scholarly journals Anticoagulation in cancer-associated thromboembolism with thrombocytopenia: a prospective, multi-center cohort study

2021 ◽  
Author(s):  
Brian J. Carney ◽  
Tzu-Fei Wang ◽  
Siyang Ren ◽  
Gemlyn George ◽  
Amer Al Homssi ◽  
...  
Keyword(s):  
Cohort Study ◽  
Cumulative Incidence ◽  
Hematologic Malignancy ◽  
Safe Alternative ◽  
Major Hemorrhage ◽  
Full Dose ◽  
Patients With Cancer ◽  
Therapeutic Anticoagulation ◽  
Recurrent Vte ◽  
Risk Of Hemorrhage

Venous thromboembolism (VTE) with concurrent thrombocytopenia is frequently encountered in patients with cancer. Therapeutic anticoagulation in the setting of thrombocytopenia is associated with a high risk of hemorrhage. Retrospective analyses suggest the utility of modified-dose anticoagulation in this population. To assess the incidence of hemorrhage or thrombosis according to anticoagulation strategy, we performed a prospective, multi-center, observational study. Patients with active malignancy, acute VTE, and concurrent thrombocytopenia (platelet count < 100,000/µL) were enrolled. The cumulative incidences of hemorrhage or recurrent VTE were determined considering death as a competing risk. Primary outcomes were centrally adjudicated and comparisons made according to initial treatment with full-dose or modified-dose anticoagulation. A total of 121 patients were enrolled at six hospitals. Seventy-five patients were initially treated with full-dose anticoagulation (62%), 33 (27%) with modified-dose anticoagulation, while 13 (11%) received no anticoagulation. Most patients who received modified-dose anticoagulation had a hematologic malignancy (31 of 33, 94%) and an acute DVT (28 of 33, 85%). In patients who initially received full-dose anticoagulation, the cumulative incidence of major hemorrhage at 60 days was 12.8% (95% CI, 4.9-20.8%) and 6.6% (95% CI, 2.4-15.7%) in those who received modified-dose anticoagulation (Fine-Gray HR 2.18, 95% CI 1.21-3.93). The cumulative incidence of recurrent VTE at 60 days in patients who initially received full-dose anticoagulation was 5.6% (95% CI, 0.2-11%) and 0% in patients who received modified-dose anticoagulation. In conclusion, modified-dose anticoagulation appears to be a safe alternative to therapeutic anticoagulation in patients with cancer who develop DVT in the setting of thrombocytopenia.

The Kids-DOTT Trial: Novel Aspects of the ‘Parallel Cohort RCT‘ Design and Its Application to the Investigation of Duration of Anticoagulant Therapy for Pediatric Venous Thromboembolism.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4169-4169
Author(s):  
Neil A. Goldenberg ◽  
Mark Tripputi ◽  
Mark A. Crowther ◽  
Thomas C. Abshire ◽  
Donna M. DiMichele ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Cumulative Incidence ◽  
Trial Design ◽  
Clinical Risk Factor ◽  
Trial Participation ◽  
Major Hemorrhage ◽  
Equal Distribution ◽  
Off Label ◽  
Recurrent Vte

