Anti-Xa Activity and Event Risk in Patients With Direct Factor Xa Inhibitors Initiated Early After Stroke

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Acute ischemic stroke or TIA with non-valvular atrial fibrillation (n=325). Intervention: Anti-Xa activity (AXA) levels vs. Lower anti-Xa activity levels. Primary outcome: Hemorrhagic events (HR 2.07, 95% CI 1.18-3.65, p=0.01).

Shinichi Wada; Ḱazunori Toyoda; Shoichiro Sato; Takayuki Matsuki; Takuya Okata; Masaya Kumamoto; Naoki Tagawa; Manabu Inoue; Akira Okamoto; Masafumi Ihara; Takanari Kitazono; Toshiyuki Miyata; Masatoshi Koga

doi:10.1253/circj.cj-18-0506

September 10, 2018Circulation JournalOpen Access

Anti-Xa Activity and Event Risk in Patients With Direct Factor Xa Inhibitors Initiated Early After Stroke

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Key result

Higher peak anti-Xa activity levels measured early after starting rivaroxaban (HR 2.07 per 1.0 IU/mL) or apixaban (HR 2.47 per 1.0 IU/mL) were significantly associated with an increased risk of future hemorrhagic events.

Why the study?

Does early measurement of anti-Xa activity predict future hemorrhagic or ischemic events in acute stroke patients with NVAF started on rivaroxaban or apixaban?

Study Design

Type

Observational (n=325)

Multicenter

No

Structured PICO

Does early measurement of anti-Xa activity predict future hemorrhagic or ischemic events in acute stroke patients with NVAF started on rivaroxaban or apixaban?

P

Population

325 patients with acute ischemic stroke or transient ischemic attack and non-valvular atrial fibrillation who started rivaroxaban or apixaban within 7 days of onset, followed for a median of 360 days.

E

Exposure

Rivaroxaban (15 mg or 10 mg daily) or apixaban (5 mg or 2.5 mg twice daily) initiated early (median 5 days) after stroke onset, with measurement of anti-Xa activity (AXA) at trough (just before) and peak (4 hours after) administration.

O

Outcome

Hemorrhagic events (major and non-major clinically relevant) and ischemic events (recurrence of ischemic stroke/TIA, systemic embolism, acute coronary syndrome, etc.) at median 360 days follow-up.safety

Main Result

Hazard Ratio: 2.07 (95% CI 1.18–3.65)

p-value: p=0.01

Measuring peak anti-Xa activity early after initiating rivaroxaban or apixaban in acute stroke patients may help identify those at higher risk for subsequent hemorrhagic events.

Limitations

Observational investigation where the choice of rivaroxaban and apixaban was not randomized, introducing potential selection bias.
Blood sampling time was set at 4 hours after medication, but there might be wide variation in the peak time among patients according to renal function, age, and feeding conditions.
Differences in the number of days from starting Xa inhibitors to the measurement of AXA may have influenced the results.
AXA was measured only once during the acute stroke phase, and the level might be affected by the stroke condition.
Observational investigation
Choice of rivaroxaban and apixaban was not randomized (potential bias)

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Implication

AXA levels may flag bleeding risk with early DOAC start post-stroke; hypothesis-generating and should not yet change practice.

Abstract

BACKGROUND: Measuring anti-Xa activity (AXA) has been reported as useful for predicting future risk of hemorrhagic and ischemic events in stroke patients taking direct factor Xa inhibitors. We evaluated AXA levels of rivaroxaban or apixaban in acute stroke patients with non-valvular atrial fibrillation. METHODS AND RESULTS: were independently related to the incidence of hemorrhagic events. CONCLUSIONS: In these patients who started rivaroxaban or apixaban early after stroke, AXA levels in the early period were related to future hemorrhagic events.

Discussion

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Cite This Study

Wada et al. (2018) conducted an observational in Acute ischemic stroke or TIA with non-valvular atrial fibrillation (n=325). Anti-Xa activity (AXA) levels vs. Lower anti-Xa activity levels was evaluated on Hemorrhagic events (HR 2.07, 95% CI 1.18-3.65, p=0.01). Higher peak anti-Xa activity levels measured early after starting rivaroxaban (HR 2.07 per 1.0 IU/mL) or apixaban (HR 2.47 per 1.0 IU/mL) were significantly associated with an increased risk of future hemorrhagic events.

synapsesocial.com/papers/6a79e56564a2339647022d6c https://doi.org/10.1253/circj.cj-18-0506

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Anti-Xa Activity and Event Risk in Patients With Direct Factor Xa Inhibitors Initiated Early After Stroke

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Anti-Xa Activity and Event Risk in Patients With Direct Factor Xa Inhibitors Initiated Early After Stroke

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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