Stroke Xarelto data in the real world reveals a risk of weak hemorrhage

In a real-world badysis involving more than 11,000 patients with atrial fibrillation from 47 countries, the risk of stroke and major bleeding in users of the direct oral anticoagulant Xarelto (rivaroxaban ) was similar or lower than that observed

The rate of one year of stroke or systemic embolism was only 1.0% and the major bleeding rate was 1.7% in the large pre-planned pooled badysis of three prospective, observational, international studies "Overall, rivaroxaban showed a favorable safety profile, with more than 96% of the pooled rivaroxaban population not showing no major bleeding, stroke / non-CNS systemic embolism (SE) or all-cause death over a follow-up period of about one year, "wrote Paulus Kirchhof, MD, of the University of Birmingham in England, and his colleagues in the [19459014JournaloftheAmericanCollegeofCardiology published online July 2.

The researchers noted that the XANTUS program offers a unique source of real data on the use of rivaroxaban for prevention stroke in Afib patients. The three prospective studies included patients from Western and Eastern Europe, Canada and Israel (XANTUS trial), the Asia Pacific region (XANAP trial), and Eastern Europe, the Middle East. East, Africa and Latin America (XANTUS-EL). Direct oral anticoagulants (DOACs) have been prescribed to patients in accordance with country-specific drug approvals.

The main findings were major bleeding during treatment, severe adverse events (AEs / AEs), and death from all causes. Secondary outcomes included emergent thromboembolic events at treatment and non-major haemorrhages.

A total of 11,121 patients were included in the badysis (mean age 70.5 ± 10.5 years, women 42.9%). Comorbidities included heart failure (21.2%), hypertension (76.2%) and diabetes (22.3%).

Event rates, calculated as one event per 100 patient-years, were:

• major bleeding: 1.7 / 100 patient-years; 95% CI 1.5-2.0)
• Death from all causes: 1.9 / 100 patient-years (95% CI 1.6-2.2)
• Stroke or systemic embolism : 1.0 / 100 patient-years (95% CI 0.8 to 1.2

Regional differences were significant, for example, major bleeding rates ranged from 0.7 per 100 patient-years in America Latin at 2.3 per 100 patient-years in a group comprising Western Europe, Canada and Israel.

The persistence of treatment at one year was 77.4%, Asia showed the lowest rate (66.4%) and eastern Europe the highest (84.4%).

The researchers concluded that the badysis of the actual treatment showed low rates of bleeding and stroke in rivaroxaban-treated patients Low rates of discontinuation have been observed around the world and results have been generally consistent across a region withthe other.

The researchers cited the following study limitations: exclusion of patients from the United States and China (with the exception of Hong Kong) In an editorial of accompaniment, cardiologist Jeff Healey, MD, of McMaster University in Hamilton, Ontario, noted that the study population was highly representative of the practices they used. "The age and proportion of patients with hypertension, diabetes and stroke in this cohort are quite similar to those of another multinational registry that recruits patients from the emergency department. , suggesting that these patients are reasonably representative of the population individuals with AF, "he wrote. "Thus, just like observational studies, the current study population is a reasonable balance of what is practical and ideal."

Kirchhof and colleagues noted that patients included in observational studies had characteristics similar to those included in the clinic.

Healey wrote that the badysis confirms that "the use of rivaroxaban is largely consistent with published guidelines, and the persistence of one-year treatment was high, at least in the practices of the participating physicians. "

These data are not population-based, they represent what a typical clinician might expect if they use a DOAC drug according to local labeling and practice guidelines , and testify to the successful introduction of DOACs into clinical practice, "wrote Healey.

"Although current work does not help us understand why translation into clinical practice has been so successful, easy-to-use drugs"

2018-07-02T15: 00: 00-0400