A Randomized Controlled Trial of a Low-Molecular-Weight Heparin (Enoxaparin) to Prevent Deep-Vein Thrombosis in Patients Undergoing Elective Hip Surgery

Turpie, Alexander G.G.; Levine, Mark; Hirsh, Jack; Carter, Cedric J.; Jay, Richard; Powers, Peter; Andrew, Maureen; Hull, Russell D.; Gent, Michael

doi:10.1056/nejm198610093151503

Cited by 488 publications

(91 citation statements)

References 23 publications

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“…This is in line with earlier enoxaparin studies in which there were no higher rates of wound complications compared with placebo-treated patients [29,30]. The low wound infection rate was similar to a study of enoxaparin and fondaparinux (0.7%) [31], and no correlation between wound infection and postoperative anticoagulation therapy following joint replacement was reported in two other studies [32,33].…”

Section: Discussionsupporting

confidence: 88%

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Dahl¹,

Kurth²,

Rosencher

et al. 2011

International Orthopaedics (SICOT)

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Purpose Prospective, double-blind studies in orthopaedic patients have been conducted using the direct thrombin inhibitor dabigatran etexilate (hereafter referred to as dabigatran), with two doses investigated and approved for adults (220 mg and 150 mg once daily) to prevent venous thromboembolism (VTE). The European Medicines Agency decided that in major joint orthopaedic surgery, the lower dose should be used in elderly patients (aged over 75 years) and those with reduced renal function (creatinine clearance between 30 and 50 ml/min). Our objective was to understand the efficacy and bleeding data for the lower dose in this subpopulation.Methods We extracted and analysed data from the elderly or from moderately renally impaired patients (n 632 of = 5,539) from the orthopaedic clinical development programme of dabigatran. Results Dabigatran 150 mg once daily was as effective as the standard European enoxaparin regimen, with numerically fewer major bleeding events. Rates of major VTE were 4.3% vs 6.4% of patients, respectively. Major bleeding events occurred in four (1.3%) vs 11 (3.3%), which shows a trend towards lower bleeding with dabigatran 150 mg [odds ratio (OR) 0.40; 95% confidence interval (CI) 0.13-1.25; p=0.110]. Mean volume of blood loss was 395 vs 417 ml, and transfused units were 2.4 vs 2.5,

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Section: Discussionsupporting

confidence: 88%

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Dahl¹,

Kurth²,

Rosencher

et al. 2011

International Orthopaedics (SICOT)

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“…To estimate untreated bleeding risk, we fi rst determined the median major bleeding event rate from the placebo (or graduated compression stockings [GCS]) arm of LMWH trials and the Pulmonary Embolism Prevention (PEP) trial (subgroup that did not receive any heparin) because those trials were more recent. [30][31][32][33][34][35][36][37][38][39] [Section 1.3.1] Schematic of estimated incidence rates for LMWH and no prophylaxis for major orthopedic surgery used for this guideline. Additional example data are from observational studies (dashed line), which usually represents a cumulative incidence rate resulting from high rates of prophylaxis in the fi rst 7 to 14 days and low rates or no prophylaxis during the extended prophylaxis period.…”

