Rivaroxaban + Antiplatelet Therapy Does Not Increase Bleeding Complications Post ACS
March 19, 2017—Washington, DC—Patients with acute coronary syndrome who were treated with rivaroxaban in addition to an antiplatelet medication (clopidogrel or ticagrelor) experienced no increase in bleeding complications vs patients who received aspirin plus an antiplatelet drug.
This outcome of the phase 2 randomized, double-blind, multicenter GEMINI-ACS-1 trial was reported at the American College of Cardiology’s 66th Annual Scientific Session, from March 17 – 19.
E. Magnus Ohman, MD, of Duke University Medical Center, Durham, North Carolina, explained that acute coronary syndrome is a sudden blockage of blood flow to the heart, and may take the form of an MI or unstable angina. Aspirin has been a mainstay of treatment for more than 30 years.
Dr. Ohman said, “The standard of care for acute coronary syndrome is for patients to take lifelong aspirin, even though little evidence supports its effectiveness in preventing recurrent MI after the early phase in acute coronary syndrome.”
Guidelines of the American College of Cardiology and American Heart Association recommend aspirin plus clopidogrel or a similar drug such as ticagrelor—dual antiplatelet therapy—after an MI. Other studies, however, have shown that even when patients receive optimal dual antiplatelet therapy, nearly 10% experience an adverse event such as an MI or stroke.
Earlier trials exploring the effect of adding an anticoagulant agent such as rivaroxaban to dual antiplatelet therapy showed that this three-drug approach increased the risk of bleeding complications twofold or more.
In GEMINI-ACS-1, however, the primary endpoint of clinically significant bleeding occurred equally, in 5.3% of patients who received rivaroxaban vs 4.9% of those who received aspirin, a non - statistically significant difference.
The most common type of bleeding was minor bleeding, such as a nosebleed. Bleeding rates did not differ significantly differ between patients taking clopidogrel and those taking ticagrelor.
Three thousand thirty-seven patients in 21 countries (average age 63 years, 75% male) participated in GEMINI-ACS-1. Patients were enrolled within 10 days of hospitalization with an MI (89%) or unstable angina (11%).
Patients were excluded if they had a history of impaired kidney function, active bleeding, or cerebral or gastrointestinal bleeding within the previous year. Patients receiving long-term anticoagulant therapy were also excluded.
After patients had received a stable dose of clopidogrel or ticagrelor for >48 h, they were randomized to either low-dose rivaroxaban (2.5 mg twice a day) or aspirin (100 mg a day).
Patients were treated for a median of 291 days. Median follow-up duration was 326 days. The number of patients who discontinued the study treatment prematurely was similar in both the rivaroxaban and aspirin groups (11.3% of those treated with rivaroxaban and 12.7% of those treated with aspirin).
In addition to collecting data on the study’s primary endpoint of clinically significant bleeding, Dr. Ohman and coinvestigators also looked at the rate of death due to an MI, stroke, other cardiovascular disease, or a blood clot in a coronary artery in which a stent had been placed. Here the rate was 5% among patients treated with rivaroxaban and 4.7% among those who received aspirin, again, a non - statistically significant difference.
Though the findings of GEMINI-ACS-1 showed that treatment with rivaroxaban and an antiplatelet drug is safe, they did not demonstrate that this regimen prevents recurrent MI. A larger, phase 3 trial would be required to definitively establish that this treatment approach is both safe and effective. Another limitation is that, since 93% of participants were white, the findings may not apply to more racially and ethnically diverse groups of patients.
Dr. Ohman concluded, “The results of this study are important because GEMINI-ACS-1 was the first trial to show that replacing aspirin with the newer, more targeted anticoagulant—low-dose rivaroxaban—presents no additional risk of bleeding complications when given as dual therapy with an antiplatelet drug.”Click on any of these tags to subscribe to Topic Alerts. Once subscribed, you can get a single, daily email any time PracticeUpdate publishes content on the topics that interest you.
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