Subcutaneous Low Molecular Weight Heparin versus Subcutaneous Unfractionated Heparin in the Treatment of Deep Vein Thrombosis: a Polish Multicenter Trial

Abstract

SummaryIn a prospective multicenter trial, 149 consecutive patients with phlebographically proven proximal and/or distal deep vein thrombosis of the leg were randomly allocated to receive subcutaneously for 10 days either low molecular weight heparin CY 216 (Fraxiparine) in a fixed dose or unfractionated heparin (UFH) in doses adjusted according to the activated partial thromboplastin time. Pre- and post-treatment phlebograms were assessed blindly using the Arnesen’s score system in 134 patients available for analysis of the treatment efficacy. The mean phlebographic score after 10 days of treatment was significantly decreased in both groups (p <0.001) in comparison with the baseline score but the difference in score changes between the two groups was not statistically significant. There was an improvement in 45/ 68 patients (66%) in the Fraxiparine group and in 32/66 patients (48%) in the UFH group, and an increase in the thrombus size in 10/68 (15%) and 12/66 (18%), respectively. One symptomatic non-fatal pulmonary embolism and one major bleeding episode were observed in the UFH group. During a follow-up period of 3 months, two rethromboses had occurred in the UFH group and none in the Fraxiparine group. It is concluded that subcutaneous fixed dose Fraxiparine is safe and at least as effective as subcutaneous adjusted UFH in the treatment of deep vein thrombosis.

Anticoagulation for the initial treatment of venous thromboembolism in patients with cancer

“…No heterogeneity was detected (I 2 5 0%), and the quality of evidence was moderate. After excluding the 3 studies with small and imbalanced arms, 13,23,27 the benefit maintained borderline statistical significance (RR of 0.72; 95% CI, 0.52-1.00). The inverted funnel plot for the outcome of death did not suggest a publication bias (Fig.…”

“…In 3 studies, the subgroups of patients with cancer had small and imbalanced arms with respect to the number of patient randomized to each treatment (ie, the number of patients in the LMWH and UFH arms for the 3 studies were 6 and 12, 7 and 2, 7 and 2, respectively). 13,23,27 The methodologic quality for death and recurrent VTE outcomes, respectively, was moderate and low for patients with cancer and low for both outcomes among patients without cancer (summary of findings tables are available from the authors on request).…”

“…Patients with cancer, as noted earlier, constituted subgroups in all studies that were included. [12][13][14][15][16]21,[23][24][25][26][27][28][29] The 13 studies recruited a total of 1016 patients with cancer and 4797 patients without cancer. None of the studies specified the type(s) of cancer of participants.…”

“…12,13,15,21,[23][24][25][26][27][28][29] In patients with cancer, LMWH significantly reduced mortality compared with UFH (RR of 0.71; 95% confidence interval [95% CI], 0.52-0.98) (Fig. 2).…”

New developments in the treatment of deep venous thrombosis

“…In these studies two different out come assessments were used. First, the change in thrombus size was assessed by repeating venography at the end of the course of treatment [33][34][35][36][37]: LMWH were as effective as SH. Second, most studies used the occurrence of the symptomatic recurrent DVT as end-point; there was a strong trend for LMWH to be more effective and safer than SH [38][39][40][41].…”