Abstract Abstract 4169 The randomized controlled trial (RCT) is the gold-standard clinical trial design by which safety and efficacy of new medical therapies are evaluated in comparison to placebo or established treatments. Randomization serves as a primary means of ensuring equal distribution of confounding factors, minimizing selection bias, and upholding key assumptions of the statistical analysis. In some circumstances, when prognostic heterogeneity is hypothesized but evidence is not definitive, lack of equipoise among experts in the field may preclude randomization in a particular subgroup. In traditional RCT designs, patients in this subpopulation are then excluded from trial participation. However, these patients often constitute an important subgroup of the disease population. By taking advantage of existing RCT infrastructure, efforts to evaluate such patients in a parallel cohort arm – using a “parallel-cohort RCT” design – would provide an efficient means of generating multi-center prospective data on natural history, toward the development of future RCTs involving these subgroups. A current example of the parallel-cohort RCT design is the Kids-DOTT trial, an ongoing investigator-initiated multi-center randomized trial of the duration of anti-thrombotic therapy for venous thrombosis in children. The target population is children with first-episode acute VTE (excluding pulmonary embolism) in whom a reversible prothrombotic clinical risk factor has been identified and comprehensive laboratory assessment reveals no severe or multi-trait thrombophilia. Children meeting eligibility criteria and in whom no persistent occlusive thrombosis at the six-week follow-up time point are randomized to shortened-duration (six weeks) versus conventional-duration (three months) anticoagulant therapy (Figure 1). The primary endpoint is the cumulative incidence (i.e., risk) of recurrent VTE at two years, and will be compared between the two arms. Secondary outcomes include cumulative incidence of post-thrombotic syndrome (PTS) at two years and of major hemorrhage during anticoagulant therapy. The primary hypothesis of the study is that shortened-duration anticoagulation is non-inferior to conventional-duration therapy. The study also evaluates two groups of patients in parallel cohorts (Figure 1). The first group is comprised of patients with a persistent occlusive thrombosis following the first six weeks of anticoagulation; this cohort is allocated to a conventional course of anticoagulation. The second parallel cohort in the Kids-DOTT trial consists of patients with persistent antiphospholipid antibodies, who are allocated to a course of anticoagulation ranging from 3 months to lifelong. For each of these subpopulations, there was lack of equipoise toward inclusion in the randomization to shortened- versus conventional-duration therapy, due to perception of possible increased recurrence risk. The specific aims involving the parallel cohorts are to determine whether: (1) persistent thrombotic veno-occlusion is a prognostic indicator of recurrent VTE and/or PTS, among children treated with a three month conventional course of anticoagulation (comparison of randomization arm B vs. parallel cohort arm C in Figure 1); and (2) duration of therapy influences risk of recurrent VTE and/or PTS among children with persistent APA, when anticoagulated for a minimum duration of three months (within parallel cohort arm D in Figure 1). In this way, the parallel-cohort RCT model of the Kids-DOTT trial provides additional efficiency in trial design, maximizing the information gained from subpopulations of interest that are excluded from randomization. Broader application of the parallel-cohort RCT design should be considered, particularly in rare disease areas, where efforts to maximize inclusion of the diseased population are critical to trial feasibility and applicability. Disclosures: Off Label Use: The presentation refers to the use of anticoagulants as a drug class in general in the treatment of venous thromboembolism (VTE) in children. Despite their use in the standard care for pediatric VTE, all anticoagulants remain off-label for this indication in children.

scholarly journals Risk of Major Hemorrhage after Kidney Transplantation

2015 ◽  
Vol 41 (1) ◽  
pp. 73-80 ◽  
Author(s):  
Manish M. Sood ◽  
Amit X. Garg ◽  
Sarah E. Bota ◽  
Limesh Marisiddappa ◽  
Eric McArthur ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
General Population ◽  
Propensity Score ◽  
Cumulative Incidence ◽  
Deceased Donor ◽  
Older Individuals ◽  
Kidney Transplant Recipients ◽  
Major Hemorrhage ◽  
Risk Of Hemorrhage ◽  
Incidence Of Hospitalization

Background: Major hemorrhagic events are associated with significant morbidity and mortality. We examined the three-year cumulative incidence of hospitalization with major nontraumatic hemorrhage after kidney transplantation. Methods: We performed a retrospective cohort study using healthcare administrative data of all adult-incident kidney-only transplantation recipients in Ontario, Canada from 1994 to 2009. We calculated the three-year cumulative incidence, event rate, and incident rate ratio of hospitalization with major hemorrhage, its subtypes and those undergoing a hemorrhage-related procedure. Results were stratified by patient age and donor type and compared to a random and propensity-score matched sample from the general population. Results: Among 4,958 kidney transplant recipients, the three-year cumulative incidence of hospitalization with nontraumatic major hemorrhage was 3.5% (95% confidence interval [CI] 3.0-4.1%, 12.7 events per 1,000 patient-years) compared to 0.4% (95% CI 0.4-0.5%) in the general population (RR = 8.2, 95% CI 6.9-9.7). The crude risk of hemorrhage was 3-9-fold higher in all subtypes (upper/lower gastrointestinal, intra-cranial) and 15-fold higher for gastrointestinal endoscopic procedures compared to the random sample from the general population. After propensity score matching, the relative risk for major hemorrhage and its subtypes attenuated but remained elevated. The cumulative incidence of hemorrhage was higher for older individuals and those with a deceased donor kidney. Conclusion: Kidney transplantation recipients have a higher risk of hospitalization with hemorrhage compared to the general population, with about 1 in 30 recipients experiencing a major hemorrhage in the three years following transplant.

