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1.
Blood ; 139(10): 1489-1500, 2022 03 10.
Artículo en Inglés | MEDLINE | ID: mdl-34479364

RESUMEN

Venous thromboembolism (VTE) is a common complication occurring in 5% to 10% of patients with lymphoma. As the complexity of lymphoma management has increased with novel therapies, so too has the treatment of VTE. Therapeutic options for the treatment of cancer-associated VTE have expanded from only warfarin and low-molecular-weight heparins (LMWHs) to include the direct oral anticoagulants (DOACs) apixaban, edoxaban and rivaroxaban. There have been no head-to-head trials comparing different DOACs in this setting, and randomized trials comparing a DOAC with LMWH dalteparin differ in trial design and results. Drug-drug interactions, drug-specific side effects, and patient selection are important considerations when prescribing anticoagulant therapy. In all patients, the relative risks of thrombosis and bleeding, the availability of the anticoagulant, and the life expectancy of the patient are vital elements in selecting the most appropriate anticoagulant (which can vary over time) for the individual patient. We describe the intricacies and challenges of treating thrombotic complications in patients with lymphoma with an emphasis on evidence and guideline-based care.


Asunto(s)
Linfoma , Neoplasias , Trombosis , Tromboembolia Venosa , Administración Oral , Anticoagulantes/efectos adversos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Linfoma/complicaciones , Linfoma/tratamiento farmacológico , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Trombosis/tratamiento farmacológico , Trombosis/etiología , Trombosis/prevención & control , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/etiología , Tromboembolia Venosa/prevención & control
2.
Gynecol Oncol ; 188: 131-139, 2024 Jul 03.
Artículo en Inglés | MEDLINE | ID: mdl-38964250

RESUMEN

OBJECTIVE: Patients undergoing gynecologic cancer surgery at our centre are recommended up to 28 days of enoxaparin for extended post-operative thromboprophylaxis (EP). Baseline survey revealed 92% patient adherence, but highlighted negative effects on patient experience due to the injectable route of administration. We aimed to improve patient experience by reducing pain and bruising by 50%, increasing adherence by 5%, and reducing out-of-pocket cost after introducing apixaban as an oral alternative for EP. METHODS: In this interrupted time series quality improvement study, gynecologic cancer patients were offered a choice between apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously once daily) at time of discharge. A multidisciplinary team informed project design, implementation, and evaluation. Process interventions included standardized orders, patient and care team education programs. Telephone survey at 1 and 6 weeks and chart audit informed outcome, process, and balancing measures. RESULTS: From August to October 2022, 127 consecutive patients were included. Apixaban was chosen by 84%. Survey response rate was 74%. Patients who chose apixaban reported significantly reduced pain, bruising, increased confidence with administration, and less negative impact of the medication (p < 0.0001 for all). Adherence was unchanged (92%). The proportion of patients paying less than $125 (apixaban cost threshold) increased from 45% to 91%. There was no difference in bleeding and no VTE events. CONCLUSIONS: Introduction of apixaban for EP was associated with significant improvement in patient-reported quality measures and reduced financial toxicity with no effect on adherence or balancing measures. Apixaban is the preferred anticoagulant for EP at our centre.

