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Hematocrit (HCT) Levels and Thrombotic Events Among US Veterans With Polycythemia Vera
Background: Thrombotic events (TEs) are a leading cause of death in patients with polycythemia vera (PV), contributing to lower overall survival compared with age/sex-matched controls. This analysis evaluated the relationship between HCT levels and TEs among patients with PV from the Veteran’s Health Administration (VHA) to replicate the findings of the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) trial with a real-world patient population.
Methods: This retrospective study used VHA medical record and claims data from first PV diagnosis claim (index) until death, disenrollment, or end of study (collected October 1, 2005, through September 30, 2012). Patients were aged ≥ 18 years at index, had ≥ 2 PV claims (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements/year during follow-up. This analysis focused on patients with no pre-index TE and all HCT values either < 45% or ≥ 45% during follow-up. Patient demographics and disease characteristics were assessed using descriptive statistics. Associations between HCT levels and TE occurrence were analyzed using unadjusted Cox regression models for patients with ≥ 1 HCT before TE (≥ 1 HCT subgroup). A sensitivity analysis including patients with a history of TE before the index period was also performed.
Results: Patients (n=213) were mean (SD) age 68.9 (11.5) years and predominately white (61.5%). TE during follow-up occurred in 44.1% of patients (mean follow-up, 2.3 y; rate per 100 person-years, 18.9). The 3 most common types of TE were ischemic stroke (21.6%), deep vein thrombosis (12.2%), and transient ischemic attack (9.4%). TE rates for patients with HCT values 45% vs < 45% were 54.2% and 40.3%, respectively. In the 1 HCT subgroup (n=208), the TE risk hazard ratio was 1.61 (95% CI, 1.03–2.51; P=0.036). The sensitivity analysis, which included patients with and without pre-index TEs (n=342), had similar results (76.9% vs 55.6%); hazard ratio in the 1 HCT subgroup (n=322):, 1.95 (95% CI, 1.46–2.61; P<0.0001).
Implications: These results in agreement with CYTOPV study findings and further support effective monitoring and management of HCT levels < 45% to reduce the risk of TE in veterans with PV.
Background: Thrombotic events (TEs) are a leading cause of death in patients with polycythemia vera (PV), contributing to lower overall survival compared with age/sex-matched controls. This analysis evaluated the relationship between HCT levels and TEs among patients with PV from the Veteran’s Health Administration (VHA) to replicate the findings of the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) trial with a real-world patient population.
Methods: This retrospective study used VHA medical record and claims data from first PV diagnosis claim (index) until death, disenrollment, or end of study (collected October 1, 2005, through September 30, 2012). Patients were aged ≥ 18 years at index, had ≥ 2 PV claims (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements/year during follow-up. This analysis focused on patients with no pre-index TE and all HCT values either < 45% or ≥ 45% during follow-up. Patient demographics and disease characteristics were assessed using descriptive statistics. Associations between HCT levels and TE occurrence were analyzed using unadjusted Cox regression models for patients with ≥ 1 HCT before TE (≥ 1 HCT subgroup). A sensitivity analysis including patients with a history of TE before the index period was also performed.
Results: Patients (n=213) were mean (SD) age 68.9 (11.5) years and predominately white (61.5%). TE during follow-up occurred in 44.1% of patients (mean follow-up, 2.3 y; rate per 100 person-years, 18.9). The 3 most common types of TE were ischemic stroke (21.6%), deep vein thrombosis (12.2%), and transient ischemic attack (9.4%). TE rates for patients with HCT values 45% vs < 45% were 54.2% and 40.3%, respectively. In the 1 HCT subgroup (n=208), the TE risk hazard ratio was 1.61 (95% CI, 1.03–2.51; P=0.036). The sensitivity analysis, which included patients with and without pre-index TEs (n=342), had similar results (76.9% vs 55.6%); hazard ratio in the 1 HCT subgroup (n=322):, 1.95 (95% CI, 1.46–2.61; P<0.0001).
Implications: These results in agreement with CYTOPV study findings and further support effective monitoring and management of HCT levels < 45% to reduce the risk of TE in veterans with PV.
