Adherence with Injectibal Prophylaxis for Venous Thromboembolism (VTE) Following Total Hip (THR) and Total Knee (TKR) Replacement Surgery: Complete Registry.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 558-558
Author(s):  
William M Semchuk ◽  
David Backstein ◽  
John Stewart ◽  
Esmat Dessouki ◽  
Mary Kwan ◽  
...  

Abstract Abstract 558 Introduction: Patients undergoing major hip or knee arthroplasty are at high risk of venous thromboembolism (VTE). Guidelines recommend continuation of anticoagulant thromboprophylaxis for up to 35 days after hip and knee arthroplasty but little is known about adherence to injectable VTE prophylaxis. Objectives: 1) To describe adherence with injectable VTE prophylaxis following elective THR and TKR surgery 2) To analyze the factors impacting patient adherence. Methods: A prospective cohort study was conducted in 8 orthopaedic Canadian centres. Patients undergoing THR or TKR were enrolled at the time of discharge from the acute care ward. Patients prescribed with injectable prophylaxis at discharge from acute care ward / rehabilitation unit were contacted by phone within 6 weeks of discharge to collect data on their use of the prophylaxis. Overall Adherence (OA) was calculated as the weighted average of the adherence rate in the acute care ward/rehabilitation unit (inpatient) and the adherence rate for the follow-up phase (out patient). The inpatient adherence was based on records and the percent was calculated as doses administered divided by doses prescribed × 100. The outpatient adherence defines as adherence post discharge from the acute care ward/rehabilitation unit and was based on the results of the follow up call and the percent was calculated as number of syringes dispensed minus number of unused syringes left / total number of syringes that should have been injected out of the hospital as of the day of call × 100. Results: Of the 239 patients screened, 234 patients were enrolled. 198 were discharged directly home with a prescription for injectable prophylaxis and 36 patients went to a rehabilitation unit of whom 15 patients completed their injectable prophylaxis at the rehabilitation unit and 21 were subsequently discharged home with a prescription for injectable prophylaxis. Of the total 219 patients discharged home 9 (4.1%) were not reachable for the follow-up call. The inpatient adherence data were availabel for all 234 enrolled patients whereas outpatient adherence data were availabel for 210 patients. The calculated OA data for 225 patients represents the adherence of all enrolled patient who completed their injectable prophylaxis in the rehabilitation unit or discharged home and reachable for the follow-up call. Median duration of VTE prophylaxis at the follow-up phase was 10 days ranging from 1 to 45 days with 75% of the patients having duration of more than 1 week. The mean (±sd) age was 65.5 years (11.1) ranging from 23 to 91, 39.3% were males, 35.9% underwent total hip replacement. The median and interquartile range (IQ) for overall adherence was 96.6% (92.9-100.0), for inpatient adherence was 100.0% (100.0-100.0) and for outpatient adherence was 94.9% (88.9-100.0). The range of OA was from 16.7% to 180.0%. OA adherence below 80% in 6 (2.7%) patients was associated with cost of drugs (1), forgot (2), reason not specified (3). OA above 120% in 3 (1.3%) patients was associated with injecting extra syringes dispensed. Conclusion: The Complete Registry is the first Canadian registry that provides key real life data on adherence with injectable VTE prophylaxis and the factors impacting the adherence. Median inpatient and outpatient adherence was over 90% with few instances of under and over adherence. Disclosures: Semchuk: Pfizer Canada: Honoraria; Boehringer Ingelheim: Honoraria; Sanofi Aventis: Consultancy, Honoraria, Research Funding. Backstein:SanofiAventis: Honoraria. Stewart:Sanofi-Aventis Canada: Employment. Eikelboom:sanofi-aventis: Consultancy, Honoraria, Research Funding; Portola: Consultancy, Honoraria; GSK: Consultancy, Honoraria, Research Funding; BI: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Daiichi Sankyo: Consultancy, Honoraria.

