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• W3148722010 abstract "We read with interest the Commentary on thromboprophylaxis by Gordon Lowe and colleagues.1Lowe GDO Sandercock PAG Rosendaal FR Prevention of venous thromboembolism after major orthopaedic surgery: is fondaparinux an advance?.Lancet. 2003; 362: 504-505Summary Full Text Full Text PDF PubMed Scopus (44) Google Scholar The fondaparinux programme in orthopaedic surgery to which they refer led to four publications in peer-reviewed journals, and one planned meta-analysis.2Turpie AGG Bauer KA Eriksson BI Lassen MR for the Steering Committees of the Pentasaccharide Orthopaedic Prophylaxis StudiesFondaparinux versus enoxaparin for the prevention of venous thromboembolism in major orthopaedic surgery: a meta-analysis of 4 randomized double-blind studies.Arch Intern Med. 2002; 162: 1833-1840Crossref PubMed Scopus (735) Google Scholar As already stated in The Lancet, we had full access to the data and wrote the reports, the final versions of which are our sole responsibility. The fondaparinux data are clean, auditable, and have been thoroughly examined by health authorities worldwide. Several statements in the Commentary need to be clarified and corrected. First, the assertion that asymptomatic DVT detected by routine venography after surgery has no direct clinical relevance conflicts with a wide body of published work, including a rigorous review by the American College of Chest Physicians (ACCP).3Geerts WH Heit JA Clagett GP et al.Sixth ACCP Consensus Conference on antithrombotic therapy: prevention of venous thromboembolism.Chest. 2001; 119: 132S-175SSummary Full Text Full Text PDF PubMed Scopus (1620) Google Scholar Asymptomatic DVT is indeed clinically relevant and of utmost concern to practising doctors.3Geerts WH Heit JA Clagett GP et al.Sixth ACCP Consensus Conference on antithrombotic therapy: prevention of venous thromboembolism.Chest. 2001; 119: 132S-175SSummary Full Text Full Text PDF PubMed Scopus (1620) Google Scholar Second, the composite endpoint used in our trials is the standard primary efficacy endpoint used in most modern thromboprophylaxis studies and is the one recommended by the ACCP and health authorities.3Geerts WH Heit JA Clagett GP et al.Sixth ACCP Consensus Conference on antithrombotic therapy: prevention of venous thromboembolism.Chest. 2001; 119: 132S-175SSummary Full Text Full Text PDF PubMed Scopus (1620) Google Scholar, 4Committee for Proprietary Medicinal ProductsPoints to consider on clinical investigation of medicinal products for prophylaxis of intra- and postoperative venous thromboembolic risk. The European Agency for the Evaluation of Medicinal Products, LondonJune 29, 2000Google Scholar In our trials, fondaparinux reduced the risk of total VTE by more than 55% compared with enoxaparin,2Turpie AGG Bauer KA Eriksson BI Lassen MR for the Steering Committees of the Pentasaccharide Orthopaedic Prophylaxis StudiesFondaparinux versus enoxaparin for the prevention of venous thromboembolism in major orthopaedic surgery: a meta-analysis of 4 randomized double-blind studies.Arch Intern Med. 2002; 162: 1833-1840Crossref PubMed Scopus (735) Google Scholar using the efficacy endpoint that also supported the registration and use of low-molecular-weight heparins in all their prophylactic indications. Third, with respect to symptomatic outcomes, the only conclusion that can be drawn from our trial data is that the frequency of such events up to day 11 (a secondary trial outcome) was low and did not differ between the two groups: 0·6% (22 of 3603) with fondaparinux and 0·4% (15 of 3608) with enoxaparin; the suggestion of a 47% increase in the risk of symptomatic events with fondaparinux is as statistically and scientifically invalid as suggesting a 50% increase in the risk of death with enoxaparin (0·4% [15 of 3616] with fondaparinux vs 0·6% [21 of 3621] with enoxaparin up to day 11).2Turpie AGG Bauer KA Eriksson BI Lassen MR for the Steering Committees of the Pentasaccharide Orthopaedic Prophylaxis StudiesFondaparinux versus enoxaparin for the prevention of venous thromboembolism in major orthopaedic surgery: a meta-analysis of 4 randomized double-blind studies.Arch Intern Med. 2002; 162: 1833-1840Crossref PubMed Scopus (735) Google Scholar Fourth, a rebound effect after discontinuation of heparin thromboprophylaxis after 5–11 days has never been shown. The extended-duration trial in hip fracture surgery showed that in a single study, fondaparinux administered for 4 weeks compared with 1 week provided a clinical benefit (total VTE from 35% to 1·4% [p < 0·0001] and symptomatic VTE from 2·7% to 0·3% [p=0·021]).4Committee for Proprietary Medicinal ProductsPoints to consider on clinical investigation of medicinal products for prophylaxis of intra- and postoperative venous thromboembolic risk. The European Agency for the Evaluation of Medicinal Products, LondonJune 29, 2000Google Scholar Such a significant reduction in symptomatic events in patients having hip replacement surgery was also suggested for low-molecular-weight heparins using meta-analyses. Fifth, with respect to bleeding, although in our studies fondaparinux could be started before 6-h postoperatively, there was no difference between fondaparinux and enoxaparin or placebo in bleeding leading to death or re-operation, or involving a critical organ. The only difference was in the frequency of bleeding with a bleeding index of two or more, the relevance of which is uncertain.2Turpie AGG Bauer KA Eriksson BI Lassen MR for the Steering Committees of the Pentasaccharide Orthopaedic Prophylaxis StudiesFondaparinux versus enoxaparin for the prevention of venous thromboembolism in major orthopaedic surgery: a meta-analysis of 4 randomized double-blind studies.Arch Intern Med. 2002; 162: 1833-1840Crossref PubMed Scopus (735) Google Scholar, 5Eriksson BI Lassen MR for the PENTasaccharide in Hip-FRActure Surgery Plus (PENTHIFRA Plus) investigatorsDuration of prophylaxis against venous thromboembolism with fondaparinux after hip fracture surgery: a multicenter, randomized, placebo-controlled, double-blind study.Arch Intern Med. 2003; 163: 1337-1342Crossref PubMed Scopus (357) Google Scholar Moreover, only registered regimens are of interest to practising doctors. The frequency of major bleeding in patients who received their first injection, according to the fondaparinux labelling (at least 6 h after surgery) was low and similar to that in enoxaparin-treated patients. Using the standard methods endorsed by international guidelines, we have shown that fondaparinux represents a clinically important advance in the prevention of VTE after major orthopaedic surgery. The fondaparinux studies were supported by NV Organon and Sanofi-Synthelabo. All authors have served as consultants to these companies." @default.
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• W3148722010 title "Fondaparinux and prevention of venous thromboembolism after orthopaedic surgery" @default.
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