Section: Baseline Risk For Major Bleeding Eventsmentioning

confidence: 99%

Prevention of VTE in Orthopedic Surgery Patients

Falck‐Ytter

Francis²,

Johanson³

et al. 2012

Chest

1,729

963

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Background: VTE is a serious, but decreasing complication following major orthopedic surgery. This guideline focuses on optimal prophylaxis to reduce postoperative pulmonary embolism and DVT. Methods: The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement. Results: In patients undergoing major orthopedic surgery, we recommend the use of one of the following rather than no antithrombotic prophylaxis: low-molecular-weight heparin; fondaparinux; dabigatran, apixaban, rivaroxaban (total hip arthroplasty or total knee arthroplasty but not hip fracture surgery); low-dose unfractionated heparin; adjusted-dose vitamin K antagonist; aspirin (all Grade 1B); or an intermittent pneumatic compression device (IPCD) (Grade 1C) for a minimum of 10 to 14 days. We suggest the use of low-molecular-weight heparin in preference to the other agents we have recommended as alternatives (Grade 2C/2B), and in patients receiving pharmacologic prophylaxis, we suggest adding an IPCD during the hospital stay (Grade 2C). We suggest extending thromboprophylaxis for up to 35 days (Grade 2B). In patients at increased bleeding risk, we suggest an IPCD or no prophylaxis (Grade 2C). In patients who decline injections, we recommend using apixaban or dabigatran (all Grade 1B). We suggest against using inferior vena cava fi lter placement for primary prevention in patients with contraindications to both pharmacologic and mechanical thromboprophylaxis (Grade 2C). We recommend against Doppler (or duplex) ultrasonography screening before hospital discharge (Grade 1B). For patients with isolated lowerextremity injuries requiring leg immobilization, we suggest no thromboprophylaxis (Grade 2B). For patients undergoing knee arthroscopy without a history of VTE, we suggest no thromboprophylaxis (Grade 2B). Conclusions: Optimal strategies for thromboprophylaxis after major orthopedic surgery include pharmacologic and mechanical approaches. CHEST 2012; 141(2)(Suppl):e278S-e325SAbbreviations: DUS 5 Doppler (or duplex) ultrasonography; GCS 5 graduated compression stockings; HFS 5 hip fracture surgery; INR 5 international normalized ratio; IPCD 5 intermittent pneumatic compression device; IVC 5 inferior vena cava; LDUH 5 low-dose unfractionated heparin; LMWH 5 low-molecular-weight heparin; PE 5 pulmonary embolism; PEP 5 Pulmonary Embolism Prevention trial; RCT 5 randomized controlled trial; RR 5 risk ratio; THA 5 total hip arthroplasty; TKA 5 total knee arthroplasty; UFH 5 unfractionated heparin; VFP 5 venous foot pump; VKA 5 vitamin K antagonist

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“…For example, uncemented femoral components and multimodal anesthesia have been reported to improve outcome after THA (10,11). The introduction of low molecular weight heparins (LMWHs) in the early 1990s (12,13), the trend toward shorter hospital stays, and aggressive accelerated rehabilitation programs might further contribute to lower mortality (14). On the other hand, the surgery is now being performed in older patients who often have multiple comorbidities.…”

mentioning

confidence: 99%

Changes in Mortality Patterns Following Total Hip or Knee Arthroplasty Over the Past Two Decades: A Nationwide Cohort Study

Lalmohamed

Vestergaard

Boer

et al. 2014

Arthritis & Rheumatology

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Objective. Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are effective procedures for patients with moderate-to-severe osteoarthritis. Mortality rates after THA and TKA may have changed because of new surgical techniques, improvement of peri-and postoperative care, and performance of surgery in older patients having multiple comorbidities. However, data on secular mortality trends are scarce. We undertook this study to evaluate mortality patterns between 1989 and 2007 in patients undergoing elective THA and TKA.Methods. In a Danish retrospective nationwide cohort study, 71,812 patients who underwent THA and 40,642 patients who underwent TKA were identified between January 1989 and December 2007. All-cause and disease-specific mortality was assessed, stratified by calendar periods. Using Cox proportional hazards models, relative risks (RRs) of mortality were calculated between different calendar periods, adjusted for age, sex, and comorbid diseases. Conclusion. Mortality rates following elective THA and TKA have decreased substantially since the early 1990s, despite patients having more presurgical comorbidity. These findings are reassuring for patients undergoing elective THA or TKA.Total hip arthroplasties (THAs) and total knee arthroplasties (TKAs) are considered safe and effective surgical procedures in patients with moderate-to-severe osteoarthritis (1). Given this effectiveness, the number of these procedures has substantially increased over the past decades. Estimates indicate that 1.8 million procedures are performed worldwide each year (2,3). Nevertheless, studies have shown an excess mortality rate shortly after THA and TKA (4-7), particularly due to venous thromboembolism and acute myocardial infarction (MI) (8). The all-cause mortality rate during the first 90 days following these orthopedic surgeries has been estimated at 0.7%.Improvements in surgical technique and the introduction of new therapeutic agents may have improved survival following THA and TKA during the past

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A Randomized Controlled Trial of a Low-Molecular-Weight Heparin (Enoxaparin) to Prevent Deep-Vein Thrombosis in Patients Undergoing Elective Hip Surgery

Cited by 488 publications

References 23 publications

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Thromboprophylaxis with dabigatran etexilate in patients over seventy-five years of age with moderate renal impairment undergoing or knee replacement

Prevention of VTE in Orthopedic Surgery Patients

Changes in Mortality Patterns Following Total Hip or Knee Arthroplasty Over the Past Two Decades: A Nationwide Cohort Study

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