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Long term clinical outcomes of cancer associated venous thromboembolism: findings from the MASTER registry
Abstracts / Thrombosis Research 129, Supplement 1 (2012) S155–S194
S163
POSTERS Poster Session 1: Epidemiology
PO-01 Long term clinical outcomes of cancer associated venous thromboembolism: findings from the MASTER registry D. Imberti 1 , G. Agnelli 2 , W. Ageno 3 , M. Moia 4 , G. Palareti 5 , R. Pistelli 6 , M. Verso 2 , for the MASTER Investigators 1 Hospital of Piacenza, Piacenza; 2 University of Perugia, Perugia; 3 University of Insubria, Varese; 4 Fondazione IRCCS Ca’ Granda, Milan; 5 University of Bologna, Bologna; 6 Catholic University, Rome, Italy and the MASTER study centers Background: The clinical characteristics of venous thromboembolism (VTE) have been reported to be different in cancer and in non cancer patients included in randomised clinical trials. However, sparse information is available on the long-term clinical outcomes of VTE in a large cohort of unselected cancer patients. Aim: To prospectively evaluate whether long-term clinical outcomes of VTE are different in cancer and non cancer patients. Methods: MASTER is a multicenter registry of consecutively recruited patients with symptomatic, objectively confirmed, acute VTE. Patients were followed-up at 6, 12 and 24 months for many major clinical outcomes. Results: 2,119 patients with acute VTE were enrolled in the registry. For the aim of this study, we restricted the analysis to the 1,883 patients followed with at least one visit at 6, 12 or 24 months; 343 patients (19.3%) had cancer. The excess of risk for death or recurrence of VTE were estimated in a Cox model and expressed as Hazard Ratio (HR) between patients affected and not affected by cancer. The risk of death (HR=6.84; 95% CI 4.32-10.83; p<0.0001) and recurrence of VTE (HR=1.62; 95% CI 0.98-2.68; p=0.056) was higher in cancer patients. We analysed the cumulative incidence of the following major outcomes as Odds Ratio (OR) between patients with cancer and without cancer: post-thrombotic syndrome (25.3% versus 5.9%; OR: 5.39; 95% CI 3.92-7.41; p<0.0001), acute myocardial infarction (1.7% versus 0.5%; OR: 3.17; 95% CI 1.09-9.21; p=0.02), ischemic stroke (0.6% versus 0.4%; OR: 1.39; 95% CI 0.28-6.95; p=0.68), any bleeding (5.5% versus 1.8%; OR: 3.1; 95% CI 1.72-5.58; p<0.0001), inferior vena cava (IVC) filter implantation (7.2% versus 4.3%; OR: 1.69; 95% CI 1.06-2.71; p=0.02). Conclusions: During the two year follow-up, the risk of death and recurrence of VTE was higher in patients with cancer than in patients without cancer. In addition, post-thrombotic syndrome, myocardial infarction, and bleeding were more common in cancer patients.
PO-02 Rate and time course of thromboembolism events in cancer patients R. Hull 1 , T. Merali 2 , A. Mills 3,4 , J. Liang 1 , N. Komari 5 1 University of Calgary, Calgary; 2 Drug Intelligence Inc., Toronto; 3 Pharmacy Services, Trillium Health Centre, Mississauga; 4 Leslie Dan Faculty of Pharmacy, University of Toronto; 5 Sanofi-aventis Canada Inc., Laval, QC, Canada 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 1,134 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 had a cancer diagnosis at hospital admission and had a planned cancer surgery, were receiving cancer treatment or palliative treatment or whose cancer treatment was not specified. Records were excluded if the patient was admitted for VTE, 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 up to 100 days post discharge. Results: A total of 358 patients met criteria over the review period. 73% (261/358) of all active cancer patients received mechanical or pharmacological prophylaxis in hospital. 23% 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.
