Documenting patterns and outcomes of venous thromboembolism (VTE) management and degree of adherence by clinicians to treatment guidelines could help identify remediable gaps in patient care. Prospective, clinical practice-based data from Canadian outpatient settings on management of VTE, degree of adherence with treatment guidelines and frequency of recurrent VTE and bleeding during follow-up was obtained in a multicentre, prospective observational study. From 12 Canadian centres, we assessed 868 outpatients with acute symptomatic VTE who received the low-molecular-weight heparin (LMWH) enoxaparin alone or with vitamin K antagonists (VKA), at baseline and at six months (or at the end of treatment, whichever came first). Index VTE was limb deep venous thrombosis (DVT) in 583 (67.2%) patients, pulmonary embolism (PE) with or without DVT in 262 (30.2%) patients, and unusual site DVT in 23 (2.6%) patients. VTE was unprovoked in 399 (46.0%) patients, associated with cancer in 74 (8.5%) patients, transient risk factors in 327 (37.7%) patients and hormonal factors in 68 (7.8%) patients.With regard to guideline adherence, 58 (7.3%) patients received <5 days LMWH and 114 (14.5%) had overlap <1 day. Among patients with cancer-related VTE, 59.5% were prescribed LMWH monotherapy and 43.2% received such treatment for >3 months. Only 38.1% of patients with transient VTE risk factors had received thromboprophylaxis. Our study provides useful information on clinical presentation, management and related outcomes in Canadian outpatients with VTE. Our results suggest there may be important gaps in use of thromboprophylaxis to prevent VTE and use of LMWH monotherapy to treat cancer-related VTE.
Background Familial chylomicronemia syndrome (FCS) is a rare autosomal recessive disorder characterized by persistent extreme hypertriglyceridemia as a result of lipoprotein lipase deficiency. Canada is an important region for FCS research due to the high prevalence rates. The burden of illness and quality of life of Canadian patients, however, have been inadequately addressed in the literature. Objective To understand the burden of illness of FCS on Canadian patients’ lives. Methods IN-FOCUS is a global web-based survey open to patients with FCS, including patients in Canada. This survey captured information on diagnostic experience, symptoms, comorbidities, disease management, and impact on multiple life dimensions. Results A total of 37 Canadian patients completed the IN-FOCUS survey. Patients saw a mean of 4 physicians before their FCS diagnosis despite 89% reporting an FCS family history. Patients experience multiple physical, emotional, and cognitive symptoms in addition to FCS-related comorbidities. Notably, 35% of those who answered the survey have experienced acute pancreatitis, averaging 14 lifetime episodes per patient. In the preceding 12 months, 46% of patients had an FCS-related hospitalization, averaging 3 nights’ stay. All respondents restricted fat intake, with 27% following an extremely low-fat diet. Despite this, 100% of patients reported fasting TG levels above the normal range. FCS impacted career choice in nearly all patients (97%) and employment status in all patients who were employed part time, disabled, or homemakers, causing many (> 75%) to choose careers below their level of abilities. Furthermore, 2/3 of patients reported FCS had a significant impact on their decision regarding whether to have children. Most report significant interference with their emotional/mental well-being, social relationships, and the majority were concerned about the long-term impact of FCS on their health (89%). Conclusions This study provides the first and largest study to investigate the multi-faceted psychosocial and cognitive impacts of FCS on patients. Canadian patients with FCS experience significant multi-faceted burdens that diminish their quality of life, employment opportunities, social relationships, and mental/emotional well-being. These results highlight the need for greater disease awareness, improved clinical diagnosis, broader clinical management for heterogenous symptoms, and more effective treatment options for FCS.
