The Year in Cardiology

Coronary Interventions: The Year in Cardiology 2019

Andreas Baumbach; Christos V. Bourantas; PatrickW. Serruys; William Wijns

Disclosures

Eur Heart J. 2020;41(3):394-405. 

In This Article

Adjunctive Pharmacotherapy

The type and the duration of antiplatelet therapy in patients undergoing PCI is an area of intensive research. The Ticagrelor with Aspirin or Alone in High-Risk Patients after Coronary Intervention (TWILIGHT) study was designed to examine the optimal duration of dual antiplatelet therapy (DAPT) following PCI in high bleeding risk patients.[30] The study randomized 7119 patients to DAPT therapy for 3 months and then treatment with ticagrelor monotherapy or DAPT for 12 months. Short duration DAPT was associated with a lower incidence of bleeding [rate of Bleeding Academic Research Consortium (BARC) type 2, 3, and 5 bleeding: 4.0% in the short duration DAPT group vs. 7.1% in the group receiving DAPT for 12 months, P < 0.001], while there was no difference between groups in the incidence of the composite endpoint death, MI, or stroke.

Conversely, a post hoc analysis of the Global Leaders study including 4570 patients undergoing complex PCI demonstrated that the experimental regimen of aspirin for 1 month and ticagrelor for 24 months was associated with a lower incidence of the primary endpoint death, MI at 2 years of follow-up compared to conventional DAPT for 12 months and then aspirin monotherapy (3.51% vs. 5.43%; P = 0.002). Of note, there was no difference between groups in the risk of bleeding (incidence of BARC type 3 or 5 bleeding: 2.45% vs. 2.54%; P = 0.834). These findings were confirmed by a patient-level analysis of eight randomized control trials including 14 963 patients which demonstrated that in low bleeding risk patients (PREdicting bleeding Complications in patients undergoing stent Implantation and SubsequEnt Dual AntiPlatelet Therapy score <25) prolonged DAPT therapy was associated with a lower incidence of ischaemic events especially in patients undergoing complex PCI. Conversely, long-term DAPT in high bleeding risk patients did not reduce the risk of ischaemic events and increased the risk of bleeding.[31]

Patients suffering from atrial fibrillation undergoing PCI are at increased risk of bleeding as they receive a combination of antiplatelet and anticoagulation therapy. The optimal treatment of these patients has been extensively investigated by several large scale randomized control studies over the last years. The AUGUSTUS trial published this year was a multicentre randomized study with a 2 × 2 factorial design that randomized 4614 patients with atrial fibrillation undergoing PCI to treatment with a P2Y12 inhibitor, and apixaban or vitamin K antagonist, and to aspirin or placebo for 6 months.[32] The recruited patients received standard of care antithrombotic therapy the first days post-PCI as randomization to study groups was performed 6 (interquartile range 3–10) days post-intervention. The incidence of major or clinically relevant non-major bleeding was higher in patients receiving vitamin K antagonist than those treated with apixaban (14.7% vs. 10.5%, P < 0.001) and in those treated with aspirin than those receiving placebo (16.1% vs. 9.0%, P < 0.001). Patients on apixaban had a lower incidence of death or hospitalization than the vitamin K antagonist group (23.5% vs. 27.4%, P = 0.002) and a similar incidence of ischaemic events. Conversely, aspirin did not have an effect to these endpoints.

Similar were the findings of the ENTRUST-AF PCI study which investigated in 1506 patients with atrial fibrillation undergoing PCI the safety and efficacy of the combination of a P2Y12 inhibitor plus edoxaban against the combination DAPT plus vitamin K antagonist.[33] The recruited patients were randomized to the two study groups ≈45 h post-PCI. There was no difference between groups in the incidence of major bleeding-clinically relevant non-significant bleeding or the incidence of the composite endpoint of cardiovascular death, stroke, systemic embolic events, MI, and definite stent thrombosis at 12 months of follow-up. A meta-analysis of randomized controlled trials investigating the safety and efficacy of dual vs. triple antithrombotic therapy in patients with atrial fibrillation undergoing PCI, published this year, confirmed the above findings demonstrating a lower incidence of bleeding (13.4% vs. 20.8%; P < 0.0001) but a higher risk of stent thrombosis (1% vs. 0.6%; P = 0.040) in patients receiving dual therapy.[34]

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