PO-03 Are high D-Dimer levels in patients with acute VTE a sign of possible occult cancer? S. Cavazza, C. Legnani, C. Pili, G. Palareti U.O. Angiology and blood coagulation disorders, S. Orsola-Malpighi University Hospital-Bologna, Italy Introduction: it is known that patients with unprovoked venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have a higher risk of cancer; there is no consensus, however, if they should be extensively screened for occult malignancy. Previous studies reported conflicting data on an association between high D-dimer (DD) levels at presentation and the presence of occult cancer. Aim of our study was to investigate the possible correlation between high DD levels at presentation in patients with acute symptomatic VTE and the presence or subsequent diagnosis of cancer at least 1 year follow up in order to identify a population of patients which could take advantage of more extensive screening for malignancy. Materials and methods: We performed a retrospective cohort study based on hospital records of consecutive in-patients referred to our unit for documented acute DVT and/or PE. Criteria of inclusion was DD measurement available at presentation. Criteria of exclusion were: age over 85, isolated distal DVT, anticoagulant therapy. Patients were considered tumor free if radical surgery was performed more than 3 months before the presentation; otherwise or in case of ongoing chemotherapy they were considered cancer patients. Results: From January 2008 to October 2010, 207 (91 women) consecutive patients admitted to our ward with acute VTE were included. Median follow up was 17.5 months. An already known cancer was present in 45 (21.7%) of them; the median DD value was 4.65 μg/mL (range 1.31-10.91). Ten (4.8%) patients received a new diagnosis of malignancy after admission to hospital, 5 during hospitalization and 5 during follow-up (median time for diagnosis 13 months). Their median DD value was 3.9 μg/mL (range 0.77-7.59). In the 152 patients negative for cancer at the end of follow-up the median DD value was 3.77 μg/mL (range 0.37-27.52). DD levels were not significantly different in the three groups using non parametric test. No cases of malignancy were detected among the 43 patients with provoked VTE (post trauma, immobilization, surgery, pregnancy or hormonal therapy). Conclusions: DD levels at presentation for VTE appeared not to be related to the presence or absence of overt or occult cancer. Other elements such as site and extension of thrombosis or presence of thrombophilic alterations (data not shown) are likely more associated with DD levels.
S163
POSTERS Poster Session 1: Epidemiology
PO-01 Long term clinical outcomes of cancer associated venous thromboembolism: findings from the MASTER registry D. Imberti 1 , G. Agnelli 2 , W. Ageno 3 , M. Moia 4 , G. Palareti 5 , R. Pistelli 6 , M. Verso 2 , for the MASTER Investigators 1 Hospital of Piacenza, Piacenza; 2 University of Perugia, Perugia; 3 University of Insubria, Varese; 4 Fondazione IRCCS Ca’ Granda, Milan; 5 University of Bologna, Bologna; 6 Catholic University, Rome, Italy and the MASTER study centers Background: The clinical characteristics of venous thromboembolism (VTE) have been reported to be different in cancer and in non cancer patients included in randomised clinical trials. However, sparse information is available on the long-term clinical outcomes of VTE in a large cohort of unselected cancer patients. Aim: To prospectively evaluate whether long-term clinical outcomes of VTE are different in cancer and non cancer patients. Methods: MASTER is a multicenter registry of consecutively recruited patients with symptomatic, objectively confirmed, acute VTE. Patients were followed-up at 6, 12 and 24 months for many major clinical outcomes. Results: 2,119 patients with acute VTE were enrolled in the registry. For the aim of this study, we restricted the analysis to the 1,883 patients followed with at least one visit at 6, 12 or 24 months; 343 patients (19.3%) had cancer. The excess of risk for death or recurrence of VTE were estimated in a Cox model and expressed as Hazard Ratio (HR) between patients affected and not affected by cancer. The risk of death (HR=6.84; 95% CI 4.32-10.83; p<0.0001) and recurrence of VTE (HR=1.62; 95% CI 0.98-2.68; p=0.056) was higher in cancer patients. We analysed the cumulative incidence of the following major outcomes as Odds Ratio (OR) between patients with cancer and without cancer: post-thrombotic syndrome (25.3% versus 5.9%; OR: 5.39; 95% CI 3.92-7.41; p<0.0001), acute myocardial infarction (1.7% versus 0.5%; OR: 3.17; 95% CI 1.09-9.21; p=0.02), ischemic stroke (0.6% versus 0.4%; OR: 1.39; 95% CI 0.28-6.95; p=0.68), any bleeding (5.5% versus 1.8%; OR: 3.1; 95% CI 1.72-5.58; p<0.0001), inferior vena cava (IVC) filter implantation (7.2% versus 4.3%; OR: 1.69; 95% CI 1.06-2.71; p=0.02). Conclusions: During the two year follow-up, the risk of death and recurrence of VTE was higher in patients with cancer than in patients without cancer. In addition, post-thrombotic syndrome, myocardial infarction, and bleeding were more common in cancer patients.
