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

S Lopaciuk; A J Meissner; S Filipecki; K Zawilska; J Sowier; L Ciesielski; M Bielawiec; S Glowinski; E Czestochowska; others

doi:10.1055/s-0038-1656309

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 1992; 68(01): 014-018
DOI: 10.1055/s-0038-1656309

Original Article

Schattauer GmbH Stuttgart

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

Authors

S Lopaciuk

The Institute of Hematology, Warsaw, Poland
A J Meissner

The Institute of Hematology, Warsaw, Poland
S Filipecki

¹The Institute of Tuberculosis and Lung Diseases, Warsaw, Poland
K Zawilska

²The Department of Hematology, Medical School, Poznan, Poland
J Sowier

³The Department of Surgery, Medical School, Poznan, Poland
L Ciesielski

⁴The 1st Department of Surgery, Medical School, Lodz, Poland
M Bielawiec

⁵The Department of Hematology, Medical School, Bialystok, Poland
S Glowinski

⁶The Department of Vascular Surgery and Transplantology, Medical School, Bialystok, Poland
E Czestochowska

⁷The Medical School, Bialystok, and IV-th Department of Internal Medicine, Medical School, Gdansk, Poland

others

Abstract

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Summary

In 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.

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Referenzen

References
1 Salzman EW, Deykin D, Shapiro RM. The management of heparin therapy. Controlled prospective trial. N Engl J Med 1975; 292: 1046-1050
2 Bentley PG, Kakkar VV, Scully MF, MacGregor IR, Webb P, Chan P, Jones N. An objective study of alternative methods of heparin administration. Thromb Res 1980; 18: 177-187
3 Andersson G, Fagrell B, Holmgren K, Johnsson H, Ljungberg R, Nilsson E, Wilhelmsson S, Zetterquist S. Subcutaneous administration of heparin. A randomised comparison with intravenous administration of heparin to patients with deep-vein thrombosis. Thromb Res 1982; 27: 631-639
4 Walker GM, Shaw JW, Thomson GJL, Cumming JGR, Lea Thomas M. Subcutaneous calcium heparin versus intravenous sodium heparin in treatment of established acute deep vein thrombosis of the legs: a multicentre prospective randomised trial. Br Med J 1987; 294: 1189-1192
5 Doyle DJ, Turpie AGG, Hirsh J, Best C, Kinch D, Levine MN, Gent M. Adjusted subcutaneous heparin or continuous intravenous heparin in patients with acute deep vein thrombosis. Ann Intern Med 1987; 107: 441-445
6 Lopaciuk S, Misiak A, Wislawski S, Ciesielski L, Korzycki J, Judkiewicz L, Lewandowski K, Tokarz A, Kloczko J, Bielawiec M, Tyminski M, Czestochowska E. Subcutaneous injections vs intravenous infusion of sodium heparin in the treatment of deep thrombosis of inferior limbs. Pol Tyg Lek 1990; 45: 949-952
7 Pini M, Pattacini C, Quintavalla R, Poli T, Megha A, Tagliaferri A, Manotti C, Dettori AG. Subcutaneous vs intravenous heparin in the treatment of deep venous thrombosis – a randomized clinical trial. Thromb Haemostas 1990; 64: 222-226
8 Bratt G, Tornebohm E, Widlund L, Lockner D. Low molecular weight heparin (Kabi 2165, Fragmin): pharmacokinetics after intravenous and subcutaneous administration in human volunteers. Thromb Res 1986; 42: 613-620
9 Harenberg J, Wurzner B, Zimmermann R, Schettler G. Bioavailability and antagonization of the low molecular weight heparin CY 216 in man. Thromb Res 1986; 44: 549-554
10 Bratt G, Tornebohm E, Lockner D, Bergstrom K. A human pharmacological study comparing conventional heparin and a low molecular weight heparin fragment. Thromb Haemostas 1985; 53: 208-211
11 Thomas DP, Merton RE, Lewis WE, Barrowcliffe TW. Studies in man and experimental animals of low molecular weight heparin fraction. Thromb Haemostas 1981; 45: 214-218
12 Carter CJ, Kelton JG, Hirsh J, Cerskus A, Santos AV, Gent M. The relationship between the hemorrhagic and antithrombotic properties of low molecular weight heparins in rabbits. Blood 1982; 59: 1239-1245
