Large Claims Study on DOACs Finds Less Major Bleeding, Stroke With Apixaban

An analysis of claims data from 180 million people—half the US population—has found that the direct oral anticoagulant (DOAC) apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) had lower rates of major bleeding and stroke/systemic embolism in a series of head-to-head comparisons among apixaban, dabigatran, and rivaroxaban.

The study was presented Sunday at the 67th Scientific Session of the American College of Cardiology in Orlando, Florida.

The 3 best-selling DOACs are alternatives to traditional anticoagulants, such as warfarin, which require monthly blood tests and dietary restrictions. DOACs require less monitoring for stroke prevention and clear the system more quickly when necessary.

Researchers for ARISTOPHANES started with CMS claims data and 4 large commercial databases (Truven MarketScan, IMS PharMetrics Plus, Optum Clinformatics Data Mart, and the Humana Research Database). From here, they culled records for 162,707 patients with non-valvular atrial fibrillation, for the period between January 1, 2013, and September 30, 2015. Three DOAC-to-DOAC comparisons were done for each database, and then the results were pooled. Patients were followed for 6 months.

Results were as follows:

• Apixaban use was associated with a 17% lower rate of stroke/systemic embolism compared with rivaroxaban (hazard ratio [HR], 0.83; 95% CI, 0.73 to 0.94; P = .004), and a 46% lower rate of major bleeding (HR, 0.54; 95% CI, 0.50 to 0.58; P <.001).
• Apixaban use was associated with a 31% lower rate of stroke/systemic embolism compared with dabigatran (HR, 0.6; 95% CI, 0.56 to 0.8; P <.001), and a 23% lower rate of major bleeding (HR:0.77; 95% CI, 0.68 to 0.8;, P <.001).
• In the comparison between dabigatran and rivaroxaban, rivaroxaban was associated with an 18% higher rate of stroke/systemic embolism than dabigatran (HR, 1.1; 95% CI, 0.98-1.43; P = .080), while rivaroxaban was associated with 33% lower rate of major bleeding than dabigatran (HR, 0.67; 95% CI, 0.60-0.74; P <.001).

Steven B. Deitelzweig, MD, MMM, SFHM, FACP FACC, medical director of Regional Business Development at Oschner Medical Center in New Orleans, Louisiana, said the large size of the data set was a strength of the study. “This has been shown before in single databases, so it’s more confirmatory,” he said.

Sharing the results with payers will be the next step, Deitelzweig said. With lower event rates, and knowing that a major bleeding event means a trip to the hospital, “it’s not hard to enter into the cost discussion, which should be compelling for them, given the scale.”

Real-world data also revealed that the results held up even at lower doses of the drug, which is prescribed much more frequently than in clinical trials, Deitelzweig said. Apixaban is available in 2.5 mg and 5 mg tablets.

Bristol-Myers Squibb and Pfizer funded the study.

Reference

Deitelzweig S, Keshishian A, Li X, et al. Comparison of effectiveness, safety, and the net clinical outcome between direct oral anticoagulants in 162,707 non-valvular atrial fibrillation patients treated in US clinical practice. Presented at the 67th Scientific Session of the American College of Cardiology, Orlando, Florida, March 11, 2018. Abstract 900-10.