PO-02 Rate and time course of thromboembolism events in cancer patients R. Hull 1 , T. Merali 2 , A. Mills 3,4 , J. Liang 1 , N. Komari 5 1 University of Calgary, Calgary; 2 Drug Intelligence Inc., Toronto; 3 Pharmacy Services, Trillium Health Centre, Mississauga; 4 Leslie Dan Faculty of Pharmacy, University of Toronto; 5 Sanofi-aventis Canada Inc., Laval, QC, Canada 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 1,134 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 had a cancer diagnosis at hospital admission and had a planned cancer surgery, were receiving cancer treatment or palliative treatment or whose cancer treatment was not specified. Records were excluded if the patient was admitted for VTE, 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 up to 100 days post discharge. Results: A total of 358 patients met criteria over the review period. 73% (261/358) of all active cancer patients received mechanical or pharmacological prophylaxis in hospital. 23% 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.
PO-03 Are high D-Dimer levels in patients with acute VTE a sign of possible occult cancer? S. Cavazza, C. Legnani, C. Pili, G. Palareti U.O. Angiology and blood coagulation disorders, S. Orsola-Malpighi University Hospital-Bologna, Italy Introduction: it is known that patients with unprovoked venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have a higher risk of cancer; there is no consensus, however, if they should be extensively screened for occult malignancy. Previous studies reported conflicting data on an association between high D-dimer (DD) levels at presentation and the presence of occult cancer. Aim of our study was to investigate the possible correlation between high DD levels at presentation in patients with acute symptomatic VTE and the presence or subsequent diagnosis of cancer at least 1 year follow up in order to identify a population of patients which could take advantage of more extensive screening for malignancy. Materials and methods: We performed a retrospective cohort study based on hospital records of consecutive in-patients referred to our unit for documented acute DVT and/or PE. Criteria of inclusion was DD measurement available at presentation. Criteria of exclusion were: age over 85, isolated distal DVT, anticoagulant therapy. Patients were considered tumor free if radical surgery was performed more than 3 months before the presentation; otherwise or in case of ongoing chemotherapy they were considered cancer patients. Results: From January 2008 to October 2010, 207 (91 women) consecutive patients admitted to our ward with acute VTE were included. Median follow up was 17.5 months. An already known cancer was present in 45 (21.7%) of them; the median DD value was 4.65 μg/mL (range 1.31-10.91). Ten (4.8%) patients received a new diagnosis of malignancy after admission to hospital, 5 during hospitalization and 5 during follow-up (median time for diagnosis 13 months). Their median DD value was 3.9 μg/mL (range 0.77-7.59). In the 152 patients negative for cancer at the end of follow-up the median DD value was 3.77 μg/mL (range 0.37-27.52). DD levels were not significantly different in the three groups using non parametric test. No cases of malignancy were detected among the 43 patients with provoked VTE (post trauma, immobilization, surgery, pregnancy or hormonal therapy). Conclusions: DD levels at presentation for VTE appeared not to be related to the presence or absence of overt or occult cancer. Other elements such as site and extension of thrombosis or presence of thrombophilic alterations (data not shown) are likely more associated with DD levels.