Monotherapy with oral anticoagulant beyond 1 year after PCI as effective and safe as dual therapy in stable AF patients

Introduction and methods

Background

European AF guidelines recommend treating patients with stable AF and an increased risk of stroke (CHA2DS2VASc score ≥2) beyond 1 year after PCI with anticoagulant monotherapy, rather than dual therapy with an oral anticoagulant and antiplatelet drug [1-4]. However, the evidence for this is scarce [5,6]. The Japanese AFIRE trial showed that monotherapy with rivaroxaban was safer, and as effective as dual therapy with rivaroxaban and aspirin or a P2Y12 inhibitor in patients with AF who had undergone PCI or CABG more than 1 year earlier or who had stable CAD [6]. However, participants did not receive the recommended doses of rivaroxaban. Moreover, the trial was stopped early because of increased mortality in the dual therapy group.

Aim of the study

The aim of this study was to compare the effectiveness and safety of long-term monotherapy with an oral anticoagulant to long-term dual therapy with an oral anticoagulant and antiplatelet drug beyond 1 year after PCI in patients with stable AF. Moreover, in patients treated with monotherapy, direct oral anticoagulant (DOAC) therapy was compared to VKA therapy.

Methods

The researchers performed a retrospective analysis of data from the Western Denmark Heart Registry of 3331 patients with stable AF who had undergone first-time PCI between 2003 and 2017 and received monotherapy (with an oral anticoagulant) or dual therapy (with an oral anticoagulant and antiplatelet drug) 1 year later. In the monotherapy group, 1275 patients were subdivided in those treated with a DOAC and those treated with a VKA. For the analyses comparing DOAC monotherapy with VKA monotherapy, the inclusion period was limited to 2011-2017, as DOACs were unavailable before this period.

Outcomes

The outcomes of interest were hospitalization for bleeding and major adverse cardiac events (MACE). MACE was a composite of ischemic stroke, myocardial infarction, and all-cause mortality. Hospitalization for bleeding was a composite of primary or secondary diagnoses of cerebral bleeding, bleeding from the respiratory tract, gastrointestinal bleeding, bleeding from the urinary tract, or anemia from acute or chronic bleeding. Follow-up began 15 months after PCI and continued for up to 4 years (median follow-up: 2.5 years).

Main results

Monotherapy vs. dual therapy

• Cumulative incidence rates of hospitalization for bleeding (5.3 vs. 5.9 events per 100 person-years; HR: 0.90; 95%CI: 0.75-1.09) and MACE (10.1 vs. 8.9 events per 100 person-years; HR: 1.04; 95%CI: 0.90-1.19) were similar between the monotherapy group (n=1724) and dual therapy group (n=1607).
• This was also true for the individual components of MACE, namely ischemic stroke (1.5 vs. 1.3 events per 100 person-years; HR: 1.16; 95%CI: 0.81-1.67), myocardial infarction (1.4 vs. 1.6 events per 100 person-years; HR: 0.78; 95%CI: 0.55-1.12) and all-cause mortality (7.9 vs. 6.8 events per 100 person-years; HR: 1.05; 95%CI: 0.89-1.23).
• These results were consistent across different subgroups of patients, including those with a CHA2DS2-VASc score ≥3.

DOAC monotherapy vs. VKA monotherapy

• Cumulative incidence rates of hospitalization for bleeding (4.6 vs. 4.3 events per 100 person-years; HR: 1.27; 95%CI: 0.84-1.92) and MACE (10.9 vs. 10.9 events per 100 person-years; HR: 1.15; 95%CI: 0.87-1.50) were similar between the DOAC monotherapy group (n=543) and VKA monotherapy group (n=732).
• The risk of myocardial infarction was higher in the DOAC monotherapy group than in the VKA monotherapy group (2.0 vs. 1.1 events per 100 person-years; HR: 2.10; 95%CI: 1.09-4.04), but this was not true for ischemic stroke (0.7 vs. 1.7 events per 100 person-years; HR: 0.59; 95%CI: 0.21-1.67) and all-cause mortality (8.4 vs. 8.3 events per 100 person-years; HR: 1.14; 95%CI: 0.84-1.54).

Conclusion

References

Find this article online at Eur Heart J Cardiovasc Pharmacother.