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Optimal Dosing of Bemiparin As Prophylaxis Against Venous Thromboembolism in Surgery for Cancer: an Audit of Practice

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Optimal Dosing of Bemiparin As Prophylaxis Against Venous Thromboembolism in Surgery for Cancer: an Audit of Practice View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector International Journal of Surgery (2007) 5, 114e119 www.theijs.com Optimal dosing of bemiparin as prophylaxis against venous thromboembolism in surgery for cancer: An audit of practice J.L. Balibrea a,*, J. Altimiras b, I. Larruzea c,*,A.Go´mez-Outes d, J. Martı´nez-Gonza´lez d, E. Rocha e, on behalf of the Bemiparin Cooperative Study Group in Surgery for Cancerf a Department of Surgery, School of Medicine, Universidad Complutense, Madrid, Spain b Department of Pharmacy, Corporacio´ Sanitaria Parc Taulı´, Sabadell, Barcelona, Spain c Department of Surgery, Hospital de San Eloy, Baracaldo, Vizcaya, Spain d Medical Department, Laboratorios Farmace´uticos Rovi, S.A., Madrid, Spain e Haematology Service, University Clinic of Navarra, Pamplona, Spain KEYWORDS Abstract Aims: Low-molecular-weight heparins are drugs of first choice for thromboprophy- Low-molecular-weight laxis in cancer surgery. We sought to determine the optimal use of bemiparin in cancer surgery heparin; in standard clinical practice. Bemiparin; Patients and methods: A retrospective, multicentre audit on the use of bemiparin in patients Venous undergoing cancer surgery and given prophylaxis with bemiparin was undertaken. Surgeons’ as- thromboembolism; sessment of venous thromboembolic (VTE) risk (moderate or high) was compared to the crite- Cancer surgery ria of current Consensus Guidelines for VTE management. We assessed the incidence of documented symptomatic VTE, bleeding events, thrombocytopenia, deaths and total events related to VTE or bemiparin prophylaxis (i.e. bleeding, thrombocytopenia). The potential economic impact of postoperative vs. preoperative bemiparin was also analysed. Results: Clinical records from 197 patients from 5 Spanish centres were checked. Prophylaxis was started postoperatively in 45 patients (22.8%). According to the surgeons’ criteria, 73 (37.1%) patients were at high VTE risk and received bemiparin 3500 IU/d. However, according to the criteria of current Guidelines, 189 (95.9%) patients were at high risk of VTE (heteroge- neity P-value < 0.0001). Three (1.5%) patients, all of them receiving bemiparin 2500 IU/d, developed a symptomatic confirmed VTE. There were 4 major and 5 minor bleeding events dur- ing bemiparin prophylaxis. A lower incidence of bleeding (2.2% vs. 5.3%; P Z 0.48) and total events (2.2% vs. 9.9%; P Z 0.11) was seen with bemiparin started postoperatively as compared * Corresponding authors. Department of Surgery, School of Medicine, Universidad Complutense, C/Dr. Martı´n Lagos s/n, 28040 Madrid, Spain. Tel./fax: þ34 91 3303177 (J.L. Balibrea). E-mail address: [email protected] (J.L. Balibrea). f Members of the Bemiparin Cooperative Study Group in Surgery for Cancer are listed in the Appendix. 1743-9191/$ - see front matter ª 2006 Published by Elsevier Ltd on behalf of Surgical Associates Ltd. doi:10.1016/j.ijsu.2006.07.005 Bemiparin thromboprophylaxis in cancer surgery 115 to preoperative bemiparin. Bleeding rates did not significantly differ between patients given low or high bemiparin prophylactic doses (4.0% vs. 5.5%; P Z 0.72). Two patients died due to cardio-respiratory failure and sepsis, respectively. Postoperative bemiparin provided net cost savings of V909 per patient compared to preoperative start of prophylaxis due to shorter hospital stays (9 vs. 11 days) and lower incidence of complications in the postoperative bemiparin group. Conclusions: Many cancer patients are still poorly assessed for risk of VTE. Bemiparin 3500 IU/d is associated with a lower incidence of VTE without significant increase in complications as com- pared with bemiparin 2500 IU/d. Postoperative bemiparin prophylaxis seems to be as effective and safer than preoperative start of prophylaxis. Further prospective clinical studies are needed to fully address this issue. ª 2006 Published by Elsevier Ltd on behalf of Surgical Associates Ltd. Introduction Patients received open label prophylaxis with bemiparin (Hiborâ, Laboratorios Farmace´uticos Rovi, Madrid, Spain) at Low-molecular-weight heparins (LMWH) are effective and the daily subcutaneous dose of 2500 IU or 3500 IU, depend- safe for prophylaxis of venous thromboembolism (VTE) in ing on the degree of risk according to surgeons’ criteria. 1,2 An additional stratification of thromboembolic risk was per- surgical patients, and represent a thromboprophylactic 3 3,4 formed based on the ACCP Consensus Conference and the method of first choice. 