Real-life treatment of venous thromboembolism with direct oral anticoagulants: The influence of recommended dosing and regimens

2017 ◽  
Vol 117 (02) ◽  
pp. 382-389 ◽  
Author(s):  
Javier Trujillo-Santos ◽  
Pierpaolo Di Micco ◽  
Francesco Dentali ◽  
James Douketis ◽  
José Antonio Díaz-Peromingo ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Initial Therapy ◽  
Term Therapy ◽  
Long Term Therapy ◽  
Recommended Therapy

SummaryIn patients with venous thromboembolism (VTE), the influence on outcome of using direct oral anticoagulants (DOACs) at non-recommended doses or regimens (once vs twice daily) has not been investigated yet. We used the RIETE (Registro Informatizado Enfermedad TromboEmbólica) registry to compare the outcomes in patients with VTE receiving DOACs according to the recommendations of the product label versus in those receiving non-recommended doses and/or regimens. The major outcomes were the rate of VTE recurrences, major bleeding and death during the course of therapy. As of March 2016, 1635 VTE patients had received DOACs for initial therapy and 1725 for long-term therapy. For initial therapy, 287 of 1591 patients (18 %) on rivaroxaban and 22 of 44 (50 %) on apixaban did not receive the recommended therapy. For long-term therapy, 217 of 1611 patients (14 %) on rivaroxaban, 29 of 81 (36 %) on apixaban and 15 of 33 (46 %) on dabigatran did not receive the recommended therapy. During the course of therapy with DOACs, eight patients developed VTE recurrences, 14 had major bleeding and 13 died. Patients receiving DOACs at non-recommended doses and/or regimens experienced a higher rate of VTE recurrences (adjusted HR: 10.5; 95 %CI: 1.28–85.9) and a similar rate of major bleeding (adjusted HR: 1.04; 95 %CI: 0.36–3.03) or death (adjusted HR: 1.41; 95 %CI: 0.46–4.29) than those receiving the recommended doses and regimens. In our cohort, a non-negligible proportion of VTE patients received non-recommended doses and/or regimens of DOACs. This use may be associated with worse outcomes.

scholarly journals Direct Oral Anticoagulants or Standard Anticoagulant Therapy in Fragile Patients with Venous Thromboembolism

TH Open ◽  
2019 ◽  
Vol 03 (01) ◽  
pp. e67-e76 ◽  
Author(s):  
Juan López-Núñez ◽  
Ricard Pérez-Andrés ◽  
Pierpaolo Di Micco ◽  
Sebastian Schellong ◽  
Covadonga Gómez-Cuervo ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Anticoagulant Therapy ◽  
Major Bleeding ◽  
Lower Risk ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Term Therapy ◽  
Composite Outcome ◽  
Long Term Therapy

Background The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients (age ≥ 75 years and/or creatinine clearance levels ≤ 50 mL/min and/or body weight ≤ 50kg) with venous thromboembolism (VTE) has not been evaluated. Methods We used the RIETE database to compare the rates of the composite of VTE recurrences or major bleeding during anticoagulation in fragile patients with VTE, according to the use of DOACs or standard anticoagulant therapy. Results From January 2013 to April 2018, 24,701 patients were recruited. Of these, 10,054 (41%) were fragile. Initially, 473 fragile patients (4.7%) received DOACs and 8,577 (85%) low-molecular-weight heparin (LMWH). For long-term therapy, 1,298 patients (13%) received DOACs and 5,038 (50%) vitamin K antagonists (VKAs). Overall, 95 patients developed VTE recurrences and 262 had major bleeding. Patients initially receiving DOACs had a lower rate of the composite outcome (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.08–0.88) than those on LMWH. Patients receiving DOACs for long-term therapy had a nonsignificantly lower rate of the composite outcome (HR: 0.70; 95% CI: 0.46–1.03) than those on VKAs. On multivariable analysis, patients initially receiving DOACs had a nonsignificantly lower risk for the composite outcome (HR: 0.36; 95% CI: 0.11–1.15) than those on LMWH, while those receiving DOACs for long-term therapy had a significantly lower risk (HR: 0.61; 95% CI: 0.41–0.92) than those on VKAs. Conclusions Our data suggest that the use of DOACs may be more effective and safe than standard therapy in fragile patients with VTE, a subgroup of patients where the risk for bleeding is particularly high.

