Major Bleeding, Mortality, and Efficacy of Fondaparinux in Venous Thromboembolism Prevention Trials

Eikelboom, John W.; Quinlan, DJ; O’Donnell, Martin J.

doi:10.1016/j.jvs.2010.04.005

Cited by 9 publications

(10 citation statements)

References 20 publications

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“…13,000 patients enrolled in fondaparinux trials demonstrated a hazard ratio of death of close to 7 (8.6% vs 1.7%), demonstrating a strong relationship between major bleeding and poor outcome irrespective of the study drug used. 5 Whether this fi nding can be generalized to other populations and interventions is unknown.…”

Section: Remarksmentioning

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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Section: Remarksmentioning

confidence: 99%

Prevention of VTE in Orthopedic Surgery Patients

Falck‐Ytter

Francis²,

Johanson³

et al. 2012

Chest

1,729

963

View full text Add to dashboard Cite

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“…Despite this, low responsiveness to clopidogrel as determined with a point-of-care platelet function assay has been associated with thrombotic events after percutaneous coronary intervention (PCI) with a drug-eluting stent (DES) [3]. A recent study showed that 150 mg d )1 clopidogrel is associated with reduced platelet reactivity and enhanced platelet inhibition when compared to the 75 mg d )1 dose used in some patients undergoing elective PCI [4]. The addition of cilostazol to aspirin and clopidogrel significantly increases the inhibition of P2Y 12 -induced aggregation in primary PCI [5].…”

Section: Disclosure Of Conflict Of Interestsmentioning

confidence: 99%

“…In a recent systematic review of randomized trials addressing the value of fondaparinux for prevention of VTE in high-risk surgical or medical patients, Eikelboom et al [4] were able to confirm this association. Comparable results were obtained in a large series of patients who had received antithrombotic drugs for the treatment of VTE in a community setting [5].…”

mentioning

confidence: 96%

Major bleeding as a predictor of mortality in patients with venous thromboembolism: findings from the RIETE Registry

Prandoni

Trujillo‐Santos

Sánchez‐Cantalejo

et al. 2010

Journal of Thrombosis and Haemostasis

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Although there is emerging evidence that bleeding is a strong predictor of mortality in patients with acute arterial thrombosis receiving antithrombotic therapy [1][2][3], whether a similar association between bleeding and mortality also exists in patients with venous thromboembolism (VTE) has not been thoroughly investigated. In a recent systematic review of randomized trials addressing the value of fondaparinux for prevention of VTE in high-risk surgical or medical patients, Eikelboom et al. [4] were able to confirm this association. Comparable results were obtained in a large series of patients who had received antithrombotic drugs for the treatment of VTE in a community setting [5]. Recently, Nieto et al. [6] reported a high mortality rate in the follow-up of 407 patients, who belonged to the RIETE registry and had developed major bleeding while on conventional anticoagulation. However, in this study no attempt was made to compare the mortality rate between patients who bled and those who did not, and nor were study results adjusted for potential confounders. We describe here the association between major bleeding and mortality after the enrollment of almost 30 000 patients with acute VTE in the multicenter RIETE registry.Between March 2001 and December 2009, 29 903 consecutive patients with acute VTE, as confirmed by objective tests, were enrolled in the RIETE registry, received conventional anticoagulation, and were followed up for 3 months (80% of the study cohort) or longer periods of time after the index episode. Bleeding complications were classified as major if they were overt and required a transfusion of at least two units of blood, were retroperitoneal, spinal or intracranial, or were immediately (within 24 h) fatal [6]. The primary study aim was to compare the overall risk of death occurring during the follow-up between patients who bled and those who did not.The baseline characteristics of patients who bled and those who did not were compared with the use of the chi-square test for categorical variables and the Student t-test for continuous variables. All variables possibly associated with bleeding (P < 0.10 after univariate analysis) were included in the model, and Cox proportional hazards regression analyses were used to examine the association between patientsÕ demographic, clinical and treatment characteristics and major bleeding. Cox proportional hazards regression analyses were used to examine the association between baseline and treatment characteristics and death, with major bleeding as a timedependent covariate. All P-values were two-sided and were considered to be statistically significant at the 5% level.

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“…Evidence suggests that bleeding from antithrombotic agents is a strong predictor of mortality and reduces the overall benefits of VTE prophylaxis in hospitalized patients (14,(45)(46)(47)(48).…”

Section: Contraindications To Prophylaxismentioning

confidence: 99%

Thromboprophylaxis in Elderly Surgical Patients: Current State and Future Considerations

Delimpalta¹,

Ponchietti²

2017

chr

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RezumatTromboembolismul venos reprezintã cea mai frecventã cauzã evitabilã de deces în rândul pacienţilor spitalizaţi. Pacienţii vârstnici care suferã intervenţii operatorii în sfera Chirurgiei Generale prezintã o susceptibilitate crescutã pentru Tromboza Venoasã Profundã /Tromboembolism Pulmonar Acut (TVP/TEPA). Riscul de TVP/TEPA creşte de altfel adiţional în prezenţa comorbiditãţilor prevalente în grupul pacienţilor vârstnici. Cu toate acestea, TVP/TEPA este de multe ori subdiagnosticat şi subtratat în acest grup de pacienţi. În prezent existã o serie de scoruri de risc clinice care clasificã pacienţii în categorii de risc scãzut/moderat/crescut pentru TVP/TEPA. Ghidurile clinice de bunã practicã pentru tromboprofilaxie propun fie o combinaţie de procedee mecanice (ciorapi elastici sau compresie gambiera penumaticã intermitentã), fie agenţi farmacologici (ex. Heparina cu greutate molecularã redusã sau anticoagulante orale). Dat fiind faptul cã riscul de sângerare ca efect secundar al tratamentului reprezintã o cauzã semnificativã de îngrijorare în ceea ce priveşte populaţia vârstnicã, metodele de tromboprofilaxie trebuie ajustate astfel încât acest risc sa fie cât mai scãzut. Atât opţiunea pentru un anumit tromboprofilactic, cât şi doza acestuia pot fi, de asemenea, influenţate de o alterare a funcţiei renale. Durata necesarã tromboprofilaxiei este încã neclarã, ea putând varia între c. o sãptãmânã şi o lunã, în funcţie de patologia pacientului şi evaluarea riscului individual de TVP/TEPA. AbstractVenous thromboembolism is the number one cause of preventable death for hospital inpatients. Aging general surgical patients are especially susceptible to DVT/PE and this risk increases in the presence of other comorbidities prevalent in the elderly. However, it is often unrecognised and undertreated. Various risk scores classify patients in low, moderate and high risk categories. Current guidelines for thromboprophylaxis advocate combination of mechanical methods in the form of elastic stockings or intermittent pneumatic leg compression and pharmacological agents such as low molecular weight heparins and oral anticoagulants. Increased bleeding risk is a concern in this population and the method of prophylaxis needs to be adjusted as a result. Decreased renal function also influences the choice and dosage of medication. The required duration of prophylaxis is unclear but can range from one week to more than a month depending on the underlying pathology and individual risk assessment.

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Major Bleeding, Mortality, and Efficacy of Fondaparinux in Venous Thromboembolism Prevention Trials

Cited by 9 publications

References 20 publications

Prevention of VTE in Orthopedic Surgery Patients

Prevention of VTE in Orthopedic Surgery Patients

Major bleeding as a predictor of mortality in patients with venous thromboembolism: findings from the RIETE Registry

Thromboprophylaxis in Elderly Surgical Patients: Current State and Future Considerations

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