"We demonstrate that the concomitant administration of rivaroxaban (2.5mg twice daily) and aspirin (100mg once daily) is effective across a broad range of body weights without dose adjustment," Dr. Tomasz Guzik of the University of Glasgow, UK, told Reuters Health by email. "This adds critical data to the emerging discussion on the use of...direct oral anticoagulants in obese and overweight patients in other clinical indications."
"While this is one step forward, we still need further studies to confirm these results in subjects with very high or very low weights, as these patients were not sufficiently represented in the COMPASS trial population," he acknowledged. "This is important, as nearly 10% of US population is severely obese."
As reported in the Journal of the American College of Cardiology, safety and efficacy outcomes in this secondary analysis of the COMPASS trial were analyzed in relation to BMI - 18.5- under 25 kg/m2 (normal); 25-under 30 (overweight); 30 or higher (obese) - and body weight: up to 70 kg; 70-90; over 90.
The study included more than 27,000 patients (mean age, 65; about 23% women): 24% of participants had normal BMI; 44% were overweight; and 32% were obese.
As Dr. Guzik noted, rivaroxaban plus aspirin reduced cardiovascular death, stroke, or myocardial infarction, regardless of BMI or body weight, compared to aspirin alone. Specifically, for normal BMI, event rates were 3.5% with the combination versus 5% for aspirin alone, HR 0.73; for overweight individuals, 4.3% versus 5.1%, HR, 0.80; and for obese participants, 4.2% versus 6.1%, HR, 0.71.
For body weight, event rates for up to 70 kg were 4.1% versus 5.3%, HR 0.75; for 70-90 kg, 4.1% versus 5.3%; HR 0.76; and for over 90 kg, 4.2% vs. 5.7%; HR: 0.74.
Effects on bleeding, mortality, and net clinical benefit were similar, regardless of BMI or body weight.
Dr. Karlyn Martin of Northwestern University Feinberg School of Medicine in Chicago, coauthor of a related editorial, commented in an email to Reuters Health, "The findings in this sub-analysis remain unchanged from the primary analysis, which should give clinicians comfort in using this antithrombotic strategy in patients with mild-to-moderate obesity."
"Possible barriers to using this strategy in clinical practice include bleeding, as the addition of rivaroxaban to aspirin caused higher rates of major bleeding across weight subgroups, as well as the cost associated with the addition of rivaroxaban," she said.
Dr. Michael Go, a vascular surgeon and associate professor of surgery at The Ohio State University Wexner Medical Center in Columbus, also commented by email. "I do think that the addition of rivaroxaban will make a significant difference, including for obese patients. Some may argue, however, that though the advantage of rivaroxaban/aspirin over aspirin alone is statistically significant, the absolute benefit, particularly for any single individual, may not be clinically relevant."
Another recent report of COMPASS trial data in Circulation found that the net clinical benefit, "considering both cardiovascular advantages and bleeding complications with treatment, did indeed favor the addition of rivaroxaban," he said. (https://bit.ly/2MK2ULk)
"But to put that finding in perspective, out of every 100 patients, 10 on aspirin compared with eight on rivaroxaban/aspirin were expected to experience a cardiovascular death, stroke, myocardial infarction, or bleeding event by 36 months," he noted, citing a letter to the editor of Circulation published in January. (https://bit.ly/39BjDcG) "This is an absolute difference of 1.7%. So, to any one individual, the advantage may be relatively small, but is real."
"Thus, I believe this is a regimen clinicians should be implementing for patients, regardless of BMI, while using discretion based on individual patient factors," Dr. Go told Reuters Health. "If a patient in general has more risk for a cardiovascular outcome, doctors should feel good about adding rivaroxaban. However, if a patient has pre-existing risk factors for bleeding, it may be best to stick with aspirin alone."
Bayer AG funded the COMPASS trial. Dr. Guzik and a number of coauthors have received fees from the company, and two coauthors are employees.
SOURCE: https://bit.ly/3taX2vk and https://bit.ly/2La9IS9 Journal of the American College of Cardiology, online February 1, 2021.
By Marilynn Larkin
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