Intracranial Hemorrhage in Patients with Primary Brain Tumors Treated with Therapeutic Enoxaparin: A Matched Cohort Study

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 142-142 ◽  
Author(s):  
Charlene Mantia ◽  
Erik Uhlmann ◽  
Maneka Puligandla ◽  
Donna S. Neuberg ◽  
Griffin M. Weber ◽  
...  
Keyword(s):  
Cohort Study ◽  
Venous Thromboembolism ◽  
Brain Tumors ◽  
Intracranial Hemorrhage ◽  
Cumulative Incidence ◽  
Competing Risk ◽  
Matched Cohort ◽  
Intracranial Hemorrhages ◽  
Primary Brain Tumors ◽  
Therapeutic Anticoagulation

Abstract BACKGROUND Venous thromboembolism occurs in approximately 15-30% of individuals with primary brain tumors (e.g. glioblastoma, astrocytoma, and oligodendroglioma). Spontaneous intracranial hemorrhage (ICH) is also a frequent complication of primary brain tumors thus complicating the decision to administer therapeutic anticoagulation. Therapeutic anticoagulation does not appear to increase the risk of intracranial hemorrhage among patients with solid tumor brain metastases but whether anticoagulation is safe to administer to patients with primary brain tumors is less clear. The aim of this study was to determine the rate of intracranial hemorrhage associated with therapeutic enoxaparin for treatment of venous thromboembolism in patients with primary brain tumors compared to those patients with brain tumors not exposed to therapeutic anticoagulation. METHODS A 1:1 matched, cohort study was performed using a large hospital-based online medical record database (CQ2) linking ICD-9 codes with prescription medication records, cases were initially identified based on coding for primary brain tumors, venous thromboembolism, and prescription of enoxaparin. Matched controls were identified using a "round-robin" algorithm that ranked controls according to a scoring formula based on successful match for year of diagnosis, age, and gender. A blinded review of radiographic imaging was performed and intracranial hemorrhages were categorized as trace, measurable, and significant. Measurable intracranial hemorrhages were those defined as greater than 1 mL in volume and "significant" intracranial hemorrhages were defined as greater than 10 mL in volume, symptomatic (defined as focal neurologic deficit, headache, nausea, or change in cognitive function), or required surgical intervention. Time-to-event statistical analysis was performed using a competing risk analysis to account for death from any cause as an absorbing competing risk. Statistical comparison of event rates between cases and controls was performed using Fine and Gray competing risk regression. RESULTS A total of 100 patients with primary brain tumors were included in the study. The most common diagnosis was glioblastoma (85%), followed by anaplastic oligodendroglioma (8%), and anaplastic astrocytoma (7%). The two cohorts were well matched for age (60 years old), gender (65% male), and types of treatment received (99% radiation, 34% stereotactic radiosurgery, and 71% surgical resection). There was no statistical difference in the rate of measurable intracranial hemorrhage for the group of patients who received therapeutic enoxaparin at any point following the diagnosis of glioma compared to those who did not receive anticoagulation (subdistribution ratio hazard ratio 1.09, 95% CI 0.53-2.22). The 1-year cumulative incidence of measurable hemorrhage among those who were treated with enoxaparin was 23.6% compared with 20.0% in the control group (Gray's test P=0.48). The 1-year cumulative incidence of significant hemorrhage was 13.1% in those receiving enoxaparin compared with 6.0% in controls (sHR 1.45, 95% CI .47-4.65, P=0.68). The median survival was similar for the enoxaparin (1.56 years) and controls (1.63 years, Log rank P=0.81). CONCLUSION Intracranial hemorrhage is common in patients with primary brain tumors. In this matched cohort analysis utilizing a blinded radiologic review, the administration of therapeutic low molecular weight heparin did not significantly increase the risk of intracranial hemorrhage in the setting of glioma and venous thromboembolism. In patients with primary brain tumors, the diagnosis of venous thromboembolism treated with therapeutic enoxaparin did not impact overall survival. Disclosures Zwicker: Quercegen Pharma: Research Funding.

