[Decrease of total hemorrhage with reduced doses of enoxaparin in high risk unstable angina. ENHNFAI study. (Enoxaparin vs non-fractionated heparin in unstable angina). Preliminary report].
In this prospective, randomized and controlled study, we compare complications in 2 groups of patients: group 1, enoxaparin 0.8 mg/kg, subcutaneous every 12 hours during 5 days, and group 2, intravenous unfractionated heparin during 5 days, by infusion treated to activate partial tromboplastin time 1.5-2 the upper limit of normal. Blood samples were obtained at 4, 12, 24 hours and at day 5 of treatment, to measure anti-Xa levels, and also, evaluated end points at 30 days, between groups. Univariate and multivariate logistic regression analyses were performed with clinical and angiographic variables between groups, with p < 0.05.


RESULTS
203 consecutive patients, average age of 60.5 +/- 11.2 years, and 80% men, were included. There were no differences in clinical and angiographic characteristics. All patients with enoxaparin had therapeutic levels of anti-Xa, of 0.5 to 0.67 U/mL. There was increasing risk of total bleeding in group 2 (18.7%) than in group 1 (5.6%), with RR = 1.72 (95% CI 1.29, 2.29), p = .003. Also, there was 33.3% of MACE in group 2, and only 17.8% in group 1, with RR = 1.88 (CI 95% 1.29, 2.29), p = .011.


CONCLUSIONS
1) Low doses of enoxaparine achieve therapeutic levels, since the first 4 hours of treatment. 2) A significant reduction of total bleeding occurred with the low doses of enoxaparin, with the same efficacy to reduce MACE during follow-up.
Campos
José Victoria
JV
Unidad Coronaria del Instituto Nacional de Cardiología lgnacio Chávez, INCICH, Juan Badiano No. 1, Col. Sección XVI, Tlalpan, 14080 México, D.F.
Juárez Herrera
Ursulo
U
Rosas Peralta
Martín
M
Lupi Herrera
Eulo
E
González Pacheco
Héctor
H
Martínez Sánchez
Carlos
C
Chuquiure Valenzuela
Eduardo
E
Vieyra Herrera
Gerardo
G
Cardozo Zepeda
Carlos
C
Barrera Sánchez
Carlos
C
Reyes Corona
Jesús
J
Cortina de la Rosa
Evelyn
E
de la Peña Díaz
Aurora
A
Izaguirre Avila
Raúl
R
de la Peña Fernández
Andrés
A
D000368:Aged; D000789:Angina, Unstable / Q000097:blood / Q000188:drug therapy*; D000925:Anticoagulants / Q000008:administration & dosage* / Q000097:blood; D017984:Enoxaparin / Q000008:administration & dosage* / Q000097:blood; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology / Q000517:prevention & control*; D006493:Heparin / Q000008:administration & dosage* / Q000097:blood; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors
D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin