Effectiveness and Safety of Apixaban Vs Warfarin Among Venous Thromboembolism Patients Using Five US Databases: A Subgroup Analysis of Obesity

Background: Obesity is associated with an increased risk of VTE. Although four direct oral anticoagulants (DOACs) have been approved for the treatment of VTE, limited real-world evidence is available on their effectiveness and safety in obese patients. This study pooled 5 US healthcare claims databases to evaluate the risk of recurrent VTE, major bleeding (MB), and clinically relevant non-major (CRNM) bleeding among VTE patients initiating apixaban or warfarin stratified by obesity. Methods: A pooled retrospective study of adult VTE patients who initiated apixaban or warfarin from 01MAR2014-31DEC2018 was conducted using CMS Medicare and four other claims databases. Patients were followed to the earliest of: index therapy discontinuation, switch to another oral anticoagulant, initiation of a new parenteral anticoagulant, health plan disenrollment, death, study end, or a maximum of 6 months. Stabilized inverse probability treatment weighting (IPTW) was conducted to balance patient characteristics between the treatment cohorts within each database. After pooling post-IPTW cohorts from the five databases, subgroup interaction analysis was conducted to evaluate whether treatment effects were consistent across patients with and without obesity. Obesity was identified based on diagnosis codes that indicated obesity or codes that indicated a body mass index of at least 30. Cox proportional hazard models were used to evaluate the risk of recurrent VTE, MB, and CRNM bleeding. The statistical significance (P<0.10) of the interaction between treatment and obesity was evaluated. Results: After applying eligibility criteria, 60,786 VTE patients were selected into the apixaban treatment cohort, and 94,333 were selected into the warfarin treatment cohort. Apixaban patients were younger (65 vs 67 years) and had a lower mean CCI (2.1 vs. 2.3) compared to warfarin patients. After IPTW, all patient characteristics were balanced. In the post-IPTW population, apixaban was associated with a significantly lower risk of recurrent VTE, MB, and CRNM bleeding compared to warfarin during the follow-up (p<0.001 [Figure]). When stratified by obesity, for each treatment cohort, obese patients were younger (64-65 vs. 68 years), more likely to be diagnosed with PE (51.2%-53.0% vs. 39.9%-40.5%), experienced a higher proportion of provoked VTE events (63.3-63.9% vs. 53.3-53.7%), had higher mean CCI (2.6-2.7 vs. 2.0) and were more likely to have comorbidities such as hypertension (80.2%-80.3% vs. 64.7%-64.8%), hyperlipidemia (57.1%-57.8% vs. 44.6%-44.7%), and diabetes (41.9%-43.9% vs. 24.4-26.7%) compared to non-obese patients. Comparison of apixaban with warfarin when stratifying by obesity showed consistently lower risk of recurrent VTE, MB, and CRNM bleeding associated with apixaban across obese and non-obese patients and these subgroup findings were consistent with those of the overall population. No significant interactions were observed for treatment and obesity on recurrent VTE, MB, or CRNM bleeding (Figure). Conclusion: In the VTE patients initiating apixaban or warfarin, obese patients showed differences in patient characteristics as compared to non-obese patients. Across subgroups of patients with and without obesity, apixaban patients had a lower risk of recurrent VTE, MB, and CRNM bleeding compared to warfarin patients, which was consistent with the overall population results. These findings may be useful in informing treatment decisions for this high-risk subgroup of VTE patients. Disclosures Cohen: Pfizer, Inc.: Research Funding; Bristol-Myers Squibb Company: Research Funding. Sah:Bristol-Myers Squibb Company: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company; Pfizer, Inc.: Other: I am a paid employee of STATinMED Research which is a paid consultant to Pfizer, Inc.. Lee:Pfizer, Inc.: Current Employment. Wygant:Bristol-Myers Squibb Company: Current Employment. Rosenblatt:Bristol-Myers Squibb Company: Current Employment. Hlavacek:Pfizer, Inc.: Current Employment. Emir:Pfizer, Inc.: Current Employment. Keshishian:Pfizer, Inc.: Other: I am a paid employee of STATinMED Research which is a paid consultant to Pfizer, Inc.; Bristol-Myers Squibb Company: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company.. Delinger:Bristol-Myers Squibb Company: Other: I am a paid employee of STATinMED Research which is a paid consultant to Bristol-Myers Squibb Company.; Pfizer, Inc.: Other: I am a paid employee of STATinMED Research which is a paid consultant to Pfizer, Inc.. Luo:Pfizer, Inc.: Current Employment.

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Effectiveness and Safety of Apixaban vs. Warfarin in Venous Thromboembolism Patients with Obesity and Morbid Obesity

Journal of Clinical Medicine ◽

10.3390/jcm10020200 ◽

2021 ◽

Vol 10 (2) ◽

pp. 200

Author(s):

Alexander Cohen ◽

Janvi Sah ◽

Theodore Lee ◽

Lisa Rosenblatt ◽

Patrick Hlavacek ◽

...

Keyword(s):

Venous Thromboembolism ◽

Lower Risk ◽

Interaction Analysis ◽

Patient Characteristics ◽

Morbidly Obese ◽

Obese Patients ◽

Diagnosis Codes ◽

Obesity Status ◽

Cox Proportional Hazard Models ◽

Recurrent Vte

This study integrated 5 United States healthcare claims databases to evaluate the risk of recurrent venous thromboembolism (VTE) and major bleeding (MB) among VTE patients who initiated apixaban vs. warfarin, stratified by obesity. Obese and morbidly obese patients were identified based on diagnosis codes. Stabilized inverse probability treatment weighting (IPTW) was conducted to balance observed patient characteristics between treatment cohorts. An interaction analysis was conducted to evaluate treatment effects of apixaban vs. warfarin according to obesity status. Cox proportional hazard models were used to evaluate the risk of recurrent VTE and MB among IPTW weighted obese and morbidly obese patients. A total of 112,024 non-obese patients and 43,095 obese patients were identified, of whom 19,751 were morbidly obese. When stratified by obesity status post-IPTW, no significant interactions were observed for effects of apixaban vs. warfarin on recurrent VTE or MB (interaction p > 0.10). Among IPTW obese and morbidly obese patients, apixaban was associated with a significantly lower risk of recurrent VTE (obese: 0.73 [0.64–0.84]; morbidly obese: 0.65 [0.53–0.80]) and MB (obese: 0.73 [0.62–0.85]; morbidly obese: 0.68 [0.54–0.86]) as compared with warfarin. In this large sample of obese and morbidly obese VTE patients, apixaban had a significantly lower risk of recurrent VTE and MB vs. warfarin.

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Anticoagulation Regimens and Interventional Pain Procedures

10.1093/med/9780190271787.003.0039 ◽

2018 ◽

Author(s):

Christine Oryhan ◽

Kevin Vorenkamp ◽

Daniel Warren

Keyword(s):

Chronic Pain ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Patient Characteristics ◽

The United States ◽

Bleeding Complications ◽

Risk Of Bleeding ◽

Increased Risk ◽

Spinal Epidural ◽

The Ideal

With the aging population and new anticoagulant medications, such as direct oral anticoagulants, being marketed in the United States, it is very important for pain physicians to be aware of the anticoagulants available and how they affect the safety of interventional pain procedures. In addition to anticoagulant and antiplatelet medications, other medications commonly used in the chronic pain population may put patients at increased risk of bleeding complications. Certain patient characteristics, particularly in the chronic pain population, may also increase a patient’s risk of bleeding. The chapter reviews common and emerging anticoagulant and antiplatelet medications and the ideal holding time before or after interventional pain procedures, particularly in the spine. The chapter also discusses the diagnosis, treatment, and outcomes of spinal epidural hematomas.

