Is the recommended hematocrit target in polycythemia vera evidence based? Tiziano BARBUI, MD Ospedali Riuniti, Bergamo, Italy
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1 Is the recommended hematocrit target in polycythemia vera evidence based? Tiziano BARBUI, MD Ospedali Riuniti, Bergamo, Italy
2 We have generated a transgenic mouse line that reaches a hematocrit concentration of 0.85 due to constitutive overexpression of human erythropoietin in an oxygen independent manner. Unexpectedly, this excessive erythrocytosis did not lead to thrombembolic complications in all investigated organs at any age.
3 Elevated hematocrit, risk of thrombosis, and polycythemia vera ( Prchal, Blood 2003,letter) In conditions associated with elevated hematocrit such as polycythemia of high altitude, erythropoietin receptor mutations, Chuvash polycythemia, hemoglobin mutants with high oxygen affinity, and 2,3 BPG deficiency, the rates of thrombotic complications are far below those seen in patients with PV. These observations suggest that the thrombotic complications of PV may be induced, at least in part, by other unique features of PV, such as quantitative and qualitative defects of platelets and neutrophils; these myeloid cells are, after all, the progeny of the same mutated hematopoietic stem cell as the red cells.
4 Thrombosis during follow up in 1638 PV patients (Eclap)* Fatal and nonfatal cardiovascular events n=226 Myocardial infarction 0.9 Stroke/TIA Peripheral arterial thrombosis Deep vein thrombosis and PE Marchioli et al, JCO 2005
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6 . Risk of stroke in adults with cyanotic congenital heart disease. Perloff JK, Marelli AJ, Miner PD. Circulation Jun;87(6): cyanotic patients years old (mean, 36 +/ 11.7 years) in the UCLA Adult Congenital Heart Disease Center Registry were selected for study by virtue of continuous observation for 1 12 years (total, 748 patient years). No patient with either compensated or decompensated erythrocytosis, irrespective of hematocrit level, iron stores, or the presence, degree, or recurrence of cerebral hyperviscosity symptoms, progressed to clinical evidence of a complete stroke (cerebral arterial thrombosis with brain infarction).
7 Results from the Tromsø study* in the general population (survey in Tromsø, Norway) show that a hematocrit in the upper 20th percentile was found to be associated with a 1.5 fold increased risk of venous thrombosis. The link found between high hematocrit and risk of venous thrombosis is real, but there is uncertainty on whether the relation is causal or explained by other diseases. No clear data from multivariate analysis. Do high levels of hematocrit interact with other risk factors for venous thrombosis and, therefore, increase the risk of venous thrombosis even more? Could it indeed explain part of the link between arterial and venous thrombosis, as the authors suggest? * Brækkan et al, Haematologica 2012
8 Evidence for recommendation to maintain Ht<45% PVSG 01 Treatment by phlebotomy alone resulted in a higher incidence of thrombosis during the first 3 years 60 Percentage P Phlebotomy Chlorambucil Death Thrombosis AML Malignancy 1
9 Hematocrit was not a risk factor for thrombosis in the PVSG 01 trial In multivariate analysis, pre-treatment hematocrit was not associated with thrombosis. In a case-control analysis, Ht measured at the closest observation prior to thrombotic event (up to 52%) - and compared with that in the matched control at the corresponding time on study - was not associated with thrombosis
10 ECLAP Central Coordination Central registry RCT Clear Indication to ASA 518 ASA Uncertain benefit/risk ratio Clear Contraindication for ASA Cohort for the Evaluation of Natural History (1,638 pts)
11 Packed Cell Volume (L/L) 0,60 0,55 0,50 0,45 0,40 0,35 0,30 Hematocrit 0,550 0,506 0,500 0,500 0,498 0,484 0,468 0,453 0,453 0,453 0,455 0,455 0,400 0,407 0,396 0,388 0,382 0, No. of patients ,431 1,240 1, Months
12 Time dependent multivariate analysis on the relative risk of major thrombosis among men and women with Polycythemia Vera (N = 1,638)* *Model adjusted for: age, gender, time from PV diagnosis to recruitment, thrombotic or hemorrhagic events prior to recruitment, smoking, history of diabetes, hypertension, claudicatio intermittens, erythromelalgia, splenomegaly, circulating immature cells, leukocyte count, total blood cholesterol, phlebotomy use, interferon use, hydroxyurea use, antiplatelets use, anticoagulants use, 32 P use, busulfan use, chlorambucil use, and pipobroman use Di Nisio, Barbui, et al., Brit J.Haematol.2007
13 Time-dependent multivariate analysis on the relative risk of major thrombosis among men and women with Polycythemia Vera (N = 1,638)* Hazard ratio (95% CI), P-value Hematocrit (%) 45 (N=556) 1 (Reference) (N=530) 0.89 ( ), 0.6 > 50 (N=345) 1.04 ( ), 0.9 Platelet number (x10 9 /l) 300 (N=592) 1 (Reference) (N=622) 0.78 ( ), 0.2 > 500 (N=407) 0.67 ( ), 0.1 *Model adjusted for: age, gender, time from PV diagnosis to recruitment, thrombotic or hemorrhagic events prior to recruitment, smoking, history of diabetes, hypertension, claudicatio intermittens, erythromelalgia, splenomegaly, circulating immature cells, leukocyte count, total blood cholesterol, phlebotomy use, interferon use, hydroxyurea use, antiplatelets use, anticoagulants use, 32 P use, busulfan use, chlorambucil use, and pipobroman use Di Nisio, Barbui et al, 2007
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15 EFFECT OF ASPIRIN ON THE RISK OF MAJOR ARTERIAL OR VENOUS EVENT, OR DEATH FROM CARDIOVASCULAR CAUSES IN VARIOUS SUBGROUPS N Engl J Med, 2004;350:
16 Polycythemia vera: myths, mechanisms, and management Jerry L. Spivak (Blood 2002 ) «unless the red cell mass is appropriately reduced, antiplatelet therapy or chemotherapy will be futile «
17 A large scale trial testing the intensity of CYTOreductive therapy to prevent cardiovascular events In patients with Polycythemia Vera (PV) CYTO PV (Clinical Trials Gov NCT Study Chair: Tiziano BARBUI Sponsor: Consorzio Mario Negri Sud Study funded by Agenzia Italiana del Farmaco (AIFA), Project #FARM6YNXAN
18 Eligible patients Confirmed diagnosis of PV All inclusion criteria No exclusion criteria Entry visit* Written informed consent Standard cytoreduction (HCT 40-45%) Experimental cytoreduction (HCT 45-50%) A patient can be randomized in the trial, provided she/he meets all recruitment criteria. Clinical visits at 3*, 6*, 12*, 18, 24*, 30, 36*, 42, 48*, 54, 6 0* months. * the following laboratory tests must be performed: hematocrit, hemoglobin, red and white cell count, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, uricoemia, glucose levels, total CK, ALT, AST, creatinine, potassium, sodium, fibrinogen, spleen and liver ultrasonography (specific tests for PV to added). Figure 1 Study design
19 Hematocrit (%) during the study Pct <45% Median <45% 25 Pct <45% 75 Pct 45 50% Median 45 50% 25 Pct 45 50% 47,4 48,3 48,3 47,0 47,2 47,5 47,7 47,2 46,9 44,7 45,0 44,2 44,4 44,4 44,3 44, No of patients Months
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