Non-ST-segment elevation acute coronary syndromes: an algorithm for decision: reply
Department of Cardiology
University Hospital Jean Minjoz
Boulevard Fleming
25000 Besançon
France
Tel: +33 381 668 539
Fax: +33 381 668 582
Email: jpbassan{at}univ-fcomte.fr
Kerckhoff Heart Center
Benekestr. 2-8
61231 Bad Nauheim
Germany
We read with great interest the letter by Bertrand et al. and appreciated their positive comments about the recently published guidelines on management of non-ST-segment elevation acute coronary syndromes,1 especially concerning the new chapters included in the document on topics such as special populations, complications, bleeding, and the problems posed by blood transfusions. However, Bertrand et al. indicate that there is no clear recommendation about the use of anticoagulation, and base their argument on the fact that six possible anticoagulation regimens are provided in Table 11 of the article. They suggest that both ischaemic and bleeding risks should be taken into consideration before deciding on treatment strategy and anticoagulation. Their comments are illustrated by a figure describing which anticoagulant to use, and how, depending on the risk of bleeding and the risk of ischaemic events.
We share the view of the authors that the choice of anticoagulation should depend on bleeding risk and therefore gave clear recommendations in bold at the end of the respective chapter (pp. 1615–1616). Table 11 simply refers to all currently available anticoagulants, as many of the drugs listed in this table may not be available in every country in Europe and around the world. As the class of recommendation in these guidelines is based on the efficacy–safety profile, fondaparinux is proposed as first-line anticoagulant on the basis of the fact that it has a better efficacy–safety profile than enoxaparin in the Oasis-5 study.2 The other available low molecular weight and unfractionated heparins cannot be recommended over fondaparinux because there has been no direct comparison between these compounds and fondaparinux. The use of bivalirudin was recommended only in the setting of percutaneous coronary intervention, since the ACUITY trial3 suffers from some methodological shortcomings, described in the corresponding section of the guidelines document. Thus, all the remarks made by Bertrand et al. are actually addressed in detail in the article.
Furthermore, Bertrand et al. propose using a risk score to grade the risk of bleeding. However, although the individual predictors of bleeding have been clearly identified through registries and clinical trials, there is no generally accepted risk score for bleeding. The only existing score has recently been described on the basis of the data from the REPLACE-1 and 2 trials.4 However, this risk score was established in the setting of planned percutaneous coronary interventions, and is therefore not suitable for wider application. A risk score for bleeding could only be proposed if it had been derived from robust data collected in registries and/or clinical randomized trials, and validated on existing databases or prospectively. Several such scores have been developed for assessing ischaemic risk, but to date, not for bleeding risk.
In addition, the criteria included in the table represent an oversimplified, partly unvalidated approach with respect to the definition of ischaemic and bleeding risk, particularly high-risk patients. Criteria included for the definition of bleeding risk are rather arbitrarily defined. The risk of bleeding is not dichotomous according to gender, or based on any specific threshold for age or creatinine clearance. Furthermore, the recommendations proposed for the selection of anticoagulants are not fully supported by study evidence. Fondaparinux has been shown to result in a lower risk of bleeding vs. enoxaparin, irrespective of initial ischaemic risk and irrespective of gender, age, and creatinine clearance. Indeed, a recent publication has shown that even with creatinine clearance < 30 mL/min, the risk of bleeding was still lower with fondaparinux compared with reduced doses of enoxaparin.5 The table presented by Bertrand et al. would seem to present fondaparinux as an option only in patients with high bleeding risk, whereas it is actually appropriate in almost all conditions. Therefore, we think that a table such as this is helpful to illustrate the overall concept, but does not meet the requirements for individual decision making in complex situations. Accordingly, owing to these limitations, it cannot be introduced into the guidelines.
References
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[Abstract/Free Full Text] - Fox KA, Bassand JP, Mehta SR, Wallentin L, Theroux P, Piegas LS, Valentin V, Moccetti T, Chrolavicius S, Afzal R, Yusuf S. Influence of renal function on the efficacy and safety of fondaparinux relative to enoxaparin in non-ST-segment elevation acute coronary syndromes. Ann Intern Med (2007) 147:304–310.
[Abstract/Free Full Text]
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