Real-World Analysis of Venous Thromboembolism Rates and Thromboprophylaxis Prescribing In US Patients with Cancer.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3802-3802
Author(s):  
Alpesh N Amin ◽  
Jay Lin ◽  
Stephen Thompson ◽  
Daniel Wiederkehr

Abstract Abstract 3802 Background: Deep-vein thrombosis (DVT) is a frequent complication of cancer and treatment of cancer. Among clinical guidelines, there is broad consensus regarding the importance of thromboprophylaxis in hospitalized cancer patients, including prolonged prophylaxis in high-risk patients. The objective of this analysis was to assess the real-world use of prophylaxis for DVT, as well as symptomatic rates of DVT and pulmonary embolism (PE) in cancer patients, both during hospitalization and after hospital discharge. Methods: Data were extracted from the US Premier Perspective(tm)-i3 Pharma Informatics linked database for non-surgical cancer patients who were admitted to hospital from January 2005 to November 2007. Included patients were aged ≥ 18 years and had ≥ 6 months' continuous plan enrollment. Patients were excluded if they were discharged to an acute-care facility, had length of hospital stay ≤ 0 or > 30 days, had missing/unknown gender or age data, or if they were diagnosed with atrial fibrillation during index hospitalization. Clinical rates of DVT/PE, as well as thromboprophylaxis status and duration were evaluated for during hospitalization and post-discharge. Results: Of the 3,759 cancer patients analyzed, 51.9% received inpatient pharmacological and/or mechanical prophylaxis, and 2.8% received outpatient pharmacological prophylaxis in the 14 days following discharge. During index hospitalization 40.0% of patients received mechanical prophylaxis and 21.1% pharmacological prophylaxis, with 9.3% of patients receiving a combination of mechanical and pharmacological prophylaxis. Mean (± standard deviation) duration of prophylaxis was 1.3 (± 2.3) days for inpatients and 0.7 (± 4.5) days post-discharge among all cancer patients. Symptomatic DVT/PE occurred in 2.4% of patients during hospitalization. In the 30 days following hospital discharge, 1.7% of patients was either rehospitalized for DVT/PE or treated for DVT/PE in the outpatient setting. Conclusions: This real-world analysis demonstrates considerable symptomatic rates of DVT/PE in hospitalized cancer patients, with approximately half of patients not receiving any thromboprophylaxis. The risk of DVT/PE persisted into the outpatient setting, but few patients received anticoagulants post-discharge. Further efforts are needed to ensure that patients with cancer receive appropriate thromboprophylaxis and that it is of adequate duration to reduce the large burden of DVT/PE. Acknowledgment: This study was funded by sanofi-aventis U.S., Inc. The authors received editorial/writing support in the preparation of this abstract provided by Tessa Hartog, PhD of Excerpta Medica, funded by sanofi-aventis U.S., Inc. Disclosures: Amin: sanofi-aventis US Inc.: Honoraria, Speakers Bureau. Lin:sanofi-aventis US Inc.: Employment, Research Funding. Thompson:sanofi-aventis US Inc.: Employment. Wiederkehr:sanofi-aventis US Inc.: Research Funding.

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 479-479
Author(s):  
Alpesh N Amin ◽  
Nicole Princic ◽  
Jay Lin ◽  
Stephen Thompson ◽  
Stephen Johnston

Abstract Abstract 479 Background: Patients hospitalized for major surgery are at significant risk of developing venous thromboembolism (VTE). In the US, the length of acute hospitalization for surgery has been decreasing. Given the decreased length of hospital stays, the time during which surgical patients are at risk for VTE is not well-understood in real-world clinical practice. Such information could provide insights into whether current recommendations regarding VTE prophylaxis reflect the real world needs. This retrospective, observational study assessed the incidence and time course of VTE events following admission to the hospital for major surgery in a large, real-world patient population. Methods: This study employs administrative claims data derived from the Thomson Reuters MarketScan®Inpatient Drug Link File, which comprises longitudinal patient-level inpatient and outpatient medical and pharmaceutical claims data for individuals with employer-sponsored primary or Medicare supplemental health insurance. Patients at risk for VTE due to a hospital admission between January 1, 2005, and December 31, 2008, for either abdominal or orthopedic surgery were included in this study (obtained through charge codes for types of surgical procedures that reflect the American College of Chest Physicians guideline risk groups for VTE). Patients were included if they had been continuously enrolled for at least 12 months prior to admission and at least 180 days after admission. Additionally, patients included in the analysis were required to have received some form of pharmacological prophylaxis during their hospitalization. Appropriateness of prophylaxis was not determined. The cumulative risk and hazard of VTE were established across an evaluation period of 180 days. The distribution of cumulative risk was described by the Kaplan Meier product limit method of survival analysis. The distribution of the hazard of VTE was described by a locally weighted regression procedure. The hazard function is measured as the number of VTE events per 1,000 person-days by number of days after hospital admission date to the first occurrence of VTE. Results: The study cohort consisted of 6,445 surgical patients who received prophylaxis, of whom 3,726 (57.8%) were admitted for orthopedic surgery and 2,719 (42.2%) for abdominal surgery. Patients had a mean (standard deviation [SD]) age of 64.0 (13.6) years and 63.8% were female. The mean (SD) length of stay in hospital was 5.4 (6.1) days, during which all patients received prophylaxis for VTE (criteria for inclusion) with a mean (SD) duration of 4.7 (4.3) days. 30% of patients received anticoagulation therapy within the period extending from discharge to 35 days after discharge. A total of 243 VTE events (171 DVT and 96 PE) occurred during the 180-day evaluation period. 104 (43%) VTE events occurred during the index hospitalization, and 139 (57%) VTE events occurred post-discharge. The time course of VTE events showed that the highest number of events occurred during the first 9 days (66 events, 80% in-hospital; proportion of 180-day cumulative risk ∼22%) and during days 10–19 (55 events, 58% in-hospital; proportion of 180-day cumulative risk ∼50%) following admission for the index hospitalization. VTE hazard peaked at approximately 1.4 per 1,000 person-days on the 9th day following admission for the index hospitalization. By the 21st day following index admission 50% of the cumulative 180-day risk had been incurred. The frequency of VTE then further decreased during days 20–29 (21 events, 38% in-hospital; proportion of 180-day cumulative risk ∼58%) and gradually declined thereafter, fluctuating at a background level of 1–7 events during each 10-day interval from 70–79 days up to 170–180 days. Conclusions: Over a 180-day period after admission to the hospital 243 (3.8%) out of 6,455 at-risk surgery patients receiving pharmacological prophylaxis experienced an incident VTE event. Of these VTE events, 43% occurred during the index hospitalization, while 57% occurred post-discharge. Of all VTE events that occurred within the 180-day period, a quarter occurred within 10 days and half within 3 weeks. Results from this study show that the risk of VTE was highest within the first 19 days after admission to the index hospitalization. During this high-risk period, 30% of VTE events occurred after discharge, suggesting that a non-trivial risk of VTE extends into the period after discharge. Disclosures: Amin: sanofi-aventis US Inc.: Acknowledgment: This study was funded by sanofi-aventis U.S., Inc. The authors received editorial/writing support provided by Tessa Hartog, PhD of Excerpta Medica, in the preparation of this poster funded by sanofi-aventis U.S., Inc., Honoraria, Speakers Bureau. Princic:sanofi-aventis US Inc.: Research Funding. Lin:sanofi-aventis US Inc.: Employment, Research Funding. Thompson:sanofi-aventis US Inc.: Employment. Johnston:sanofi-aventis US Inc.: Research Funding.


Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3020-3020
Author(s):  
Lauren Elreda ◽  
Reena K Vora ◽  
Alice J. Cohen

Abstract Background: Venous thromboembolism (VTE) remains a major cause of morbidity and mortality in hospitalized patients with cancer. In 2007, both ASCO and the NCCN developed clinical practice guidelines to help prevent and treat thrombosis in patients with cancer. Adherence to these guidelines has led to successful reduction of VTE in hospitalized patients. Because noncompliance with anticoagulant prophylaxis was an ongoing problem at our institution, a standardized order set for thromboprophylaxis (TP) utilizing anticoagulant therapy was developed and implemented for patients with cancer diagnoses. Methods: All patients admitted to the inpatient oncology unit with a cancer diagnosis were screened for VTE prophylaxis utilizing a standardized order set. Cancer diagnosis and other risk factors for VTE were recorded on the TP order set along with choice of anticoagulant TP. Treatment options included Lovenox 40 mg once subcutaneous (sc)daily for patients with normal renal function, lovenox 30 mg sc daily for creatinine clearance <30cc/min, heparin(h) 5000 units sc every 8 hours. Pneumatic compression devices were utilized in patients who had contraindications to anticoagulation. Exclusion criteria included patients already on therapeutic anticoagulation, active bleeding, and platelet count (plt) <50,000. TP was instituted upon admission and continued until discharge. Patients were clinically monitored for VTE for 4 weeks post discharge and if symptomatic, venous Dopplers, VQ and/or Spiral CT scans were performed. Retrospective review of all VTE events in hospitalized cancer patients occurring in the previous quarter prior to initiation of the standardized order set was performed and number of VTE events and length of stay (LOS) were compared to the treatment group. Results: 100 cancer patients were admitted to the inpatient oncology unit from 4/08–7/08 with use of the standardized TP order set for all patients. 89 patients received TP as follows: 79 received lovenox 40 mg sc daily, 2 lovenox 30mg sc daily, 5 h 5000 units sc q 8 hours, and 3 flowtron boots. 11 patients did not receive TP for the following reasons: 6 were on therapeutic anticoagulation for previous VTE, 4 had a plt < 50,000, 1 had brain metastases with surrounding edema. Of those who did receive TP, no VTE occurred during hospitalization and for 1 month post discharge. No bleeding complications were seen. As compared to those patients treated with the TP order set, 20/207 (9.6%) non-surgical hospitalized patients with cancer developed VTE during their hospitalization in the previous quarter (p<0.01). Of these patients, 11 did not receive TP, and 9 patients received TP: 5 with flowtron boots, 2 short term TP lovenox which was discontinued prematurely, 2 h 5000 units sc 8 hours. The average LOS of patients managed utilizing the TP order set was 7.1 days compared to 19.0 days (p<0.0001) in hospitalized cancer patients with VTE events prior to use of the TP order set. Conclusion: Hospitalized cancer patients are at significant risk for the development of VTE. The implementation of a standard order set ensures compliance with TP and significantly reduces VTE events. LOS is significantly reduced in hospitalized cancer patients by preventing VTE.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1178-1178 ◽  
Author(s):  
Michael Streiff ◽  
Dejan Milentijevic ◽  
Keith McCrae ◽  
Daniel Yannicelli ◽  
Jonathan Fortier ◽  
...  