2022 ◽  
Vol 12 ◽  
Author(s):  
Yi-hu Yi ◽  
Song Gong ◽  
Tian-lun Gong ◽  
Ling-yun Zhou ◽  
Can Hu ◽  
...  

Background: There is controversy over whether use of new oral anticoagulants (NOACs) associates with increased hemorrhage risk compared with non-NOAC. Meanwhile, determining which NOAC to use remains unclear. We aimed to summarize the evidence about NOACs in venous thromboembolism (VTE) prevention for patients with total hip and knee arthroplasty (THA and TKA).Methods: We searched RCTs assessing NOACs for VTE prophylaxis in adults undergoing THA and TKA in Medline, Embase, and Cochrane up to May 2021. Primary outcomes were VTE [included deep vein thrombosis (DVT) and pulmonary embolism (PE)], major VTE, and major bleeding. The rank probabilities of each treatment were summarized by the surface under the cumulative ranking curve area (SUCRA).Results: 25 RCTs with 42,994 patients were included. Compared with non-NOAC, NOACs were associated with a decreased risk of VTE (RR 0.68; 95% CI 0.55–0.84) and major VTE (RR = 0.52; 95% CI 0.35–0.76). Additionally, rivaroxaban, apixaban, and edoxaban but not dabigatran and betrixaban, did confer a higher efficacy compared with non-NOAC. None of the individual NOACs increased the risk of bleeding, while apixaban and betrixaban were even associated with a decreased risk of bleeding. In the comparison of different NOACs, rivaroxaban was associated with the greatest benefits in VTE (SUCRA = 79.6), DVT (SUCRA = 88.8), and major VTE (SUCRA = 89.9) prevention. Furthermore, subgroup analysis confirmed that NOACs associated with a higher efficacy tendency in patients with follow-up duration <60 days than follow-up duration ≥60 days.Conclusion: Evidence suggests that NOACs exert more benefits on VTE prophylaxis, and none of the individual NOACs increased hemorrhage compared with non-NOAC. Among various NOACs, rivaroxaban is recommended in patients with lower bleeding risk, and apixaban is recommended in patients with higher bleeding risk.Systematic Review Registration: [https://www.crd.york.ac.uk/prospero/], identifier [CRD42021266890].


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 7-7
Author(s):  
Anna L. Parks ◽  
Swetha Kambhampati ◽  
Bita Fakhri ◽  
Charalambos Andreadis ◽  
Lissa Gray ◽  
...  

Introduction: Chimeric antigen receptor modified T Cell (CAR-T) therapy is a rapidly developing treatment for patients with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). Although this population is at high risk for thrombosis, there are few data about rates of venous thromboembolism (VTE) and arterial thromboembolism (ATE) with CAR-T. Additionally, treatment with anticoagulation is complicated because of the prevalence of thrombocytopenia following CAR-T. Our goal was to determine the incidence, associated risk factors, management and outcomes of VTE and ATE in the 60 days following CAR-T therapy. Methods: We performed a single-center, retrospective cohort study of all patients who received inpatient CAR-T cells at UCSF Medical Center between January 2018 and May 2020 for R/R NHL or MM as standard-of-care or on a clinical trial. The outcomes of incident VTE and ATE were identified by ICD-10 codes and medical record review. Patient characteristics, pre-existing thrombosis risk factors, laboratory results, medications, and major or clinically relevant non-major bleeding or recurrent thrombotic complications were obtained through chart review. We used descriptive statistics to delineate risk factors, incidence, management and outcomes of thrombotic events. Results: Ninety-one patients who underwent CAR-T therapy were included in the analysis, 37 with NHL and 54 with MM. For NHL, mean age was 63 (range 38-82), and 41% were women. For MM, mean age was 62 (range 33-77), and 50% were women. Patients with NHL were treated with either investigational or Federal Drug Administration-approved CD19-directed therapies, and patients with MM were treated with a variety of investigational B-cell maturation antigen-directed (BCMA) therapies. For thrombotic risk factors, 13% of patients with NHL had a history of VTE, 3% had a history of ATE, 27% had a BMI ≥30, 59% had a recent procedure including central venous catheter (CVC) placement, 14% had an intensive care unit (ICU) stay, and 22% had an infectious complication in the 30 days pre- or post-CAR-T. Forty-one percent of patients with NHL had neurotoxicity of any grade, and 59% had CRS of any grade. At 30 days, 57% had a complete response, 41% had a partial response, 3% had stable disease. For MM, 6% of patients had a pre-existing history of VTE, 2% had a history of ATE, 19% had a BMI ≥30, 96% had a recent procedure, 11% had an ICU stay and 19% had an infection. Seventeen percent had neurotoxicity, and 85% had CRS. Thirty-two percent of patients with NHL and 48% with MM received pharmacologic VTE prophylaxis while undergoing CAR-T. For those who did not receive VTE prophylaxis, thrombocytopenia was the reason for holding prophylaxis, which occurred in 51% and 50% of NHL and MM patients, respectively. In the 60 days post-CAR-T, 4 (11%) patients with NHL were diagnosed with VTE-3 pulmonary embolism (PE) and 1 lower extremity deep vein thrombosis (DVT) associated with a previously placed inferior vena cava filter. Four (7%) patients with MM were diagnosed with VTE-1 PE and 3 upper extremity DVTs associated with CVCs. Five out of these 8 (63%) patients had symptomatic VTE, while the remainder were incidental on PETCT. Mean time from CAR-T infusion to VTE diagnosis was 20 days (range 6-39 days). There were no documented ATEs. Six out of 8 (75%) were treated with therapeutic anticoagulation. Of those who were anticoagulated, 4 patients received direct oral anticoagulants and 2 received low-molecular-weight-heparin. Duration was 3 months in 3 patients, 11 days in 1, 150 days in 1, and indefinitely in 1 with atrial fibrillation. Among all 8 patients with VTE, there were no bleeding events or recurrent thromboses regardless of whether or not they received anticoagulation. Discussion: In this cohort of patients with R/R NHL or MM who received either CD19- or BCMA-directed therapies, almost 1 in 10 developed VTE in the 60 days post-CAR-T. This occurred in the context of a high prevalence of risk factors for thrombosis and low rates of pharmacologic prophylaxis. Among those who developed VTE, the majority were treated with therapeutic anticoagulation for at least 3 months, without documented bleeding or recurrent VTE. Our findings provide crucial information on a common complication that can inform patients, clinicians and researchers and should be expanded upon in larger, prospective studies to identify optimal preventive and therapeutic strategies. Disclosures Fakhri: University of California San Francisco: Current Employment. Andreadis:Jazz Pharmaceuticals: Honoraria; Karyopharm: Honoraria; Incyte: Consultancy; Merck: Research Funding; Gilead/Kite: Consultancy; Novartis: Research Funding; BMS/Celgene/Juno: Honoraria, Research Funding; Genentech: Consultancy, Current equity holder in publicly-traded company. Wong:Janssen: Research Funding; Amgen: Consultancy; Roche: Research Funding; Fortis: Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Research Funding; GSK: Research Funding. Shah:BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar: Research Funding; GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm: Consultancy.


Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1762-1762 ◽  
Author(s):  
Victor F. Tapson ◽  
Herve Decousus ◽  
Jean-Fran[ccedi]ois Bergmann ◽  
Beng H. Chong ◽  
James B. Froehlich ◽  
...  

Abstract Background Despite consensus group recommendations indicating that medical patients should receive appropriate venous thromboembolism (VTE) prophylaxis, prophylaxis practices remain poorly characterized. This analysis of IMPROVE, a prospective study of acutely ill medical patients, describes in-hospital prophylaxis practices prior to the publication of updated VTE prevention guidelines by the American College of Chest Physicians. Methods Patient recruitment began in July 2002. Patients ≥18 years old, and hospitalized for ≥3 days with an acute medical illness are enrolled consecutively. Exclusion criteria are: therapeutic antithrombotics/thrombolytics at admission; major surgery or trauma during 3 months prior to admission; and VTE treatment begun within 24 hours of admission. Results Data were from 4315 patients (32% from USA) enrolled up to 30 June 2004 in 37 hospitals in 11 countries (76% with 3-month follow-up data). Patients are 50% female, median (IQR) age 69 (50–80) years, median length of hospital stay 8 (5–14) days, median weight 68 (58–80) kg, and 40% were immobile for ≥3 days (median length of immobility 7 [4–14] days, including immobility immediately prior to admission). In-hospital VTE prophylaxis was received by 41% of patients (Table 1). Of patients with no risk factors (44%), one risk factor (40%), or ≥2 risk factors (16%), 25%, 49%, and 67% received prophylaxis, respectively. 12% of IMPROVE patients would have been eligible for inclusion in the MEDENOX study. Of these, only 52% received prophylaxis in hospital. Prophylaxis was provided to 6% of patients during the 3-month follow-up period, and continued in 11% of patients after discharge. Conclusions Only 41% of IMPROVE patients received VTE prophylaxis, with considerable variation in types and regimens of prophylaxis used. While MEDENOX showed the benefits of VTE prophylaxis (enoxaparin 40 mg) in acutely ill medical patients, only half of MEDENOX-eligible patients received prophylaxis. Table 1. Use of in-hospital VTE prophylaxis (N=4315) VTE prophylaxis Patients receiving VTE prophylaxis, % ROW, rest of world; *Excluding elastic stockings and aspirin ≥1 type of VTE prophylaxis* 41 LMWH - USA (Q12h, Qd) 7 (5, 1) LMWH- ROW (Q12h, Qd) 31 (29, 2) UFH - USA (Q12h, Q8h) 28 (15, 11) UFH - ROW (Q12h, Q8h) 6 (5, 0) Intermittent pneumatic compression (USA, ROW) 6 (19, 0) Aspirin (USA, ROW) 4 (7, 3) Elastic stockings (USA, ROW) 6 (3, 8)


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 18-18
Author(s):  
Doaa Attia ◽  
Xuefei Jia ◽  
Mailey L Wilks ◽  
Barbara Tripp ◽  
Christopher D'Andrea ◽  
...  

Background: The treatment paradigm for cancer associated thrombosis (CAT) has evolved over recent years from using low molecular weight heparin (LMWH) to direct oral anticoagulants (DOACs). Some randomized trials suggest decreased rates of recurrent venous thromboembolism (VTE) in CAT patients treated with DOACs compared to LMWH but also reported increased rates of bleeding. The Cleveland Clinic Taussig Cancer Center has been treating cancer thrombosis in a centralized CAT clinic since 2014. Here we report our rates of bleeding and recurrent VTE in cancer patients treated with anticoagulation. Methods: We prospectively followed cancer patients referred to our clinic from 8/2014-10/2019. A total of 1548 patients were referred to the clinic, of whom 462 were diagnosed with an acute VTE. VTE events, including deep venous thrombosis, pulmonary embolism, and visceral thrombosis, were noted. The comparison of bleeding rates (defined using ISTH criteria for major and clinically relevant non major bleeding, CRNMB) among treatment groups (LMWH vs DOACs) was examined using chi-square test. Rate of recurrent VTE was analyzed using a competing model in which death was treated as a competing risk. Results: The study population comprised 462 patients with acute VTE with a mean age of 62.67±12.23 and 51.8 % males. Of these, 234 (52.9%) received LMWH, 161(36.4%) received DOACs, and 47 (10.6%) received other agents including warfarin for initial anticoagulation. Overall, the 6-month, 1 year, and 2-year VTE recurrence rate was 5.9%, 6.6%, 7.9%, respectively. Recurrent VTE rates were similar for LMWHs, DOACs and other agents (P>0.05). Of 368 patients for whom follow-up data was available, 74 (16.7%) had bleeding event , of which 25 (33.8%) had major bleeding and 49 (66.4%) had CRNMB at 6 month follow-up with no difference across three treatment groups (p=0.56). Conclusion: In this real-world practice setting, rates of recurrent VTE and bleeding were similar for DOACs and LMWH suggesting that with careful patient selection the concern for higher bleeding with DOACs in cancer patients can be safely overcome. Disclosures McCrae: Momenta Pharmaceuticals: Consultancy; Novartis: Honoraria; Rigel: Consultancy; Dova: Consultancy. Khorana:Merck: Research Funding; Medscape: Honoraria; Leo Pharma: Honoraria; Seattle Genetics: Honoraria; Pharmacyte: Honoraria; Pharmacyclics: Honoraria; Array: Other: Research funding (to institution); Janssen: Honoraria; Bayer: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria; BMS: Honoraria, Research Funding; Leap: Research Funding.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kai Tong ◽  
Hankun Liu ◽  
Jun Qin ◽  
Zhengqi Pan ◽  
Yangfan Shangguan ◽  
...  

Abstract Background Venous thromboembolism (VTE) is a potentially fatal complication after arthroplasty. Numerous prophylactic strategies and studies to reduce VTEs have focused on the duration of the hospital stay and on few extramural hospitals. This study aimed to investigate extramural hospital management of VTE after total hip/knee arthroplasty (THA/TKA) in China with a novel survey tool. Methods A total of 180 patients undergoing arthroplasty, including 68 THA patients and 112 TKA patients, were enrolled in this study. All patients received anticoagulant treatment management. A survey querying VTE management and adherence, such as therapy information, understanding of anticoagulation, satisfaction with the ability of medical staff, and satisfaction with health care costs, was administered by a questionnaire (TKA/THA Patients’ Experience with Anticoagulation in the Post-discharge Period) for quality improvement. Results The average age of the patients was 65.27 ± 13.62 years. All patients knew their follow-up times. 85 % of them were suggested that re-examine at the next 14 days, and the others at the next 28 days. All patients continued to visit the orthopaedic clinic after discharge without choosing other types of outpatient services, such as an anticoagulant clinic or home visit with a nurse/pharmacist or remote evaluation by telephone. A total of 96.6 % of all patients used new oral anticoagulants, and the most common treatment duration was 2–4 weeks (93.3 %). 48 % informed their physicians that they were taking anticoagulation medications when they visited ophthalmology, dentistry, dermatology, and other departments. The overall rate of satisfaction with anticoagulation management was 81.67 %, and 6.67 % of patients were not unsatisfied with their medical expenses. Patient compliance decreased with increasing follow-up time. Continuous follow-ups after discharge significantly improved patient compliance. Conclusions These results elucidate how we can improve the quality of anticoagulation. Continuous follow-up appointments for 30 days after discharge, especially for individuals over 65 years old, significantly improved patient satisfaction and reduced the incidence of VTE and medical costs.


Author(s):  
Alex Tang ◽  
Stephen G. Zak ◽  
Daniel Waren ◽  
Richard Iorio ◽  
James D. Slover ◽  
...  

AbstractVenous thromboembolism (VTE) events are rare, but serious complications of total joint replacement affect patients and health care systems due to the morbidity, mortality, and associated cost of its complications. There is currently no established universal standard of care for prophylaxis against VTE in patients undergoing revision total knee arthroplasty (rTKA). The aim of this study was to determine whether a protocol of 81-mg aspirin (ASA) bis in die (BID) is safe and/or sufficient in preventing VTE in patients undergoing rTKAs versus 325-mg ASA BID. In 2017, our institution adopted a new protocol for VTE prophylaxis for arthroplasty patients. Patients initially received 325-mg ASA BID for 1 month and then changed to a lower dose of 81-mg BID. A retrospective review from 2011 to 2019 was conducted identifying 1,438 consecutive rTKA patients and 90-day postoperative outcomes including VTE, gastrointestinal, and wound bleeding complications, acute periprosthetic joint infection, and mortality. In the 74 months prior to protocol implementation, 1,003 rTKAs were performed and nine VTE cases were diagnosed (0.90%). After 26 months of the protocol change, 435 rTKAs were performed with one VTE case identified (0.23%). There was no significant difference in rates or odds in postoperative pulmonary embolism (PE; p = 0.27), DVT (p = 0.35), and total VTE rates (p = 0.16) among patients using either protocol. There were also no differences in bleeding complications (p = 0.15) or infection rate (p = 0.36). No mortalities were observed. In the conclusion, 81-mg ASA BID is noninferior to 325-mg ASA BID in maintaining low rates of VTE and may be safe for use in patients undergoing rTKA.


