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Edward Lee Carter: SINGLE-AF Challenges the Gray Zone in AF Anticoagulation
Edward Lee Carter/LinkedIn
Aug 30, 2026, 10:21

Edward Lee Carter: SINGLE-AF Challenges the Gray Zone in AF Anticoagulation

Edward Lee Carter, Clinical Pharmacist Practitioner at U.S. Department of Veterans Affairs, shared on LinkedIn:

“CHA₂DS₂ VASc score of 1 has long been one of anticoagulation’s grayest zones.

SINGLE-AF just made it a little less gray.

Presented today at ESC Congress 2026 and published simultaneously in NEJM, SINGLE-AF is the first randomized trial to test a DOAC against no routine anticoagulation specifically in patients with AF and one nongender stroke-risk factor.

1,803 patients were randomized to apixaban or rivaroxaban versus no anticoagulation.

At 24 months, the composite of stroke, systemic embolism, major bleeding, or cardiovascular death occurred in:

  • 0.5 percent with a DOAC
  • 1.5 percent without anticoagulation

HR 0.31 (95 percent CI 0.10–0.94)

A 69 percent relative reduction sounds dramatic.

But the more important story is in the details.

The difference appeared to be driven by ischemic stroke. Only 3 patients in the DOAC group versus 10 without anticoagulation experienced stroke. Major bleeding was similar between groups.

That is encouraging—but it is not a mandate to anticoagulate every patient with a single risk factor.

The absolute event rates were low. The confidence interval was wide. Fewer endpoints occurred than expected. The trial was open-label, conducted entirely in South Korea, and enrolled a relatively young population (mean age of approximately 60).

There is another nuance: antiplatelet use was considerably more common in the no-anticoagulation group, which makes a simplistic comparison of bleeding risk less certain.

And importantly, current guidelines were already leaning in this direction.

The 2023 ACC/AHA/ACCP/HRS guideline says anticoagulation is reasonable when estimated annual thromboembolic risk is 1–2 percent—roughly CHA₂DS₂-VASc 1 in men or 2 in women. The 2024 ESC guideline similarly says anticoagulation should be considered at CHA₂DS₂-VA of 1.

So what changed?

For the first time, we have randomized evidence supporting a decision that previously rested largely on observational data and extrapolation.

To me, SINGLE-AF moves the conversation from:

‘Is anticoagulation reasonable?’

toward:

‘How much does this individual patient stand to benefit?’

That still requires looking beyond a single number:

  •  Which risk factor gives the point?
  •  What is the AF burden?
  • Paroxysmal or persistent AF?
  • How well controlled is hypertension?
  • What is the renal function?
  • Are aspirin, NSAIDs, or interacting drugs adding bleeding risk?
  • What does the patient value?

The gray zone did not disappear.

But it became better informed.

SINGLE-AF strengthens the case for DOAC therapy in appropriately selected patients with AF and one nongender stroke-risk factor—but with such low absolute event rates, individualized assessment and shared decision-making remain essential.

This is a decision—not a mandate.”

Edward Lee Carter: SINGLE-AF Challenges the Gray Zone in AF Anticoagulation

Find more posts featuring Edward Lee Carter on Hemostasis Today.

 

Anticoagulation Atrial Fibrillation Cardiology Clinical Pharmacy DOAC Edward Lee Carter evidence-based medicine Hemostasis News Hemostasis Today Medication Safety stroke prevention
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