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Inherited Thrombophilic Risk Factors and Venous Thromboembolism^*

Distinct Role in Peripheral Deep Venous Thrombosis and Pulmonary Embolism

^* From the Unita’ di Aterosclerosi e Trombosi (Drs. Margaglione and Grandone), Istituto di Ricovera e Cura a Carattere Scientifico "Casa Sollievo della Sofferenza," S. Giovanni Rotondo; Divisione di Ematologia (Dr. Brancaccio), Unità di Coagulazione, Ospedale "A. Cardarelli," Napoli; Istituto di Patologia Generale e Oncologia (Dr. De Lucia), Seconda Università di Napoli; Centro Emofilia e Trombosi "A. Bianchi Bonomi" (Dr. Martinelli), IRCCS Ospedale Maggiore, Università di Milano, Milan; Divisione di Ematologia (Dr. Ciampa), Ospedale "G. Moscati," Avellino; and Istituto di Medicina Interna e Geriatria (Dr. Di Minno), Università di Palermo, Palermo, Italy.

Correspondence to: Maurizio Margaglione, MD, Unità di Aterosclerosi e Trombosi, IRCCS "Casa Sollievo della Sofferenza," viale Cappuccini, San Giovanni Rotondo (FG) 71013, Italy; e-mail: ate.tro{at}operapadrepio.it

Study objectives: To investigate whether the FII A²⁰²¹⁰ mutation is associated with isolated pulmonary embolism (PE).

Design: Case-control study.

Setting: Five thrombosis centers in southern Italy.

Patients: Six hundred forty-seven consecutive referred patients with objectively documented venous thrombosis and 1,329 control subjects.

Measurements and results: Medical histories were collected. The G-to-A transition at nucleotide 1691 within the factor V gene (FV Leiden) and the G-to-A transition at nucleotide position 20210 within the prothrombin gene locus (FII A²⁰²¹⁰), levels of anticoagulant factors, and levels of antiphospholipid antibodies were determined by standard techniques. Patients with deep venous thrombosis (DVT) of the lower extremities (n = 346) or with additional PEs (n = 175) showed similar prevalences of FV Leiden mutation (24.3% and 16.6%, respectively) and FII A²⁰²¹⁰ mutation (14.2% and 12.6%, respectively), and similar deficiencies of natural anticoagulants (4.9% and 2.3%, respectively). In both groups, the frequencies of FV Leiden and/or FII A²⁰²¹⁰ mutation were higher than those observed among 1,329 apparently healthy control subjects (4.8% and 4.4%, respectively; p < 0.0001). Among patients with isolated PE (n = 126), prevalences of FV Leiden (7.1%) and FII A²⁰²¹⁰ mutation (8.7%) were similar to those of control subjects. Inherited thrombophilic abnormalities were less frequent among patients with PE only (15.6%) than among those with DVT only (37.0%; p < 0.001) or whose conditions were complicated by PE (28.0%; p = 0.020). Adjusting for age and sex, FV Leiden mutation , FII A²⁰²¹⁰ mutation, or both mutations were associated with DVT with PE (FV Leiden mutation: odds ratio [OR], 3.0; 95% confidence interval [CI], 1.6 to 5.5; FII A²⁰²¹⁰ mutation: OR, 2.6; 95% CI, 1.3 to 5.2; and both mutations: OR, 82.1; 95% CI, 7.5 to 901.2) or without PE (FV Leiden mutation: OR, 6.1; 95% CI, 4.0 to 9.3; FII A²⁰²¹⁰ mutation: OR, 2.8; 95% CI, 1.7 to 4.8; and both mutations: OR, 167.5; 95% CI, 21.6 to 1,297.7), but not with isolated PE (FV Leiden mutation: OR, 1.2; 95% CI, 0.5 to 2.8; FII A²⁰²¹⁰ mutation: OR, 1.2; 95% CI, 0.5 to 3.1; and both mutations: OR, 22.1; 95% CI, 1.3 to 370.2).

Conclusions: FII A²⁰²¹⁰ mutation is associated with DVT in the lower extremities alone or when complicated by PE, but it is not associated with isolated PE.

Key Words: risk factors • thrombosis • veins

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