Subgroup Analysis of Patients with Cancer in Xalia - a Non-Interventional Study of Rivaroxaban in Routine Treatment of Deep Vein Thrombosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 1438-1438 ◽  
Author(s):  
Alexander G G Turpie ◽  
Lorenzo G Mantovani ◽  
Sylvia Haas ◽  
Reinhold Kreutz ◽  
Danja Monje ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Incidence Rates ◽  
Vein Thrombosis ◽  
All Cause Mortality ◽  
Recurrent Vte ◽  
Deep Vein ◽  
Active Cancer

Abstract Background: XALIA is a prospective, non-interventional study of rivaroxaban in the treatment of acute deep vein thrombosis. The overall XALIA results showed that rivaroxaban was associated with similarly low rates of major bleeding and symptomatic recurrent venous thromboembolism (VTE) as standard anticoagulation. A subset of patients in XALIA had active cancer at the time of enrolment into the study. Purpose: To describe the demographics, clinical characteristics, treatment strategies and outcomes of patients in XALIA with cancer and VTE. The primary outcomes were major bleeding, recurrent VTE and all-cause mortality. Methods: Patients with deep vein thrombosis with or without concomitant pulmonary embolism aged ≥18 years who had active cancer and were scheduled to receive ≥3 months of anticoagulation with rivaroxaban or standard therapy were eligible. Therapy type, dose and duration were at the physician's discretion. For the purpose of this substudy, we defined the following treatment cohorts: rivaroxaban cohort (patients treated with rivaroxaban alone or who received heparin/fondaparinux for ≤48 hours before switching to rivaroxaban); early switchers cohort (patients treated with rivaroxaban who received heparin/fondaparinux for >48 hours-14 days and/or a vitamin K antagonist [VKA] for 1-14 days before changing to rivaroxaban); standard anticoagulation cohort (patients treated with heparin/fondaparinux and a VKA or a VKA only); and heparin/fondaparinux cohort (patients treated with heparin/fondaparinux alone). Results: Of 5136 patients in XALIA who received study medication, 587 (11.4%) had active cancer at baseline. Of these, 146 (24.9%) received rivaroxaban, 30 (5.1%) were early switchers, 167 (28.4%) received standard anticoagulation (of which 26 [4.4%] received a VKA only) and 244 (41.6%) received heparin/fondaparinux only, of whom 223 (38.0%) received low molecular weight heparin and the remainder other heparins or fondaparinux. Demographics are shown in Table 1. The most common type of active cancer at baseline in all cohorts was genitourinary, with the exception of the heparin/fondaparinux cohort where gastrointestinal cancer was the most common type (Table 2). The incidence rates for the primary outcomes for each cohort are shown in Figure 1. The rates of major bleeding were highest in the standard anticoagulation cohort (n=8 [4.8%]) and lowest in the early switchers (no major bleeding events occurred). The rates of recurrent VTE were similar in the in the rivaroxaban, early switcher and standard anticoagulation cohorts (n=5 [3.4%], n=1 [3.3%] and n=6 [3.6%], respectively) and were highest in the heparin/fondaparinux cohort (n=12 [4.9%]). All-cause mortality was highest in the heparin/fondaparinux cohort (n=61 [25.0%]) and lowest in the early switchers (no deaths occurred). Conclusions: In the real-world XALIA study, 38.0% of patients with cancer received treatment with low molecular weight heparin, which was in line with guidelines. The remaining patients received rivaroxaban, standard anticoagulation or were early switchers. For the three primary outcomes, the lowest incidence rates were observed in the early switcher cohort. The highest rates were in the standard anticoagulation cohort for major bleeding and the heparin/fondaparinux cohort for recurrent VTE and all-cause mortality; rates for all three primary outcomes were low in the rivaroxaban cohort, suggesting that rivaroxaban may be a safe and effective treatment option for patients with VTE and active cancer. Figure 1 Primary outcomes in patients with active cancer at baseline by treatment group. VTE, venous thromboembolism. Figure 1. Primary outcomes in patients with active cancer at baseline by treatment group. / VTE, venous thromboembolism. Disclosures Turpie: Janssen Research & Development, LLC: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria. Mantovani:Janssen-Cilag Ltd: Research Funding; Boehringer Ingelheim: Research Funding; Daiichi Sankyo: Consultancy; Bayer Pharma AG: Consultancy; Pfizer Inc: Research Funding. Haas:Sanofi SA: Consultancy; Pfizer Inc: Consultancy; Daiichi Sankyo: Consultancy; Bristol-Myers Squibb: Consultancy; Bayer Pharma AG: Consultancy; Aspen Pharmacare: Consultancy. Kreutz:Bayer Pharma AG: Honoraria; Servier Laboratories Ltd: Consultancy; Lundbeck Ltd: Consultancy; Daiichi Sankyo: Consultancy; Berlin-Chemie Menarini: Consultancy; Bayer Pharma AG: Consultancy; Bristol-Myers Squibb: Honoraria; Daiichi Sankyo: Honoraria. Monje:Bayer Pharma AG: Employment. Schneider:Bayer Pharma AG: Employment. van Eickels:Bayer Pharma AG: Employment. Gebel:Bayer Pharma AG: Employment. Ageno:Boehringer Ingelheim: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Bayer Pharmaceuticals: Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Bayer Pharma AG: Consultancy, Honoraria.