Clinical course of pulmonary embolism patients treated with DOACs: comparing prognosis, recurrent thromboembolism, and major bleeding between patients with and without cancer

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
Y Nakano ◽  
R Imai ◽  
M Yoshida ◽  
S Shimokata ◽  
S Adachi ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Clinical Course ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Patients With Cancer ◽  
Kaplan Meier ◽  
Significant Difference ◽  
Recurrent Vte

Abstract Background Venous thromboembolism (VTE) is the third frequent acute cardiovascular syndrome in the Europe and Japan. Since direct oral anticoagulants (DOACs) are widely used now, the morbidity and mortality of pulmonary embolism (PE) patients especially associated with cancer needs to be re-evaluated. Purpose We evaluated the clinical course of patients with PE mainly treated with DOACs. Methods This retrospective observational study was conducted in a single center. The data were collected from the medical record of consecutive patients who received inpatient treatment of PE. In this study, we have compared PE patients with cancer (cancer PE) to those without cancer (non-cancer PE) and evaluated the mortality, recurrent of VTE and major bleedings. Results In total, 140 patients were enrolled: 94 patients were cancer-related, and 46 patients were without cancer (Table). The type of the tumor in cancer PE patients were as follows: gastric 8 (9%), esophageal 5 (5%), pancreatic 12 (13%), lung 14 (15%), lymphoma 2 (2%), gynecologic 17 (18%), renal 2 (2%), bile duct 8 (9%), colon 12 (13%), and others 17 (18%). Kaplan-Meier curve showed that the cumulative all-cause mortality was significantly higher in the cancer PE group (35/94 (37%) vs. 2/46 (4%), P<0.001 (log rank), HR 10.3 [95% CI:2.5–43.3]). The cumulative incidence of recurrent VTE was significantly higher in the cancer PE group (7/94 (7%) vs. 0/46, P=0.03 (log rank)). There was no significant difference in the cumulative incidence of major bleeding between the cancer PE group and the non-cancer PE group (8/94 (9%) vs. 5/46 (11%)). Conclusions The risk of recurrent VTE was still higher in cancer PE patients compared to non-cancer PE patients, although DOACs were used. Meanwhile the incidence of major bleeding was comparable in both groups, the risk of bleeding might be acceptable with using DOACs especially in cancer PE patients. Figure 1 Funding Acknowledgement Type of funding source: None

scholarly journals Validation of the Ottawa Score in Cancer Patients with Venous Thromboembolism. the Predicare Cohort Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 167-167 ◽  
Author(s):  
Guy Meyer ◽  
Celine Chapelle ◽  
Philippe Girard ◽  
Florian Scotté ◽  
Anne Lamblin ◽  
...  
Keyword(s):  
Cohort Study ◽  
Venous Thromboembolism ◽  
Board Of Directors ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Research Funding ◽  
Advisory Committees ◽  
Patients With Cancer ◽  
Recurrent Vte ◽  
Support Research

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 < 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.

scholarly journals Recurrent Intracranial Hemorrhage and Venous Thromboembolism Following Initial Intracranial Hemorrhage in Patients with Brain Tumors on Anticoagulation

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2438-2438
Author(s):  
Brian J. Carney ◽  
Erik J. Uhlmann ◽  
Maneka Puligandla ◽  
Charlene Mantia ◽  
Griffin M. Weber ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Brain Tumors ◽  
Brain Metastases ◽  
Intracranial Hemorrhage ◽  
Cumulative Incidence ◽  
Research Funding ◽  
Ivc Filter ◽  
Intracranial Hemorrhages ◽  
Major Hemorrhage ◽  
Recurrent Vte