Abstract Introduction: Anticoagulation is effective for the treatment of venous thromboembolism (VTE) in cancer patients, but it is also associated with an increased risk of bleeding. Previous clinical trials (e.g., CLOT and CATCH) of LMWH and warfarin for the treatment of VTE in cancer patients reported major bleeding in 3% to 6% of treated patients. The objective of this observational study was to compare the risk of major bleeding in cancer patients treated with anticoagulants for VTE in a real world setting. Methods: Medical and pharmacy claims from the Humana Database from 1/1/2013 to 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis, and with ≥1 dispensing of an anticoagulant within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban (other agents not included due to low utilization). Inverse probability of treatment weights based on propensity score were used to adjust for differences between treatment cohorts for the following comparisons: LMWH vs. rivaroxaban, LMWH vs. warfarin, and rivaroxaban vs. warfarin. Patients were followed up until the earliest event, either treatment non-persistence (gap > 60 days between the end of the days of supply of a dispensing and the start date of the next dispensing), or end of data availability. Major bleeding events were identified using validated criteria (Cunningham et al., 2011). Kaplan-Meier rates at 3 and 6 months and Cox proportional hazards models were used to compare the risk of bleeding between different treatment cohorts. To better understand the risk of major bleeding in cancer patients unrelated to anticoagulation, a cohort of patients with cancer who did not have VTE and did not receive an anticoagulant was added as a control cohort. Results: A total of 2,428 patients (LMWH: n=660; warfarin: n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced among treatment cohorts. Median duration of therapy with LMWH was shorter than rivaroxaban (1.0 vs. 3.0 months, p<.0001) and warfarin (1.0 vs. 3.5 months, p<.0001). Rates of major bleeding for LMWH and rivaroxaban were 8.3% and 8.2%, respectively at 6 months with a hazard ratio (HRs [95% CI]) of 1.03 (0.64-1.65; Figure 1A). In the comparison between LMWH and warfarin cohorts, major bleeding rates were 8.5% and 8.6%, respectively at 6 months with hazard ratio (HRs [95% CI]) of 1.04 (0.69-1.57; Figure 1B). The risk of major bleeding was also similar for rivaroxaban and warfarin cohorts, 9.0% and 8.7%, respectively at 6 months with a hazard ratio (HR [95% CI]) of 1.01 (0.71-1.43; Figure 1C). For the control cohort of cancer patients without VTE and not receiving anticoagulation median follow-up was 5.6 months. Rates of major bleeding events for the control cohort were 2.6% and 4.2 % at 3 and 6 months, respectively. Conclusion: This real world study of cancer patients treated for VTE found that the risk of major bleeding was similar for the 3 most widely prescribed anticoagulants in current clinical practice: LMWH, warfarin, and rivaroxaban. The observed rates of major bleeding were generally higher than what has been reported for LMWH and warfarin in the CLOT and CATCH trials. Patient characteristics such as older age (average age 73 years) could have contributed to the higher major bleeding rate seen in this study compared to the CLOT and CATCH trials, respectively. Figure 1 Rates of Major Bleeding Events LMWH vs. rivaroxaban cohorts Figure 1. Rates of Major Bleeding Events. / LMWH vs. rivaroxaban cohorts Figure 2 LMWH vs. warfarin cohorts Figure 2. LMWH vs. warfarin cohorts Figure 3 rivaroxaban vs. warfarin cohorts Figure 3. rivaroxaban vs. warfarin cohorts Disclosures Streiff: Portola: Research Funding; Janssen: Consultancy, Research Funding; Roche: Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Yannicelli:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Nelson:Janssen Scientific Affairs: Employment, Equity Ownership. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Roche: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 24-25
Author(s):  
Mansi R Shah ◽  
Imraan Jan ◽  
Jeremy Johns ◽  
Kuldip Singh ◽  
Pallavi Kumar ◽  
...  