Background: Thrombotic events (TEs) are a leading cause of death in patients with polycythemia vera (PV), contributing to lower overall survival compared with age/sex-matched controls. This analysis evaluated the relationship between HCT levels and TEs among patients with PV from the Veteran’s Health Administration (VHA) to replicate the findings of the Cytoreductive Therapy in Polycythemia Vera (CYTO-PV) trial with a real-world patient population.
Methods: This retrospective study used VHA medical record and claims data from first PV diagnosis claim (index) until death, disenrollment, or end of study (collected October 1, 2005, through September 30, 2012). Patients were aged ≥ 18 years at index, had ≥ 2 PV claims (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements/year during follow-up. This analysis focused on patients with no pre-index TE and all HCT values either < 45% or ≥ 45% during follow-up. Patient demographics and disease characteristics were assessed using descriptive statistics. Associations between HCT levels and TE occurrence were analyzed using unadjusted Cox regression models for patients with ≥ 1 HCT before TE (≥ 1 HCT subgroup). A sensitivity analysis including patients with a history of TE before the index period was also performed.
Results: Patients (n=213) were mean (SD) age 68.9 (11.5) years and predominately white (61.5%). TE during follow-up occurred in 44.1% of patients (mean follow-up, 2.3 y; rate per 100 person-years, 18.9). The 3 most common types of TE were ischemic stroke (21.6%), deep vein thrombosis (12.2%), and transient ischemic attack (9.4%). TE rates for patients with HCT values 45% vs < 45% were 54.2% and 40.3%, respectively. In the 1 HCT subgroup (n=208), the TE risk hazard ratio was 1.61 (95% CI, 1.03–2.51; P=0.036). The sensitivity analysis, which included patients with and without pre-index TEs (n=342), had similar results (76.9% vs 55.6%); hazard ratio in the 1 HCT subgroup (n=322):, 1.95 (95% CI, 1.46–2.61; P<0.0001).
Implications: These results in agreement with CYTOPV study findings and further support effective monitoring and management of HCT levels < 45% to reduce the risk of TE in veterans with PV.
Demographic and Clinical Characteristics of Patients With Polycythemia Vera (PV) in the U.S. Veterans Population
Introduction: PV is associated with an increased risk of thrombosis, which contributes to morbidity and mortality of patients. Limited data exist on patients with PV among the Veterans Health Administration (VHA) population. The objective of this study is to describe the demographic and clinical characteristics of patients with PV in the VHA population.
Methods: A retrospective, observational analysis was conducted using longitudinal data from the VHA database. The analysis included adult patients who had ≥ 2 claims for PV (ICD-9 238.4) ≥ 30 days apart between 01/01/2007 and 12/31/2009 and ≥ 12 months of continuous enrollment before the first PV claim (index date). Patients were followed from the index date until the earliest date of death, disenrollment, or end of study (9/30/2012). Demographics and comorbid conditions during the pre-index period, and cytoreductive treatments, select laboratory values, thrombotic event (TE) rate, and mortality rate during the follow-up period are reported.
Results: The analysis included 7718 patients with PV; most patients were ≥ 60 years of age (70.7%), male (97.9%), and white (63.9%). The 3 most common comorbid conditions reported during the pre-index period were hypertension (71.7%), dyslipidemia (54.2%), and diabetes (24.0%). Additionally, 8.8% had arterial thrombosis, 4.5% had venous thrombosis, and 8.7% had bleeding. During the follow-up period (median 4.8 years), 23.2% of patients received cytoreductive pharmacotherapy (86.7% hydroxyurea), 32.8% had phlebotomy, and 53.0% had neither cytoreductive therapy nor phlebotomy. 86.4% and 63.3% of patients were using antihypertensive agents and anti-lipid medications, respectively. 86.7% of patients had ≥ 2 elevated HCT levels (≥ 45%) and 37.3% had ≥ 2 elevated WBC counts ( ≥ 11*109/L). 22.9% of patients had ≥ 1 TE (16.5% arterial thrombosis and 8.78% venous thrombosis). The TE rate was 60.5 per 1,000 patient years. Deaths due to any cause were reported for 23.0% of patients during follow-up.
Conclusion: The TE burden is significant among patients with PV in the VHA population. A large proportion of patients had elevated blood values, which may indicate uncontrolled PV, and may predispose patients to greater risk of clinical complications and consequences of PV.
