October 24, 2020Clinical Research in CardiologyOpen Access

Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Atrial fibrillation following successful coronary stenting (n=1506). Intervention: Edoxaban plus a P2Y12 inhibitor vs. Vitamin K antagonist plus a P2Y12 inhibitor and aspirin. Primary outcome: Composite of major or clinically relevant non-major (CRNM) bleeding within 12 months (HR 0.83, 95% CI 0.654-1.047).

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Key result

In patients with atrial fibrillation undergoing percutaneous coronary intervention, an edoxaban-based regimen resulted in a major or clinically relevant non-major bleeding rate of 20.7%/year compared to 25.6%/year with a VKA-based regimen (HR 0.83).

Why the study?

This ENTRUST-AF PCI trial sub-analysis evaluated the type of AF and CHA2DS2-VASc score parameters as predictors of clinical outcomes after PCI.

Do AF type and CHA2DS2-VASc score predict clinical outcomes in AF patients receiving antithrombotic therapy after PCI?

Study Design

Type

RCT (n=1,506)

Blinding

Open-label with masked outcome evaluation

Randomization

1:1

Multicenter

Yes

Structured PICO

Do AF type and CHA2DS2-VASc score predict clinical outcomes in AF patients receiving antithrombotic therapy after PCI?

Population

1,506 patients with atrial fibrillation who underwent successful percutaneous coronary intervention, randomized to an edoxaban-based or VKA-based antithrombotic regimen and followed for 12 months.

Intervention

Edoxaban (60 mg/30 mg once daily) plus a P2Y12 inhibitor for 12 months

Comparator

Vitamin K antagonist (VKA) plus a P2Y12 inhibitor and aspirin (100 mg once daily, for 1-12 months)

Outcome

Composite of major/clinically relevant non-major bleeding (CRNM) within 12 monthssafety

Main Result

Hazard Ratio: 0.83 (95% CI 0.654–1.047)

Absolute Event Rate: 20.7% vs 25.6%

In AF patients undergoing PCI, higher CHA2DS2-VASc scores predict increased bleeding and stent thrombosis risk, while paroxysmal AF is associated with a higher risk of myocardial infarction.

Limitations

Retrospective subgroup analyses of clinical trials are subject to many limitations and should be viewed as hypothesis-generating only.
The burden of AF or AF recurrences were not systematically assessed during the follow-up period, and no constant rhythm monitoring was done.
1 year of follow-up may not be long enough to change the pre-existing type of AF.
The study was too small to elaborate differences in various treatments regimens (triple versus dual therapy) in accordance to the risk score system.
A statistically powered analysis appears difficult due to the overall small events rates, including stent thromboses.

Implication

Supports risk stratification by CHA2DS2-VASc after PCI in AF; extends data on paroxysmal AF and MI risk.

Abstract

Aims This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. Methods Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1–12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. Results Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654–1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711–1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). Conclusion After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.

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Cite This Study

Goette et al. (2020) conducted an RCT in Atrial fibrillation following successful coronary stenting (n=1,506). Edoxaban plus a P2Y12 inhibitor vs. Vitamin K antagonist plus a P2Y12 inhibitor and aspirin was evaluated on Composite of major or clinically relevant non-major (CRNM) bleeding within 12 months (HR 0.83, 95% CI 0.654-1.047). In patients with atrial fibrillation undergoing percutaneous coronary intervention, an edoxaban-based regimen resulted in a major or clinically relevant non-major bleeding rate of 20.7%/year compared to 25.6%/year with a VKA-based regimen (HR 0.83).

synapsesocial.com/papers/6a94d7cc222f50f5880b1ae7 https://doi.org/10.1007/s00392-020-01760-4