Medicina ◽  
2020 ◽  
Vol 56 (9) ◽  
pp. 416 ◽  
Author(s):  
Daniel C. Santana ◽  
Ahmed K. Emara ◽  
Melissa N. Orr ◽  
Alison K. Klika ◽  
Carlos A. Higuera ◽  
...  

Patients undergoing total hip and knee arthroplasty are at high risk for venous thromboembolism (VTE) with an incidence of approximately 0.6–1.5%. Given the high volume of these operations, with approximately one million performed annually in the U.S., the rate of VTE represents a large absolute number of patients. The rate of VTE after total hip arthroplasty has been stable over the past decade, although there has been a slight reduction in the rate of deep venous thrombosis (DVT), but not pulmonary embolism (PE), after total knee arthroplasty. Over this time, there has been significant research into the optimal choice of pharmacologic VTE prophylaxis for individual patients, with the objective to reduce the rate of VTE while minimizing adverse side effects such as bleeding. Recently, aspirin has emerged as a promising prophylactic agent for patients undergoing arthroplasty due to its similar efficacy and good safety profile compared to other pharmacologic agents. However, there is no evidence to date that clearly demonstrates the superiority of any given prophylactic agent. Therefore, this review discusses (1) the current prevalence and trends in VTE after total hip and knee arthroplasty and (2) provides an update on pharmacologic VTE prophylaxis in regard to aspirin usage.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 565-565
Author(s):  
Susan R Kahn ◽  
Sam Schulman ◽  
Josée Martineau ◽  
John A Stewart ◽  
Anne McLeod ◽  
...  