3.
Artículo en Inglés | MEDLINE | ID: mdl-38735015

RESUMEN

BACKGROUND: Treating cancer-associated venous thromboembolism (CAT) with anticoagulation prevents recurrent venous thromboembolism (rVTE), but increases bleeding risk. OBJECTIVES: To compare incidence of rVTE, major bleeding, and all-cause mortality for rivaroxaban versus low molecular weight heparin (LMWH) in patients with CAT. METHODS: We developed a cohort study using Swedish national registers 2013-2019. Patients with CAT (venous thromboembolism within 6 months of cancer diagnosis) were included. Those with other indications or with high bleeding risk cancers were excluded (according to guidelines). Follow-up was from index-CAT until outcome, death, emigration, or end of study. Incidence rates (IR) per 1000 person-years with 95% confidence interval (CI) and propensity score overlap-weighted hazard ratios (HRs) for rivaroxaban versus LMWH were estimated. RESULTS: We included 283 patients on rivaroxaban and 5181 on LMWH. The IR for rVTE was 68.7 (95% CI 40.0-109.9) for rivaroxaban, compared with 91.6 (95% CI 81.9-102.0) for LMWH, with adjusted HR 0.77 (95% CI 0.43-1.35). The IR for major bleeding was 23.5 (95% CI 8.6-51.1) for rivaroxaban versus 49.2 (95% CI 42.3-56.9) for LMWH, with adjusted HR 0.62 (95% CI 0.26-1.49). The IR for all-cause mortality was 146.8 (95% CI 103.9-201.5) for rivaroxaban and 565.6 (95% CI 541.8-590.2) for LMWH with adjusted HR 0.48 (95% CI 0.34-0.67). CONCLUSIONS: Rivaroxaban performed similarly to LMWH for patients with CAT for rVTE and major bleeding. An all-cause mortality benefit was observed for rivaroxaban which potentially may be attributed to residual confounding. TRIAL REGISTRATION NUMBER: NCT05150938 (Registered 9 December 2021).

4.
Stroke ; 54(11): 2724-2736, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37675613

RESUMEN

BACKGROUND: Emerging data suggest that direct oral anticoagulants may be a suitable choice for anticoagulation for cerebral venous thrombosis (CVT). However, conducting high-quality trials in CVT is challenging as it is a rare disease with low rates of adverse outcomes such as major bleeding and functional dependence. To facilitate the design of future CVT trials, SECRET (Study of Rivaroxaban for Cerebral Venous Thrombosis) assessed (1) the feasibility of recruitment, (2) the safety of rivaroxaban compared with standard-of-care anticoagulation, and (3) patient-centered functional outcomes. METHODS: This was a phase II, prospective, open-label blinded-end point 1:1 randomized trial conducted at 12 Canadian centers. Participants were aged ≥18 years, within 14 days of a new diagnosis of symptomatic CVT, and suitable for oral anticoagulation; they were randomized to receive rivaroxaban 20 mg daily, or standard-of-care anticoagulation (warfarin, target international normalized ratio, 2.0-3.0, or low-molecular-weight heparin) for 180 days, with optional extension up to 365 days. Primary outcomes were annual rate of recruitment (feasibility); and a composite of symptomatic intracranial hemorrhage, major extracranial hemorrhage, or mortality at 180 days (safety). Secondary outcomes included recurrent venous thromboembolism, recanalization, clinically relevant nonmajor bleeding, and functional and patient-reported outcomes (modified Rankin Scale, quality of life, headache, mood, fatigue, and cognition) at days 180 and 365. RESULTS: Fifty-five participants were randomized. The rate of recruitment was 21.3 participants/year; 57% of eligible candidates consented. Median age was 48.0 years (interquartile range, 38.5-73.2); 66% were female. There was 1 primary event (symptomatic intracranial hemorrhage), 2 clinically relevant nonmajor bleeding events, and 1 recurrent CVT by day 180, all in the rivaroxaban group. All participants in both arms had at least partial recanalization by day 180. At enrollment, both groups on average reported reduced quality of life, low mood, fatigue, and headache with impaired cognitive performance. All metrics improved markedly by day 180. CONCLUSIONS: Recruitment targets were reached, but many eligible participants declined randomization. There were numerically more bleeding events in patients taking rivaroxaban compared with control, but rates of bleeding and recurrent venous thromboembolism were low overall and in keeping with previous studies. Participants had symptoms affecting their well-being at enrollment but improved over time. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03178864.


