syndromes, PCI, CABG, and a variety of nonischemic clinical conditions.

“There are many things that can cause damage to the heart muscle that would allow troponin to leak in the circulation where we can measure it, and it’s not always due to heart attack,” said L. Kristin Newby, the co-chair of the writing committee, in an ACC press release. “So if we are indiscriminate in how we order these tests or we aren’t paying attention to the clinical scenario before us, we may miss something important.”

“We need to be thinking about why we are ordering the troponin test before we order it,” said Newby. “We hope this document provides a road map to help clinicians be more deliberate when ordering these tests and interpreting the results.”
Click here to read the ACC press release…