Abstract Abstract 565 Introduction: Little is known about patterns and quality of venous thromboembolism (VTE) management in Canadian outpatient settings, including how closely clinicians adhere to evidence based treatment guidelines. Such information could help identify gaps in patient care requiring attention. Objectives: To obtain prospective, clinical practice-based data from Canadian outpatient settings on 1) management of VTE; 2) determinants of patterns of VTE management; 3) degree of adherence with ACCP 2008 VTE treatment guidelines; and 4) frequency of bleeding and recurrent VTE during follow-up. Methods: We performed a multi-centre prospective observational study to evaluate physician practice patterns and degree of adherence to ACCP consensus guidelines for VTE treatment. From 2007–2010, we enrolled 915 consecutive patients with objectively confirmed acute symptomatic VTE who received treatment with the low molecular weight heparin (LMWH) enoxaparin alone or with warfarin in the outpatient setting (mainly thrombosis clinics) in 12 Canadian centers. Patients attended an enrolment visit, where data on demographics, site(s) of VTE, VTE risk factors, bleeding risk factors, creatinine clearance and initial treatment were recorded. A follow-up visit occurred when anticoagulant treatment was stopped or at 6 months, whichever occurred first. Indicators of adherence to VTE treatment guidelines included: (1) having received any thromboprophylaxis for VTE associated with transient risk factors (recent medical admission, major surgery or leg immobilization); (2) use of LMWH monotherapy to treat cancer-associated VTE; (3) at least 5 days median duration of LMWH in patients treated with initial LMWH overlapped with warfarin; (4) at least 1 day overlap of LMWH and warfarin once INR was therapeutic. Recurrent VTE, bleeding and adverse events were recorded throughout study follow-up. Results: At the time of abstract submission, end of study data were available for 747 of 915 enrolled patients. Average age was 56 years, 54% were male and mean body mass index was 28.3 kg/m2. Index VTE was lower or upper extremity deep venous thrombosis (DVT) in 511 (68.4%) patients, pulmonary embolism (PE) with or without DVT in 218 (29.2%) patients, and unusual site DVT in 18 (2.4%) patients. VTE was associated with cancer in 70 (9.4%) patients, transient risk factors in 289 (38.7%) patients, hormonal risk factors in 55 (7.4%) patients and was deemed unprovoked in 331 (44.3%) patients. Overall, enoxaparin was prescribed at a dose/frequency of 1.5 mg/kg QD in 85.4% of patients, 1.0 mg/kg BID in 14.6% of patients and 1.0 mg/kg QD for one patient who had creatinine clearance <30ml/min. Among patients with VTE risk factors such as recent medical admission, recent surgery or paralysis, only 37.3% had been prescribed thromboprophylaxis. Among patients with cancer-related VTE (n=70), 61.4% were prescribed LMWH monotherapy, a majority received 1.5 mg/kg once daily, and 42.9% received such treatment for >3 months. Among patients treated with initial LMWH overlapped with warfarin (n= 667; 89.3%), median duration of LMWH was 8 days (IQR 6–10 days), median duration of warfarin was 182 days (IQR 115–190) and median overlap with LMWH once INR was therapeutic was 1 day (IQR 1–2 days). However, 48 (7.2%) patients received <5 days LMWH and 99 (15%) patients had overlap <1 day. During follow-up, 16 (2.1%) patients had recurrent VTE, at a median of 71 days follow-up; rate of recurrent VTE was highest (8.6%) and occurred earliest (median, 49 days) in cancer patients. Major bleeding events (primarily GI or GU) occurred in 10 (1.3%) patients at a median of 23 days; at the time of bleed, 2 patients were receiving LMWH alone, 3 patients, LMWH and warfarin, and 5 patients, warfarin alone. Conclusions: Our study provides useful information on clinical features of patients, management of VTE and rates of recurrence and bleeding in Canadian outpatients. Our results suggest that there are important gaps in (1) use of thromboprophylaxis to prevent VTE and (2) use of LMWH monotherapy to treat VTE in cancer patients. Conversely, in patients treated with combination LMWH/warfarin therapy, adherence to recommendations regarding minimum duration of LMWH and minimum overlap of LMWH and warfarin once INR was therapeutic was quite good. Disclosures: Kahn: Sigvaris: Research Funding; sanofi-aventis: Advisory Board, Research Funding; Boehringer Ingelheim:. Schulman:Sanofi Aventis: Honoraria.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 201-201 ◽  
Author(s):  
Martha Q Lacy ◽  
Shaji K. Kumar ◽  
Betsy R. LaPlant ◽  
Kristina Laumann ◽  
Morie A Gertz ◽  
...  