Introduction: Current evidence suggests that the COVID-19 related mortality and morbidity is higher in cancer patients due to increased visits to healthcare facilities (e.g., doctor's visits, phlebotomy, imaging, social work, financial consultations, therapy administration, etc) and inherent or therapy-induced immunosuppression. Patients with hematologic malignancies harboring SARS-CoV-2 have the highest mortality compared with other cancer patients. Although COVID-19 is knowingly transmitted person to person via respiratory droplets, there is potential for infection from contact with surfaces (e.g. plastic, metal, cardboard, etc) polluted with fomites that have been shown to have viable virus up to 72 hours in laboratory settings (Van Doremalen et al. NEJM 2020). The risk of nosocomial infections is hypothesized to be due to environmental contact and contamination, but there are no real-world analyses that exist that demonstrate the impact of recently established infection control policies (e.g., strict use of personal protective equipment (PPE), social distancing, hand hygiene, disinfectant protocols, etc) in hematology/oncology patient settings. This study evaluated the frequency of SARS-CoV-2 on a multitude of environmental surfaces in outpatient and inpatient settings in a large tertiary COVID-19 referral cancer center in New Jersey. Methods: IRB approval was obtained to conduct the study in a COVID-19 referral center in 2 large, freestanding outpatient clinics (i.e., malignant hematology and medical oncology) and co-localized infusion suites as well as two physically separated inpatient units (i.e., a leukemia/lymphoma/CART unit and an active COVID-19 floor, the latter housing cancer patients actively infected with SARS-CoV-2 and persons under investigation (PUI) for infection). Surface testing for viral RNA in the outpatient infusions suites included spaces where several patients with recent SARS-CoV-2 infection were receiving cancer treatment in the outpatient setting. High-impact areas were selected based on frequency of use, patient and healthcare provider contact, and risk of contamination from COVID-19 positive subjects (COVID-19+) and PUIs due to virus transmissibility. Surfaces were sampled on Mondays, Wednesdays and Fridays from 6/17/20 through 6/29/20 prior to scheduled cleaning and disinfection services, but after patient or staff use, following WHO protocols for COVID-19 surface sampling. Specimens were analyzed with real-time reverse transcriptase PCR analysis. Results: Overall, 204 total environmental samples were collected over the study period. Testing sites were categorized as 1) Public areas (waiting rooms, infusion areas, bathrooms, floors, elevator banks, doors, and exam rooms included designated isolation rooms for known COVID-19+/PUIs); 2) Staff areas (computer equipment, pneumatic tubing stations, pharmacy bench, and medication rooms); and 3) Medical equipment (IV poles, chemotherapy bags, vitals monitor, telemetry stations, and linen carts). Among the 130 surfaces examined from the two outpatient hematology-oncology clinics and 36 tests from the inpatient leukemia/lymphoma/CART cell unit, all 166 surfaces were negative for SARS-CoV-2 viral RNA (see Table). Among the inpatient COVID-19+ and PUI units, one of 38 samples were positive (2.6%). The one positive sample was taken from the floor of an elderly patient with multiple medical comorbidities being treated with remdesevir, dexamethasone, and apixaban for SARS-CoV-2 pneumonia. Altogether, the positive test rate for SARS-CoV-2 RNA across all surfaces in the combined outpatient and inpatient hematology/oncology units was 0.5% (1/204). Discussion : This systematic investigation of 'real world' environmental surfaces performed in outpatient and inpatient hematology-oncology units revealed overall negligible detection of active SARS-CoV-2 RNA. It highlights the efficacy of current, detailed infection control policies (e.g., screening, nursing-directed triage for PUIs/COVID-19+ patients, visitor restriction, telehealth, social distancing, and disinfection protocols) and should also mitigate concerns of healthcare providers and patients, particularly those in the healthcare setting with blood disorders. Additionally, the one positive sample from a COVID-19 unit emphasizes the need for physical separation of patients with SARS-CoV-2. Disclosures Evens: Research To Practice: Honoraria, Speakers Bureau; Merck: Consultancy, Honoraria, Research Funding; Pharmacyclics: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; MorphoSys: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria, Research Funding; Epizyme: Consultancy, Honoraria, Research Funding; Mylteni: Consultancy, Honoraria.


Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4202-4202
Author(s):  
Martha L Louzada ◽  
Alejandro Lazo-Langner ◽  
Marc Carrier ◽  
Vi Dao ◽  
Jerry Zhang ◽  
...  

Abstract Abstract 4202 Background: It is unknown whether patients with cancer who develop VTE after a surgical procedure have the same risk of recurrent VTE as clinical patients cancer-associated thrombosis. VTE recurrence risk in non-cancer patients with VTE after surgery is approximately 1% in the 3 months following completion of anticoagulation. It is unknown whether surgical patients with cancer follow the low risk of recurrence as other provoked VTEs or whether they have the high recurrence risk typical of cancer patients. Methods: We performed a post-hoc analysis of a single centre retrospective cohort study conducted at the Thrombosis Unit of the Ottawa Hospital. The charts of patients with cancer and VTE followed from 2002 to 2004 and from 2007 to 2008 were reviewed. We sought to compare the risk of recurrent VTE between patients with cancer who developed a first VTE after major surgery with all other patients with cancer-associated thrombosis. We included patients > or = 18 years of age with active malignancy and objectively diagnosed index VTE [pulmonary embolism (PE), proximal deep venous thrombosis (DVT) of the legs or arms, PE + DVT; unusual site thrombosis]. After the first VTE, all patients received a minimum of 6 months of anticoagulation. In the surgery group, index VTE was considered associated with the intervention if it occurred within the first 3 months after the procedure. Results: 543 patients were included. 121 patients had VTE after surgery and 17 (13.1%) developed a recurrence during therapeutic anticoagulation. Of 422 clinical patients, 61 (14.7%) had a recurrent VTE (Table). The relative risk of recurrent VTE comparing patients who had and who did not have surgery was non-significant (RR= 0.97 (95%CI: 0.587 – 1.574; p= 1.000) suggesting that patients with cancer who undergo surgery have similar risk of developing a recurrent VTE during anticoagulation as patients with cancer-associated VTE who do not undergo surgery. VTE recurrence occurred predominantly within the first 6 months of anticoagulation [Surgery: 9 of 17 patients (52.9 %); no surgery: 45 of 61 (73.7%) patients (p=0.1377)] (Figure). There was no significant difference in VTE recurrence risk according to anticoagulant strategy, tumor site, histology, TNM stage, age or gender between surgery and no surgery groups. Conclusion: Patients with cancer who develop VTE after surgery have similar risk of developing a recurrent VTE during the anticoagulation period as clinical patients with cancer-associated VTE. Disclosures: Rodger: Pfizer: Research Funding; Leo Pharma: Research Funding; Sanofi Aventis: Membership on an entity's Board of Directors or advisory committees, Research Funding; Canadian Institutes of Health Research: Research Funding; Heart and Stroke Foundation: Research Funding.


Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 4232-4232 ◽  
Author(s):  
Derek Weycker ◽  
Richard Barron ◽  
Alex Kartashov ◽  
Jason C. Legg ◽  
Gary H. Lyman

Abstract Abstract 4232 Background: Febrile neutropenia (FN) is a life-threatening side effect of myelosuppressive chemotherapy. The incidence and consequences of FN requiring inpatient care have been evaluated using healthcare claims or hospital administrative databases (Kuderer et al, Cancer 2006; Caggiano et al, Cancer 2005; Lyman et al, Eur J Cancer 1998). These sources did not include absolute neutrophil counts (ANC) and body temperature; thus the accuracy of case-ascertainment methods and findings is unknown. Moreover, none of these studies considered FN managed in the outpatient setting. Because some of these limitations may be overcome using electronic health records (EHR), a new study was undertaken. Methods: Data were obtained from Humedica's National EHR-Derived Longitudinal Patient-Level Database (2007–2010), which includes comprehensive point-of-care information from EHR and administrative data stores across the continuum of care for ∼5 million patients. The study population included adult patients who initiated 1 or more new courses of myelosuppressive chemotherapy for the treatment of a solid tumor or non-Hodgkin's lymphoma (NHL). For each patient, each chemotherapy course and each cycle within each course was identified. FN was identified on a cycle-specific basis based on ANC <1.0 × 109/L and evidence of infection or fever (ie, temperature ≥38.3°C, diagnosis, or antibiotic use); inpatient diagnosis of neutropenia, fever, or infection; outpatient diagnosis of neutropenia and antibiotic use; or mention of FN in physician notes. Episodes of FN were categorized as inpatient or outpatient based on initial locus of care. Consequences of FN included hospital length of stay and mortality (inpatient cases only) and number of FN-related outpatient management visits. Means, percentages, and corresponding 95% confidence intervals (CIs) are reported below. Results: The study population included 2131 patients who received 2323 courses and 8999 cycles of chemotherapy. About 50% of patients were aged ≥65 years, and more patients were female (59.7%). The most common cancers were breast (23.0%), lung (19.9%), genitourinary (17.5%), NHL (10.7%), and colorectal (10.4%). The most common chemotherapy regimens were docetaxel/cyclophosphamide (TC; 33.9% of breast cancer patients); paclitaxel/carboplatin (PC; 42.9% of lung cancer and 51.1% of genitourinary cancer patients); cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP; 42.0% of NHL patients); and fluorouracil/leucovorin/oxaliplatin (FOLFOX; 60.5% of colorectal cancer patients). Among the 2131 patients in the study population, 401 patients experienced a total of 458 FN events, which occurred most frequently (41.0%) in cycle 1. Among the 2323 chemotherapy courses identified, the FN risk was 16.8% (95% CI: 15.3, 18.4). FN risk was highest in cycle 1 (8.1%; 95% CI: 7.1, 9.3) and cycle 2 (4.9%; 95% CI: 3.9, 6.0). Among the 8999 cycles of chemotherapy, 83.2% of FN events were initially treated in the inpatient setting and 16.8% were initially treated in the outpatient setting. Of events initially treated in the outpatient setting, 3.9% required subsequent hospitalization. Among FN events initially treated in the inpatient setting, mean hospital length of stay was 8.4 (95% CI: 7.7, 9.1) days, and inpatient mortality was 8.1% (95% CI: 5.8, 11.1). Among FN events initially treated in the outpatient setting, the mean total number of FN-related outpatient management visits was 2.6 (95% CI: 2.1, 3.1); most encounters were in the physician's office (69.2%) or emergency department (26.9%). Conclusions: Nearly 1 in 5 patients receiving myelosuppressive chemotherapy experienced FN. Most FN events (83.8%) required hospitalization either for initial treatment or subsequent to outpatient treatment, and mean hospital length of stay was greater than 8 days. Outpatient care alone was used to successfully treat 16.2% of FN events. Outpatient FN events required 2.6 outpatient management visits, most of which were in the physician's office. Disclosures: Weycker: Amgen Inc: Research Funding. Barron:Amgen Inc.: Employment, Equity Ownership. Kartashov:Amgen Inc.: Research Funding. Legg:Amgen Inc. : Employment, Equity Ownership. Lyman:Amgen Inc: Research Funding.


Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 627-627 ◽  
Author(s):  
Dana E Angelini ◽  
Todd Greene ◽  
Julie N Wietzke ◽  
Scott A Flanders ◽  
Suman L. Sood