Asunto(s)
Tromboembolia Venosa , Trombosis de la Vena , Humanos , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Masculino , Rivaroxabán/efectos adversos , Anticoagulantes/efectos adversos , Tromboembolia Venosa/inducido químicamente , Estudios Prospectivos , Estudios de Factibilidad , Calidad de Vida , Canadá , Hemorragia/inducido químicamente , Trombosis de la Vena/tratamiento farmacológico , Hemorragias Intracraneales/inducido químicamente , Cefalea
5.
Br J Haematol ; 198(5): 812-825, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-35611985

RESUMEN

Cancer-associated venous thromboembolism (VTE) is a leading cause of morbidity and mortality in patients with cancer. Treatment of cancer-associated VTE comes with a heightened risk of anticoagulant-related bleeding that differs by choice of anticoagulant as well as by patient- and disease-specific risk factors. Available data from randomized controlled trials and observational studies in cancer-associated VTE suggest that direct oral anticoagulants are effective, continuing anticoagulation beyond six months is indicated in those with active cancer and that patients who develop 'breakthrough' thrombotic events can be effectively treated. We review the evidence that addresses these key clinical questions and offer pragmatic approaches in individualizing care. While significant investigative efforts over the past decade have made impactful advances, future research is needed to better define the factors that contribute to anticoagulant-related bleeding and VTE recurrence, in order to aid clinical decision-making that improves the care of patients with cancer-associated VTE.


Asunto(s)
Neoplasias , Trombosis , Tromboembolia Venosa , Anticoagulantes , Coagulación Sanguínea , Hemorragia/inducido químicamente , Heparina de Bajo-Peso-Molecular/uso terapéutico , Humanos , Neoplasias/complicaciones , Neoplasias/tratamiento farmacológico , Trombosis/inducido químicamente , Tromboembolia Venosa/tratamiento farmacológico , Tromboembolia Venosa/etiología
6.
N Engl J Med ; 380(8): 711-719, 2019 02 21.
Artículo en Inglés | MEDLINE | ID: mdl-30511879

RESUMEN

BACKGROUND: Patients with active cancer have an increased risk of venous thromboembolism, which results in substantial morbidity, mortality, and health care expenditures. The Khorana score (range, 0 to 6, with higher scores indicating a higher risk of venous thromboembolism) has been validated to identify patients with cancer at elevated risk for this complication and may help select those who could benefit from thromboprophylaxis. METHODS: We conducted a randomized, placebo-controlled, double-blind clinical trial assessing the efficacy and safety of apixaban (2.5 mg twice daily) for thromboprophylaxis in ambulatory patients with cancer who were at intermediate-to-high risk for venous thromboembolism (Khorana score, ≥2) and were initiating chemotherapy. The primary efficacy outcome was objectively documented venous thromboembolism over a follow-up period of 180 days. The main safety outcome was a major bleeding episode. RESULTS: Of the 574 patients who underwent randomization, 563 were included in the modified intention-to-treat analysis. Venous thromboembolism occurred in 12 of 288 patients (4.2%) in the apixaban group and in 28 of 275 patients (10.2%) in the placebo group (hazard ratio, 0.41; 95% confidence interval [CI], 0.26 to 0.65; P<0.001). In the modified intention-to-treat analysis, major bleeding occurred in 10 patients (3.5%) in the apixaban group and in 5 patients (1.8%) in the placebo group (hazard ratio, 2.00; 95% CI, 1.01 to 3.95; P = 0.046). During the treatment period, major bleeding occurred in 6 patients (2.1%) in the apixaban group and in 3 patients (1.1%) in the placebo group (hazard ratio, 1.89; 95% CI, 0.39 to 9.24). CONCLUSIONS: Apixaban therapy resulted in a significantly lower rate of venous thromboembolism than did placebo among intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy. The rate of major bleeding episodes was higher with apixaban than with placebo. (Funded by the Canadian Institutes of Health Research and Bristol-Myers Squibb-Pfizer Alliance; AVERT ClinicalTrials.gov number, NCT02048865.).


Asunto(s)
Inhibidores del Factor Xa/uso terapéutico , Neoplasias/tratamiento farmacológico , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Tromboembolia Venosa/prevención & control , Administración Oral , Anciano , Antineoplásicos/uso terapéutico , Método Doble Ciego , Inhibidores del Factor Xa/efectos adversos , Femenino , Hemorragia/inducido químicamente , Humanos , Incidencia , Análisis de Intención de Tratar , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Neoplasias/complicaciones , Pirazoles/efectos adversos , Piridonas/efectos adversos , Factores de Riesgo , Tromboembolia Venosa/etiología
7.
Semin Thromb Hemost ; 45(6): 638-647, 2019 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31382307