Introduction Both venous thromboembolism (VTE) and intracranial hemorrhage (ICH) are common potentially life-threatening complications of primary and metastatic brain tumors. Despite emerging evidence regarding the safety of anticoagulation in patients with brain tumors, there is little evidence on appropriate management of VTE following an ICH. Potential management options after an ICH in patients with brain tumors include resumption of full or modified dose anticoagulation or cessation of anticoagulant therapy with or without placement of an inferior vena cava (IVC) filter. We evaluated rates of recurrent VTE and ICH following an initial ICH occurring on anticoagulant therapy. Methods A retrospective cohort study was performed using a hospital-based online medical record database (CQ2) which links ICD-9 and ICD-10 codes with prescription medication records. Cases were identified based on coding for primary brain tumors or brain metastases, after which charts were manually reviewed for a diagnosis of ICH. A blinded review of radiographic imaging was performed, and the initial ICH was categorized as either trace, measurable, or major. Measurable intracranial hemorrhages were those defined as greater than 1 mL in volume and major intracranial hemorrhages were defined as greater than 10 mL in volume, symptomatic, or requiring surgical intervention. The electronic medical record was reviewed to ascertain longitudinal anticoagulation status after the initial ICH. The primary endpoints of the study were recurrent ICH and venous thromboembolism (VTE) within 12 months from the initial ICH. Gray's test was used to compare the cumulative incidence of recurrent ICH and VTE between the groups, with death as a competing risk. Results A total of 79 patients with primary brain tumors or brain metastases and confirmed ICH were included in the study. Fifty-four patients (68.4%) restarted anticoagulation after ICH and 25 patients discontinued anticoagulation entirely. The cohorts were well-matched for tumor diagnosis, age, and comorbidities that portend an increased risk of ICH such as hypertension, chronic kidney disease, and concomitant aspirin use (Table 1). The cumulative incidence of recurrent ICH (95% CI) at one year was 6.1% (1.5 - 15.3) in the restart cohort compared to 4.2% (0.3 - 18.3) in patients who did not restart anticoagulation. Median time from anticoagulation restart to recurrent ICH was 36 days. A total of 16 of 31 patients with major ICH restarted anticoagulation and among these patients two developed subsequent ICH (cumulative incidence 14.5%, 95% CI 2.1 - 38.3). Among the 15 patients with a major ICH who did not restart anticoagulation, the cumulative incidence was 6.7% (0.3 - 27.5). Eleven of 15 patients with measurable ICH restarted anticoagulation and among these patients one subsequently developed ICH (cumulative incidence 0.1%, 95% CI 0.0 - 0.3). No recurrent ICH events were observed in 33 patients with trace initial hemorrhages regardless of restart status. All recurrent ICH events met criteria for classification as a major hemorrhage on the basis of clinical symptoms, and 30-day mortality after recurrent ICH was 100%. The cumulative incidence of recurrent VTE was significantly lower in the restart cohort compared to cohort of patients who did not restart anticoagulation (8.1 vs. 35.3, P=0.003, Figure 1). There were a total of five VTE events in the restart cohort, three deep vein thrombi (DVT) and two pulmonary emboli (PE). Two of the DVT were associated with an IVC filter. There were a total of nine VTE events in patients who did not restart anticoagulation, seven DVT and two PE. Five of the DVT were associated with an IVC filter. The two PE were both submassive events requiring ICU admission. Conclusions Recurrent VTE events are less frequent and less severe in patients who restart anticoagulation following ICH in patients with brain tumors on anticoagulation. Restarting anticoagulation after smaller ICH (trace or measurable) appears safe. However, approximately 1 in 7 patients with major initial ICH who restarted anticoagulation subsequently developed recurrent major ICH that was associated with a very high mortality rate. This raises serious questions as to the safety of restarting therapeutic anticoagulation following major hemorrhage in the setting of brain tumors. Disclosures Neuberg: Pharmacyclics: Research Funding; Madrigal Pharmaceuticals: Equity Ownership; Celgene: Research Funding. Zwicker:Quercegen: Research Funding; Daiichi: Consultancy; Seattle Genetics: Consultancy; Parexel: Consultancy; Incyte: Research Funding; Bayer: Consultancy; Portola: Consultancy.

Treatment and Long-Term Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer: An International Prospective Cohort Study

2019 ◽  
Vol 37 (20) ◽  
pp. 1713-1720 ◽  
Author(s):  
Noémie Kraaijpoel ◽  
Suzanne M. Bleker ◽  
Guy Meyer ◽  
Isabelle Mahé ◽  
Andrés Muñoz ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Cohort Study ◽  
Venous Thromboembolism ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Patients With Cancer ◽  
Incidental Pulmonary Embolism ◽  
Recurrent Venous Thromboembolism

