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Thromb Haemost 1999; 82(01): 30-34
DOI: 10.1055/s-0037-1614625
Rapid Communication
Schattauer GmbH

Dermatan Sulphate for the Prevention of Postoperative Venous Thromboembolism in Patients with Cancer

Valerio Di Carlo
1   From the Dipartimento di Chirurgia, IRCCS Ospedale San Raffaele, Università di Milano, Milano, Italy
,
Giancarlo Agnelli
2   Istituto di Medicina Interna e Medicina Vascolare, Università di Perugia, Milano, Italy
,
Paolo Prandoni
3   Istituto di Semeiotica Medica, Università di Padova, Firenze, Milano, Italy
,
Sergio Coccheri
4   Cattedra e Divisione di Angiologia, Università di Bologna, Firenze, Milano, Italy
,
Gian Franco Gensini
5   U. O. di Clinica Medica e Cardiologia, Università di Firenze, Azienda Ospedaliera Careggi, Firenze, Milano, Italy
,
Francesco Gianese
6   Dipartimento Medico, Mediolanum Farmaceutici, Milano, Italy
,
Pier Mannuccio Mannucci
7   Centro Emofilia e Trombosi “A. Bianchi Bonomi”, IRCCS Ospedale Maggiore, Milano, Italy
,
for the “DOS” (Dermatan sulphate in Oncologic Surgery) Study Group › Author AffiliationsStudy monitoring and statistical data handling were performed by Medicina Domani Pharma, Milano (L. M. Fuccella, R. Lepore) and Genova (L. Menta). The study was supported in part by a grant from Mediolanum Farmaceutici, Milano.
Further Information

Publication History

Received 25 January 1999

Accepted after revision 15 April 1999

Publication Date:
11 December 2017 (online)

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Summary

Background: Patients undergoing surgery for cancer are at high risk for venous thromboembolism (VTE). Agents that selectively inhibit thrombin, such as dermatan sulphate, have potential for a favourable benefit-risk ratio in the prevention of this complication.

Methods: Patients scheduled for elective abdominal, thoracic, gynecologic or urologic surgery for cancer resection, were randomised to dermatan sulphate (600 mg intramuscularly on the second day before surgery, then 300 mg once daily), or calcium heparin (5,000 IU subcutaneously t.i.d., starting 2 hours before operation). Both treatments were continued until postoperative day 7 or until adequate mobilisation was achieved. Bilateral venography was scheduled at the end of treatment. Venograms were centrally assessed in blind conditions. The study outcomes were VTE (venographically proven deep vein thrombosis [DVT] or symptomatic, objectively confirmed pulmonary embolism) and bleeding complications.

Results: At 27 centres, 842 patients were randomised and underwent surgery (418 dermatan sulphate, 424 heparin). Efficacy was assessed in 521 patients with adequate venography and/or confirmed pulmonary embolism. DVT was observed in a total of 96 patients; symptomatic non-fatal pulmonary embolism developed in 2 patients (one per group), who also had DVT at venography. Postoperative VTE occurred in 40 of 267 patients on dermatan sulphate, 15.0%, versus 56 of 254 patients on heparin, 22.0% (p = 0.033). Relative risk reduction was 32.7% (95% confidence interval, 3.1 to 53.2%). The rate of bleeding complications in all operated patients was 6.9% with dermatan sulphate and 7.5% with heparin (confidence interval for the absolute risk difference, -4.1 to 2.9%). The inhospital mortality rate was 1.2% and 1.4%, respectively.

Conclusions: In oncologic surgery, dermatan sulphate prevents VTE more effectively than heparin without increasing bleeding complications.

 

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