Abstract Introduction: VTE affects 1.6-1.8/1000 hospitalized patients per year; active cancer increases the rate of VTE 6-fold. Despite the high risk of VTE, studies show cancer patients receive inpatient VTE prophylaxis at a lower rate than general medical patients. In addition, VTE prophylaxis is often held for a platelet value of <50x109/L, despite a lack of evidence. Current recommendations for all inpatients with cancer (and no contraindication to blood thinners) are to receive prophylactic anticoagulation, regardless of an increased bleeding tendency in this population. A formal risk:benefit ratio of inpatient VTE prophylaxis for cancer patients has not been evaluated to date. Methods: The Michigan Hospital Medicine Safety Consortium, a 49 hospital quality collaborative, has prospectively collected data on VTE risk factors and outcomes in medical patients > 18 years of age. Exclusion criteria include surgical patients, pregnancy, admission to the ICU or for palliative care, therapeutic anticoagulation, diagnosis of acute thrombus, history of VTE within 6 months, and length of stay < 2 days. We compared rates of VTE prophylaxis, bleeding and new VTE between cancer and general medicine patients who were eligible for prophylaxis (i.e. no contraindications including active bleed within 3 months, coagulopathy, or high risk brain metastasis). Student's t-test was used for continuous variables and chi-square for categorical data. Logistic regression was used to calculate odds ratio (OR). The number needed to treat and number needed to harm were used to derive a risk:benefit ratio. Results: Between 7/2012-7/2015, 86,634 admissions were captured in the cohort; 70,086 were eligible for VTE prophylaxis and included in this analysis. 22% of cases had a diagnosis of cancer. Table 1. Demographics on Admission Cancer (n= 15,166), % General Medicine (n=54,920), % p Race (Caucasian) 82.3 74.3 <0.001 Age mean yrs (SD) 72.5 (14.4) 63.7 (18.8) <0.001 Gender (female) 53.6 56.5 <0.001 Central Line 17.8 4.1 <0.001 History of VTE 7.6 5.3 <0.001 Caprini risk score ≥ 5 88.1 35.8 <0.001 Charleston Index mean (SD) 5.1 (2.5) 2.1 (2.0) <0.001 Ever Smoked 59.6 56.3 <0.001 Obese 29.3 37.1 <0.001 Surgery w/in 30 days 3.6 2.1 <0.001 Trauma w/in 30 days 0.3 0.4 0.01 Of cancer admissions, 89.5% had solid tumors, 13.5% hematologic malignancies, 3.4% both and 20% metastatic disease. Active treatment for cancer was delivered <6 months from index admission in 32.1%, within 6-12 mo in 3.2%, >12 mo in 44.4% and no treatment or unknown in 20.3%. When compared to general medical admissions, cancer admissions were more likely to receive VTE prophylaxis (72.16% vs 69.21%, p<0.001), and have a new VTE out to 90 days post discharge despite prophylaxis (0.91% vs 0.45%, p<0.001, unadjusted OR 2.07 (95% CI 1.6-2.7)). There was no difference in VTE rate with regard to platelet count in cancer cases (0.43% for plt < 50 vs 1.08% for plt ≥ 50, p=0.10). Among all patients receiving VTE prophylaxis, bleeding was more common in cancer cases (major bleeding 0.84% vs 0.58%, p=0.005; minor bleeding 1.80% vs 1.36%, p=0.002). Among cancer cases, bleeding rates were higher in patients with platelet <50 vs ≥ 50 (major bleed 4.86% vs 1.88%, p<0.001; minor bleed 2.88% vs 1.7%, p=0.04). Table 2. The Number Needed to Treat (NNT) to Prevent One VTE During Admission or 90 Days Post Discharge and Number Needed to Harm (NNH) to Cause One Major Bleed During Admission with Risk:Benefit Ratio (NNH:NNT) General Medicine Cancer NNT 1428 NNT 1000 NNH 2500 NNH 277.9 NNH:NNT 1.75 NNH:NNT 0.28 Conclusions: In this prospective inpatient cohort, we compared general medicine to cancer cases and found cancer admissions received VTE prophylaxis at a higher rate. This is different than previously reported data, likely due to the exclusion of patients with contraindications to prophylaxis. However, despite prophylaxis, cancer patients had a higher rate of VTE during admission and 90 days post discharge as well as more bleeding complications. The risk:benefit ratio of VTE prophylaxis is 6 times worse in cancer patients due to bleeding. While bleeding occurs more frequently in cancer patients with platelet count <50x109/L, VTE occurs at a similar rate regardless of platelet count, meaning that cancer patients are at high risk of both clotting and bleeding. Recommendations for inpatient VTE prophylaxis for cancer patients require a targeted approach to identify a subset who would most benefit from VTE prophylaxis. Disclosures Flanders: Institute for Healthcare Improvement and the Society of Hospital Medicine: Consultancy; Wiley Publishing: Patents & Royalties; CDC Foundation: Research Funding; Blue Cross Blue Shield of Michigan: Research Funding; Michigan Hospital Association: Research Funding. Sood:Bayer: Research Funding.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4734-4734
Author(s):  
Alok A. Khorana ◽  
Keith R. McCrae ◽  
Dejan Milentijevic ◽  
Jonathan Fortier ◽  
François Laliberté ◽  
...  