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Update on Direct Oral AntiCoagulants (DOACs)

Phlebologie ◽

10.1055/s-0038-1657856 ◽

2018 ◽

Vol 47 (03) ◽

pp. 137-145

Author(s):

C. Rosenthal ◽

C. von Heymann ◽

J. Koscielny

Keyword(s):

Elective Surgery ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Patient Characteristics ◽

Clinical Decision ◽

Major Surgery ◽

Preoperative Treatment ◽

Risk Of Bleeding ◽

Increased Risk ◽

Meta Analyses

SummaryRecent findings require an update of previous recommendations for the perioperative use of Direct Oral AntiCoagulants (DOACs). A break in preoperative treatment of 24-96 hours is recommended based on the pharmacokinetic profiles of DOACs and depends on individual patient characteristics, their renal and possibly liver function, and their surgery-related risk of bleeding. In cases of renal or hepatic insufficiency, whether to extend the preoperative interruption of IIa- and Xa-inhibitors is a clinical decision that must be reached on an individual patient basis. In cases of epidural or spinal anaesthesia, more conservative pausing-intervals are recommended due to the risk of persistent neurologic deficits (e.g., paraplegia) following the development of spinal subdural and epidural haematomas. Elective surgery should be postponed according to these recommendations. Preoperative “bridging” with LMWH (more precisely referred to as “switching”) should be omitted due to a significantly increased risk of bleeding. In addition, the incidence of perioperative thromboembolic risks, such as DVT, PE, and stroke, are no different whether interruption or „switching” is undertaken. Postoperatively, the DOACs can be reinstituted within the first 24 hours. In cases of major surgery or if there is a higher risk of bleeding, resumption of DOACS should only begin after 24-72 hours. In patients with an elevated thromboembolic risk, transient postoperative LMWH administration can be recommended during this period.Interaction of DOACs with other drugs usually occurs during the absorption, transport and elimination of these drugs. Therefore, substance-specific restrictions and recommendations should be observed during these times. In everyday clinical practice, webbased, independent information portals on drug-interactions are very helpful in providing safe and rapid information about potential interactions when DOACs are used in combination with other drugs, especially during perioperative management.Non-adherence to medications is a worldwide problem that has dangerous and costly consequences. Present data suggest that persistence is the primary factor that supports adherence. Despite the adherence data presented in the DOACS approval studies (e.g., persistence in the treatment of acute venous thromboembolism has been reported to be between 94-99%), the first registries and meta-analyses provide sobering results regarding the incidence of persistence and the success rate of interventions designed to improve adherence with DOACs in cases of long-term usage.Nachdruck aus und zu zitieren als: Hämostaseologie 2017; 37: 267–275 https://doi.org/10.5482/HAMO-16-10-1657856

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A retrospective real-world major bleeding (MB) comparison of direct oral anticoagulants (DOAC) and low molecular weight heparin (LMWH) in genitourinary cancer-associated venous thromboembolism (GU-CAVTE) with reported randomized clinical trials (RTC).

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.410 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 410-410

Author(s):

Ulyana Dashkevych ◽

Eric Brucks ◽

Kathylynn Saboda ◽

Juan Chipollini ◽

Hani M. Babiker ◽

...

Keyword(s):

High Risk ◽

Real World ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Statistical Significance ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Retrospective Chart Review ◽