RESUMEN

Cancer-associated thrombosis (CAT) is a common occurrence in the journey of a cancer patient and its management poses significant challenges. Low molecular weight heparin (LMWH) is the standard of care but the high cost and the inconvenience of daily injections have led to low persistence with therapy. Direct oral anticoagulants (DOACs) are effective and safe for the treatment of venous thromboembolism (VTE) compared with vitamin K antagonist (VKA) therapy in noncancer patients, and emerging data comparing their use with LMWH in CAT are rapidly changing clinical practice. Recent randomized controlled trials also reported that specific DOACs are effective for primary prevention of CAT in patients undergoing systemic cancer therapy, but this benefit might be offset by an increased risk of bleeding. Undoubtedly, the option of an effective and safe oral anticoagulant is appealing to physicians and patients but critical limitations of DOACs, particularly bleeding and drug-drug interaction, need careful consideration. Understanding the scientific data, as well as each patient's preferences and values, are paramount in individualizing therapy in this special population of patients. This review summarizes the current evidence for DOACs for the treatment and prevention of CAT, discusses the importance of careful patient selection, and highlights upcoming new studies that will inform guideline recommendations.


Asunto(s)
Anticoagulantes/uso terapéutico , Neoplasias/tratamiento farmacológico , Anticoagulantes/farmacología , Humanos , Factores de Riesgo
8.
Blood ; 130(23): 2484-2490, 2017 12 07.
Artículo en Inglés | MEDLINE | ID: mdl-29212805

RESUMEN

The optimal duration of anticoagulation in patients with cancer-associated venous thromboembolism (VTE) is unknown. Without well-designed studies evaluating the efficacy, safety and cost-effectiveness of continuing anticoagulant therapy beyond the acute treatment period of 3 to 6 months, evidence-based recommendations are lacking. Consensus guidelines generally suggest continuing anticoagulation in patients with active cancer or receiving cancer treatment, with periodic reassessment of the risks and benefits. Unfortunately, with very little published data on the epidemiology of cancer-associated VTE beyond the initial 6 months, it is not possible for clinicians and patients to weigh risks and benefits in a quantitatively informed manner. Further research is needed to provide reliable and contemporary estimates on the risk of recurrent VTE off anticoagulation, risk of bleeding on anticoagulation, case fatality or all-cause mortality, and other important consequences of living with cancer-associated VTE. This chapter provides an overview of the published literature on real-world data on anticoagulant therapy use, the risks and risk factors of recurrent VTE and bleeding, and patient preference and values regarding long-term anticoagulation. It will conclude with a pragmatic, experience-informed approach for tailoring anticoagulant therapy in patients with cancer-associated VTE.

9.
J Thromb Thrombolysis ; 47(4): 495-504, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-30859370

RESUMEN

In patients with active cancer and acute venous thromboembolism (VTE), the low-molecular-weight-heparin (LMWH) dalteparin is more effective than vitamin K antagonist (VKA) in reducing the risk of recurrent venous thromboembolism (rVTE) without increasing the risk of bleeding. However, the relative benefit of LMWH versus VKA in patients with active cancer at high or low risk of rVTE and bleeding is unclear. This post hoc analysis used data from the CLOT study to explore the efficacy and safety of LMWH versus VKA in preventing recurrent thrombosis in high- and low-risk patients with active cancer. High-risk patients were defined by metastatic disease and/or antineoplastic treatment at baseline; low-risk patients presented with neither. Among high-risk patients, rVTE occurred in 25/318 (8%) (LMWH) versus 53/314 (17%) (VKA) (hazard ratio, 0.44; p = 0.001). No significant difference was detected in the rate of major or any bleeding. The 6-month mortality rate was 40% (LMWH) versus 41% (VKA). In low-risk patients, 2/20 (10%) (LMWH) had rVTE versus 0/24 (0%) (VKA) (hazard ratio, not estimable; p = 0.998). No significant difference was detected in the rate of major or any bleeding. The 6-month mortality rate was 20% (LMWH) versus 29% (VKA). In patients with cancer-associated thrombosis at high risk of rVTE and bleeding, the LMWH dalteparin was more effective than VKA in reducing the risk of rVTE without increasing the risk of bleeding. No difference in rate of rVTE or bleeding was observed between LMWH and VKA among low-risk patients.