Comparative study on risk factors and early outcome of symptomatic distal versus proximal deep vein thrombosis: Results from the OPTIMEV study

2009 ◽  
Vol 102 (09) ◽  
pp. 493-500 ◽  
Author(s):  
Marie-Antoinette Sevestre-Pietri ◽  
Jean-Luc Bosson ◽  
Jean-Pieere Laroche ◽  
Marc Righini ◽  
Dominique Brisot ◽  
...  
Keyword(s):  
Risk Factors ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Lower Limbs ◽  
Early Outcome ◽  
Vein Thrombosis ◽  
Recurrent Venous Thromboembolism ◽  
Deep Vein ◽  
Active Cancer

SummaryThere is a lack of consensus on the value of detecting and treating symptomatic isolated distal deep-vein thrombosis (DVT) of the lower limbs. In our study, we compared the risk factors and outcomes in patients with isolated symptomatic distal DVT with those with proximal symptomatic DVT. We analysed the data of patients with objectively confirmed symptomatic isolated DVT enrolled in the national (France), multicenter, prospective OPTIMEV study.This sub-study outcomes were recurrent venous thromboembolism, major bleeding and death at three months. Among the 6141 patients with suspicion of isolated DVT included between November 2004 and January 2006, DVT was confirmed in 1643 patients (26.8%). Isolated distal DVT was more frequent than proximal DVT (56.8% vs. 43.2%, respectively; p=0.01). Isolated distal DVT was significantly more often associated with transient risk factors (recent surgery, recent plaster immobilisation, recent travel), whereas proximal DVT was significantly more associated with more chronic states (active cancer, congestive heart failure or respiratory insufficiency, age >75 years). Most patients (96.8%) with isolated distal DVT received anticoagulant therapies.There was no difference in the percentage of recurrent venous thromboembolism and major bleeding in patients with proximal DVT and isolated distal DVT. However, the mortality rate was significantly higher (p<0.01) in patients with proximal DVT (8.0%) than in those with isolated distal DVT (4.4%). Symptomatic isolated distal DVT differs from symptomatic proximal DVT both in terms of risk factors and clinical outcome. Whether these differences should influence the clinical management of these two events remains to be determined.

scholarly journals Long-term recurrence of venous thromboembolism after short-term treatment of symptomatic isolated distal deep vein thrombosis: A cohort study

2017 ◽  
Vol 22 (6) ◽  
pp. 518-524 ◽  
Author(s):  
Marco P Donadini ◽  
Francesco Dentali ◽  
Samuela Pegoraro ◽  
Fulvio Pomero ◽  
Chiara Brignone ◽  
...  
Keyword(s):  
Cohort Study ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Term Treatment ◽  
Short Term ◽  
Short Term Treatment ◽  
Vein Thrombosis ◽  
Recurrent Vte ◽  
Deep Vein

Isolated distal deep vein thrombosis (IDDVT) is a common clinical manifestation of venous thromboembolism (VTE). However, there are only scant and heterogeneous data available on the long-term risk of recurrent VTE after IDDVT, and the optimal therapeutic management remains uncertain. We carried out a retrospective cohort study of consecutive patients diagnosed with symptomatic IDDVT between 2004 and 2011, according to a predefined short-term treatment protocol (low molecular weight heparin (LMWH) for 4–6 weeks). The primary outcome was the occurrence of recurrent VTE. A total of 321 patients were enrolled. IDDVT was associated with a transient risk factor or cancer in 165 (51.4%) and 56 (17.4%) patients, respectively. LMWH was administered for 4–6 weeks to 280 patients (87.2%), who were included in the primary analysis. Overall, during a mean follow-up of 42.3 months, 42 patients (15%) developed recurrent VTE, which occurred as proximal DVT or PE in 21 cases. The recurrence rate of VTE per 100 patient-years was 3.5 in patients with transient risk factors, 7.2 in patients with unprovoked IDDVT, and 5.9 in patients with cancer ( p=0.018). At multivariable analysis, unprovoked IDDVT and previous VTE were significantly associated with recurrent VTE (HR 2.16, 95% CI 1.12–4.16 and HR 1.97, 95% CI 1.01–3.86, respectively). In conclusion, the long-term risk of recurrent VTE after IDDVT treated for 4–6 weeks is not negligible, in particular in patients with unprovoked IDDVT or cancer. Further studies are needed to clarify whether a longer, but definite treatment duration effectively prevents these recurrences.

The Optimal Duration of Anticoagulant Therapy In Patients with Cancer-Related Deep Vein Thrombosis: The Advantage of Using Residual Vein Thrombosis (the Cancer-DACUS Study)

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 190-190 ◽  
Author(s):  
Sergio Siragusa ◽  
Alessandra Malato ◽  
Doris Mascheroni ◽  
Walter Ageno ◽  
Eugenio Bucherini ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Recurrent Events ◽  
Lower Limbs ◽  
Vein Thrombosis ◽  
Optimal Duration ◽  
Group B ◽  
Deep Vein ◽  
Active Cancer

Abstract Abstract 190 Type and duration of anticoagulation is still matter of debate in cancer patients with acute Deep Vein Thrombosis (DVT) of the lower limbs. Residual Vein Thrombosis (RVT) has been proven to be effective for assessing the optimal duration of oral anticoagulants in non cancer patients (Siragusa S et al Blood 2008:112:511-5). In the present study we evaluate the role of a RVT-based management of anticoagulation with Low-Molecular Weight Heparin in cancer patients with acute DVT. Materials and Methods. Patients with active cancer and a first episode of DVT were treated with LMWH for 6 months (the first month at full dosage followed by dose reduction of 25% in the next 5 months). At the end of treatment, they were managed according to RVT findings: those with RVT were randomized to continue anticoagulants for 6 additional months (Group A1) or to stop it (Group A2), while patients without RVT stopped LMWH (Group B). Outcomes were recurrent venous thromboembolism and/or major bleeding; patients were followed up for one year after LMWH discontinuation. Results. Over a period of 36 months, 409 patients were evaluated; 62 were excluded (refusal, need for continuing anticoagulation, etc). In total, 347 were included in the study (Table 1). RVT was detected in 242 (69.7%) patients; recurrent events occurred in 21.9% of those randomized to discontinue and 14.2% of those who continued LMWH. In patients without RVT (105, 30.3%), recurrent events occurred in 3 cases (2.8%) (Table 2 and Figure 1). The adjusted Hazard Ratio (HR) for age and sex between RVT groups (Group A2 vs A1) was 1.58 (95% confidence interval [CI], 0.85–2.93; P=.145). The adjusted HR between group A1 versus RVT-negative group (B) was 4.54 (CI 2.3–6.66; P =.028). Five major bleeding events occurred in Group A1 and two events both in Group A2 and B (Table 2). Overall, 89 (25.6%) patients died due to cancer progression after a median follow-up of 10.2 months after heparin withdrawn. Conclusions. The Cancer DACUS is the first ever study evaluating an individual marker for assessing duration of anticoagulation in active cancer population. Final results of the study show that absence of RVT identifies a group of patients at low risk for recurrent thrombosis who can safely stop LMWH after 6 months. Disclosures: No relevant conflicts of interest to declare.

Once- or Twice-Daily Rivaroxaban for the Treatment of Proximal Deep Vein Thrombosis: Similar Efficacy and Safety to Standard Therapy in Dose-Ranging Studies.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 572-572 ◽  
Author(s):  
Harry R. Büller ◽  
Giancarlo Agnelli ◽  
Keyword(s):  
Deep Vein Thrombosis ◽  
Secondary Prevention ◽  
Major Bleeding ◽  
Standard Therapy ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Vein Thrombosis ◽  
Dose Ranging ◽  
Recurrent Vte ◽  
Deep Vein

Abstract Rivaroxaban (BAY 59–7939) is an oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of venous and arterial thromboembolic disorders. Two phase IIb, randomized, dose-ranging studies were performed to investigate the efficacy and safety of rivaroxaban, relative to open-label standard therapy (LMWH/heparin+vitamin K antagonist), for the initial treatment and secondary prophylaxis of deep vein thrombosis (DVT). The EINSTEIN-DVT study included 543 patients with acute, symptomatic, objectively confirmed proximal DVT, without symptomatic pulmonary embolism (PE), who received rivaroxaban 20, 30, or 40 mg once daily (od) or standard therapy. The ODIXa-DVT study (n=613) included similar patients who received rivaroxaban 10, 20, 30 mg twice daily (bid), or 40 mg od, or standard therapy. Patients had a quantitative ultrasound (US) and a perfusion lung scan (PLS) at baseline, and after 3 weeks’ treatment in ODIXa-DVT and 3 months’ treatment in EINSTEIN-DVT. The efficacy outcome was the composite of venous thromboembolism (VTE) - objectively confirmed, symptomatic recurrent DVT or symptomatic, fatal or non-fatal PE - and asymptomatic deterioration on the repeat US or PLS at 3 weeks (ODIXa-DVT), or 3 months (EINSTEIN-DVT). Bleeding was classed as major; clinically relevant, non-major; or minor in EINSTEIN-DVT, and major or minor in ODIXa-DVT. EINSTEIN-DVT: Symptomatic, recurrent VTE or deterioration of US or PLS at 3 months occurred in 6.0%, 5.4%, and 6.6% of patients receiving rivaroxaban 20, 30, and 40 mg od, respectively, and in 9.9% of patients receiving standard therapy. ODIXa-DVT: Symptomatic, recurrent VTE or deterioration of US or PLS at 3 weeks occurred in 3.0%, 4.3%, 5.7%, and 4.8% of patients receiving rivaroxaban 10, 20, 30 mg bid, and 40 mg od, respectively, and in 2.9% of patients receiving standard therapy. Symptomatic, recurrent VTE at 3 months occurred in 1.0%, 1.0%, 0.9%, 1.8%, and 0.9% of patients receiving rivaroxaban 10, 20, 30 mg bid, 40 mg od, and standard therapy, respectively. Improvement in thrombotic burden by US or PLS at 3 weeks was observed in 71.7%, 69.1%, 67.9%, and 58.1% of patients receiving rivaroxaban 10, 20, 30 mg bid, and 40 mg od, respectively, and in 61.2% of patients receiving standard therapy. The incidence of major bleeding was low in both studies at 3 months (Table). In conclusion, rivaroxaban, given od or bid over a wide dose range, was as effective and safe as standard therapy for the treatment of acute, symptomatic DVT. At 3 weeks, the bid regimens were associated with greater improvement in the thrombotic burden than the od regimen, possibly because of higher rivaroxaban trough levels with bid dosing. At 3 months, the bid and od regimens performed similarly, compared with standard therapy. Therefore, rivaroxaban can be used for both the primary treatment and secondary prevention of VTE. For secondary prevention, these data support the use of long-term rivaroxaban 20 mg od for phase III studies. Rivaroxaban (total daily dose) Standard therapy 20 mg 30 mg 40 mg 60 mg *Secondary outcome; **results are shown as 20 mg bid/40 mg od ODIXa-DVT (bid) Recurrent VTE or deterioration in US at 3 months* 1.1% - 1.1%/3.0%** 1.0% 1.0% Major bleeding 1.7% - 1.7%/1.7%** 3.3% 0% EINSTEIN-DVT (od) Recurrent VTE or deterioration in US or PLS at 3 months 6.1% 5.4% 6.6% - 9.9% Major bleeding 0.7% 1.5% 0% - 1.5%

Residual Vein Obstruction (RVO) Predicts Recurrence for Cancer Patients with Secondary VTE: A Meta-Analysis.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2259-2259
Author(s):  
Murali Janakiram ◽  
Matt R Sullivan ◽  
Marina Shcherba ◽  
Shuang Guo ◽  
Henny Heisler Billett
Keyword(s):  
Clinical Trials ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Cancer Patients ◽  
Meta Analysis ◽  
Vein Thrombosis ◽  
Patients With Cancer ◽  
Recurrent Vte ◽  
Deep Vein ◽  
Residual Vein Obstruction

Abstract Abstract 2259 Background: Venous thrombosis is a common disease and long term anticoagulation is effective in the prevention of venous thromboembolism (VTE). Studies to detect residual vein obstruction (RVO) performed at the end of the anticoagulation period has been investigated as a predictive marker for recurrent thrombotic risk. The value of this test has been questioned, and different methodologies, different patient populations, and varying lengths of prior anticoagulation may be responsible for the disparate results published. In order to assess the true predictive worth of RVO we performed a meta-analysis of published studies to determine whether RVO can predict the risk of recurrent VTE. Methods: A comprehensive literature search with the terms “deep vein thrombosis”, “residual vein thrombosis“, and “recurrent venous thromboembolism” was performed on PubMed, MEDLINE, EMBASE, Web of Science, the Cochrane dataset, Science Direct and CINAHL. Clinical trials published in English between January 1990 and December 2011 were eligible for this analysis. The selection of abstracts was based on the following criteria: studies had to be prospective, VTE patients had to have been anticoagulated with unfractionated heparin, low molecular weight heparin or warfarin for at least 6 weeks, and the presence of RVO and recurrent thromboembolic events had to have been recorded. The diagnosis of RVO was allowed if 1) a venous thrombosis of >2mm was present 2) the thrombus occupied >40% of vein diameter or 3) the presence of positive thrombosis on duplex was noted. Recurrent events were defined if a new contralateral deep vein thrombosis (DVT), a new ipsilateral DVT (if the prior DVT was documented to be recanalised) or a new PE (documented by perfusion scan, Computed Tomographic Angiography or pulmonary angiography) was noted. Data were analyzed with STATS Direct meta-analysis software. Analyses were performed for the whole VTE population as well as for unprovoked and provoked VTE cohorts. A sub-analysis of patients with cancer within the provoked cohort was performed. Odds Ratios (OR) with 95% confidence intervals were calculated for individual studies and Forrest plots were generated. Results: We identified 1955 potential publications, of which 28 were relevant. Thirteen studies met inclusion criteria and were included in the final analysis. 4546 patients, mean age 61years, with 3476 events were included. Five studies were prospective studies which recruited patients with only primary VTE, four studies examined secondary VTE only and four studies investigated both primary and secondary VTE. For all patients with VTE, primary and secondary, the presence of RVO was associated with a significantly higher recurrent VTE risk (OR 1.93. 95%CI: 1.29 –2.89, p = 0.001). When analyzed separately for primary VTE, RVO did not demonstrate a statistically significant increased recurrent VTE risk (OR 1.38, 95%CI: 0.87 – 2.08), results consistent with prior observations. When results were analyzed for patients with secondary VTE, the OR was 2.78 (95% CI: 1.4 – 5.5, p= 0.003). However, when patients with cancer were eliminated from the secondary VTE cohort, the OR decreased to 1.73 and was no longer significant (95% CI: 0.82 – 3.66). In contrast, for the two studies with cancer patients, the odds ratio for recurrent VTE given a positive RVO study was 5.14 (95% CI: 1.59 – 16.65 p = 0.006). While RVO studies showed recanalization and/or normalization after 6 months in 93% of post-operative patients, recanalization occurred in only 53% of patients who were treated for cancer, only 20% of patients with active cancer had negative RVO studies. Conclusions: A meta-analysis of 13 studies examining the predictive value of RVO studies did not detect significant utility for patients with primary VTE. RVO predicted recurrence in secondary VTE but subset analysis demonstrated that RVO seems to have predictive value primarily in the subgroup of patients with cancer. Current ACCP and NCCN guidelines for thrombosis in cancer differ in their recommemdation for duration of anticoagulation but both recommend extended anticoagulant therapy. A negative RVO study might reliably predict a group which might not need extended anticoagulation. Further prospective clinical trials are needed determining the utility of RVO in cancer patients with VTE. Disclosures: No relevant conflicts of interest to declare.

Safety and effectiveness of rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis in routine clinical practice

Phlebologie ◽  
2016 ◽  
Vol 45 (04) ◽  
pp. 187-193 ◽  
Author(s):  
S. Haas ◽  
R. Kreutz ◽  
M. Gebel ◽  
J. Herold ◽  
J. Schneider ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Clinical Practice ◽  
Major Bleeding ◽  
Term Treatment ◽  
Routine Clinical Practice ◽  
Vein Thrombosis ◽  
Long Term Treatment ◽  
All Cause Mortality ◽  
Deep Vein

SummaryIn addition to parenteral anticoagulants and vitamin K antagonists (standard AC), non-vitamin K antagonist oral anticoagulants (NOAC) are increasingly being used for the acute and long-term treatment of deep vein thrombosis (DVT).The international, prospective, non-interventional XALIA study compared the acute and long-term treatment of DVT with rivaroxaban or standard AC under routine clinical practice and confirmed the safety and efficacy of rivaroxaban demonstrated in Phase III studies: annual event rates for major bleeding, VTE and all-cause mortality were 1.2 %, 2.4 % and 0.8 % respectively, compared to 3.4 %, 3.9 %, and 6.2 % with standard AC.The XALIA-DE subgroup analysis examined whether the XALIA results were applicable to Germany. The 586 rivaroxaban patients were younger and fewer had active cancer than the 355 treated with standard AC. As in XALIA, the incidence of major bleeding (1.6 vs. 4.1/100 patient-years [PY]), recurrent VTE (1.9 vs. 4.7/100 PY) and all-cause mortality (1.6 vs. 6.8/100 PY) were lower under rivaroxaban than under standard AC. These rates indicate a favourable benefit-risk profile of rivaroxaban under the conditions of everyday practice.

scholarly journals Duration of anticoagulation after isolated pulmonary embolism

2016 ◽  
Vol 47 (5) ◽  
pp. 1429-1435 ◽  
Author(s):  
Gualtiero Palareti ◽  
Benilde Cosmi ◽  
Emilia Antonucci ◽  
Cristina Legnani ◽  
Nicoletta Erba ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Subgroup Analysis ◽  
Italian Study ◽  
Index Event ◽  
Vein Thrombosis ◽  
Recurrent Vte ◽  
Deep Vein ◽  
D Dimer

In the D-dimer and ULtrasonography in Combination Italian Study (DULCIS), serial D-dimer measurement in combination with assessment of residual thrombosis (in patients with deep vein thrombosis (DVT)) identified patients who safely discontinued anticoagulation after an unprovoked venous thromboembolism (VTE).In this subgroup analysis, the value of D-dimer tests was assessed in patients with isolated pulmonary embolism (PE) compared with those with DVT, with or without PE (DVT/PE). The DULCIS database was reanalysed in relation to this target.26.8% of the DULCIS patients had isolated PE as the index event; this was more prevalent in females (34.1%) than in males (21.1%; p<0.0001). The rate of positive D-dimer was similar in isolated PE and DVT/PE. The rate of recurrences was not different in isolated PE or DVT/PE patients (4.8% ppy versus 3.8% ppy; nonsignificant) who stopped anticoagulation for negative D-dimer, but it was markedly high (11.2% ppy; p<0.0001) in those with isolated PE who remained without anticoagulation despite positive D-dimer. Recurrences were more frequently new isolated PE in patients with isolated PE than with DVT/PE (six (46.2%) out of 13 versus two (7.4%) out of 27; p=0.0085).Serial D-dimer assessment can inform on the risk of recurrent VTE and help determine the duration of anticoagulation in patients with isolated PE.

