A 62-year-old Caucasian male patient presents to your office for routine follow-up. His medical history is significant for hypertension, diabetes mellitus, and coronary artery disease. He had an inferior wall myocardial infarction 4 years ago that was treated with a drug-eluting stent. His last echocardiogram, done 1 year ago, showed normal left ventricular ejection fraction. He currently takes aspirin 81 mg daily, rosuvastatin 20 mg daily, losartan 50 mg daily, and metformin 1,000 mg twice daily.
During today's visit, he reports feeling well without any anginal symptoms. His heart rate is 76 bpm, and his blood pressure is 128/72 mmHg. The remainder of the physical examination is normal. He inquires if he would benefit from the addition of anticoagulant drugs to his medical regimen. The electrocardiogram shows normal sinus rhythm with inferior Q-waves. He denies a history of bleeding or gastrointestinal ulcerations.
Which of the following is the best recommendation regarding anticoagulant use for this patient based on available data?
Show Answer
The correct answer is: C. Rivaroxaban 2.5 mg twice daily in addition to daily low-dose aspirin reduces his risk of future major cardiovascular events.
Cardiovascular disease (CVD) risk reduction in patients with diabetes mellitus is important given the substantially higher risk of CVD in the diabetic population. Secondary preventive therapies for residual CVD risk reduction were studied in several recent clinical trials. Results of the COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) study, which included 27,395 patients, demonstrated that the use of rivaroxaban 2.5 mg twice daily plus aspirin 100 mg daily reduced the risk of a composite of cardiovascular death, stroke, or myocardial infarction better than aspirin alone (hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.66-0.86; p < 0.001) in patients with stable coronary or peripheral artery disease.1 Combination therapy with aspirin and rivaroxaban significantly reduced the risk for all-cause mortality and ischemic stroke. These finding makes the use of dual pathway inhibition with aspirin plus low-dose rivaroxaban attractive in this high-CVD-risk population.
In a pre-specified sub-group analysis of patients with (n = 10,341) and without (n = 17,054) diabetes mellitus, a similar relative risk reduction for rivaroxaban plus aspirin compared to aspirin alone for the composite endpoint (HR 0.74, p = 0.002 and HR 0.77, p = 0.005, respectively, p for interaction = 0.77) and all-cause mortality (HR 0.81, p = 0.05 and HR 0.84, p = 0.09, respectively, p for interaction = 0.82) was noted.2 Results also indicated that the absolute risk reductions were greater for patients with diabetes than those without for the primary efficacy endpoint (2.3% vs. 1.4%, p for interaction < 0.0001), all-cause mortality (1.8% vs. 0.6%, p for interaction = 0.02), and major vascular events (2.7% vs. 1.7%, p for interaction < 0.0001) at 3 years.2 This greater absolute efficacy occurs without any incremental increase in major bleeding complications in those with versus those without diabetes mellitus.
References
Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban With or Without Aspirin in Stable Cardiovascular Disease. N Engl J Med 2017;377:1319-30.
Bhatt DL, Eikelboom JW, Connolly SJ, et al. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation 2020;141:1841-54.
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