Elsevier

American Heart Journal

Volume 236, June 2021, Pages 4-12
American Heart Journal

Clinical Investigations
Rivaroxaban versus warfarin in patients with atrial fibrillation enrolled in Latin America: Insights from ROCKET AF

https://doi.org/10.1016/j.ahj.2021.02.004Get rights and content

Background

ROCKET AF demonstrated the efficacy and safety of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism (SE) in patients with atrial fibrillation (AF). We examined baseline characteristics and outcomes in patients enrolled in Latin America compared with the rest of the world (ROW).

Methods

ROCKET AF enrolled 14,264 patients from 45 countries. Of these, 1,878 (13.2%) were from 7 Latin American countries. The clinical characteristics and outcomes (adjusted by baseline characteristics) of these patients were compared with 12,293 patients from the ROW. Treatment outcomes of rivaroxaban compared with warfarin were also stratified by region.

Results

The annual rate of stroke/SE was similar in those from Latin American and ROW (P= .63), but all-cause and vascular death were significantly higher than in ROW (HR 1.40, 95% CI 1.20-1.64; HR 1.38, 95% CI 1.14-1.68; P< .001). Rates of major or nonmajor clinically relevant bleeding tended to be lower in Latin America (HR 0.89, 95% CI 0.80-1.0; P= .05). Rates of stroke and/or SE were similar with rivaroxaban and warfarin in patients from Latin America and ROW (HR 0.83, 95% CI 0.54-1.29 vs HR 0.89, 95% CI 0.75-1.07; interaction P= .77).

Conclusions

Patients with AF in Latin America had similar rates of stroke and/or SE, higher rates of vascular death, and lower rates of bleeding compared with patients in the ROW. The effect of rivaroxaban compared with warfarin in Latin America was similar to the ROW. Further studies analyzing patient- and country-specific determinants of these regional differences in Latin America are warranted.

Section snippets

Methods

ROCKET AF (NCT00403767) was a randomized, multicenter, double-blind, double-dummy, intention-to-treat, event-driven trial that enrolled 14,264 patients at 1,178 participating sites in 45 countries. Randomization was stratified by country; vitamin K antagonist (VKA) use; and history of stroke, transient ischemic attack (TIA), or noncentral nervous system (CNS) embolism. The design and main results have been published1,12.

The objective of ROCKET AF was to compare once-daily rivaroxaban with

Patient recruitment

Of the 14,264 patients randomized in the ROCKET AF trial, 1,878 (13.2%) were from Latin America and were included in this subgroup analysis. Of these, 569 patients were from Argentina, 483 from Brazil, 286 from Chile, 268 from Colombia, 168 from Mexico, 84 from Peru, and 20 from Venezuela.

Baseline demographics

Baseline characteristics for patients in the Latin American cohort of ROCKET AF and the (ROW) are shown in Table I. When compared with the ROW, patients in Latin America were older, had more persistent AF,

Discussion

This subgroup analysis from ROCKET AF provides insight into the efficacy and safety of rivaroxaban compared with warfarin in patients with AF enrolled in Latin America compared with those in the ROW. The incidence of stroke and/or systemic embolism was similar in patients in Latin America compared with the ROW; the type of anticoagulant (rivaroxaban vs warfarin) did not significantly modify the risk between regions. All-cause and vascular mortality were higher in the Latin American cohort

Limitations

This study has limitations. First, this was a non-prespecified post-hoc analysis of the ROCKET AF trial and the Latin American cohort was only 13.2% of the 14,264 patients recruited in the main study. The small number of events accrued in the Latin American cohort reduced statistical power and the precision of the estimates for the outcomes of interest. Second, comorbidities and important risks factors for the study outcomes were not balanced between the ROW and the Latin American cohort at

Conclusion

Patients with AF in Latin America had similar rates of stroke and systemic embolism, higher rates of vascular death, and lower rates of bleeding compared with those with AF in the ROW. Rivaroxaban appears to be a safe and effective alternative to warfarin for thromboprophylaxis in patients in Latin America with AF. Further studies analyzing patient-specific determinants of the regional differences in vascular event rates found in Latin America compared with the ROW are warranted.

Sources of funding

ROCKET AF was funded by Janssen Pharmaceuticals and Bayer.

Disclosures

Blumer, Rivera, Hellkamp: None. Corbalán: Consultant/advisory boards for Bayer HealthCare and Pfizer. Becker: Scientific advisory boards for Janssen, Ionis, and Akcea; and data safety monitoring boards for Ionis and Akcea. Berkowitz: Employee of Bayer U.S., LLC. Breithardt: Honoraria; Modest; Bayer HealthCare, BMS/Pfizer. Consultant/Advisory Board; Modest; Bayer HealthCare, BMS/Pfizer, Sanofi Aventis. Hacke: Research Grant; Significant; Boehringer Ingelheim. Consultant/Advisory Board; Modest;

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