scholarly journals Isolated Distal Deep Vein Thrombosis: Perspectives from the GARFIELD-VTE Registry

2019 ◽  
Vol 119 (10) ◽  
pp. 1675-1685 ◽  
Author(s):  
Sebastian M. Schellong ◽  
Samuel Z. Goldhaber ◽  
Jeffrey I. Weitz ◽  
Walter Ageno ◽  
Henri Bounameaux ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Anticoagulant Therapy ◽  
Vein Thrombosis ◽  
Risk Of Death ◽  
Global Trend ◽  
Incident Cancer ◽  
All Cause Mortality ◽  
Distal Deep Vein Thrombosis ◽  
Deep Vein ◽  
Active Cancer

AbstractIsolated distal deep vein thrombosis (IDDVT) represents up to half of all lower limb DVT. This study investigated treatment patterns and outcomes in 2,145 patients with IDDVT in comparison with those with proximal DVT (PDVT; n = 3,846) and pulmonary embolism (PE; n = 4,097) enrolled in the GARFIELD-VTE registry. IDDVT patients were more likely to have recently undergone surgery (14.6%) or experienced leg trauma (13.2%) than PDVT patients (11.0 and 8.7%, respectively) and PE patients (12.7 and 4.5%, respectively). Compared with IDDVT, patients with PDVT or PE were more likely to have active cancer (7.2% vs. 9.9% and 10.3%). However, influence of provoking factors on risk of recurrence in IDDVT remains controversial. Nearly all patients (IDDVT, PDVT, and PE) were given anticoagulant therapy. In IDDVT, PDVT, and PE groups the proportion of patients receiving anticoagulant therapy was 61.4, 73.9, and 81.1% at 6 months and 45.8, 54.7, and 61.9% at 12 months. Over 12 months, the incidence of all-cause mortality, cancer, and recurrence was significantly lower in IDDVT patients than PDVT patients (hazard ratio [HR], 0.61 [95% confidence interval [CI], 0.48–0.77]; sub-HR [sHR], 0.60 [95% CI, 0.39–0.93]; and sHR, 0.76 [95% CI, 0.60–0.97]). Likewise, risk of death and incident cancer was significantly (both p < 0.05) lower in patients with IDDVT compared with PE. This study reveals a global trend that most IDDVT patients as well as those with PDVT and PE are given anticoagulant therapy, in many cases for at least 12 months.

scholarly journals Cancer-Associated Deep Vein Thrombosis: The Role of Residual Vein Thrombosis for Assessing the Duration of Low Molecular Weight Heparin (the EXTENDED Cancer-DACUS)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4277-4277
Author(s):  
Mariasanta Napolitano ◽  
Giorgia Saccullo ◽  
Simona Raso ◽  
Salvatrice Mancuso ◽  
Alessandra Casuccio ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Deep Vein Thrombosis ◽  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Low Molecular Weight ◽  
Recurrent Thrombosis ◽  
Bleeding Events ◽  
Vein Thrombosis ◽  
Recurrent Vte ◽  
Deep Vein