scholarly journals MAC Project—Monitoring Anticoagulant Therapy Observational Study: Rationale and Protocol

2021 ◽  
Vol 7 ◽  
Author(s):  
Giuseppe Camporese ◽  
Enrico Bernardi ◽  
Cristiano Bortoluzzi ◽  
Franco Noventa ◽  
Ngoc Vo Hong ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Observational Study ◽  
Major Bleeding ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Minor Bleeding ◽  
Italian Population ◽  
Serious Adverse Events ◽  
Clinical Trial Registration

Real-life studies complement data from registrative trials. Because of the delayed registration of direct oral anticoagulants in Italy, scarce real-life data on such treatments is available for the Italian population. The aim of the MAC project is to collect real-life clinical information in unselected patients given oral anticoagulants for venous thromboembolism, during a 5-year follow-up period. This is a prospective-cohort, multi-center, observational study performed in four Italian centers. The estimated samples size is 4,000 patients. The efficacy outcomes are: incidence of symptomatic recurrent venous thromboembolism and of post-thrombotic syndrome. The safety outcomes are: incidence of major bleeding, clinically relevant non-major bleeding, minor bleeding, serious adverse events, and mortality. The MAC project has the potential to improve our understanding of the epidemiology and of the therapeutic strategies adopted in Italian patients with venous thromboembolism.Clinical Trial Registration: WWW.ClinicalTrials.Gov, identifier: NCT0432939.

scholarly journals Clinical characteristics of italian patients with venous thromboembolism enrolled in the RIETE Registry

2012 ◽  
pp. 255-260
Author(s):  
Pierpaolo Di Micco ◽  
Alessandra Bura-Riviere ◽  
Renzo Poggio ◽  
Eros Tiraferri ◽  
Roberto Quintavalla ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Clinical Characteristics ◽  
Vitamin K Antagonists ◽  
Treatment Strategies ◽  
Initial Therapy ◽  
Term Therapy ◽  
Vte Prophylaxis ◽  
Fatal Bleeding ◽  
Long Term Therapy

Introduction: The clinical characteristics, treatment strategies and outcome of patients with venous thromboembolism (VTE) may vary from country to country. Materials and methods: The RIETE (Registro Informatizado su la Enfermedad TromboEmbolica) is an ongoing, prospective registry of consecutive patients with acute, objectively confirmed, symptomatic VTE. Our aim was to assess the influence of surgery and immobility for non-surgical reasons on 3-month outcomes of all Italian patients registered in the RIETE. Results: Through July 2008, 21,397 patients with acute VTE were registered in the RIETE. Of these, 896 (4.2%) were Italian, and 360 (40%) presented with pulmonary embolism (PE). Overall, 137 (15%) developed VTE after surgery; 156 (17%) developed VTE after >4 days of immobility, and 603 (67%) developed VTE in the absence of surgery or immobility. Most patients (83%) received initial therapy with low-molecular-weight heparin; 15% received unfractionated heparin. For long-term therapy, 63% of patients received vitamin K antagonists. The incidence of fatal PE during the first 3 months of therapy was 1.5% for patients with postoperative VTE, 7.7% for who developed VTE after immobility, and 1.2% for the remaining patients. The incidence of fatal bleeding among these patients was 1.5%, 1.9% and 0.3%, respectively. Of the 137 patients with postoperative VTE, 61% had received VTE prophylaxis. Of the 156 patients with recent immobility, 24% had received VTE prophylaxis. Conclusions: VTE arising after a period of immobility was associated with the highest rates of fatal PE and fatal bleeding during the first 3 months of therapy. The use of thromboprophylaxis in this population should be improved.