Asunto(s)
Cumarinas/administración & dosificación , Dalteparina/administración & dosificación , Neoplasias/tratamiento farmacológico , Trombosis/tratamiento farmacológico , Tromboembolia Venosa/tratamiento farmacológico , Anciano , Cumarinas/efectos adversos , Dalteparina/efectos adversos , Supervivencia sin Enfermedad , Femenino , Hemorragia/inducido químicamente , Hemorragia/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/mortalidad , Neoplasias/patología , Tasa de Supervivencia , Trombosis/mortalidad , Trombosis/patología , Tromboembolia Venosa/mortalidad , Tromboembolia Venosa/patología
10.
N Engl J Med ; 382(17): 1650-1652, 2020 04 23.
Artículo en Inglés | MEDLINE | ID: mdl-32223115
11.
Value Health ; 21(4): 449-455, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29680102

RESUMEN

BACKGROUND: Venous thromboembolism (VTE) is common in cancer patients and its treatment is associated with a high risk of recurrent VTE (rVTE) and bleeding. OBJECTIVES: To analyze data from the Comparison of Acute Treatments in Cancer Hemostasis (CATCH) trial to describe the impact of rVTE and bleeding events on health-related quality of life. METHODS: The three-level EuroQol five-dimensional questionnaire (EQ-5D) data were collected monthly for up to 7 months in patients starting anticoagulation for newly diagnosed VTE. Analyses were designed to describe the impact of rVTE and bleeding on EQ-5D scores while controlling for effects of covariates such as background and clinical variables and longitudinal changes. A repeated-measures model with specification of the variance-covariance matrix to characterize the intrapatient correlation was used to estimate the utility values. The impact of an rVTE or a bleeding event was assumed to be reflected in the utility value when it occurred within 2 weeks from a planned data collection point. RESULTS: Data were available from 883 patients. A total of 76 rVTE and 159 bleeding events occurred during follow-up. rVTE had a significant impact on EQ-5D scores, with a decrement of -0.075 on the basis of our reference case (male, no metastasis, Eastern Cooperative Oncology Group score = 1, Western European), but different patients might have different decrements. Bleeding events had a smaller (nonstatistically significant) impact on EQ-5D scores. CONCLUSIONS: This data set study has quantified the decline in EQ-5D scores associated with experiencing rVTE or bleeding events in cancer patients. These results indicate the net gain in quality of life and impact on cost-effectiveness of secondary VTE prevention.


Asunto(s)
Anticoagulantes/efectos adversos , Hemorragia/inducido químicamente , Neoplasias/complicaciones , Calidad de Vida , Tromboembolia Venosa/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Anticoagulantes/administración & dosificación , Costo de Enfermedad , Femenino , Hemorragia/psicología , Humanos , Masculino , Persona de Mediana Edad , Neoplasias/diagnóstico , Recurrencia , Factores de Riesgo , Encuestas y Cuestionarios , Factores de Tiempo , Resultado del Tratamiento , Tromboembolia Venosa/diagnóstico , Tromboembolia Venosa/etiología , Tromboembolia Venosa/psicología
12.
Thromb J ; 16: 21, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30186045