Abstract Introduction. The optimal duration of Low Molecular Weight Heparin (LMWH) after cancer associated deep vein thrombosis (DVT) is unknown; current guidelines suggest to prolong anticoagulation until cancer is active. We have recently demonstrated, in a randomized trial, that detection of Residual Vein Thrombosis (RVT) after 6 months of LMWH identify patients who require or not extension of therapy with anticoagulants (JCO in press). Now we present data of a prospective study evaluating a RVT-based management of patients with cancer-associated DVT, in whom LMWH has been extended up to 2 years in patients considered at high-risk for recurrent DVT because of persistence of RVT. Material and Methods. Patients were included at the time of a first diagnosis of cancer-associated DVT of the lower limbs. All received LMWH at therapeutic dosage for the first month (approximately 100 UI anti-FXa b.i.d.) then reduced at 75% for the following months. After 6 months of heparin, the presence of RVT was detected: those without RVT (no-RVT group) suspended treatment, while those with RVT (RVT group) continued LMWH for up to 2 years. Recurrent thrombosis and/or bleeding events were recorded during treatment and one year after LMWH withdrawal. Baseline differences between groups were assessed by the chi-square test (Yates’ correction) for categorical variables and ANOVA test or Kruskal-Wallis test for parametric and nonparametric analyses. Relative risks (RRs) and 95% confidence intervals (CIs) were evaluated. Results. Between January 2009 and April 2011, 211 cancer patients were enrolled; RVT was detected in 129 patients (61.1%). Recurrent VTE occurred in 19 (14.7%); 4 episodes (3.1%) occurred while on heparin. Among patients without RVT (82), 3 (3.6%) developed recurrent VTE (after LMWH therapy). Adjusted HR for RVT vs no-RVT group was 5.8 (95% CI, 1.9 to 19.2; p 0.0003). Three major bleeding events occurred in RVT group and one in no-RVT group (during LMWH administration). The HR for major bleeding (RVT vs no-RVT group) was 2.58 (95% CI, 0.66 to 12.43;p 0.103). Overall, 44 patients (20.8%) died during follow-up as a result of cancer progression. Conclusions. These results indicate that in patients without RVT, a short period of treatment with a LMWH is sufficient; in those with persistent RVT, treatment extended to 2 years substantially reduces, but does not eliminate, the risk of recurrent thrombosis. However, when still on LMWH, the risk for recurrent VTE is low. Disclosures No relevant conflicts of interest to declare.

scholarly journals Systematic Screening for Deep Vein Thrombosis in Critically Ill Inpatients With COVID-19: Impact on the Incidence of Venous Thromboembolism

2021 ◽  
Vol 7 ◽  
Author(s):  
François-Xavier Lapébie ◽  
Vincent Minville ◽  
Agnès Ribes ◽  
Bertrand Combis ◽  
Arthur Thery ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Cumulative Incidence ◽  
Randomized Study ◽  
University Hospital ◽  
Open Label ◽  
Systematic Screening ◽  
Vein Thrombosis ◽  
Deep Vein

Background: Several studies suggest an increased incidence of thrombosis in COVID-19 patients. However, evidence on how to prevent and even treat it is scarce. The aim of this study was to compare the cumulative incidence of venous thromboembolism (VTE) of two different methods for lower extremity deep vein thrombosis (LE-DVT) diagnosis: systematic vs. clinically guided complete compression venous ultrasonography (CCUS). We conducted a monocentric, prospective, open-label, non-randomized study. All consecutive patients admitted in three intensive care units (ICUs) of University Hospital of Toulouse for COVID-19 pneumonia were included: one performed systematic screening for LE-DVT, the others did not. The primary outcome was the 21-day cumulative incidence of VTE. The secondary end points were the 21-day cumulative incidences of major bleeding and death.Results: Among the 78 patients included, 27 (34.6%) underwent systematic screening for DVT 7 ± 2 days after ICU admission. Thirty-two patients (41.0%) were diagnosed with VTE, with a 21-day cumulative incidence of 42.3% (95% CI, 31.4–55.2), without difference between screened and non-screened patients (hazard ratio 1.45, 95% CI, 0.72–2.93). In the screened group, the frequency of isolated DVT was higher (25.9 vs. 5.9%, p-value = 0.027), but the frequency of pulmonary embolism was not reduced (25.9 vs. 29.4%, p-value = 0.745). The 21-day cumulative incidences of major bleeding and death were 9.6% (95% CI, 4.7–19.2) and 10.3% (95% CI, 5.0–20.8), respectively, without difference between the two groups.Conclusions: A systematic screening for DVT in patients hospitalized in ICU was not associated with a higher diagnosis of VTE or a reduced diagnosis of PE.

Sign in / Sign up

Export Citation Format

Share Document