Comparison of enoxaparin and unfractionated heparin in endovascular interventions for the treatment of peripheral arterial occlusive disease: a randomized controlled trial

Summary. Background: Although unfractionated heparin (UFH) is an effective antithrombotic agent in endovascular interventions for the treatment of peripheral occlusive arterial disease (PAOD), it produces a highly variable anticoagulant response. Intravenous (i.v.) enoxaparin might be an effective and safe alternative. Patients and methods: In a prospective, open‐label, randomized, single‐center trial, 210 patients with PAOD (Fontaine stage IIb to IV) were randomly assigned in a 1 (UFH): 2 (enoxaparin) fashion to receive an i.v. bolus of 60 units UFH per kg body weight or 0.5 mg enoxaparin per kg body weight, respectively, before endovascular intervention. The primary composite endpoint assessed the clinical performance of enoxaparin by comparing the peri‐interventional rate of thromboembolia/occlusion (efficacy) of endovascularly reconstructed areas, of bleeding according to the Global Utilization of Streptokinase and t‐PA for Occluded Coronary Arteries (GUSTO) criteria (safety) and of any necessary re‐intervention for any percutaneous transluminal angioplasty (PTA)‐related bleeding. The secondary endpoint evaluated anti‐factor (F)Xa levels during intervention. Results: The primary composite endpoint showed a better performance of enoxaparin (10.5% vs. 2.5% absolute difference – 8.0%; P < 0.05). The concomitant use of acetylsalicylic acid (ASA) significantly (P < 0.05) increased the risk of a complication in the UFH group, but not in the enoxaparin group. Within 15 min, anti‐Xa levels were reached by 63.7% of patients treated with enoxaparin and only by 39.1% with UFH. Conclusion: Enoxaparin has a better performance than UFH in endovascular interventions for the treatment of PAOD. In patients with concomitant use of ASA, the risk of complications with UFH increases significantly compared with enoxaparin.     

A comparative study of the different diagnostic criteria of gestational diabetes mellitus and its incidence

Background

High prevalence of diabetes and genetic predisposition to metabolic syndrome among Indians places Indian women at risk to develop gestational diabetes mellitus (GDM) and its complications. Literature defines multiple criteria for GDM. This prospective study compares available diagnostic criteria for GDM in Indian women and their correlation with perinatal morbidity.

Method

Nine hundred and forty-eight consecutive voluntary nondiabetic pregnant women were recruited for the study. Seven hundred and twenty-three of these (mean age 23.45 years; 75.7% < 25 years) who reported for the follow-up were screened for GDM at 24–28 weeks gestation by American College of Obstetrics and Gynaecology (ACOG) guidelines and World Health Organization (WHO) criteria. Glycated haemoglobin (HbA_1c) and fasting and two-hours postglucose plasma insulin levels were also analysed. Pregnancy outcome was known for 291 of these. Concordance of risk factors and perinatal complications was analysed with respect to GDM.

Results

Prevalence of GDM at 24–28 weeks gestation was found to be 4.8% by WHO criteria, 6.36% by Carpenter and Coustan''s criteria, and 3.5% by O''Sullivan''s criteria. Prevalence was marginally higher in women of higher age, having past history of abortion or family history of diabetes mellitus (DM) (P > 0.05). None of these women had HbA_1c > 6%. Relative risk of abnormal delivery (pregnancy outcome) was 1.93, 1.39, and 1.17 in women with GDM by O''Sullivan''s, WHO, and Carpenter''s criteria, respectively (P > 0.05). Abnormal deliveries were marginally higher in women with high postglucose load insulin levels. Mean weight of the newborns was essentially the same in GDM and nonGDM women by any of the criteria. One-hour and two-hours postglucose values were more sensitive in diagnosing GDM by O''Sullivan''s criteria while fasting plasma glucose value had the poorest specificity with 2.5% of nonGDM women having values above the cut-off. Modifications of these criteria did not im-prove their predictive value for abnormal delivery over that of O''Sullivan''s criteria.

Conclusion

Prevalence of GDM and abnormal delivery in women < 35 years of age is low. Therefore, global screening for GDM may not be very useful in women < 25 years of age unless family history of DM or past history of abortion is present. Existing evidence is inadequate to justify the switchover from O''Sullivan''s criteria for diagnosis of GDM.Key Words: Carpenter''s criteria, GDM, O''Sullivan''s criteria, WHO criteria     

A comparative study of the different diagnostic criteria of gestational diabetes mellitus and its incidence

Background

High prevalence of diabetes and genetic predisposition to metabolic syndrome among Indians places Indian women at risk to develop gestational diabetes mellitus (GDM) and its complications. Literature defines multiple criteria for GDM. This prospective study compares available diagnostic criteria for GDM in Indian women and their correlation with perinatal morbidity.

Method

Nine hundred and forty-eight consecutive voluntary nondiabetic pregnant women were recruited for the study. Seven hundred and twenty-three of these (mean age 23.45 years; 75.7% < 25 years) who reported for the follow-up were screened for GDM at 24–28 weeks gestation by American College of Obstetrics and Gynaecology (ACOG) guidelines and World Health Organization (WHO) criteria. Glycated haemoglobin (HbA_1c) and fasting and two-hours postglucose plasma insulin levels were also analysed. Pregnancy outcome was known for 291 of these. Concordance of risk factors and perinatal complications was analysed with respect to GDM.

Results

Prevalence of GDM at 24–28 weeks gestation was found to be 4.8% by WHO criteria, 6.36% by Carpenter and Coustan's criteria, and 3.5% by O'Sullivan's criteria. Prevalence was marginally higher in women of higher age, having past history of abortion or family history of diabetes mellitus (DM) (P > 0.05). None of these women had HbA_1c > 6%. Relative risk of abnormal delivery (pregnancy outcome) was 1.93, 1.39, and 1.17 in women with GDM by O'Sullivan's, WHO, and Carpenter's criteria, respectively (P > 0.05). Abnormal deliveries were marginally higher in women with high postglucose load insulin levels. Mean weight of the newborns was essentially the same in GDM and nonGDM women by any of the criteria. One-hour and two-hours postglucose values were more sensitive in diagnosing GDM by O'Sullivan's criteria while fasting plasma glucose value had the poorest specificity with 2.5% of nonGDM women having values above the cut-off. Modifications of these criteria did not im-prove their predictive value for abnormal delivery over that of O'Sullivan's criteria.

Conclusion

Prevalence of GDM and abnormal delivery in women < 35 years of age is low. Therefore, global screening for GDM may not be very useful in women < 25 years of age unless family history of DM or past history of abortion is present. Existing evidence is inadequate to justify the switchover from O'Sullivan's criteria for diagnosis of GDM.     

High frequency oscillation and exogenous surfactant in the treatment of neonatal respiratory distress syndrome

Surfactant therapy has become widely used in neonates suffering from respiratory distress syndrome. High frequency oscillation has been shown to be efficient and safe in animal models, but somewhat less convincing in human neonates. An overview is given of the experimental and clinical data assessing the combination of these two techniques. Personal preliminary data are briefly presented.