82 Background: Current guidelines recommend that venous thromboembolism (VTE) prophylaxis should be given to high-risk medical inpatients based on evidence of reduced VTE events and reduced mortality. However, current guidelines do not specify the appropriate length of VTE prophylaxis in this population, especially after discharge. The EXCLAIM study showed a 90 day VTE incidence of 4.2% in those patients who received enoxaparin for 10 days in the hospital, with 1.1% being symptomatic VTE. However, real world data is needed to understand the risk of VTE for this patient population after they are discharged from acute care and the prevalence of symptomatic VTE. Objective: To determine the incidence of late VTE events in high-risk medical patients in every day clinical practice and in the absence of systematic screening for VTE. Methods: Charts from 1134 consecutive high-risk medical patients who were hospitalized in the Calgary region and discharged between January and February 2008 were abstracted using standardized case record forms. All hospitals in the region use a common unique patient identifier number, thus enabling the tracking of subsequent patient visits to the emergency room, inpatient admissions or outpatient visits occurring anywhere in the region's acute care system. High-risk medical patients were defined as age > 60 years and having at least one of the following risk factors: malignancy, respiratory illness, neurological illness, inflammatory bowel disease, previous VTE, acute infection or heart failure. Records excluded were those of patients who were admitted for VTE or to rule out VTE, those receiving chronic anticoagulation, those with acute coronary syndromes, patients whose hospital stay was ≤ 3 days, surgical patients, orthopedic patients, and pregnant patients. Data was collected on patient risk factors, thromboprophylaxis received in hospital and at discharge, VTE related events for up to 100 days post discharge. Results: 989 patients met criteria over the review period. 74% (733/989) of all patients received mechanical or pharmacological prophylaxis in hospital: 28% (281) received unfractionated heparin, 28% (281) received LMWH and 4% (40) received mechanical prophylaxis and 13% (131) received a combination of modalities. The prevailing medical risk factors were malignancy (46%), respiratory illness (44%), neurological illness (15%), inflammatory bowel disease (6%), previous VTE (4%), acute infection (17%), heart failure (9%). Only 2% (95% CI, 1.6% to 3.6%) of all patients received anticoagulation prophylaxis at discharge. Twenty one percent of patients in the population studied received medical care for symptoms associated with VTE. Of these, 4% (95% CI, 2.7% to 5.2%) had confirmation of VTE by diagnostic testing while the other 17% (95% CI, 15.0% to 19.8%) had diagnostic tests that were negative or inconclusive. The mean length of time to confirmed VTE was 34.1 days post hospital admission. Conclusion: This study demonstrates that in a real life setting 21% of high-risk patients would develop symptoms of VTE requiring a health professional's attention with 4% having VTE confirmed by diagnostic testing. These events occurred despite prophylaxis in hospital and suggest that the risk of symptomatic VTE could be higher in real life compared to that reported in randomized clinical trials where patients are screened for asymptomatic VTE. These findings show that the prevalence of VTE warrants consideration of extended thromboprophylaxis in selected high-risk medical patients, as the benefits of extended prophylactic therapy may outweigh the risks in this population. Disclosures: Hull: sanofi-aventis Canada Inc: Consultancy, Research Funding. Brocklebank:sanofi-aventis Canada Inc: Honoraria; Bayer, Inc.: Honoraria; Leo Pharma: Honoraria. Komari:sanofi-aventis Canada Inc: Employment. Merali:sanofi-aventis Canada Inc: Consultancy, Research Funding.
4182 Background: Venous thromboembolism (VTE) prophylaxis has been identified in clinical guidelines as an appropriate strategy for high-risk medical inpatients as it results in reduced VTE events and reduced mortality. However, real life data regarding the timing of VTE events and the relationship between risk factors and VTE in this population is lacking. Further knowledge of the time course of recurrence and influence of risk factors in actual practice may help clinicians determine strategies regarding the frequency of clinical surveillance and the appropriate duration of treatment. Objective: To document the time course of symptomatic VTE events in high-risk medical patients in every day clinical practice and to relate the frequency of risk factors to the likelihood of VTE development. Methods: Charts from 1134 consecutive high-risk medical patients who were hospitalized in the Calgary region and discharged between January and February 2008 were abstracted using standardized case record forms. All hospitals in the region use a common unique patient identifier number, thus enabling the tracking of subsequent patient visits to the emergency room, inpatient admissions or outpatient visits occurring anywhere in the region's acute care system. Any identified patient was followed for a subsequent visit related to VTE. High-risk medical patients were defined as age > 60 years and having at least one of the following risk factors: malignancy, respiratory illness, neurological illness, inflammatory bowel disease, previous VTE, acute infection or heart failure. Records were excluded if the patient was admitted for VTE or to rule out VTE, receiving chronic anticoagulation, experiencing acute coronary syndromes, had a hospital stay ≤ 3 days, was a surgical or orthopedic patient, or pregnant. Data was collected on the timing of VTE related events for up to 100 days post