Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.

Abstract

BACKGROUND:

Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y12 inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization.

METHODS:

Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y12 inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment.

RESULTS:

The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66-0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62-0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not.

CONCLUSIONS:

Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT.

CLINICAL TRIAL REGISTRATION:

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.

• Authors: C Michael Gibson, Duane S Pinto, Gerald Chi, Douglas Arbetter, Megan Yee, Roxana Mehran, Christoph Bode, Jonathan Halperin, Freek W A Verheugt, Peter Wildgoose, Paul Burton, Martin van Eickels, Serge Korjian, Yazan Daaboul, Purva Jain, Gregory Y H Lip, Marc Cohen, Eric D Peterson, Keith A A Fox
• Journal: Circulation (Circulation) Vol. 135 Issue 4 Pg. 323-333 (Jan 24 2017) ISSN: 1524-4539 [Electronic] United States
• PMID: 27881555 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2016 The Authors.

Chemical References

• Factor Xa Inhibitors
• Vitamin K
• Rivaroxaban

Topics

• Aged
• Atrial Fibrillation (drug therapy)
• Factor Xa Inhibitors (administration & dosage, therapeutic use)
• Female
• Hospitalization
• Humans
• Male
• Rivaroxaban (administration & dosage, therapeutic use)
• Stents (statistics & numerical data)
• Treatment Outcome
• Vitamin K (antagonists & inhibitors, therapeutic use)