Abstract Abstract 201 Background: Pomalidomide at doses of 2 or 4 mg/d has demonstrated excellent activity in patients with relapsed multiple myeloma (MM). Between November 2007 and March 2012, we opened 6 sequential phase 2 trials and treated 345 patients with relapsed MM with pomalidomide at differing doses with weekly dexamethasone (Pom/dex). Results of 164 of these patients have been previously published. Here we describe long term follow up of these patients as well as results of an additional 181 patients with relapsed MM treated with the Pom/dex regimen. Methods: The six cohorts consisted of: Cohort 1 (N=60): relapsed MM with 1–3 prior regimens, 2 mg dose; Cohort 2 (N=34): lenalidomide (LEN) refractory, 2 mg dose; Cohort 3 (N=35): BZ)/LEN refractory, 2 mg dose; Cohort 4 (N=35): BZ/LEN refractory, 4 mg dose; Cohort 5 (N=60) LEN refractory, 1–3 prior regimens, 4 mg dose; and Cohort 6 (N=120) LEN refractory, 4 mg dose. Pomalidomide was given orally 2 mg daily or 4mg daily on days 1–28(cohorts 1–5) or 1–21 (cohort 6) of a 28-day cycle with oral dexamethasone given 40 mg daily on days 1, 8, 15 and 22. Response was assessed by the International Myeloma Working Group Uniform Response criteria. All patients received aspirin 325 mg daily for deep venous thrombosis (VTE) prophylaxis or full dose anticoagulation. Results: A total of 345 patients were enrolled across all 6 cohorts. One patient was ineligible and excluded from analysis. The median age was 64 years (32–88). The median time since diagnosis was 53 months. The median number of prior therapies was 3 (1–14). 147 (44%) had high-risk molecular markers by mSMART criteria. Prior therapies consisted of thalidomide 52%, lenalidomide 87%, bortezomib 75%, autologous stem cell transplant 70% and allogeneic transplant 3%. The median follow-up is 10.4 months (5.4–34 months). Sixty-seven percent are alive and 32% remain progression free. 46 patients are continuing to receive treatment. The most common toxicities (grade 3 or higher) were neutropenia (31%), anemia (16%), thrombocytopenia (12%), pneumonia (8%) and fatigue (8%). VTE was seen in 10 patients (3%). Outcomes are shown in Table 1. Across all 6 cohorts confirmed responses of partial response (PR) or better were seen in 34%. The response rate in all patients with mSMART high risk status was 30.6%. Responses and duration of response (DOR) in those with high risk molecular markers include: 17p– 19 of 56 (34%) DOR 8.2 months; t(4;14) 6 of 24 (25%) and DOR 4.8 months; t(14;16) 7 of 11(64%) and DOR 9.5 months; deletion 13 by cytogenetics 13 of 37 (35%) with DOR 8.2 months. In a multivariate analysis, only LDH > ULN, number of prior regimens, and prior BZ therapy were predictive of a shorter TTP and factors associated with a poor OS following initiation of pomalidomide therapy included B2M > 5.5, LDH > ULN,number of prior regimens, and prior BZ therapy. Conclusions: Pom/dex is active and well tolerated even in heavily pretreated patients and those with high risk molecular markers. Remissions are durable. Response rates and toxicity are similar between the 2 mg and 4 mg doses. Disclosures: Lacy: Celgene: Research Funding. Stewart:Celgene: Consultancy, Honoraria. Reeder:Celgene: Mayo Clinic receives funding from Celgene to support clinical trials Other, Research Funding.


2018 ◽  
Vol 9 ◽  
pp. 215013271879744
Author(s):  
Francisco Roman ◽  
Jay-Sheree Allen ◽  
Heather Catherine Wurm ◽  
Kathy MacLaughlin

A 62-year-old Caucasian man with past medical history significant for coronary artery disease, status post drug eluting stent to the left anterior descending artery 10 years prior, was admitted for elective total right knee arthroplasty. His intraoperative course was uneventful, and he was discharged on hospital day 2 on aspirin 325 mg twice daily for 6 weeks for venous thromboembolism (VTE) prophylaxis. Three weeks later the patient developed chest pain shortly after an approximately 1-hour flight and presented to a local emergency department where computed tomography angiogram showed pulmonary emboli involving segmental and subsegmental pulmonary arteries bilaterally. He was transitioned from aspirin 325 mg twice a day to rivaroxaban 15 mg twice daily for 21 days, with a plan to transition to 20 mg daily to complete a 3-month course. He returned to his primary care physician 6 days after discharge with questions about his current anticoagulation therapy as well as the regimen he was on prior to the pulmonary embolism. Two major organizations, The American Academy of Orthopedic Surgeons and The American College of Chest Physicians, provide recommendations for VTE prophylaxis, but they differ regarding the preferred pharmacologic modality and duration. Although the goal is to provide optimal patient care, lack of guideline consensus may lead to different postoperative recommendations. It is important for clinicians to discuss with their patients the pharmacologic options available for VTE prophylaxis, how organizations differ in their recommendations, and the limitations of these pharmacologic agents.


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