13 Kakkar VV, Murray WJ. Efficacy and safety of low molecular weight heparin (CY 216) in preventing postoperative venous thromboembolism. A co-operative study. Br J Surg 1985; 72: 786-791
14 Encke A, Breddin K. Comparison of a low molecular weight heparin and unfractionated heparin for the prevention of deep vein thrombosis in patients undergoing abdominal surgery. Br J Surg 1988; 75: 1058-1063
15 Caen JP. A randomized double-blind study between a low molecular weight heparin Kabi 2165 and standard heparin in the prevention of deep vein thrombosis in general surgery. Thromb Haemostas 1988; 59: 216-220
16 Turpie AGG, Levine MN, Hirsh J, Carter CJ, Jay RM, Powers PJ, Andrew M, Hull RD, Gent M. A randomized controlled trial of a low-molecular-weight heparin (Enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. N Engl J Med 1986; 315: 925-929
17 Besson L, Azzar D, Davidas JL, Massignon D, Rondelet B, Banssillon V, Dejour H. Efficacy and safety of CY 216 in the prevention of deep vein thrombosis after total hip replacement. Fraxiparine Schattauer; Stuttgart: 1989: 127-133
18 Leyvraz PF, Postel M. Prevention of thromboembolic events in total hip replacement surgery. Fraxiparine vs standard heparin using adjusted doses: European multicenter randomized trial. Fraxiparine Schattauer; Stuttgart: 1990: 23-25
19 Pezzuoli G, Neri Serneri GG, Settembrini PG, Coggi G, Olivari N, Negri G, Comedo R, Galli G, Roveri S. STEP Study Group Effectiveness and safety of the low-molecular weight heparin CY 216 in the prevention of fatal pulmonary embolism and thromboembolic death in general surgery. Haemostasis 1990; 20 (Suppl 1) 193-204
20 Holm AH, Ly B, Handeland GF, Abildgaard U, Arnesen KE, Gottschalk P, Hoeg V, Aandahl M, Haugen K, Laerum F, Scheel B, Sortland O, Vinje B. Subcutaneous heparin treatment of deep venous thrombosis: a comparison of unfractionated and low molecular weight heparin. Haemostasis 1986; 16 (Suppl 2) 30-37
21 Parker CJ, Huber DE, Hedges AR, Kakkar VV. A trial of subcutaneous versus intravenous administration of low molecular weight (LMW) heparin and unfractionated (UF) heparin in the treatment of established deep venous thrombosis (DVT). Thromb Haemostas 1987; 58: 380 (Abstr 1390)
22 Bratt G, Aberg W, Johansson M, Tornebohm GranquistS, Lockner D. Two daily subcutaneous injections of Fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis (DVT). Thromb Haemostas 1990; 64: 506-510
23 Ninet J, Duroux P. Treatment of proximal deep venous thrombosis with the low-molecular-weight subcutaneous heparin (Fraxiparine) or unfractionated intravenous heparin. A European multicenter randomized clinical trial. Fraxiparine Schattauer; Stuttgart: 1990: 63-75
24 Harenberg J, Huck K, Bratsch H, Stehle G, Dempfle CE, Mall K, Blauth M, Usadel KH, Heene DL. Therapeutic application of subcutaneous low-molecular-weight heparin in acute venous thrombosis. Haemostasis 1990; 20 (Suppl 1) 205-219
25 Prandoni P, Vigo M, Cattelan AM, Ruol A. Treatment of deep venous thrombosis by fixed doses of a low-molecular-weight heparin (CY 216). Haemostasis 1990; 20 (Suppl 1) 220-223
26 Hull RD, Raskob GE, Hirsh J, Yay RM, Leclerc JR, Geerts WH, Rosenbloom D, Sackett DL, Anderson C, Harisson L, Gent M. Continuous intravenous heparin compared with intermittent subcutaneous heparin in the initial treatment of proximal-vein thrombosis. N Engl J Med 1986; 315: 1109-1114
27 Arnesen H, Heilo A, Jacobsen E, Ly B, Skaga E. A prospective study of streptokinase and heparin in the treatment of deep vein thrombosis. Acta Med Scand 1978; 203: 457-463
28 Hommes DW, Bura A, Mazzolai L, Buller HR, ten Cate JW. Subcutaneous heparin compared to continuous intravenous heparin administration in the initial treatment of deep vein thrombosis: a systemic overview and meta-analysis. Thromb Haemostas 1991; 65: 753 (Abstr 305)