PURPOSE Pulmonary embolism is incidentally diagnosed in up to 5% of patients with cancer on routine imaging scans. The clinical relevance and optimal therapy for incidental pulmonary embolism, particularly distal clots, is unclear. The aim of the current study was to assess current treatment strategies and the long-term clinical outcomes of incidentally detected pulmonary embolism in patients with cancer. PATIENTS AND METHODS We conducted an international, prospective, observational cohort study between October 22, 2012, and December 31, 2017. Unselected adults with active cancer and a recent diagnosis of incidental pulmonary embolism were eligible. Outcomes were recurrent venous thromboembolism, major bleeding, and all-cause mortality during 12 months of follow-up. Outcome events were centrally adjudicated. RESULTS A total of 695 patients were included. Mean age was 66 years and 58% of patients were male. Most frequent cancer types were colorectal (21%) and lung cancer (15%). Anticoagulant therapy was initiated in 675 patients (97%), of whom 600 (89%) were treated with low-molecular-weight heparin. Recurrent venous thromboembolism occurred in 41 patients (12-month cumulative incidence, 6.0%; 95% CI, 4.4% to 8.1%), major bleeding in 39 patients (12-month cumulative incidence, 5.7%; 95% CI, 4.1% to 7.7%), and 283 patients died (12-month cumulative incidence, 43%; 95% CI, 39% to 46%). The 12-month incidence of recurrent venous thromboembolism was 6.4% in those with subsegmental pulmonary embolism compared with 6.0% in those with more proximal pulmonary embolism (subdistribution hazard ratio, 1.1; 95% CI, 0.37 to 2.9; P = .93). CONCLUSION In patients with cancer with incidental pulmonary embolism, risk of recurrent venous thromboembolism is significant despite anticoagulant treatment. Patients with subsegmental pulmonary embolism seemed to have a risk of recurrent venous thromboembolism comparable to that of patients with more proximal clots.

scholarly journals J-ministernotomy for aortic valve replacement: a retrospective cohort study

2021 ◽  
Vol 29 (1) ◽  
Author(s):  
Mohammad A. Torky ◽  
Amr A. Arafat ◽  
Hosam F. Fawzy ◽  
Abdelhady M. Taha ◽  
Ehab A. Wahby ◽  
...  
Keyword(s):  
Cohort Study ◽  
Aortic Valve ◽  
Aortic Valve Replacement ◽  
Valve Replacement ◽  
Permanent Pacemaker ◽  
Safe Alternative ◽  
Free Survival ◽  
Pacemaker Insertion ◽  
Cardiac Operations ◽  
Low Ejection Fraction

Abstract Background The advantage of minimally invasive sternotomy (MS) over full sternotomy (FS) for isolated aortic valve replacement (AVR) is still controversial. We aimed to examine if J-shaped MS is a safe alternative to FS in patients undergoing primary isolated AVR. This study is a retrospective and restricted cohort study that included 137 patients who had primary isolated AVR from February 2013 to June 2015. Patients with previous cardiac operations, low ejection fraction (< 40%), infective endocarditis, EuroSCORE II predicted mortality > 10%, and patients who had inverted T or inverted C-MS or right anterior thoracotomy were excluded. Patients were grouped into the FS group (n=65) and MS group (n=72). Preoperative variables were comparable in both groups. The outcome was studied, balancing the groups by propensity score matching. Results Seven (9%) patients in the MS group were converted to FS. Cardiopulmonary bypass (98.5 ± 29.3 vs. 82.1 ± 13.95 min; p ≤ 0.001) and ischemic times (69.1 ± 23.8 vs. 59.6 ± 12.2 min; p = 0.001) were longer in MS. The MS group had a shorter duration of mechanical ventilation (10.1 ± 11.58 vs. 10.9 ± 6.43 h; p = 0.045), ICU stay (42.74 ± 40.5 vs. 44.9 ± 39.3; p = 0.01), less chest tube drainage (385.3 ± 248.6 vs. 635.9 ± 409.6 ml; p = 0.001), and lower narcotics use (25.14 ± 17.84 vs. 48.23 ± 125.68 mg; p < 0.001). No difference was found in postoperative heart block with permanent pacemaker insertion or atrial fibrillation between groups (p = 0.16 and 0.226, respectively). Stroke, renal failure, and mortality did not differ between the groups. Reintervention-free survival at 1, 3, and 4 years was not significantly different in both groups (p = 0.73). Conclusion J-ministernotomy could be a safe alternative to FS in isolated primary AVR. Besides the cosmetic advantage, it could have better clinical outcomes without added risk.

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