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Patients with stable atherosclerotic vascular disease who take rivaroxaban (2.5mg twice daily) plus aspirin (100mg once daily) have better cardiovascular outcomes than those who take aspirin alone, results from the COMPASS trial presented at the ESC Hot Line session yesterday revealed. These results could herald a change in guidelines in this setting, experts opined.
COMPASS results suggested that a patient group that takes the rivaroxaban-plus-aspirin regimen will see fewer cardiovascular deaths, strokes and myocardial infarction, but more major bleeding events than a group that takes aspirin alone. Yet, there is no significant increase in fatal, intracranial or critical organ bleeding between these two groups and rivaroxaban-plus-aspirin provides a net clinical benefit, delegates heard. They were also told that rivaroxaban monotherapy offers no benefits over rivaroxaban-plus-aspirin or aspirin alone.
Doctor John Eikelboom (Department of Medicine, McMaster University, Hamilton, Canada) presented data from the double-blinded, randomised COMPASS trial (Cardiovascular OutcoMes for People Using Anticoagulation StrategieS). The trial was designed to determine whether rivaroxaban in combination with aspirin or given alone is more effective than aspirin alone in reducing cardiovascular death, stroke or myocardial infarction, with acceptable safety in patients with stable atherosclerotic vascular disease. It was conducted in 602 centres in 33 countries and involved 27,395 patients. “Aspirin is widely used for secondary prevention but is only modestly effective. Warfarin trial results demonstrate the potential of anticoagulation to provide benefit. [Low dose] Rivaroxaban has been shown to reduce mortality post acute coronary syndrome (ATLAS ACS-2 TIMI 51),” said Prof. EIkelboom.
Rivaroxaban is a selective direct factor Xa inhibitor that is used to prevent and treat venous thromboembolism and to prevent stroke or systemic embolism in atrial fibrillation.
The researchers randomly assigned participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5mg twice daily) plus aspirin (100mg once daily; ; n=9,152), rivaroxaban (5mg twice daily; n=9,117), or aspirin (100mg once daily; n=9,126). The primary efficacy outcome was a composite of cardiovascular death, stroke, or myocardial infarction.
The mean age of participants was 68.2 years, and 22% were women. Nearly 90% used lipid-lowering agents. A total of 90.6% of the participants had a history of coronary artery disease, and 27.3% had a history of peripheral arterial disease.
The independent data and safety monitoring board recommended early discontinuation of the comparison of rivaroxaban with or without aspirin vs. aspirin alone, for clear evidence of efficacy outcome in favour of rivaroxaban plus aspirin after a mean follow-up of 23 months.
A primary outcome event of cardiovascular death, stroke or myocardial infarction occurred in 379 patients (4.1%) who were assigned to rivaroxaban-plus-aspirin, 448 (4.9%) who were assigned to rivaroxaban alone and 496 (5.4%) who were assigned to aspirin alone. There was a statistically significant difference in primary outcomes between the rivaroxaban-plus-aspirin group and the aspirin-alone group (p<0.0001). However, patients in the rivaroxaban-alone group did not experience significantly fewer cardiovascular deaths, strokes or myocardial infarctions than those in the aspirin-alone group (p=0.12).
The secondary composite outcome of ischaemic stroke, myocardial infarction, acute limb ischaemia, or death from coronary heart disease occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (329 patients [3.6%] vs. 450 patients [4.9%]; p<0.0001).
Major bleeding events occurred in more patients in the rivaroxaban- plus-aspirin group (288 bleeds [3.1%]) than in the aspirin alone group (170 [1.9%]). There were 255 (2.8%) bleeds in the group that received rivaroxaban only. There was a statistically significant difference (p<0.0001) when the number of bleeds experienced by the rivaroxaban-plus-aspirin group was compared with those in the aspirin only group. However, there was no significant difference in intracranial or fatal bleeding between these two groups. Investigators also recorded a statistically significant difference between the number of bleeds in the rivaroxaban monotherapy and aspirin monotherapy groups (p<0.0001).
“There is a highly significant net clinical benefit observed when primary outcome and severe bleeding events are pooled together, with 431 (4.7%) of the rivaroxaban-plus-aspirin group undergoing an event as compared to 534 (5.9%) events in the aspirin monotherapy group (p=0.0005),” Dr. Eikelboom said.
Professor Eugene Braunwald (Brigham and Women’s Hospital, Harvard Medical School, Boston, USA) noted that the trial was an important step in thrombocardiology. “COMPASS has taken a step forward by demonstrating in stable, chronic coronary artery disease that a combination of low dose aspirin and very low dose rivaroxaban is superior to aspirin monotherapy as well as rivaroxaban monotherapy. COMPASS is a large, rigorously conducted trial with unambiguous results which, I believe, should change guidelines.”
Data on peripheral arterial disease patients from the trial (COMPASS-PAD) were presented by Professor Sonia Anand, McMaster University, Hamilton, Canada, that showed similar benefits with rivaroxaban-plus-aspirin in this subgroup. Consistent with the overall results of COMPASS, in PAD patients the addition of low dose rivaroxaban to aspirin, compared with aspirin alone, reduced cardiovascular death, stroke or heart attack by 28%, and limb-threatening ischaemia, including amputation, by 46%. Considering both outcomes together, rivaroxaban and aspirin lowered major adverse cardiovascular or limb events by 31%.
Resources of the presentation: Cardiovascular OutcoMes for People using Anticoagulation StrategieS (COMPASS) trial: Primary Results
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