Venous Thromboembolism and Renal Impairment: Insights from the SWIss Venous ThromboEmbolism Registry (SWIVTER)

2019 ◽  
Vol 45 (08) ◽  
pp. 851-858 ◽  
Author(s):  
David Spirk ◽  
Tim Sebastian ◽  
Martin Banyai ◽  
Jürg H. Beer ◽  
Lucia Mazzolai ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Renal Impairment ◽  
Clinical Outcomes ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Similar Rate ◽  
Increased Risk

AbstractRenal impairment (RI) has increased substantially over the last decades. In the absence of data from confirmatory research, real-life data on anticoagulation treatment and clinical outcomes of venous thromboembolism (VTE) in patients with RI are needed. In the SWIss Venous ThromboEmbolism Registry (SWIVTER), 2,062 consecutive patients with objectively confirmed VTE were enrolled. In the present analysis, we compared characteristics, initial and maintenance anticoagulation, and adjusted 90-day clinical outcomes of those with (defined as estimated creatinine clearance < 30 mL/min) and without severe RI. Overall, 240 (12%) patients had severe RI; they were older, and more frequently had chronic and acute comorbidities. VTE severity was similar between patients with and without severe RI. Initial anticoagulation in patients with severe RI was more often performed with unfractionated heparin (44 vs. 24%), and less often with low-molecular-weight heparin (LMWH) (52 vs. 61%) and direct oral anticoagulants (DOACs; 4 vs. 12%). Maintenance anticoagulation in patients with severe RI was more frequently managed with vitamin K antagonists (70 vs. 60%) and less frequently with DOAC (12 vs. 21%). Severe RI was associated with increased risk of 90-day mortality (9.2 vs. 4.2%, hazard ratio [HR]: 2.27, 95% confidence interval [CI]: 1.41–3.65), but with similar risk of recurrent VTE (3.3 vs. 2.8%, HR: 1.19, 95% CI: 0.57–2.52) and major bleeding (2.1 vs. 2.0%, HR: 1.05, 95% CI: 0.41–2.68). In patients with severe RI, the use of LMWH versus any other treatment was associated with reduced mortality (HR: 0.37; 95% CI: 0.14–0.94; p = 0.036) and similar rate of major bleeding (HR: 0.59, 95% CI: 0.17–2.00; p = 0.39). Acute or chronic comorbidities rather than VTE severity or recurrence may explain increased early mortality in patients with severe RI. The higher rate of VTE recurrence, specifically fatal events, than major bleeding reinforces the need for effective anticoagulation in VTE patients with severe RI.

Long-term therapy with low-molecular-weight heparin in cancer patients with venous thromboembolism

2012 ◽  
Vol 107 (01) ◽  
pp. 37-43 ◽  
Author(s):  
Pablo Marchena ◽  
José Nieto ◽  
María Guil ◽  
Ferrán García-Bragado ◽  
Ramón Rabuñal ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Propensity Score ◽  
Cancer Patients ◽  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Term Therapy ◽  
Low Molecular Weight ◽  
Long Term Therapy

SummaryLong-term therapy with low-molecular-weight heparin (LMWH) is the treatment of choice for cancer patients with venous thromboembolism (VTE). However, the ideal doses of LMWH have not been thoroughly studied. We used the RIETE Registry data to assess the influence of the daily LMWH dosage on outcome during the first three months after VTE. We used propensity score-matching to compare patients who received <150 vs. those receiving ≥150 UI/kg/day LMWH. Up to July 2010, 3,222 cancer patients with VTE received long-term therapy with fixed doses of LMWH. Of these, 1,472 (46%) received <150 IU/kg/day (mean, 112 ± 28), and 1,750 received ≥150 IU/kg/day (mean, 184 ± 32). Results of the propensity score matching involved 1269 matched pairs. During follow-up, the incidence of pulmonary embolism (PE) recurrences was similar (1.2% vs. 1.9%), but patients receiving <150 IU/kg/day LMWH had a lower incidence of fatal PE than those treated with ≥150 IU/kg/day (0.2% vs. 1.0%; p=0.004). Multivariate analysis confirmed that patients receiving <150 IU/kg/day LMWH had a lower risk for fatal PE (odds ratio [OR]: 0.2; 95% confidence interval [CI]: 0.06–0.8) and for major bleeding (OR: 0.6; 95% CI: 0.3–1.0) than those treated with ≥150 IU/kg/day. In real life, one in every two cancer patients with VTE received lower doses of LMWH than those used in randomised trials, with large variations from patient to patient. Unexpectedly, patients treated with <150 IU/kg/day LMWH had fewer fatal PE cases and fewer major bleeding events than those receiving ≥150 IU/kg/day LMWH. This finding, however, should be validated in prospective clinical trials.

