NOMAC-E2 use was not associated with a higher risk of VTE or ATE compared with COCLNG. The risk of all VTE and ATE was not higher in NOMAC-E2 users compared with COCLNG users. The main analysis comparing the risk of DVT of the lower extremities and PE in NOMAC-E2 users versus COCLNG users yielded an HRadj of 0.59 (95% CI, 0.25-1.35) (adjusted for age, BMI, family history of VTE, and current duration of use). NOMAC-E2 users had a higher mean age (31.0 ± 8.63 years) than COCLNG users (29.3 ± 8.53 years) but other baseline characteristics were similar between the cohorts. Incidence rates, crude (HRcrude), and adjusted (HRadj) hazard ratios were calculated.Ī total of 101,498 women (49,598 NOMAC-E2 users and 51,900 COCLNG users) were enrolled and followed for up to 2 years (144,901 WY of observation).
Data on confounders were captured and independent blinded adjudication assessed the classification of events. Secondary outcomes included all VTE and ATE. The main outcome of interest was VTE, specifically deep venous thrombosis of the lower extremities (DVT) and pulmonary embolism (PE). Women were followed up directly and self-reported outcomes of interest were validated via treating physicians. New users of NOMAC-E2 and COCLNG were recruited in 12 countries in Australia, Europe, and Latin America. This large, prospective, observational active surveillance study used a non-inferiority design. To assess and compare the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) in NOMAC-E2 users with levonorgestrel-containing combined oral contraceptive (COCLNG) users.
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