Table 5.
Real-world evidence from US registries of NOACs: risk of bleeding.
| Lip et al. [38] | Lin et al. [39] | Tepper et al. [40] | Deitelzweig et al. [41] | |
|---|---|---|---|---|
| Data source | US Truven MarketScan commercial and Medicare supplemental databases | US Humedica deidentified EHR data | US Truven MarketScan Earlyview insurance claims database | US Premier Hospital database |
| Study population | Age ≥18 y Newly prescribed NOAC or warfarin with NVAF diagnosis |
Age ≥18 y ewly prescribed NOAC or warfarin with NVAF diagnosis |
Age ≥18 y Switched from warfarin or newly prescribed a NOAC during study period |
Age ≥18 y Hospital discharge code indicating primary or secondary diagnosis of AF Prescribed NOAC during hospitalization |
| Study drug (n) | A (n = 2402) R (n = 10,050) D (n = 4173) W (12,713) |
A (n = 2038) R (n = 6407) D (n = 2440) W (24,872) |
A (n = 8785) R (n = 30,529) D (n = 20,963) |
A (n = 4138) R (n = 37,754) D (n = 32,838) |
| Study period | Jan. 1, 2012–Dec. 31, 2013 (includes 1 y baseline) | Jan. 1, 2013–Jun. 30, 2014 | Jan. 1, 2013–Oct. 31, 2014 | Jan. 1, 2012–March 31, 2014 |
| Follow-up | Up to 1 y | Up to 180 d | Up to 6 mo | Up to 1 mo following hospitalization for NVAF |
| Endpoint(s): Adjusted HR (95% CI) |
Major bleeding W vs. A: 1.93 (1.12–3.33) R vs. A: 2.19 (1.26–3.79) D vs. A: 1.71 (0.94–3.1) |
Any bleeding W vs. A: 1.34 (1.13–1.58) R vs. A: 1.46 (1.23–1.75) D vs. A: 0.91 (0.73–1.13) |
Major bleeding D vs. A: HR 0.99 (0.88–1.10) R vs. A: 1.36 (1.23–1.52) CRNM D vs. A: 1.07 (0.98–1.15) R vs. A: 1.43 (1.34–1.54) Any bleeding D vs. A: 1.06 (0.99–1.13) R vs. A: 1.41 (1.32–1.50) |
Bleeding-related hospital readmission within 1 mo D vs. A: 1.2 (0.9–1.6) R vs. A: 1.4 (1.1–1.9) |
| Bleeding definition/diagnosis | Bleeding requiring hospitalization with a bleeding diagnosis code as the first listed ICD-9-CM code | At least one encounter with an ICD-9-CM code indicative of a major or CRNM bleed in any setting | Based on ICD-9-CM diagnostics codes, CPT and HCPCS procedure codes | ICD-9-CM codes |
Hazard ratios in bold are statistically significantly different for comparison.
A = apixaban; CI = confidence interval; CPT = Common Procedural Terminology; CRNM = clinically relevant nonmajor; D = dabigatran; EHR = electronic health record; HCPCS = Healthcare Common Procedure Coding System; HR = hazard ratio; ICD-9-CM = International Classification of Diseases, 9th Revision, Clinical Modification; NOAC = non-vitamin K antagonist oral anticoagulant; NVAF = nonvalvular atrial fibrillation; R = rivaroxaban; W = warfarin.