Abstract Introduction: Patients with cancer are not only at a high risk for developing primary but also recurrent venous thromboembolism (VTE). These events lead to increased burden of cancer management and healthcare costs. It was estimated that all-cause health care costs for cancer patients with VTE were $30,538/patient higher than in those without VTE (Khorana, 2013). To our knowledge, very little information exists on cost of VTE recurrence among cancer patients. The objective of this study was to analyze resource utilization and costs of patients with cancer experiencing a VTE recurrence using a large claims database. Methods: Medical and pharmacy claims from the Humana Database between 1/1/2013 and 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis and with ≥1 dispensing of an anticoagulant agent within 7 days after their VTE diagnosis, were selected. Baseline characteristics were evaluated during the 6 month period prior to the index VTE. VTE recurrences were defined as hospitalizations with a primary diagnosis of VTE. Patients were classified into two groups: patients who experienced a VTE recurrence and patients who did not. Resource utilization and costs were evaluated for the entire follow up period, starting with the initiation of the anticoagulant therapy until whichever was earlier, end of eligibility or end of data. Healthcare resource utilization evaluated included number of hospitalizations, hospitalization days, emergency room (ER) visits, and outpatient visits. All-cause and VTE-related healthcare resource utilization was evaluated. Comparisons between patients with a VTE recurrence and patients without a VTE recurrence were performed using rate ratios (RR) and statistical differences between groups as well as 95% confidence intervals [95% CI] were calculated using Poisson regression models. All-cause and VTE-related healthcare costs were evaluated in per-patient-per-year (PPPY) and compared using mean cost difference. Results: A total of 2,428 newly diagnosed cancer patients who developed VTE and were treated with anticoagulants were identified. Of these, 413 (17.1%) experienced recurrent VTE during the follow up period. Patients who developed recurrent VTE and those who did not were similar in terms of age, gender, race, and region. No statistically significant differences between groups were observed in Charlson comorbidity index or in selected comorbidities during the 6 month baseline period. However, more patients with recurrent VTE recurrence had their index VTE documented during a hospitalization (61.3% vs. 55.4%, p=0.03). Patients with a VTE recurrence had significantly more ER and outpatient visits at baseline compared to those without recurrence, but no statistically significant difference was observed in baseline total healthcare costs ($29,352 vs. $27,955, p=0.44, respectively). The mean follow-up was similar between groups: 9.6 months for patients experiencing a VTE recurrence and 9.3 months for patients without a VTE recurrence (p=0.4059). Patients with a VTE recurrence had higher all-cause resource utilization rates (RRs; 95% CI) compared to patients without a VTE recurrence (hospitalization [2.37; 2.23 - 2.52], hospitalization days [2.64; 2.57 - 2.72], ER visits [1.62; 1.48 - 1.76], and outpatient visits [1.26; 1.24 - 1.28]). The rates of VTE-related hospitalization and VTE-related hospitalization days were close to $30,000 higher in patients with a VTE recurrence (Figure 1). The all-cause healthcare costs were $84,708 PPPY in patients with a VTE recurrence compared to $44,903 in patients without a VTE recurrence. The difference was mainly explained by lower VTE-related hospitalization costs (Figure 2). Conclusion: This real-world claims analysis showed that cancer patients with recurrent VTE consume significantly more healthcare resources. Total healthcare costs were nearly 2-fold higher in cohort with than in cohort without VTE recurrence. Close to 75% of the total cost difference was associated with VTE recurrence. VTE-related costs were ~4-fold higher in cohort with than in cohort without VTE recurrence. Reducing VTE recurrence in patients with cancer could lead to substantial healthcare cost savings. Figure 1 VTE-Related Healthcare Resource Utilization Figure 1. VTE-Related Healthcare Resource Utilization Figure 2 VTE-Related Healthcare Costs, PPPY Figure 2. VTE-Related Healthcare Costs, PPPY Disclosures Khorana: Pfizer: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding; Leo: Consultancy, Honoraria, Research Funding; Roche: Consultancy, Honoraria. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 167-167 ◽  
Author(s):  
Guy Meyer ◽  
Celine Chapelle ◽  
Philippe Girard ◽  
Florian Scotté ◽  
Anne Lamblin ◽  
...  

Introduction Venous thromboembolism (VTE) is a difficult to treat condition in patients with cancer with a persisting risk of recurrent VTE during anticoagulant treatment with low-molecular weight heparin (LMWH). Recent data suggest that direct oral anticoagulants (DOACS) are associated with a lower risk of recurrence but a higher risk of bleeding in these patients. Predicting the risk of recurrent VTE with LMWH may help to select the best treatment option. We conducted a prospective multicenter observational cohort study in cancer patients with VTE treated with tinzaparin for 6 months in order to validate the Ottawa score (NCT03099031) and search for additional risk of recurrent VTE. The Ottawa score is composed of 5 variables, female sex (+1), lung cancer (+1), breast cancer (-1) cancer stage 1 (-2) and previous DVT (+1). A score ≤0 is associated with a low risk of recurrent VTE. Methods Adult cancer patients with recent diagnosis of documented symptomatic or incidental VTE (deep vein thrombosis (DVT) or pulmonary embolism (PE) treated with tinzaparin for 6 months were included in the study. The primary endpoint was the recurrence of symptomatic or asymptomatic VTE within the first 6 months of treatment with tinzaparin. Other endpoints were symptomatic recurrent VTE, major bleeding, heparin induced thrombocytopenia (HIT), all-cause mortality within 3 and 6 months. All events were adjudicated by a Central Adjudication Committee. Time-to-event outcomes were estimated by the Kalbfleisch and Prentice method to take into account the competing risk of death. Cumulative incidences were presented with corresponding 95% confidence interval (95% CI). To validate the Ottawa score, the area under the curve (AUC) and its 95% CI were calculated on receiver operating characteristic (ROC) curve analysis; the most discriminant cut-off was then determined by calculating the Youden index. Univariate and multivariate analyses were performed to identify additional predictive factors of recurrent VTE to those included in the Ottawa score using the Fine and Gray method and adjusted on factors included in the Ottawa score. Hazard ratio and their 95% CI were calculated. Results A total of 409 patients were included and analyzed on an intention-to-treat basis; the median age was 68 years and 51% of patients were males. 60.4% of patients had a PE (with or without DVT) .64% received chemotherapy at inclusion or in the month before inclusion. Lung (31.3%) and digestive track (18.3%) cancers were the most common cancer types and 67.0% had stage IV cancers. According to Ottawa score, 58% of patients were classified at high clinical probability of recurrence (score ≥ 1). During the 6 months treatment period, 23 patients had a recurrent VTE, yielding a cumulative incidence of 6.1% (95% CI 4.0-9.3) with a median time for recurrent VTE of 33 days. The recurrence rate of VTE was estimated to 7.8% (95% CI 4.9-12.5) for patients classified at high risk of recurrence according to the Ottawa score (score ≥ 1) compared to 3.8% (95%CI 1.6-8.9) for other patients (Ottawa score &lt; 1). AUC of the Ottawa score was 0.60 (95% CI 0.55-0.65). In multivariable analysis, none of the potential risk factors for recurrent VTE was significantly associated with recurrent VTE at 6 months. During the 6 months treatment period, 15 patients had a major bleeding and 2 patients experienced a HIT. At 3 and 6 months, 104 and 144 patients had died yielding a cumulative incidence of 26.1%, (95% CI 21.8-30.4) and 37.8% (95% CI 32.8-42.9), respectively. The main cause of death was underlying cancer. Conclusion In this prospective cohort of patients with cancer receiving LMWH for VTE, the Ottawa score did not accurately predict recurrent VTE. No other clinical predictor of recurrent VTE was identified in this study. Disclosures Meyer: Bayer: Other: travel support; LEO pharma: Other: travel support, Research Funding; SANOFI: Other: travel support, Research Funding; BMS-Pfizer: Other: travel support, Research Funding; Boehringer Ingelheim: Research Funding. Girard:Leo Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: travel support. Scotté:LEO Pharma A/S: Honoraria, Research Funding, Speakers Bureau; Pfizer: Honoraria, Research Funding, Speakers Bureau; Tesaro: Honoraria, Research Funding, Speakers Bureau; Amgen: Honoraria, Research Funding, Speakers Bureau; BMS: Honoraria, Research Funding, Speakers Bureau; Roche: Honoraria, Research Funding, Speakers Bureau; MSD: Honoraria, Research Funding, Speakers Bureau; Pierre Fabre Oncology: Honoraria, Research Funding, Speakers Bureau. Lamblin:Leo Pharma: Employment. Laporte:Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Boston scientific: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Leo-Pharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BMS: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Boehringer-Ingelheim: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Consultancy, Membership on an entity's Board of Directors or advisory committees.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1065-1065
Author(s):  
Wei Zhao ◽  
Pin Li ◽  
Scott Kaatz ◽  
Katie Latack ◽  
Lonni Schultz ◽  
...  

