In October 2018, the Food and Drug Administration (FDA) approved a new indication for Johnson & Johnson’s Janssen Pharmaceuticals’ rivaroxaban (Xarelto). Janssen indicates that the new Xarelto vascular 2.5 mg dose—when coupled with aspirin—helps to alleviate chronic coronary or peripheral artery disease (CAD/PAD) and reduce the risk of major cardiovascular events, including myocardial infarction and stroke. Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and only marketed under the Xarelto brand. The product is specifically used to prevent and/or treat:
- Atherothrombotic events after an Acute Coronary Syndrome in patients with elevated cardiac biomarkers and no prior stroke or transient ischemic attack (when co-administered with acetylsalicylic acid, aka aspirin);
- Atherothrombotic events in adults with CAD or PAD who face a high risk for ischaemic events;
- Deep vein thrombosis;
- Pulmonary embolism; and
- Venous thromboembolism in people undergoing elective hip replacement surgery or elective knee replacement surgery.
Atherosclerosis, CAD & PAD
CAD and PAD occur as a result of atherosclerosis, a condition whereby the arteries become hardened or narrowed due to cholesterol and plaque buildup, which can then limit blood flow to the rest of the body. Atherosclerosis is the most frequent cause of CAD and PAD, which affect 16.5 and 10 million Americans in total. When left untreated, it can reportedly lead to death, heart attacks, and strokes.
The COMPASS Trial & Results
The COMPASS trial behind the FDA’s recent approval looked at 27,395 patients with chronic CAD or PAD from 33 countries and had two trial groups – those using rivaroxaban with aspirin and those using aspirin alone—for the long-term prevention of major cardiovascular events, including cardiovascular death, heart attack, and stroke. However, the study was also halted early based on the recommendation of the Independent Data and Safety Monitoring Board, who observed a consistent difference in the primary outcome in favor of rivaroxaban 2.5 mg plus aspirin. Still, ultimately, the study reportedly found a 24 percent reduction in the risk of major cardiovascular events in patients with chronic CAD and/or PAD when Xarelto was taken twice daily with aspirin (compared to groups taking aspirin alone).
This now makes Xarelto the first (and only) “Factor Xa inhibitor” approved for this specific purpose. However, the new indication also indicates that patients who take rivaroxaban face an increased risk of bleeding and may bruise more easily than those who do not take the drug. Specifically, patients that were in the Xarelto plus aspirin treatment groups had a significantly higher risk of major bleeding versus those who just took aspirin. Janssen maintains that this does not correlate with a significant increase in fatal or intracranial bleeds.
According to reports, this latest approval is expected to significantly expand the potential patient population taking Xarelto by an estimated 30 million, lifting sales to $2 billion by 2022. However, it is important to note that, earlier this year, results from other Xarelto trials failed to show the expected risk reduction and other benefits for patients at risk of venous thromboembolism.
University Of Michigan Study Takes a Different Perspective
It is also important to note that the COMPASS study was done by the makers of Xarelto, and to be aware of conflicting studies out there which demonstrate that the use of aspirin can be just as effective to address the risk of blood clots after certain types of surgeries; minus some of the health risks associated with taking Xarelto, specifically. According to orthopaedic surgeons at the University of Michigan Department of Orthopaedic Surgery, aspirin alone may provide similar protection compared to anticoagulant treatments like Xarelto. In fact, according to the associated study published in JAMA Surgery, few patients develop blood clots after surgery, and those who are put on aspirin fare just as well as those on anticoagulants. While aspirin is easy, safe, and inexpensive to take, anticoagulants require frequent dose adjustments, injections, and monitoring, and are extremely expensive.
The University of Michigan study looked at patients undergoing knee replacement surgery at 29 Michigan hospitals. In the study, 30 percent of patients took aspirin on its own; 54 percent only took an anticoagulant; and 13 percent took both an anticoagulant and aspirin. After three months, 1.16 percent of aspirin-alone patients developed a serious blood clot and 1.42 percent of anticoagulant patients did as well. In other words, aspirin and anticoagulants do not possess any significant advantage over the other in terms of preventing blood clots, but taking aspirin instead of anticoagulants offers a number of advantages, including a lack of potential serious side effects.
While previous studies have looked at the use of aspirin after surgery, many relied on the use of rivaroxaban during the first five days after surgery. Conversely, the University of Michigan study suggests that patients are adequately protected by simply using aspirin alone. This study reflects a growing trend of surgeons increasingly turning away from powerful anticoagulants like Xarelto and towards aspirin, as well as a number of non-drug treatments, such as the use of compression devices for thwarting clots. This is, in part, because the science shows that most patients have a generally low risk of blood clots after procedures such as knee replacement surgery due to the overall use of less invasive procedures today, as well as regional anesthesia and shorter surgical times. According to many doctors, the most important steps patients can take to prevent blood clots are to simply get moving after surgery and avoid sitting or lying in one position for too long.
Xarelto Pharmaceutical Attorneys
If you or someone you love has been injured or otherwise harmed by Xarelto, it is imperative that you consult with an experienced attorney right away in order to preserve your rights and find out what your options are.
The skilled attorneys of Roger Ghai Law Offices have years of bringing litigation on behalf of clients who have been injured by rivaroxaban. Contact us today to schedule a free consultation and find out more.