Introduction: PV is associated with an increased risk of thrombosis, which contributes to morbidity and mortality of patients. Limited data exist on patients with PV among the Veterans Health Administration (VHA) population. The objective of this study is to describe the demographic and clinical characteristics of patients with PV in the VHA population.
Methods: A retrospective, observational analysis was conducted using longitudinal data from the VHA database. The analysis included adult patients who had ≥ 2 claims for PV (ICD-9 238.4) ≥ 30 days apart between 01/01/2007 and 12/31/2009 and ≥ 12 months of continuous enrollment before the first PV claim (index date). Patients were followed from the index date until the earliest date of death, disenrollment, or end of study (9/30/2012). Demographics and comorbid conditions during the pre-index period, and cytoreductive treatments, select laboratory values, thrombotic event (TE) rate, and mortality rate during the follow-up period are reported.
Results: The analysis included 7718 patients with PV; most patients were ≥ 60 years of age (70.7%), male (97.9%), and white (63.9%). The 3 most common comorbid conditions reported during the pre-index period were hypertension (71.7%), dyslipidemia (54.2%), and diabetes (24.0%). Additionally, 8.8% had arterial thrombosis, 4.5% had venous thrombosis, and 8.7% had bleeding. During the follow-up period (median 4.8 years), 23.2% of patients received cytoreductive pharmacotherapy (86.7% hydroxyurea), 32.8% had phlebotomy, and 53.0% had neither cytoreductive therapy nor phlebotomy. 86.4% and 63.3% of patients were using antihypertensive agents and anti-lipid medications, respectively. 86.7% of patients had ≥ 2 elevated HCT levels (≥ 45%) and 37.3% had ≥ 2 elevated WBC counts ( ≥ 11*109/L). 22.9% of patients had ≥ 1 TE (16.5% arterial thrombosis and 8.78% venous thrombosis). The TE rate was 60.5 per 1,000 patient years. Deaths due to any cause were reported for 23.0% of patients during follow-up.
Conclusion: The TE burden is significant among patients with PV in the VHA population. A large proportion of patients had elevated blood values, which may indicate uncontrolled PV, and may predispose patients to greater risk of clinical complications and consequences of PV.
Introduction: PV is associated with an increased risk of thrombosis, which contributes to morbidity and mortality of patients. Limited data exist on patients with PV among the Veterans Health Administration (VHA) population. The objective of this study is to describe the demographic and clinical characteristics of patients with PV in the VHA population.
Methods: A retrospective, observational analysis was conducted using longitudinal data from the VHA database. The analysis included adult patients who had ≥ 2 claims for PV (ICD-9 238.4) ≥ 30 days apart between 01/01/2007 and 12/31/2009 and ≥ 12 months of continuous enrollment before the first PV claim (index date). Patients were followed from the index date until the earliest date of death, disenrollment, or end of study (9/30/2012). Demographics and comorbid conditions during the pre-index period, and cytoreductive treatments, select laboratory values, thrombotic event (TE) rate, and mortality rate during the follow-up period are reported.
Results: The analysis included 7718 patients with PV; most patients were ≥ 60 years of age (70.7%), male (97.9%), and white (63.9%). The 3 most common comorbid conditions reported during the pre-index period were hypertension (71.7%), dyslipidemia (54.2%), and diabetes (24.0%). Additionally, 8.8% had arterial thrombosis, 4.5% had venous thrombosis, and 8.7% had bleeding. During the follow-up period (median 4.8 years), 23.2% of patients received cytoreductive pharmacotherapy (86.7% hydroxyurea), 32.8% had phlebotomy, and 53.0% had neither cytoreductive therapy nor phlebotomy. 86.4% and 63.3% of patients were using antihypertensive agents and anti-lipid medications, respectively. 86.7% of patients had ≥ 2 elevated HCT levels (≥ 45%) and 37.3% had ≥ 2 elevated WBC counts ( ≥ 11*109/L). 22.9% of patients had ≥ 1 TE (16.5% arterial thrombosis and 8.78% venous thrombosis). The TE rate was 60.5 per 1,000 patient years. Deaths due to any cause were reported for 23.0% of patients during follow-up.
Conclusion: The TE burden is significant among patients with PV in the VHA population. A large proportion of patients had elevated blood values, which may indicate uncontrolled PV, and may predispose patients to greater risk of clinical complications and consequences of PV.