Purpose: A retrospective database analysis was conducted to

determine the extent to which the American College of Chest Physicians (ACCP) guidelines for VTE prophylaxis are followed after total hip replacement (THR) and total knee replacement (TKR) and

Method: A claims database associated with a large US health plan was linked to the Premier database, which provides details of in-patient medication use. Patients ≥18 years undergoing TKR/THR and enrolled in the health plan 90 days before and 90 days following discharge from hospitalization (or until death) were included. Patients were considered to have received ACCP-guideline prophylaxis if they:

received LMWH, fondaparinux, or VKA following surgery

Results: Of the 30,644 eligible patients from the health plan, 3,497 patients were linked to the in-patient database. Except for geographic indicators, there were no significant differences in demographics or baseline co-morbidities between those included and excluded from the final study sample. Of the 3,497 linked patients, 1,395 (40%) received ACCP prophylaxis. The number of DVTs occurring in the ACCP and non-ACCP groups were 28 (2.01%) and 79 (3.76%), suggesting that non-ACCP patients were almost twice as likely as ACCP patients to have a DVT (p=0.0521). The number of PEs occurring in the ACCP and non-ACCP groups were 2 (0.14%) and 25 (1.19%), respectively, suggesting that non-ACCP patients were 8.5 times more likely than ACCP patients to experience a PE (p< 0.0001).

Conclusion: This study offers a unique perspective on ‘real-world’ prophylaxis patterns and clinical outcomes in THR/TKR patients. It suggests that 40% of patients received ACCP prophylaxis and that patients not receiving ACCP prophylaxis were almost twice as likely to have a DVT and more than eight times as likely to experience a PE.

Purpose: Among patients with isolated below-knee fractures, venography studies detect deep vein thrombosis (DVT) in 20 – 40%. The clinical relevance of these thrombi is unknown. We conducted the first randomized, double-blind, multicentre study designed to assess the effectiveness and safety of low molecular weight heparin compared to placebo in preventing CIVTE in patients with isolated fractures of the distal leg.

Method: Consecutive patients with fractures of the tibia, fibula or ankle requiring surgery were randomized to dalteparin 5000 U or placebo once daily SC within 72 hours of fracture for 14 + 2 days. Patients were screened using proximal duplex ultrasound at day 14, and followed up at 6 wks and 3 mos. Clinically suspected VTE was investigated using standardized algorithms with central, blinded adjudication.

Results: From August 2002 to October 2006, 134 patients were randomized to dalteparin and 131 to placebo. 98% of patients completed 3 mo follow-up. Overall, 5 patients had CIVTE (2 asymptomatic DVT, 2 symptomatic DVT, 1 nonfatal PE); 2 (1.5%) in the dalteparin arm and 3 (2.3%) on placebo (p=0.68). There were no major bleeds.

Conclusion: The overall incidence of CIVTE after surgically-repaired, isolated tibia, fibula and ankle fractures was so low (1.9%; 95% CI 0.7 to 4.7%), with no observed differences between dalteparin and placebo either for CIVTE or safety, that recruitment was stopped early. This study also demonstrates the large discrepancy between trials that utilize venographic and CIVTE outcomes.

Purpose: We conducted the first, multicentre, prospective cohort study to define the incidence of symptomatic venous thromboembolism (VTE) in patients with tibia and ankle fractures treated conservatively and relatively minor lower leg fractures. The reported incidence of deep vein thrombosis (DVT) using routine venography in patients with lower leg injury requiring cast immobilization is approximately 20–40%, which has lead to the routine use of anticoagulant prophylaxis for several weeks in many such patients. However the vast majority of venographically-detected DVTs are asymptomatic, distal thrombi whose clinical relevance is uncertain. Therefore venography is not the best outcome measure to assess the burden of clinically important VTE.

Method: Consecutive patients with tibia and fibula fractures (treated non-operatively) and patella and foot fractures, (treated operatively or conservatively) were assessed for eligibility at 5 Ontario hospitals. Patients were enrolled after informed consent within 96 hours of injury and were followed prospectively, by telephone, at 2, 6 and 12 weeks. Those with major trauma, active cancer, and previous VTE were excluded. Thromboprophylaxis was not allowed. Education regarding symptoms of VTE was provided at study entry and patients were asked about VTE symptoms at follow up. Suspected VTE was investigated in a standardized manner.

Results: From August 2002 to June 2005, 1200 patients were enrolled from 2446 consecutively screened patients. 98% of patients completed 3-month follow-up. The mean age was 45 years (16 to 93) and 60% were female. The most common fractures were fibular (39%) and most injuries were caused by falls (75%). 99 % of these fractures were unilateral. Most fractures did not require surgical repair (93%), and 82% of patients were immobilized by cast or splint for an average of 42 ±32 days. Overall, 7 patients had symptomatic, objectively confirmed VTE (2 proximal DVT, 3 calf DVT, 2 PE) with no fatal PE – an incidence of 0.6 % (95% CI 0.2 to 1.2).

Conclusion: Symptomatic VTE is an infrequent complication after these fractures without thromboprophylaxis. Therefore routine thromboprophylaxis is neither warranted, nor likely to be cost-effective in these patients. This study also highlights the significant discrepancy between clinical endpoint studies and studies using venography.

We report preliminary results from the first, multicenter prospective study designed to define the incidence of symptomatic (Venous Thromboembolism) VTE in patients with isolated leg fractures distal to the knee. Eight hundred and twenty-six enrolled patients have completed three months of follow up. By three months, only seven patients had sustained a symptomatic VTE with no fatal PE. Symptomatic and fatal VTE were infrequent complications after isolated leg fractures distal to the knee without thromboprophylaxis. Routine thromboprophylaxis may not be warranted in isolated leg fractures distal to the knee.

To report results from the first, multicenter prospective study designed to define the incidence of symptomatic Venous Thromboembolism (VTE) in patients with isolated leg fractures distal to the knee.

Symptomatic and fatal VTE are infrequent complications after isolated leg fractures distal to the knee without thromboprophylaxis.

Routine thromboprophylaxis may not be warranted in isolated leg fractures distal to the knee.

From August 2002 to April 2004, one thousand eight hundred and eight consecutive patients with isolated leg fractures distal to the knee were screened for entry at five hospitals in Ontario. Patients with major trauma, active cancer and previous VTE were excluded. Thromboprophylaxis was not allowed. Patients were followed prospectively for three months, with telephone calls at fourteen days, six weeks and three months. Suspected DVT and PE were investigated in a standardized manner.

Eight hundred and twenty-six enrolled patients have completed three months of follow up. The mean age was forty-five years (range sixteen to ninety-three) and 59.5% of this cohort was female. 99% of these fractures were unilateral and 97% were closed. Fractures included: fibula (38%), metatarsal (29%), phalanges (13%), calcaneus, talus or tarsal (10%), tibia (10%) and patella (7%). Only 11% of fractures were surgically treated. 88% of fractures received a cast or splint for a mean duration of 41+/− 20 days. Complete follow-up was available for 97.5% of this cohort. By three months only seven patients had sustained a symptomatic VTE (2 proximal DVT, 3 calf DVT, 2 PE) with no fatal PE-an incidence of 0.9% (95% CI 0.3 to 1.8%).

Funding: This study was funded by a research grant from Pharmacia