RESUMEN

BACKGROUND: Around 20% of venous thromboembolism (VTE) cases occur in patients with cancer. Current guidelines recommend low molecular weight heparin (LMWH) as the preferred anticoagulant for VTE treatment. However, some guidelines state that vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are acceptable alternatives for long-term therapy in some patients if LMWHs are not available. LMWHs and VKAs have a number of drawbacks that can increase the burden on patients. DOACs, such as rivaroxaban, can ameliorate some burdens and may offer an opportunity to increase patient satisfaction and health-related quality of life (HRQoL). The Cancer-associated thrOmboSIs - patient-reported outcoMes with rivarOxaban (COSIMO) study is designed to provide real-world information on treatment satisfaction in patients with active cancer who switch from LMWH or VKA to rivaroxaban for the treatment of acute VTE or to prevent recurrent VTE. METHODS: COSIMO is a prospective, non-interventional, single-arm cohort study that aims to recruit 500 patients in Europe, Canada and Australia. Adults with active cancer who are switching to rivaroxaban having received LMWH/VKA for the treatment and secondary prevention of recurrent VTE for at least the previous 4 weeks are eligible. Patients will be followed for 6 months. The primary outcome is treatment satisfaction assessed as change in the Anti-Clot Treatment Scale (ACTS) Burdens score at week 4 after enrolment compared with baseline. Secondary outcomes include treatment preferences, measured using a discrete choice experiment, change in ACTS Burdens score at months 3 and 6, and change in HRQoL (assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire). COSIMO will collect data on patients' medical history, patterns of anticoagulant use and incidence of bleeding and thromboembolic events. Study recruitment started in autumn 2016. CONCLUSIONS: COSIMO will provide information on outcomes associated with switching from LMWH or VKA therapy to rivaroxaban for the treatment or secondary prevention of cancer-associated thrombosis in a real-life setting. The key goal is to assess whether there is a change in patient-reported treatment satisfaction. In addition, COSIMO will facilitate the evaluation of the safety and effectiveness of rivaroxaban in preventing recurrent VTE in this patient population. TRIAL REGISTRATION: NCT02742623. Registered 19 April 2016.

13.
J Thromb Thrombolysis ; 46(3): 386-392, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-30014300

RESUMEN

Patients with acute leukemia frequently develop catheter-related thrombosis (CRT) despite concurrent thrombocytopenia. The incidence, treatment and outcomes of this complication are poorly documented. We undertook this study to determine the incidence of CRT in patients with acute leukemia and assess the safety and effectiveness of a treatment strategy using a platelet-adjusted low molecular weight heparin (LMWH) dosing protocol. Patients (18 years and older) with newly diagnosed acute leukemia from January 2014 to December 2015 who received central venous catheters were included. The clinical data were reviewed up to 12 months from acute leukemia diagnosis to capture objectively documented CRT events. The outcome events including recurrent venous thromboembolism (VTE), bleeding events, infectious or mechanical complications, and death were reported up to 3 months from the time of CRT diagnosis. The incidence of CRT among 214 patients was 10.7% (23 patients) in the first 12 months after acute leukemia diagnosis. Among 18 patients who were treated with anticoagulation, 14 (78%) received reduced LMWH dosing due to concurrent thrombocytopenia. There were no recurrent VTE episodes, but 3 patients experienced bleeding events while on anticoagulation. Fifteen patients (83%) completed a minimum of 3 months anticoagulation. Twelve patients (52%) experienced an infectious complication, which was the main reason for catheter removal. Deaths occurred in 2 patients, related to underlying acute leukemia during 3 months period following CRT. Symptomatic CRT is frequent in patients with acute leukemia. Platelet-adjusted LMWH dosing may be effective and well tolerated despite thrombocytopenia.


Asunto(s)
Catéteres Venosos Centrales/efectos adversos , Heparina de Bajo-Peso-Molecular/administración & dosificación , Leucemia/tratamiento farmacológico , Trombosis/etiología , Enfermedad Aguda , Adolescente , Adulto , Anciano , Plaquetas , Humanos , Persona de Mediana Edad , Trombocitopenia , Resultado del Tratamiento , Tromboembolia Venosa , Adulto Joven
14.
Blood ; 126(5): 597-603, 2015 Jul 30.
Artículo en Inglés | MEDLINE | ID: mdl-25926600

