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• W3147245422 abstract "We thank De Stefano, Grandone and Martinelli 1 for their comments on our chapter in the 2012 edition of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines on Antithrombotic Therapy and Prevention of Thrombosis 2. Modification of our guidelines for antepartum prophylaxis in women with prior venous thromboembolism and in those with asymptomatic thrombophilia was based not on new data, but on a careful reappraisal of the available literature and the development of recommendations through rigorous use of the GRADE system 3. A similar process in 2008 led to significant modifications to our guidance for the anticoagulant management of pregnant women with mechanical prosthetic heart valves 4. Our decision in prior editions to include thrombophilia, along with the circumstances in which the patient's prior venous thromboembolic event occurred, was based primarily on a post hoc analysis of a prospective cohort study by Brill-Edwards et al. 5. The following led us to alter our suggestions: (i) reanalysis of the same data with inclusion of clinical circumstances alone also clearly differentiates recurrence risk; (ii) subsequent studies (including one led by De Stefano) failed to show thrombophilia to be a significant predictor of pregnancy-related recurrent venous thromboembolism 6, 7; and (iii) it is well accepted that the presence or absence of thrombophilia is not a clinically significant predictor of venous thromboembolism recurrence risk in the non-pregnant population 8. Our guidance regarding antepartum and postpartum prophylaxis in women with asymptomatic thrombophilia is based not only on the results of the systematic review of case–control studies by Robertson et al. 9 (which we used primarily for our guidelines in women with no family history of venous thromboembolism), but also on the results of several family studies. We believe that the latter provide the strongest data upon which to base recommendations for asymptomatic thrombophilic women with a family history of venous thromboembolism. We thank De Stefano, Grandone and Martinelli for highlighting the studies by Mahmoodi 10, Folkeringa 11, and Vincente 12. As outlined in the Methods section of our chapter, our literature search encompassed the time frame up to January 2010 2. The paper by Mahmoodi et al. was published 6 months subsequent to this. It will be included in any further iterations of our chapter. The papers by Folkeringa 11 and Vincente 12 are important contributions to the literature. However, they have limitations that are common to many retrospective studies in this area, including the acceptance of non-objectively diagnosed outcome events 11, the failure to clearly specify criteria for the diagnosis of venous thromboembolism 12, the inability to test all subjects for all thrombophilic defects 11, 12, and the potential for referral and recall bias 11, 12. The study by Vincente also included superficial thrombophlebitis in the outcome definition 12. All of these characteristics have the potential to lead to an overestimation of risk. It is also important to note that, in both of these studies, the majority of events occurred in the postpartum period. We do suggest postpartum prophylaxis in women with antithrombin deficiency and a positive family history. In deciding whether or not to favor prophylaxis, we considered not only the presence or absence of an increase in risk, but also the absolute magnitude of risk. This is especially important in the antepartum period, when the available prophylactic options are limited to parenteral agents, the use of which is inconvenient, uncomfortable, and costly, and results in the medicalization of a previously healthy woman. It is not possible to determine the antepartum risk of venous thromboembolism in asymptomatic thrombophilic women in the Vincente study 12; however, we note that the point estimate of antepartum risk (6.7%) cited in the paper by Folkeringa 11 is one at which many clinicians are comfortable with patient choice to discontinue anticoagulants for non-pregnant patients who have suffered an unprovoked event 8. It is important to emphasize that we ‘suggest’, rather than ‘recommend’, for these clinical situations. The guidelines regarding prophylaxis in pregnant women with thrombophilia or prior venous thromboembolism are labeled as either 2B or 2C. This is in recognition of the limited quality of the available data, with the number 2 reflecting what we label a weak recommendation, and the letters B and C reflecting moderate-quality or low-quality evidence, respectively. A 2B recommendation implies a fine balance between benefits and harms, and a recognition that that “best action may differ, depending on circumstances or patient or societal values” and that “higher quality research may well have an important impact on our confidence in the estimate of effect and may change the estimate” 3. A 2C recommendation recognizes “uncertainty in the estimates of benefits, risks, and burden”, that “higher quality research is likely to have an important impact on our confidence in the estimate of effect”, and that “other alternatives may be equally reasonable” 3. Therefore, treating physicians should use their individual judgement in these cases, in addition to the available and often limited evidence. Given the quality of research in this field and how the results may be differently valued in various populations, it is not surprising that guideline bodies may reach different conclusions. This does not mean that one set of guidelines should be considered irresponsible or wrong; rather, they simply reflect the best possible interpretation of the limited evidence base at that time. The correspondents correctly point out that our guidelines do not consider potential clinical risk factors for venous thromboembolism to the same extent as other guidelines. The available literature in this area is generally restricted to case–control studies. Reliable information on how these risk factors interact (or do not interact) is also lacking. We believe that the quality of the data is generally not sufficient to provide guidance on risk stratification. S. M. Bates has received honoraria for lectures from Leo Pharma, Inc., Sanofi-Aventis Canada, and Pfizer Canada. I. A. Greer has received honoraria for lectures and advisory board contributions from Leo Pharma and Sanofi-Aventis. S. Middeldorp has received unrestricted research funding from GlaxoSmithKline plc, and received speakers' fees from GlaxoSmithKline plc, Boehringer Ingelheim GmbH, Bayer Healthcare Pharmaceuticals, Leo Pharma, Inc., and BMS/Pfizer. P. O. Vandvik is a member of and prominent contributor to the GRADE Working Group. D. L. Veenstra and A.-M. Prabulos state that they have no conflict of interest." @default.
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• W3147245422 title "Recommendations for prophylaxis of pregnancy‐related venous thromboembolism in carriers of inherited thrombophilia. Comment on the 2012 ACCP guidelines: a rebuttal" @default.
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