Incidence of developing major cardiovascular risks can be reduced by using rivaroxaban in PAD patients after revascularization procedure. These findings were reported in the New England Journal of Medicine (NEJM) on Saturday.
— NEJM (@NEJM) March 28, 2020
Marc P. Bonaca (MD), who is an associate professor and a director of vascular research at School of Medicine, University of Colorado, and also principal author of this study, says:
It was found that the addition of a low dose rivaroxaban in PAD patients could reduce the range of complications that are feared after PAD interventions like revascularization in their lower limbs. These majorly feared complications include acute limb ischemia, heart attack, stroke, vascular amputations and myocardial infarction. This benefit was seen over a period of time as well as early.
He further added that this data also provides an evidence that antithrombotic therapy can efficiently reduce the risks. Although the bleeding rates were higher but risk versus benefit analysis remains quite favorable and could be very impactful on patients’ lives. We saw a very profound reduction in acute ischemia, there were few take back bleeds requiring a procedure to control bleeding. Although rate of incidence of MI bleeding was higher with rivaroxaben but no fatal or intracranial bleeding events were observed.
— Bayer Pharma (@BayerPharma) March 28, 2020
The study involved a double blind clinical trial and included a total of 6,564 patients with peripheral artery disease. All these patients had undergone revascularization procedure of lower limbs. They were divided into two groups after randomization: rivaroxaban group (3,286 patients) and placebo group (3,278 patients). Rivaroxaban group received 2.5mg of rivaroxaban two times a day along with aspirin whereas other group received placebo and aspirin. The incidence of primary outcomes of therapy like major amputations, limb ischemia, stroke and myocardial infarction or death from cardiovascular reasons were 17.3% and 19.9%, respectively, in both groups. These observations were spanned over 3 years.
The study also stated that major bleeding due to myocardial infarction occurred in 2.65% and 1.87%, respectively, in the two groups. Thrombosis related major bleeding was observed in 5.94% and 4.06% of the total patients respectively. The authors concluded that rivaroxaban plus aspirin therapy could be beneficial for the patients with PAD revascularization than aspirin alone. The dose of rivaroxaban should be low to achieve beneficial effect because of increased chances of major bleeding incidence due to higher doses of the two drugs.
These trials were funded collaboratively by Bayer and Janssen Pharmaceuticals under the name VOYAGER PAD ClinicalTrials.gov
Rivaroxaban (Xarelto) is an anti-coagulant and blood thinner drug that is used in major cardiovascular conditions like stroke prevention, atrial fibrillation, pulmonary embolism, heart attack, peripheral and coronary artery disease and prevention, and treatment of clots in blood vessels (deep vein thrombosis) in hip or knee replacement surgeries.