• 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.

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):

• Active cancer: 20.1% vs 5.6%

• History of cancer: 22.4% vs 9.2%

• CHF: 4.2 vs 2.5%

• Chronic immobilization: 8.2% vs 4.0%

• Renal insufficiency: 6.6% vs 2.4%

• Hospitalization: 22.0% vs 6.8%

• Surgery: 19.2% vs 8.2%

• Previous VTE: 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]).

ABBREVIATIONS:

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.