discharge. Results: A total of 989 patients met criteria over the review period. Seventy-four percent (732/989) of all patients received mechanical or pharmacological prophylaxis in hospital. Only 2% (95% CI, 1.6% to 3.6%) of all patients received anticoagulation prophylaxis at discharge. Twenty-one percent of patients in the population studied were identified as requiring medical care for symptoms associated with VTE. Confirmation of VTE by diagnostic testing occurred in 4% (95% CI, 2.7% to 5.2%) while the other 17% (95% CI, 15.0% to 19.8%) had diagnostic tests that were negative or inconclusive. The mean length of time to confirmed first VTE event was 33.5 days. Eighty percent of first events occurred by day 57 and 90% of first VTE events occurred by day 69 post hospital admission. Patients with more than 2 risk factors had a rate of confirmed symptomatic VTE events of 6.1%, increasing to 8.7% for those with more than 3 risk factors while only 2.9% of patients with 2 or less risk factors developed a confirmed VTE. (p=0.015) Conclusion: This study demonstrates that in a real life setting, 6% of those hospitalized medical patients with more than 2 risk factors would develop symptomatic VTE event confirmed by diagnostic testing, increasing to 8.7% for those with more than 3 pre-specified risk factors. The mean time to first VTE event of 33.5 days along with 80% of VTE events occurring by day 57 suggest that more consideration needs to be given to prolonged VTE prophylaxis in this high risk population. The frequency and timing of the VTE events coupled with the results of the EXCLAIM study suggest that this high risk population may benefit from prolonged thromboprophylaxis. Disclosures: Hull: LEO Pharma: Consultancy; sanofi-aventis: Consultancy; Pfizer: Consultancy; Portola: Consultancy; Merck: Consultancy; Bayer: Consultancy; Johnson & Johnson: Consultancy. Merali:LEO Pharma: Consultancy; Genzyme: Consultancy; Boehringer Ingelheim: Consultancy; Abbott: Consultancy; BMS: Consultancy; Pfizer: Consultancy; Amgen: Consultancy; sanofi-aventis: Consultancy; Nycomed: Consultancy; Otsuka: Consultancy. Mills:Pfizer: Consultancy; sanofi-aventis: Research Funding. Komari:sanofi-aventis: Employment.
4773 Background: Venous thromboembolism (VTE) prophylaxis has been recommended in clinical guidelines as an appropriate strategy for hospitalized cancer patients based on evidence of reduced VTE events and reduced mortality. However, current guidelines do not specify the appropriate length of VTE prophylaxis in this population. Real world data is needed to understand the prevalence of symptomatic and confirmed VTE for this patient population to help clinicians determine strategies regarding the appropriate duration of treatment. Objective: To document the incidence of symptomatic late VTE events in hospitalized patients who have active cancer. Methods: Charts from 1134 consecutive medical patients age > 60 years who were hospitalized in the Calgary region and discharged between January and February 2008 were abstracted using standardized case record forms. All hospitals in the region use a common unique patient identifier number, thus enabling the tracking of subsequent patient visits to the emergency room, inpatient admissions or outpatient visits occurring anywhere in the region's acute care system. Any identified patient was followed for a subsequent visit related to VTE. Active cancer patients were defined as those who have a cancer diagnosis at hospital admission and have a planned cancer surgery or receiving cancer treatment or were receiving palliative treatment or whose cancer treatment was not specified. Records were excluded if the patient was admitted for VTE or to rule out VTE, receiving chronic anticoagulation, experiencing acute coronary syndromes, had a hospital stay ≤ 3 days, had a remote cancer history, was a surgical or orthopedic patient, or pregnant. Data was collected on the timing of VTE related events for up to 100 days post discharge. Results: A total of 358 patients met criteria over the review period. Seventy-three percent (261/358) of all active cancer patients received mechanical or pharmacological prophylaxis in hospital. Twenty-three percent of these patients were identified as requiring medical care for symptoms associated with VTE. Confirmation of VTE by diagnostic testing occurred in 4.8% (95% CI, 2.6% to 7%) while the other 18% (95% CI, 14.0% to 22%) had diagnostic tests that were negative or inconclusive. The mean length of time to confirmed first VTE event was 38.2 days post admission. Conclusion: This study demonstrates that in a real life setting 23% of active cancer patients would develop symptoms of VTE requiring a health professional's attention with 4.8% having VTE confirmed by diagnostic testing. These events occurred despite thromboprophylaxis in hospital and suggest that the risk of symptomatic VTE could be higher in real life compared to that reported in randomized clinical trials where patients are screened for asymptomatic VTE. These findings show that the prevalence of VTE warrants consideration of extended thromboprophylaxis in active cancer patients, as the benefits of extended prophylactic therapy may outweigh the risks in this population. Disclosures: Hull: sanofi-aventis: Consultancy; LEO Pharma: Consultancy; Pfizer: Consultancy; Portola: Consultancy; Merck: Consultancy; Bayer: Consultancy; Johnson & Johnson: Consultancy. Merali:sanofi-aventis: Consultancy; Amgen: Consultancy; Pfizer: Consultancy; BMS: Consultancy; Abbott: Consultancy; Boehringer Ingelheim: Consultancy; Genzyme: Consultancy; LEO Pharma: Consultancy; Nycomed: Consultancy; Otsuka: Consultancy. Mills:Pfizer: Consultancy; sanofi-aventis: Research Funding. Komari:sanofi-aventis: Employment.
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