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N Engl J Med. 2013 Jan 3;368(1):22-33. doi: 10.1056/NEJMoa1208500. Epub 2012 Dec 8.

Cardiovascular events and intensity of treatment in polycythemia vera.

Collaborators (146)

Barbui T, Finazzi G, Marchioli R, Specchia G, Masciulli A, Marfisi RM, Cavazzina R, Scarano M, D'Amico A, Ferri B, Guido C, Marfisi L, Pera C, Polidoro A, Marchioli R, Sacco M, Levantesi G, Tognoni G, Barosi G, Carobbio A, Leoni P, Scortechini AR, Mulattieri S, Tomassetti S, Honorati E, Specchia G, Ricco A, Albano F, Pastore D, Carluccio P, Mazzone AM, Rossi AR, Finazzi G, Finazzi MC, Delaini F, Falanga A, Rambaldi A, Quarta G, Guaragna G, Giannotta A, Angelucci E, Usala E, Simula MP, Pilo F, Cacciola R, Cacciola E, Pezzella F, Seria E, Di Francesco E, Rapezzi D, Gallamini A, Bertolotti L, Vannucchi AM, Antonioli E, Guglielmelli P, Pieri L, Susini MC, Bartalucci N, Bosi A, Musolino C, D'Angelo A, Centorrino R, Gerace D, Allegra A, Iurlo A, Cortelezzi A, De Philippis C, Ferretti E, Ciceri F, Claudiani S, Lunghi F, Malato S, Trinca S, Pogliani EM, Belotti A, Lanzi E, Elli EM, Gaidano G, Lunghi M, Deambrogi C, Rossi D, Saglio G, Cilloni D, Rotolo A, Zanone C, Randi ML, Bertozzi I, Tezza F, Aneloni V, Siragusa S, Quintini G, Saccullo G, Caracciolo C, Cazzola M, Casetti I, Elena C, Landini B, Rumi E, Visani G, Barulli S, Guiducci B, Lucesole M, Malerba L, Isidori A, Santini S, Grossi A, De Stefanis M, Biagioni C, Tieghi A, Merli F, Imovilli A, Codeluppi K, Rubagotti S, Romano N, Bonini A, Bellesia E, Musto P, Martorelli MC, Villani O, Zifarone E, Zonno A, Santopietro V, De Stefano V, Za T, Rossi E, Ciminello AM, Betti S, Alimena G, Latagliata R, Tafuri A, Breccia M, Carmosino I, Spadea A, Pisani F, Romano A, D'Andrea M, Cascavilla N, Nobile M, Mantuano FS, Rossi G, Tricarico M, Rodeghiero F, Ruggeri M, Bedin F, Lissandrini L, Finotto S.

Author information

1
Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy. marchioli@negrisud.it

Abstract

BACKGROUND:

Current treatment recommendations for patients with polycythemia vera call for maintaining a hematocrit of less than 45%, but this therapeutic strategy has not been tested in a randomized clinical trial.

METHODS:

We randomly assigned 365 adults with JAK2-positive polycythemia vera who were being treated with phlebotomy, hydroxyurea, or both to receive either more intensive treatment (target hematocrit, <45%) (low-hematocrit group) or less intensive treatment (target hematocrit, 45 to 50%) (high-hematocrit group). The primary composite end point was the time until death from cardiovascular causes or major thrombotic events. The secondary end points were cardiovascular events, cardiovascular hospitalizations, incidence of cancer, progression to myelofibrosis, myelodysplasia or leukemic transformation, and hemorrhage. An intention-to-treat analysis was performed.

RESULTS:

After a median follow-up of 31 months, the primary end point was recorded in 5 of 182 patients in the low-hematocrit group (2.7%) and 18 of 183 patients in the high-hematocrit group (9.8%) (hazard ratio in the high-hematocrit group, 3.91; 95% confidence interval [CI], 1.45 to 10.53; P=0.007). The primary end point plus superficial-vein thrombosis occurred in 4.4% of patients in the low-hematocrit group, as compared with 10.9% in the high-hematocrit group (hazard ratio, 2.69; 95% CI, 1.19 to 6.12; P=0.02). Progression to myelofibrosis, myelodysplasia or leukemic transformation, and bleeding were observed in 6, 2, and 2 patients, respectively, in the low-hematocrit group, as compared with 2, 1, and 5 patients, respectively, in the high-hematocrit group. There was no significant between-group difference in the rate of adverse events.

CONCLUSIONS:

In patients with polycythemia vera, those with a hematocrit target of less than 45% had a significantly lower rate of cardiovascular death and major thrombosis than did those with a hematocrit target of 45 to 50%. (Funded by the Italian Medicines Agency and others; ClinicalTrials.gov number, NCT01645124, and EudraCT number, 2007-006694-91.).

PMID:
23216616
DOI:
10.1056/NEJMoa1208500
[Indexed for MEDLINE]
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