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Bartosz Hudzik: First RCT Evidence for a Long-Standing Guideline Gray Zone

Bartosz Hudzik/LinkedIn

Aug 29, 2026, 10:57

Bartosz Hudzik: First RCT Evidence for a Long-Standing Guideline Gray Zone

Bartosz Hudzik, Associate Profesor at Medical University of Silesia, shared a post on LinkedIn:

“First RCT evidence for a long-standing guideline gray zone.

Current U.S./European guidelines give oral anticoagulation a class IIa recommendation in atrial fibrillation patients at intermediate stroke risk (CHA2DS2-VASc score of 1 in men, 2 in women) – but until now, that recommendation rested on extrapolation, not trial data.

SINGLE-AF, a multicenter open-label trial from South Korea, randomized 1,803 such patients 1:1 to DOAC therapy vs. no anticoagulation. At 24 months:

Primary composite (stroke, systemic embolism, major bleeding, or CV death): 0.5% with DOAC vs. 1.5% without (HR 0.31, 95% CI 0.10–0.94, P=0.03)
Stroke specifically: 0.3% vs. 1.1%
No apparent increase in major bleeding with DOAC
No cardiovascular deaths in either arm
Serious adverse events similar between groups (8.9% vs. 9.3%)

The takeaway: in this population, anticoagulation reduced stroke without an offsetting bleeding penalty – the net clinical benefit calculus that’s been debated for years in this risk stratum now has prospective, randomized support.

This is exactly the kind of trial our field needed: Intermediate-risk AF patients are common in clinical practice, and decisions here have often been made on the strength of guideline wording rather than dedicated RCT evidence.”

Bartosz Hudzik