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Rivista di Angiologia

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 1998 Settembre;17(3):135-45

lingua: Inglese

Efficacy of a low molec­u­lar ­weight hep­ar­in admin­is­tered intra­ve­nous­ly or sub­cu­ta­ne­ous­ly in com­par­i­son with intra­ve­nous unfrac­tion­at­ed hep­ar­in in the treat­ment of deep ­venous throm­bo­sis

Kirchmaier C. M., Wolf H., Schafer H., Ehlers B., Breddin H. K.

for the Certoparin-Study group


Background. The main objec­tive of the study pre­sent­ed was to test if throm­bus regres­sion can be ­improved by treat­ment with an intra­ve­nous­ly or sub­cu­ta­ne­ous­ly admin­is­tered low molec­u­lar ­weight hep­ar­in (LMWH). Patients with acute deep vein throm­bo­sis were ran­dom­ly ­assigned to ­receive ­either intra­ve­nous UFH (131 ­patients), intra­ve­nous (i.v.) LMWH (128 ­patients), or 8000 IU of the same LMWH bid sub­cu­ta­ne­ous­ly (s.c.) (128 ­patients). All ­patients were treat­ed with hep­ar­in for 14 to 16 days. Vitamin-K-antag­o­nist pro­phy­lax­is was start­ed ­between Day 12 and Day 14 after enroll­ment into the study.
Methods. Phlebographies and per­fu­sion/ven­ti­la­tion lung scans were per­formed at base­line and on Days 12 to 16. Primary end­point of the study was a reduc­tion of the phleb­o­graph­ic Marder score. Secondary end­points were recur­rent throm­bo­sis and pul­mo­nary embo­lism (PE), major and minor bleed­ings and the rate of PE at inclu­sion and at the end of the study ­assessed by ven­ti­la­tion/per­fu­sion scans.
Results. The Marder score ­improved by at least 30% in 32.4% (95% CI: 22.6...42.2) of the ­patients receiv­ing UFH, in 34.0% (95% CI: 24.9...44.0) receiv­ing LMWH i.v. and in 42.6% (95% CI: 32.8...52.8) treat­ed with the low molec­u­lar ­weight hep­ar­in s.c.. The dif­fer­ence ­between LMWH s.c. and UFH was 10.2% (95% CI: -3.7% ...+24.5%) (p=0.11). PE with clin­i­cal signs con­firmed by objec­tive meth­ods ­occured in three ­patients of the UFH group, one of whom died and was not ­observed in ­patients of the i.v. or s.c. LMWH-­groups. During the first 15 days no ­patient receiv­ing UFH or i.v. LMWH, and one ­patient on s.c. LMWH had a recur­rent throm­bo­sis. Major bleed­ings were ­observed in four ­patients receiv­ing i.v. UFH com­pared to nine ­patients on i.v. LMWH (one of these ­patients died) and one ­patient on s.c. LMWH. Perfusion ven­ti­la­tion lung scans were ­obtained from 287 ­patients at base­line and from 246 ­patients on Days 12-16. PE, ­defined accord­ing to ­PIOPED-cri­te­ria as inter­me­di­ate or high prob­abil­ity scans, was ­observed in 38.0% of the ­patients enter­ing the study and in 18.3% on Days 12 to 16. New asymp­to­mat­ic PE ­occurred less fre­quent­ly in the ­groups on LMWH (7.1%, 7.5%, respec­tive­ly) than in the UFH-group (12.6%) (not sig­nif­i­cant).
Conclusions. S.c. treat­ment with a LMWH (certoparin) (b.i.d.) is at least as effec­tive as UFH i.v. The hypoth­e­sis of ­increased effi­ca­cy of sub­cu­ta­ne­ous LMWH in resolv­ing ­venous throm­bi will have to be con­firmed by an inde­pen­dent study com­par­ing s.c. LMWH with UFH. The i.v. con­tin­u­ous infu­sion of the LMWH for 12 to 16 days does not ­result in a high­er ­venous re-open­ing rate than intra­ve­nous stan­dard hep­ar­in.

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