September 4, 2015 — Janssen Pharmaceuticals Inc. and its development partner Bayer HealthCare announced results from PMSS and XANTUS, real-world safety studies of rivaroxaban (Xarelto) in people with non-valvular atrial fibrillation (NVAF). The results found the rates and patterns of major bleeding in routine clinical practice were low (2.89 and 2.1 per 100 person-years, respectively) and generally consistent with those observed in Phase 3 clinical research. The studies, which collectively include more than 45,000 patients from 22 countries, were presented at the European Society of Cardiology (ESC) Congress 2015.
"Real-world research is an essential complement to clinical trials and helps inform treatment decisions, and these studies confirm the safety profile of rivaroxaban in real-world settings around the globe," said PMSS study investigator W. Frank Peacock, M.D., FACEP, associate chair and research director, emergency medicine, Baylor College of Medicine. "These findings show the use of rivaroxaban in day-to-day care is consistent with the safety profile observed in ROCKET AF, the landmark Phase 3 study used by regulatory authorities worldwide to approve the medicine for the prevention of stroke in patients with non-valvular atrial fibrillation."
PMSS (Post-Marketing Safety Surveillance) is an ongoing, five-year, observational study evaluating major bleeding in NVAF patients in the United States taking once-daily Xarelto over the course of treatment. The two-year data, presented at ESC, found the rates and patterns of major bleeding were generally consistent with the Phase 3 ROCKET AF trial.
Of the 39,052 patients taking Xarelto in PMSS, the incidence of major bleeding was observed at 2.89 per 100 person-years. The most common bleeding site was gastrointestinal, followed by intracranial. Fatal bleeds were uncommon, with an incidence of 0.1 per 100 person-years. Of the 7,111 patients who took Xarelto in ROCKET AF, the incidence of major bleeding was observed at 3.6 per 100 person-years. The most common bleeding site was gastrointestinal, followed by intracranial. Fatal bleeds were uncommon, with an incidence of 0.2 per 100 person-years.
Of note, PMSS is a retrospective study with no comparator arm. Methodological differences limit the interpretation of the comparison to clinical trials.
XANTUS (Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation) is an international, prospective, single-arm, observational study to observe the rates of major bleeding and stroke over one year for people with NVAF taking Xarelto for stroke prevention in Europe, Canada and Israel. Also presented at ESC and simultaneously published in the European Heart Journal, XANTUS, like PMSS, found the rates and patterns of major bleeding in routine clinical practice to be generally consistent with Phase 3 research. Of the 6,784 patients taking Xarelto, the incidence of major bleeding was 2.1 per 100 person-years. Fatal bleeding, critical organ bleeding and intracranial hemorrhage were uncommon, and observed in 0.2, 0.7 and 0.4 per 100 person-years, respectively. The incidence of stroke was 0.7 per 100 person-years. Like PMSS, the XANTUS study had no comparator arm.
For more information: www.escardio.org
November 12, 2025 