Antithrombotic Therapy for DVT/PE

1997 ◽  
Vol 17 (03) ◽  
pp. 161-162
Author(s):  
Thomas Hyers
Keyword(s):  
Molecular Weight ◽  
Low Molecular Weight Heparin ◽  
Oral Anticoagulants ◽  
Cost Effective ◽  
Therapeutic Agents ◽  
Great Promise ◽  
Term Therapy ◽  
Low Molecular Weight ◽  
Long Term Therapy

SummaryProblems with unfractionated heparin as an antithrombotic have led to the development of new therapeutic agents. Of these, low molecular weight heparin shows great promise and has led to out-patient therapy of DVT/PE in selected patients. Oral anticoagulants remain the choice for long-term therapy. More cost-effective ways to give oral anticoagulants are needed.

scholarly journals Safety and efficacy of direct oral anticoagulants (DOACs) vs low molecular weight heparin (LMWH) in malignancy induced venous thromboembolism-a systematic review and meta analysis

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
A Abdul Razzack ◽  
N Hussain ◽  
S Adeel Hassan ◽  
S Mandava ◽  
F Yasmin ◽  
...  
Keyword(s):  
Molecular Weight ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Low Molecular Weight Heparin ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Low Molecular Weight ◽  
Efficacy And Safety ◽  
Dichotomous Data ◽  
Significant Difference

Abstract Funding Acknowledgements Type of funding sources: None. Background- Low molecular weight heparin (LMWH) and direct oral anticoagulants (DOACs) have been proven to be more effective in the management of venous thromboembolism (MVTE). The efficacy and safety of LMWH or DOACs in treatment of recurrent or malignancy induced VTE is not studied in literature. Objective To compare the efficacy and safety of LMWH and  DOACs in the management of malignancy induced  VTE Methods- Electronic databases ( PubMed, Embase, Scopus, Cochrane) were searched from inception to November  28th, 2020. Dichotomous data was extracted for prevention of VTE and risk of major bleeding in patients taking either LMWH or DOACs. Unadjusted odds ratios (OR) were calculated from dichotomous data using Mantel Haenszel (M-H) random-effects with statistical significance to be considered if the confidence interval excludes 1 and p &lt; 0.05.  Results- Three studies with 2607 patients (DOACs n = 1301 ; LMWH n = 1306) were included in analysis. All the study population had active cancer of any kind diagnosed within the past 6 months. Average follow-up period for each trial was 6 months. Patients receiving DOACs have a lower odds of recurrence of MVTE as compared to LMWH( OR 1.56; 95% CI 1.17-2.09; P = 0.003, I2 = 0). There was no significant difference in major bleeding among patients receiving LMWH or DOACs  (OR-0.71, 95%CI 0.46-1.10, P = 0.13, I2 = 22%) (Figure 1). We had no publication bias in our results (Egger’s regression p &gt; 0.05). Conclusion- DOACs are superior to LMWH in prevention of MVTE and have similar major bleeding risk as that of LMWH. Abstract Figure. A)VTE Recurrence B)Major Bleeding events

scholarly journals Edoxaban for the Long‐Term Therapy of Venous Thromboembolism: Should the Criteria for Dose Reduction be Revised?

2020 ◽  
Author(s):  
Giuseppe Camporese ◽  
Paolo Simioni ◽  
Pierpaolo Di Micco ◽  
Carmen Fernández‐Capitán ◽  
Agustina Rivas ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Dose Reduction ◽  
Term Therapy ◽  
Long Term Therapy
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