4 Cancer patients have an increased risk of both post- International Consensus Statement. According to these lat- operative VTE5 and bleeding during anticoagulant therapy6 ter criteria, major cancer surgery in patients over 40 years compared to cancer-free patients. Without prophylaxis, the of age was considered high-risk surgery. Major cancer sur- overall prevalence of systematically detected deep vein gery in patients under 40 years or minor cancer surgery in thrombosis (DVT) estimated by the fibrinogen uptake test patients over 40 years of age was considered as moderate in cancer surgery is 35%.7 Compared to placebo, LMWH risk surgery. Risk assessment by the surgeons and risk factor prophylaxis provides relative risk reductions of 81% in veno- assessment based on current VTE Consensus Guidelines graphic DVT, 71% in clinical VTE, 68% in fatal PE and 60% in were compared. Prophylaxis was maintained based on death by any cause.7e10 By contrast, major bleeding events investigator’s criteria, during the risk period or until full mo- increase from 1.4% with placebo to approximately 3.0% in bilization of the patient. Data were recorded in 2 periods: patients receiving an LMWH,7e10 and to 8.1% with unfractio- the first covered the hospitalisation time, and the second nated heparin (UFH) in cancer surgery.2 However, bleeding period comprised the time from hospital discharge to the usually follows a benign clinical course, and it seems rea- first outpatient visit. We defined 2 types of cohorts: depend- sonable to give priority to pharmacological prophylaxis, ing on the timing of first bemiparin administration (post- vs. since mortality rates are significantly reduced. Therefore, preoperative) and depending on the bemiparin dose used the use of new strategies to reduce bleeding rates in cancer (2500 IU vs. 3500 IU). Data on the dose and timing of first surgery should be encouraged. bemiparin administration were extracted from the medica- Bemiparin (Hiborâ, Ivorâ, Ziborâ, and Badyketâ) is a new tion orders and medication administration records, which ‘‘second generation’’11 LMWH with a low bleeding tendency were available from patients’ hospital medical records. that can be initiated pre- or postoperatively,11,12 without The efficacy and safety outcomes were calculated in differ- compromising efficacy.11e13 Postoperative start of bemi- ent cohorts (post- vs. preoperative, and 3500 IU vs. 2500 IU). parin prophylaxis should theoretically minimise the risk of Finally, a potential correlation of the type of surgery or con- spinal haematoma and the perioperative bleeding rates. comitant medication on bleeding rates was analysed. Thus, it could be of great interest to compare pre- and Concomitant medications, including drugs that could postoperative start of bemiparin prophylaxis, particularly alter haemostasis (analgesics or anti-platelet drugs), and as regards the relative incidence of VTE and bleeding. use of non-pharmacological treatments, such as elastic This study was designed to describe the patterns of use bandages or intermittent pneumatic compression devices, of bemiparin in cancer surgery in standard clinical practice. were extracted from clinical records. We also analysed the influence of bemiparin dose and The outcomes collected were as follows: symptomatic timing of first administration on clinical and economic VTE (DVT and/or PE) confirmed by objective testing (Dopp- outcomes. ler ultrasound or ascending contrast venography for DVT and high-probability lung scanning, pulmonary angiography for PE, or necropsy in fatal cases); major bleeding (defined as Study design and methods overt bleeding associated with a decrease in haemoglobin levels by 2 g per decilitre or more or requiring transfusion of This study was designed as a retrospective, multicentre, 2 or more units of packed red cells or whole blood, bleeding cohort study. We checked clinical records from patients requiring reoperation, fatal, retroperitoneal or intracranial who underwent surgery for cancer and had received bleeding, or bleeding requiring treatment discontinuation); thromboprophylaxis with bemiparin. Since this was a retro- minor bleeding (if it was overt but did not meet the other spective audit of practice, there were no pre-established criteria for major bleeding); moderate thrombocytopenia exclusion criteria. (platelet count lower than 100,000 platelets per cubic 116 J.L. Balibrea et al. millilitre); severe thrombocytopenia (platelet count of less Table 1 Demographic data and baseline characteristics than 50,000 per cubic millilitre); and deaths. We also ana- lysed total events related to VTE or bemiparin prophylaxis Characteristic Total (N Z 197) (i.e. bleeding, thrombocytopenia) in each cohort. Age e yr. A minimisation cost analysis of preoperative versus post- Median 70 operative start of bemiparin prophylaxis was performed by Range 15e95 analysing the summary costs for treatment and complica- Sex e male/female 111/86 tions derived from the study. Unit costs
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