Abstract Introduction Patients hospitalized with COVID-19 have an increased incidence of venous thromboembolism (VTE) and arterial thromboembolism (ATE) events. These thrombotic events increase readmission and mortality rate in COVID-19 survivors who are recently discharged from hospital. To lower the risk of VTE, a short course of post-discharge anticoagulation at either prophylactic or therapeutic dose has been variably prescribed among different facilities to COVID-19 patients. This practice, however, is challenged by less than 3% incidence of VTE in unselected patients. The net clinical benefit of extended thromboprophylaxis beyond hospitalization remains unclear. Methods We conducted a retrospective multicenter observational study of 5613 hospitalized COVID-19 patients. After applying the inclusion and exclusion criteria, 2838 patients were included in statistical analysis. Patients were excluded if they had negative SARS-CoV-2 PCR, remained hospitalized at the time of analysis, or were discharged to hospice service. The first symptomatic ATE and VTE events up to 90 days after patients' discharge from their index admission for COVID-19 were identified using ICD-10 codes, and subsequently validated by chart review. The predictors for post-discharge VTE were identified using multivariate logistic regression. The average protective effect of anticoagulation was assessed using inverse propensity score weighting. Results The mean age (SD) of our cohort was 63.4 (16.7) years old and 47.6% were male. Black, white and other races were 38.9%, 50.7% and 10.3%, respectively. Thirty-six (1.3%) patients developed post-discharge VTE events that require hospital visits (18 deep vein thromboses, 16 pulmonary embolisms and 2 portal vein thromboses). Fifteen (0.5%) patients developed post-discharge ATE events (14 acute coronary syndromes and 1 transient ischemic attack). The incidence of VTE decreased with time (p &lt;.001) with the median event time of 16 days (Figure 1). The incidence of ATE was unchanged with time (p =.369) with the median event time of 37 days (Figure 1). Patients who had a history of VTE (OR=3.24, 95% CI 1.34-7.86), peak D-dimer &gt;3 µg/mL (OR=3.76, 95% CI 1.86-7.57), and predischarge C-reactive protein &gt;10 mg/dL (OR=3.02, 95% CI 1.45-6.29) were at a high risk of developing VTE after hospital discharge (Figure 2). A short course of prophylactic or therapeutic anticoagulation after hospital discharge markedly reduced VTE (OR=0, 95% CI 0-0, p&lt;.001, and OR=0.176, 95% CI 0.04-0.75, p=.02, respectively). Conclusions Although extended thromboprophylaxis in unselected COVID-19 patients is not recommended, post-discharge anticoagulation may be considered in high-risk patients who have a history of VTE, peak D-dimer &gt;3 µg/mL and predischarge C-reactive protein &gt;10 mg/dL if their bleeding risk is low. Our study has provided the first evidence to guide the selection of hospitalized COVID-19 patients who may benefit from post-discharge anticoagulation. Figure 1 Figure 1. Disclosures Kaatz: Gilead: Consultancy; Novartis: Consultancy; CSL Behring: Consultancy; Bristol Myer Squibb: Consultancy, Research Funding; Alexion: Consultancy; Pfizer: Consultancy; Janssen: Consultancy, Research Funding; Osmosis Research: Research Funding.


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