October 17, 2019
NICE Publishes Guidance on Rivaroxaban for Preventing Atherothrombotic Events in Patients With CAD or PAD
October 17, 2019—The United Kingdom’s National Institute for Health and Care Excellence (NICE) has published its technology appraisal guidance (TA607) on evidence-based recommendations on rivaroxaban (Xarelto; Bayer AG, marketed in the United States by the Janssen Pharmaceutical Companies of Johnson & Johnson) for preventing atherothrombotic events in adults with coronary artery disease (CAD) or peripheral artery disease (PAD).
According to the NICE guidance, rivaroxaban plus aspirin is recommended within its marketing authorization as an option for preventing atherothrombotic events in adults with CAD or symptomatic PAD who are at high risk of ischemic events.
For patients with CAD, high risk of ischemic events is defined as age ≥ 65 years; or with atherosclerosis in ≥ two vascular territories (such as coronary, cerebrovascular, or peripheral arteries); or with two or more of the following risk factors: current smoking, diabetes, kidney dysfunction with an estimated glomerular filtration rate (eGFR) < 60 mL/min (note that rivaroxaban is contraindicated if the eGFR is less than 15 mL/min), heart failure, previous nonlacunar ischemic stroke.
NICE guidance advised that physicians should assess the person’s risk of bleeding before considering rivaroxaban. Treatment should only be started after an informed discussion with the patient about the risks and benefits of rivaroxaban, weighing the risk of atherothrombotic events against the risk of bleeding. The risks and benefits of continuing treatment with rivaroxaban should be regularly reviewed.
The NICE committee made these recommendations for the following reasons:
- Patients with chronic CAD or symptomatic PAD can have atherothrombotic events such as myocardial infarction and stroke.
- A clinical trial of patients at high risk of ischemic events shows that, compared with aspirin alone, rivaroxaban plus aspirin reduces the risk of having an ischemic stroke, myocardial infarction, or dying from cardiovascular disease. (However, it does increase the risk of bleeding.) It was noted that the benefits and risks of rivaroxaban plus aspirin are only known for the specific population in the trial—that is, people at high risk of ischemic events as defined by the inclusion criteria of the trial.
- The cost-effectiveness of rivaroxaban is within the range that is considered an acceptable use of National Health Services resources. Therefore, aspirin plus rivaroxaban is recommended as a treatment option for people at high risk of having atherothrombotic events who are not identified as having an increased risk of bleeding.