GARFIELD-VTE study results showed that patients with VTE and concomitant anemia had a higher risk of adverse clinical outcomes vs those without anemia.
Baseline anemia is a prominent predictor of the risk of major bleeding and all-cause mortality but does not influence the risk of recurrent VTE.*
Patients with anemia were more likely to receive parenteral anticoagulants and VKAs and less likely to receive DOACs.†
Why This Matters
GARFIELD-VTE registry study analyzed real-world population of VTE patients, thus allowing an understanding of current outcomes and treatment protocols in a clinical setting.
This study demonstrated the need for appropriate therapeutic management strategies to reduce the risk of major bleeding and mortality for patients with VTE and concomitant anemia.
GARFIELD-VTE: Global, Prospective, Non-interventional Registry (10,685 Adult Patients With Vte [415 Sites Across 28 Countries Worldwide])
Key Inclusion Criteria
Objective diagnosis of VTE within ± 30 days of entry into the registry
Key Exclusion Criteria
Long-term follow-up was not planned; Hb values were not measured; or Hb values were measured outside the 30-day window of entry into the registry
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
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%)
VTE Risk Factors (Patients with vs without Anemia):
20.1% vs 5.6%
History of cancer:
22.4% vs 9.2%
CHF: 4.2 vs 2.5%
8.2% vs 4.0%
6.6% vs 2.4%
22.0% vs 6.8%
Surgery: 19.2% vs 8.2%
10.0% vs 17.9%
Primary Clinical Outcomes (Patients with vs without Anemia)¶:
All-cause mortality: HR = 1.84
(95% CI: 1.56–2.18; P <0.0001)
Major bleeding: HR = 2.83
(95% CI: 2.14–3.75; P <0.0001)
Recurrent VTE: HR = 0.96
(95% CI: 0.79–1.16; P = 0.6440)
Secondary Clinical Outcomes (Patients with vs without Anemia)¶:
Any bleeds: HR = 1.41
(95% CI: 1.23–1.62; P <0.0001)
MI/ACS: HR = 2.01
(95% CI: 1.21–3.34; P <0.0092)
Stroke/TIA: HR = 1.56
(95% CI: 1.01–2.41; P = 0.0489)
Cancer: HR = 1.07
(95% CI: 0.83–1.38; P = 0.6150)
Patients who remained on anticoagulant treatment at 24-months (with vs without anemia): 40.0% vs 51.2%
- 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]).
ACS, acute coronary syndrome; CHF, chronic heart failure; CI, confidence interval; DOACs, direct oral anticoagulants; DVT, deep vein thrombosis; GARFIELD, Global Anticoagulant Registry in the FIELD; Hb, hemoglobin; HR, hazard ratio; MI, myocardial infarction; PE, pulmonary embolism; TIA, transient ischemic attack; VKAs, vitamin K antagonists; VTE, venous thromboembolism.
Goto S, Turpie AGG, Farjat AE, Weitz JI, Haas S, Ageno W, et al. The influence of anemia on clinical outcomes in venous thromboembolism: Results from GARFIELD-VTE. Thromb Res. 2021;203:155–162. doi: 10.1016/ j.thromres.2021.05.007. PMID: 34023735.