Clin Res Cardiol (2021). 10.1007/s00392-021-01933-9

Use, safety and efficacy of rivaroxaban in patients with atrial fibrillation undergoing PCI – Results of the prospective RIVA-PCI registry
U. Zeymer1, R. Tölg2, R. Hambrecht3, H.-P. Hobbach4, M. Hennersdorf5, R. Bekeredjian6
1Medizinische Klinik B, Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen am Rhein; 2Herzzentrum, Segeberger Kliniken GmbH, Bad Segeberg; 3Innere Medizin I, Klinikum Links der Weser, Bremen; 4Medizinische Klinik III - Kardiologie, Angologie und internistische Intensivmedizin, Kreisklinikum Siegen GmbH, Siegen; 5Klinik für Innere Medizin I, SLK-Kliniken Heilbronn GmbH, Klinikum am Gesundbrunnen, Heilbronn; 6Innere Medizin III / Kardiologie, Robert-Bosch-Krankenhaus, Stuttgart;

Background. In the PIONEER-AF trial rivaroxaban in combination with a P2Y12 inhibitor was safer and as effective as triple therapy with a vitamin K antagonist in patients with non-valvular atrial fibrillation (nv-AF) undergoing PCI. Little is known about the use, safety and efficacy of rivaroxaban in patients with nv-AF and PCI in clinical practice.

Methods. We performed a prospective registry in 51 hospitals with consecutive patients with nv-AF undergoing PCI with stent implantation. Baseline characteristics, procedural features, concomitant medications and in-hospital events were centrally collected and analysed in all patients. Central follow-up at 3 and 12 months after discharge was performed in patients treated with rivaroxaban at discharge.

Results. Between 01/2018 and 01/2020 a total of 1636 patients were enrolled. The indications for PCI were elective in 52%, unstable angina in 28 %, NSTEMI in 21 % und STEMI in 9 %. A dual combination therapy consisting of oral anticoagulation and a P2Y12 inhibitor was given in 72 %, triple therapy in 26 % and a mono therapy in 2 % of patients. Rivaroxaban was the preferred oral anticoagulant given in 700 patients (42.8 %), followed by apixaban in 27.5 %, a vitamin K antagonist in 11.5 %, edoxaban in 6.4 % and dabigatran in 5.5 %, respectively. Rivaroxaban was given as monotherapy in 1.7%, as dual therapy in combination with a P2Y12 inhibitor (98.2 % clopidogrel) in 70.7 % and as part of triple therapy in 27.9 %. During 14-month follow-up in the 448 treated with rivaroxaban for more than 9 months total mortality was 3.7 %, cardiac mortality was 1.2 %, stroke occurred in 1.0%, myocardial infarction in 1 %, stent thrombosis in 0.7 % and total bleeding was reported in 12.7 % and ISTH major bleeding in 3.6 %.

Conclusions: In patients with nv-AF undergoing PCI dual therapy with a NOAC and clopidogrel is the preferred antithrombotic combination therapy. Rivaroxaban is used in about 40 % of patients and associated with a low ischemic and bleeding event rate during the 14-month of follow-up, confirming the results of the PIONEER-AF trial in clinical practice.