Bleeding Events in Patients with VTE in a Real World Setting

New Orleans—A retrospective observational analysis of a commercial insurance and Medicare database found that among patients with venous thromboembolism (VTE), the annual incidence of major bleeding was 3.9% and the annual incidence of nonmajor bleeding was 20.1%.

The median time to major bleeding from when patients first had VTE was 2.2 months, while the mean time was 7.1 months. The median and mean times to nonmajor bleeding were 2.8 months and 7.7 months, respectively.

The results were presented during a poster presentation at the ASH meeting. The poster was titled Bleeding Incidence among Patients with Venous Thromboembolism: A Large US Insurance Database Analysis.

The authors defined major bleeding as any bleeding event resulting in hospitalization or blood transfusion and considered nonmajor bleeding as any other bleeding event.

VTE, a disease that includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with significant morbidity and mortality and is the third leading cause of cardiovascular death. Most patients with VTE are prescribed anticoagulants for 3 months or longer. Although anticoagulants reduce the risk of VTE recurrence, they also increase the risk of bleeding.

The authors examined the MarketScan claims database from January 1, 2006, through December 31, 2011, and gathered information on physician office visits, hospital stays, and usage of pharmaceuticals. Patients were included in the study if they were ≥18 years of age, had ≥2 VTE outpatient diagnoses within 3 weeks or an inpatient VTE diagnosis during the study period, and were continuously enrolled in a health plan. They could not have a VTE diagnosis in the 6 months prior to the index date.

In all, there were 267,655 patients: 68.4% had DVT only (n=182,972), 25.8% had PE only (n=69,169), and 5.8% had DVT and PE (n=15,514). Nearly half (48.8%) of patients were from 41 to 65 years of age, 11.4% were from 18 to 40 years of age, and 39.8% were ≥65 years of age. At baseline, 48.3% of patients were taking nonsteroidal anti-inflammatory drugs (NSAIDs), 22.1% were receiving antidepressants, 8.5% were taking antiplatelet therapy, 7.9% were on hormone therapy, and 5.6% were receiving chemotherapy.

Patients with DVT and PE had a major bleeding event later than patients who had DVT only or PE only (P<.0001). The authors noted that major risk factors (risk increase of at least 20%) for major bleeding included a history of major bleeding (hazard ratio [HR], 10.78), nonmajor bleeding (HR, 1.61), chemotherapy (HR, 1.27), >65 years of age compared with 40 years of age or younger (HR, 1.27), alcohol abuse (HR, 1.26), cancer (HR, 1.25), and heart disease (HR, 1.23).

The following factors were significantly associated with reduced risk for major bleeding: DVT plus PE versus DVT only (HR, 0.81), pregnancy diagnoses (HR, 0.59), NSAID usage (HR, 0.92), and hormone therapy (HR, 0.74).

Limitations of the study, according to the authors, included that it was not a random sample, claims data may be subject to selection bias and coding errors, and researchers did not have information about disease history, causes of VTE, severity, location of clot, or over-the-counter medications. In addition, they could not make any causal inferences because of the trial’s retrospective observational design.

Bristol-Myers Squibb and Pfizer, Inc., provided funding for this study.