Impact of anemia on long-term clinical outcomes in venous thromboembolism: Findings from GARFIELD-VTE registry

Key Takeaway

GARFIELD-VTE study results showed that patients with VTE and concomitant anemia had a higher risk of adverse clinical outcomes vs those without anemia.

Why This Matters

Study Design

GARFIELD-VTE: Global, Prospective, Non-interventional Registry (10,685 Adult Patients With Vte [415 Sites Across 28 Countries Worldwide])

Primary clinical outcomes: All-cause mortality, recurrent VTE, and major bleeding^‡ in patients with and without anemia over 24-months from VTE diagnosis

Secondary clinical outcomes: Non-major bleeding^§, MI/ACS, non-hemorrhagic stroke/TIA, and cancer

Key Results

72.1 % patients (7,698/10,679) diagnosed with VTE were eligible for analysis

• Patients with Anemia: n = 2,771
  • (median age = 62.6 years; DVT events = 61.1%; PE ± DVT events = 38.9%)
• Patients without Anemia: n = 4,927
  • (median age = 58.9 years; DVT events = 55.9%; PE ± DVT events = 44.0%)

Patients who remained on anticoagulant treatment at 24-months (with vs without anemia): 40.0% vs 51.2%

Key Limitations

• Data collection was non-randomized
• Intention-to-treat concept was used; however, this approach did not consider treatment duration/discontinuation or fluctuating Hb values after initial assessment at baseline
• Hb values were only available for 7,698/10,679 patients

* Patients with severe anemia vs those with mild/moderate anemia had higher risk of all-cause mortality (HR = 1.42 [95% CI: 1.17–1.72]; P = 0.0004) and major bleeding (HR = 1.84 [95% CI: 1.33–2.55]; P = 0.0003).

^† Patients with vs without anemia (at baseline): Parenteral therapy alone = 26.6% vs 11.7%; VKA alone = 5.7% vs 5.0%; VKA + parenteral therapy = 25.6% vs 28.1%; DOACs alone = 24.5% vs 32.8%; DOAC + parenteral therapy = 14.0% vs 20.7%.

^‡Clinically overt bleeding associated with a critical site, a fall in Hb of 2 g/dL, transfusion of 2 or more units of red blood cells, hemorrhagic stroke, or fatal outcome.

^§Any bleeding that did not meet the major bleeding criteria.

^¶At 24 months, after adjustment for cancer status, age, ethnicity, and BMI (adjusted HR for mortality with 95% CIs for 24-month outcomes after VTE diagnosis between patients with anemia and or with no-anemia [reference group]).