Cancer Center ◽

Recurrent Vte

410 Background: MB is a serious complication in patients with CAVTE receiving treatment with DOAC or LMWH. The most recent meta-analysis of the four major RCT showed that MB events rate were similar among the DOAC and LMWH group, however, it was noted that MB occurred at GU site 4.9 times more in DOAC than LMWH patients. While GUCA (e.g. bladder and testicular) are considered to be high-risk based on the Khorana Score, they were underrepresented among the RCT ( < 12%). We present a Real-World retrospective cohort study analyzing the MB rates in patients presenting with GU-CAVTE treated either by a DOAC or LMWH compared to those of the RTC. Methods: We performed a retrospective chart review of patients with a diagnosed GUCA and VTE who presented to The University of Arizona Cancer Center (UACC) and were subsequently placed on anticoagulant therapy with either a DOAC or LMWH from 11/2013-4/2020. MB outcome was defined as documented Hgb drop of ≥2 g/dL, ≥2 units of PRBC, MB in a critical site, or contributing to death. MB was extracted and compared from the SELECT D, ADAM VTE, and Caravaggio for DOAC and Hokusai for the LMWH control arm with the GUCA subgroup. Recurrent VTE was collected. In situations where there was insufficient data to categorize individuals, those individuals were excluded from the analysis. The proportion of MB reported in each study were compared using a binomial test. Results: Our review included 56 patients with similar baseline characteristics to the RCT, who were prescribed enoxaparin (n = 13), apixaban (n = 27) and rivaroxaban (n = 16). Our UACC data was compared to the RCT reported MB outcomes with rivaroxaban (12% vs 8%, [p = 0.63]), apixaban (11% vs 6%, [p = 0.40]), and LMWH (both 0 vs 1% [p = 0.67]). No statistical difference among DOAC selection [p = 0.90]. Our UACC rate of MB in patients with GUCA for both DOAC combined versus LWMH were 11.6% (5/43) and 0% [p = 0.1910], compared to the RCT GU subgroup was 5.7% (6/104) [p = 0.02] and 0.6% (1/175) [p = 1.0], respectively. Furthermore, our data found no statistical significance difference among the recurrent VTE rate among DOAC, LMWH, UACC Retrospective or RCT events. Conclusions: In agreement with the four major RCT, our study demonstrated that patients with high-risk GUCA and underlying VTE treated with a DOAC had a non-significant higher incidence of MB compared to those treated with LMWH. Further, our Real-World experience showed that GUCA DOAC had a significantly higher MB event rate compared to the RCT subgroup population. We acknowledge there are inherent biases in all retrospective studies and RCT. These data support the idea that DOAC should be further studied and used with caution in patients with a high risk of bleeding. We recommend LMWH being the safest anticoagulation modality for High-Risk Bleeding GU malignancy.

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Efficacy and safety of direct oral anticoagulants for secondary prevention of cancer associated thrombosis: a meta-analysis of randomized controlled trials

Scientific Reports ◽

10.1038/s41598-020-75863-3 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Ruchi Desai ◽

Gautam Krishna Koipallil ◽

Nelson Thomas ◽

Rahul Mhaskar ◽

Nathan Visweshwar ◽

...

Keyword(s):

Major Bleeding ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Vitamin K Antagonists ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Efficacy And Safety ◽

Increased Risk ◽

Recurrent Vte ◽

Cancer Associated Thrombosis

Abstract Direct oral anticoagulants (DOACs) may be good alternatives to low molecular weight heparin (LMWH) or vitamin K antagonists (VKA) for treatment of cancer associated thrombosis (CAT). We conducted a meta-analysis of ten randomized clinical trials to evaluate the efficacy and safety of DOACs in patients with CAT. All had study populations composed in entirety or in part of patients with CAT. The primary outcome (efficacy) was recurrent VTE and the secondary outcomes (safety outcomes) included major bleeding, clinically relevant non-major bleeding (CRNMB), and all bleeding (major bleeding + CRNMB). Participants treated with DOACs had lower risk of recurrent VTE, overall (RR 0.63; 95% CI 0.51–0.79; p < 0.0001), compared to LMWH (RR 0.57; 95% CI 0.40–0.83; p = 0.003), but not compared to VKA (RR 0.69; 95% CI 0.44–1.06; p = 0.09). Compared to LMWH, DOACs showed no difference in major bleeding risk (RR 1.31; 95% CI 0.78–2.18; p = 0.31), though had higher risk of CRNMB (RR 1.60; 95% CI 1.13–2.26; p = 0.008) and all bleeding (RR 1.49; 95% CI 1.10–2.01; p = 0.010). These results indicate that DOACs are more effective than LMWH for prevention of recurrent VTE with CAT though carry an increased risk for non-major bleeding compared to standard of care, LMWH.

