MedicalResearch.com Interview with:
John Eikelboom MBBS
Associate Professor, Division of Hematology & Thromboembolism
Department of Medicine
Canada Research Chair in Cardiovascular Medicine
Canadian Institutes for Health Research
MedicalResearch.com: What is the background for this study?
Response: Cardiovascular disease affects 1 in 25 persons around the world and a total of more than 300 million individuals. Thrombus formation at the site of a ruptured atherosclerotic plaque is the commonest mechanism of myocardial infarction and ischemic stroke in patients with cardiovascular disease. Aspirin is effective for the prevention of these complications but reduces the risk by only 19% during long term therapy.
Rivaroxaban has previously been tested in the ATLAS ACS-2 TIMI 51 trial at doses of 2.5 mg twice daily or 5 mg twice daily on top of background antiplatelet therapy and has been shown to reduce major adverse cardiovascular events as well as mortality. We tested these same doses of rivaroxaban for the prevention of cardiovascular death, stroke or myocardial infarction in patients with stable cardiovascular disease.
MedicalResearch.com: What are the main findings?
Response: COMPASS was a three-arm trial that compared the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily, and rivaroxaban 5 mg twice daily, with aspirin 100 mg once daily. The combination of rivaroxaban and aspirin compared with aspirin alone reduced the risk of primary outcome by 24% including a 42% reduction in stroke. The combination also reduced mortality. There was increase in major bleeding but no significant increase in fatal, intracranial, or critical organ bleeding.
In the subgroup of patients with peripheral artery disease, the combination of rivaroxaban and aspirin compared with aspirin alone reduced both major adverse cardiovascular events and major adverse limb events. The need for amputation was reduced by more than 50%.
There was no benefit of rivaroxaban 5 mg twice daily compared with aspirin.
MedicalResearch.com: What should clinicians and patients take away from your report?
Response: COMPASS has shown that an intensified treatment regimen with the combination of a “vascular protective” dose of rivaroxaban and aspirin reduces serious cardiovascular events, including the two most feared events, stroke and amputation, and improves survival. These findings represent a paradigm shift and are likely to change in the standard of care for antithrombotic therapy in patients with stable cardiovascular disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: One of the unresolved issues is at what time point patients with a recent heart attack should be transitioned to the COMPASS combination regimen. It may be appropriate to further evaluate this in a randomized trial that compares the winning COMPASS regimen with dual antiplatelet therapy during the first few months after an acute coronary syndrome.
MedicalResearch.com: Is there anything else you would like to add?
Response: The results of the COMPASS trial are represent another step forward in the path to reducing the global burden of cardiovascular disease. One of the most important challenges that we face today is to ensure that proven therapies are given to all those who are likely to benefit.
I hold the Jack Hirsh/Population Health Research Institute Chair in Thrombosis and Atherosclerosis and a career award from the Heart and Stroke Foundation. I have received honoraria and research support from companies that market antithrombotic therapies including Bayer, Boehringer-Ingelheim, Bristol-Myers-Squibb, Daiichi-Sankyo, Janssen, Pfizer, Portola and Sanofi. The COMPASS trial was sponsored by Bayer.
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Citation: ESC 2017
Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) trial: Primary Results
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