RESUMEN

Rapid exclusion of heparin-induced thrombocytopenia (HIT) is needed to determine which patients can continue to receive heparin. In this prospective management study, 526 participants had a 4Ts score, rapid particle gel immunoassay (platelet factor 4/heparin [PF4/H]-PaGIA), and serotonin-release assay (SRA) performed. While awaiting SRA results, participants with a low 4Ts score (irrespective of PF4/H-PaGIA result) or intermediate 4Ts score plus a negative PF4/H-PaGIA result received prophylactic doses of danaparoid or fondaparinux; all others received therapeutic doses of nonheparin anticoagulants. The primary outcome was the frequency of management failures defined as HIT-positive participants with a low 4Ts score (irrespective of PF4/H-PaGIA result) or intermediate 4Ts score plus negative PF4/H-PaGIA result. Six participants (1.1%; 95% confidence interval [CI], 0.2-2.1%) were management failures. A negative PF4/H-PaGIA result reduced the pretest probability of HIT from 1.9% to 0% (95% CI, 0-1.3%), 6.7% to 0% (95% CI, 0-2.7%), and 36.6% to 0% (95% CI, 0-14.3%) in the low, intermediate, and high score groups, respectively. A positive PF4/H-PaGIA result increased the probability of HIT in the low score group to 15.4% (95% CI, 5.9-30.5). Thus, a low or intermediate 4Ts score plus negative PaGIA result excluded HIT, whereas any other combination of results justified the use of alternative anticoagulants until HIT could be excluded. This trial was registered at www.clinicaltrials.gov as #NCT00489437.


Asunto(s)
Heparina/efectos adversos , Trombocitopenia/inducido químicamente , Trombocitopenia/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Algoritmos , Anticoagulantes/efectos adversos , Anticoagulantes/inmunología , Anticoagulantes/uso terapéutico , Estudios de Cohortes , Femenino , Heparina/inmunología , Humanos , Inmunoensayo/métodos , Inmunoglobulina G/sangre , Masculino , Persona de Mediana Edad , Factor Plaquetario 4/inmunología , Estudios Prospectivos , Serotonina/metabolismo , Trombocitopenia/terapia , Resultado del Tratamiento
15.
Can J Neurol Sci ; 44(1): 116-119, 2017 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-27809948

RESUMEN

Patterns of practice for management of cerebral venous thrombosis in Canada are unknown. We surveyed Canadian neurologists and hematologists regarding anticoagulation in cerebral venous thrombosis. The response rate was 28%, with 27 neurologists and 20 hematologists responding. We found that choice of first-line initial anticoagulation differed significantly between neurologists and hematologists, with 89% of neurologists favouring unfractionated heparin and hematologists' preference split between unfractionated heparin (50%) and low-molecular-weight heparin (50%). Differences in patterns of practice likely reflect clinical equipoise.


Asunto(s)
Fibrinolíticos/uso terapéutico , Hematología , Neurólogos/psicología , Trombosis de la Vena/tratamiento farmacológico , Canadá , Femenino , Encuestas Epidemiológicas , Humanos , Masculino , Selección de Paciente
17.
Circulation ; 132(3): 167-73, 2015 Jul 21.
Artículo en Inglés | MEDLINE | ID: mdl-25966905

RESUMEN

BACKGROUND: The perioperative management of dabigatran in clinical practice is heterogeneous. We performed this study to evaluate the safety of perioperative management of dabigatran using a specified protocol. METHODS AND RESULTS: Patients treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The timing of the last dose of dabigatran before the procedure was based on the creatinine clearance and procedure-related bleeding risk. Resumption of dabigatran was prespecified according to the complexity of the surgery and consequences of a bleeding complication. Patients were followed up for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism, and death. We included 541 cases: 324 procedures (60%) with standard risk of bleeding and 217 procedures (40%) with increased risk of bleeding. The last dose of dabigatran was at 24, 48, or 96 hours before surgery according to the protocol in 46%, 37%, and 6%, respectively, of the patients. Resumption was timed according to protocol in 77% with 75 mg as the first dose on the day of procedure in 40% of the patients. Ten patients (1.8%; 95% confidence interval, 0.7-3.0) had major bleeding, and 28 patients (5.2%; 95% confidence interval, 3.3-7.0) had minor bleeding events. The only thromboembolic complication was transient ischemic attack in 1 patient (0.2%; 95% confidence interval, 0-0.5), and there were 4 deaths unrelated to bleeding or thrombosis. Bridging was not used preoperatively but was administered in 9 patients (1.7%) postoperatively. CONCLUSION: Our protocol for perioperative management of dabigatran appears to be effective and feasible.


