Safety and efficacy of dual vs. triple antithrombotic therapy in patients with indication of anticoagulation treated by PCI: A retrospective analysis of the FRANCE PCI registry

In patients with long-term oral anticoagulant (OAC) therapy treated with percutaneous coronary intervention (PCI), the 2020 European guidelines recommend a dual antithrombotic therapy (DAT) combining an OAC and a single antiplatelet therapy (SAPT) for a period of 6 to 12 months according on the clinical context. Our study aims to assess real-life practices using data from the France PCI registry. All consecutive patients from the France PCI registry treated by PCI and on OAC therapy between 2014 and 2019 were included. Two groups of patients were determined. Patients with DAT (1 oral anticoagulant and SAPT) or a triple therapy (TAT) < 1 month were included in the DAT group. Patients with OAC and DAPT > 1 month constituted the TAT group. The primary endpoint was defined as significant bleeding according to the BARC classification (≥ 3) at one-year follow-up. The secondary endpoint was a composite endpoint of ischemic events including death, myocardial infarction, stroke, unscheduled revascularization or stent thrombosis. Two secondary analyses were performed using a 1:1 patient matching with a propensity score to balance the 2 populations comparing DAT vs. TAT and vitamin K antagonist (VKA) vs. direct OAC (DOAC). Between 2014 and 2019, 5768 consecutive patients were discharged with TAT (n = 3993; 69.2%) or DAT (n = 1775; 30.8%). The incidence of bleeding events was significantly increased in the DAT group as compared to the TAT group (7.1% vs. 5.1%, HR: 1.41; 95% CI: 1.41–1.76; P < 0.01). In contrast, there was no significant difference in the incidence of ischemic events (13.4% vs. 15.2%, HR: 0.88; 95% CI: 0.75–1.02; P = 0.08). After propensity score matching, there was no more significant difference in bleeding complications (7.0% vs. 5.4%, P = 0.09). On the other hand, the incidence of hemorrhagic events was significantly lower in patients on DOAC compared to those on VKA (4.2% vs. 7.1%, P < 0.01), the rate of ischemic events did not differ significantly between the two groups (13.6% vs. 14.3%, P = 0.67). The results of our study suggest that DAT is used in France in only 30% of cases and unlike randomized studies, does not reduce bleeding complications compared to TAT. Ischemic complications were similar between the 2 strategies. Furthermore, our study underlines the superiority of DOAC over VKA in patients with OAC requiring PCI.