Prophylaxis for Thromboembolic Disease with Low Molecular Weight Heparins in Adult Patients in Home Care

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A.; BARDACH, A.; CIAPPONI, A; URTASUN, M

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2012 p. 1 - 30

1668-2793

Venous Thromboembolic Disease (VTED) includes venous thrombosis and pulmonary thromboembolism (PE), its main complication. VTE main risk factors include having presented previous episodes of VTE, advanced age, exposure to surgery, trauma, hospitalization, neoplasm and paresis of the extremities. Among surgeries, those who entail higher risk are the ones of hip or knee. In Europe, the annual incidence is 160 cases of DVT every 100,000 inhabitants, 50 of them develop fatal PE. The highest mortality presents during the first hours of evolution, therefore, prophylaxis reduces it dramatically. Heparin is one of the main drugs used for preventing VTE. Initially standard or non-fractionated (NFH) was used until two decades ago when low molecular weight heparins (LMWH) appeared with higher bioavailability, faster clearance, simple administration and less need for control lab tests, although more expensive. Technology LMWH are heterogeneous substances obtained from the traditional non fractionated heparin by different chemical or enzymatic depolymerization methods thus obtaining structurally different products and with different anticoagulating/antithrombotic capabilities and different adverse effect profile. Purpose To assess the available evidence on the efficacy, safety and coverage policy related aspects about the use of LMWH vs. NFH for the prevention of VET, DVT, PE in patients immobilized at home health care due to conditions such as cancer, orthopedic surgeries or advanced age. Methods A bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems. Results No evidence comparing the use of LMWH vs. Sc NFH for patients immobilized or in home care was found. Evidence was found on the assessment of LMWH vs. comparators such as placebo or mechanical prophylactic methods for the subgroup of interest. Two systematic reviews, three randomized clinical trials (RCT), one observational prospective study of several case series, seven clinical practice guidelines, one expert consensus, two health technology evaluation reports and three health sponsor´s coverage policies were included. Patients who Underwent Orthopedic Surgeries In 2008, one systematic review on adults who underwent arthroscopy of the knee was published. It included four studies and a total of 527 patients. The methodological quality of the RCTs was variable. When comparing any kind of LMWH vs. Placebo, an Absolute Risk Reduction (ARR) of event occurrence of 6.4% and an OR of 0.14 (95%CI, 0.04-0.48) were reported in the LMWH group. Adverse events were more common in the intervention group (LMWH), being mild bleeding the most common one with a RR of 2.41 (95%CI, 1.08-5.36). Another 2000 RCT on the efficacy and safety of extended ambulatory prophylaxis after total hip replacement (THR) or total knee replacement (TKR) randomized 1,195 patients to one dose/day of Sc ardeparin (100IU/kg of weight) or placebo. No significant differences were observed in the incidence of thrombotic events or death. Another 2005 RCT assessed the effectiveness of the continuous passive motion exercise devices (CPM) after trauma. It included 227 patients randomized to therapy with CPM + LMWH vs. LMWH alone. The incidence of events in the LMWH was 2.5% vs. 3.6% (p