Asunto(s)
Antitrombinas/sangre , Bencimidazoles/sangre , Manejo de la Enfermedad , Atención Perioperativa/métodos , beta-Alanina/análogos & derivados , Anciano , Anciano de 80 o más Años , Antitrombinas/administración & dosificación , Antitrombinas/efectos adversos , Bencimidazoles/administración & dosificación , Bencimidazoles/efectos adversos , Estudios de Cohortes , Dabigatrán , Femenino , Hemorragia/sangre , Hemorragia/inducido químicamente , Hemorragia/prevención & control , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Tromboembolia/sangre , Tromboembolia/prevención & control , beta-Alanina/administración & dosificación , beta-Alanina/efectos adversos , beta-Alanina/sangre
18.
Ann Surg Oncol ; 23(5): 1422-30, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-26887853

RESUMEN

BACKGROUND: Abdominopelvic cancer surgery increases the risk of postoperative venous thromboembolism (VTE). Low-molecular-weight heparin (LMWH) thromboprophylaxis is recommended, and the role of extended thromboprophylaxis (ETP) is controversial. We performed a systematic review to determine the effect of ETP on deep vein thrombosis (DVT), pulmonary embolism (PE), major bleeding, and all-cause mortality after abdominal or pelvic cancer surgery. METHODS: A search of the MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was undertaken, and studies were included if they compared extended duration (2-6 weeks) with conventional duration of thromboprophylaxis (2 weeks or less) after cancer surgery. Pooled relative risk (RR) was estimated using a random effects model. RESULTS: Seven randomized and prospective studies were included, comprising 4807 adult patients. ETP was associated with a significantly reduced incidence of all VTEs [2.6 vs. 5.6 %; RR 0.44, 95 % confidence interval (CI) 0.28-0.70, number needed to treat (NNT) = 39] and proximal DVT (1.4 vs. 2.8 %; RR 0.46, 95 % CI 0.23-0.91, NNT = 71). There was no statistically significant difference in the incidence of symptomatic PE (0.8 vs. 1.3 %; RR 0.56, 95 % CI 0.23-1.40), major bleeding (1.8 vs. 1.0 %; RR 1.19, 95 % CI 0.47-2.97), and all-cause mortality (4.2 vs. 3.6 %; RR 0.79, 95 % CI 0.47-1.33). None of the outcomes differed if randomized trials were analyzed independently. CONCLUSIONS: ETP after abdominal or pelvic surgery for cancer significantly decreased the incidence of all VTEs and proximal DVTs, but had no impact on symptomatic PE, major bleeding, or 3-month mortality. ETP should be routinely considered in the setting of abdominal and pelvic surgery for cancer patients.


Asunto(s)
Neoplasias Abdominales/cirugía , Quimioprevención/métodos , Heparina de Bajo-Peso-Molecular/uso terapéutico , Neoplasias Pélvicas/cirugía , Complicaciones Posoperatorias/prevención & control , Tromboembolia Venosa/prevención & control , Adulto , Anticoagulantes/uso terapéutico , Humanos
19.
J Thromb Thrombolysis ; 41(1): 81-91, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26780740

RESUMEN

Venous thromboembolism (VTE) is a highly prevalent complication of malignancy with emerging changes in incidence, diagnosis and treatment paradigms. This manuscript, initiated by the Anticoagulation Forum, provides clinical guidance based on existing guidelines and consensus expert opinion where guidelines are lacking. We address a) the appropriate workup to search for occult malignancy in patients with idiopathic VTE, b) identification of high-risk cancer patients for primary thromboprophylaxis, c) the appropriate immediate and long-term treatment for people with cancer diagnosed with acute thromboembolism, d) the appropriate duration of anticoagulation and e) the appropriate treatment strategy in patients with recurrent VTE on anticoagulation. Areas of controversy and future directions in this field are highlighted.


Asunto(s)
Anticoagulantes/uso terapéutico , Neoplasias/tratamiento farmacológico , Tromboembolia Venosa/tratamiento farmacológico , Administración Oral , Humanos , Guías de Práctica Clínica como Asunto , Tromboembolia Venosa/etiología
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