Little is known about the efficacy and safety of rivaroxaban in patients with atrial
fibrillation (AF) who underwent percutaneous coronary intervention (PCI) in clinical
practice. We therefore conducted a prospective observational study to determine the
rate of ischemic, embolic, and bleeding events in patients with AF and PCI treated
with rivaroxaban in a real-world experience. The RIVA-PCI (“rivaroxaban in patients
with AF who underwent PCI”) (clinicaltrials.gov NCT03315650) is a prospective, noninterventional, multicenter study with a follow-up
until 14 months, including patients with AF who underwent PCI discharged with rivaroxaban.
Between January 2018 and March 2020, 700 patients with PCI treated with rivaroxaban
(elective in 50.1%, non-ST-elevation acute coronary syndrome 43.0%, ST-elevation myocardial
infarction in 6.9%) were enrolled at 51 German hospitals. After PCI, a dual antithrombotic
therapy consisting of rivaroxaban and a P2Y12 inhibitor was administered in 70.7%
and triple antithrombotic therapy in 27.9%, respectively. Follow-up information could
be obtained in 695 patients (99.3%). Rivaroxaban has been stopped prematurely in 21.6%
of patients. Clinical events under rivaroxaban during the 14-month follow-up compared
with those observed in the PIONEER-AF PCI trial included cardiovascular death (2.0%
% vs 2.0%), myocardial infarction (0.9% vs 3.0%), stent thrombosis (0.2% vs 0.8%),
stroke (1.3% vs 1.3%), International Society on Thrombosis and Haemostasis major (4.2%
vs 3.9%), and International Society on Thrombosis and Haemostasis nonmajor clinically
relevant bleeding (15.3% vs 12.9%). Therefore, in this real-world experience, rivaroxaban
in patients with AF who underwent PCI is associated with ischemic and bleeding event
rates comparable with those observed in the randomized PIONEER-AF PCI trial.
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Article info
Publication history
Published online: December 06, 2022
Received in revised form:
October 8,
2022
Received:
August 25,
2022
Footnotes
Funding: This study was supported by an unrestricted grant of Bayer, Germany.
Identification
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