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Recent advances in the treatment and prevention of venous thromboembolism in cancer patients: role of the direct oral anticoagulants and their unique challenges

F1000Research ◽

10.12688/f1000research.18673.1 ◽

2019 ◽

Vol 8 ◽

pp. 974 ◽

Cited By ~ 3

Author(s):

Dominique Farge ◽

Corinne Frere

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Patient Characteristics ◽

Primary Prophylaxis ◽

Disease Stage ◽

Vte Prophylaxis ◽

Patients With Cancer ◽

Increased Risk

Venous thromboembolism (VTE) is a common complication in patients with cancer and is associated with poor prognosis. Low-molecular-weight heparins (LMWHs) are the standard of care for the treatment of cancer-associated thrombosis. Primary VTE prophylaxis with LMWH is recommended after cancer surgery and in hospitalized patients with reduced mobility. However, owing to wide variations in VTE and bleeding risk, based on disease stage, anti-cancer treatments, and individual patient characteristics, routine primary prophylaxis is not recommended in ambulatory cancer patients undergoing chemotherapy. Efforts are under way to validate risk assessment models that will help identify those patients in whom the benefits of primary prophylaxis will outweigh the risks. In recent months, long-awaited dedicated clinical trials assessing the direct oral anticoagulants (DOACs) in patients with cancer have reported promising results. In comparison with the LMWHs, the DOACs were reported to be non-inferior to prevent VTE recurrence. However, there was an increased risk of bleeding, particularly in gastrointestinal cancers. Safe and optimal treatment with the DOACs in the patient with cancer will require vigilant patient selection based on patient characteristics, co-morbidities, and the potential for drug–drug interactions.

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Update on Direct Oral AntiCoagulants (DOACs)

Hämostaseologie ◽

10.5482/hamo-16-10-0041 ◽

2017 ◽

Vol 37 (04) ◽

pp. 267-275 ◽

Cited By ~ 3

Author(s):

Christoph Rosenthal ◽

Christian von Heymann ◽

Jürgen Koscielny

Keyword(s):

Elective Surgery ◽

Oral Anticoagulants ◽

Direct Oral Anticoagulants ◽

Patient Characteristics ◽

Clinical Decision ◽

Major Surgery ◽

Preoperative Treatment ◽

Risk Of Bleeding ◽

Increased Risk ◽

Meta Analyses

SummaryRecent findings require an update of previous recommendations for the perioperative use of Direct Oral AntiCoagulants (DOACs). A break in preoperative treatment of 24–96 hours is recommended based on the pharmacokinetic profiles of DOACs and depends on individual patient characteristics, their renal and possibly liver function, and their surgery-related risk of bleeding. In cases of renal or hepatic insufficiency, whether to extend the preoperative interruption of IIa- and Xa-inhibitors is a clinical decision that must be reached on an individual patient basis. In cases of epidural or spinal anaesthesia, more conservative pausing-intervals are recommended due to the risk of persistent neurologic deficits (e.g., paraplegia) following the development of spinal subdural and epidural haematomas. Elective surgery should be postponed according to these recommendations. Preoperative “bridging” with LMWH (more precisely referred to as „switching”) should be omitted due to a significantly increased risk of bleeding. In addition, the incidence of perioperative thromboembolic risks, such as DVT, PE, and stroke, are no different whether interruption or “switching” is undertaken. Postoperatively, the DOACs can be reinstituted within the first 24 hours. In cases of major surgery or if there is a higher risk of bleeding, resumption of DOACS should only begin after 24–72 hours. In patients with an elevated thromboembolic risk, transient postoperative LMWH administration can be recommended during this period.Interaction of DOACs with other drugs usually occurs during the absorption, transport and elimination of these drugs. Therefore, substance- specific restrictions and recommendations should be observed during these times. In everyday clinical practice, webbased, independent information portals on drug-interactions are very helpful in providing safe and rapid information about potential interactions when DOACs are used in combination with other drugs, especially during perioperative management.Non-adherence to medications is a worldwide problem that has dangerous and costly consequences. Present data suggest that persistence is the primary factor that supports adherence. Despite the adherence data presented in the DOACS approval studies (e.g., persistence in the treatment of acute venous thromboembolism has been reported to be between 94–99%), the first registries and meta-analyses provide sobering results regarding the incidence of persistence and the success rate of interventions designed to improve adherence with DOACs in cases of long-term usage.

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Effectiveness and Safety of Apixaban versus Warfarin in Venous Thromboembolism Patients with Chronic Kidney Disease

Thrombosis and Haemostasis ◽

10.1055/s-0041-1740254 ◽

2021 ◽

Author(s):

Alexander T. Cohen ◽

Janvi Sah ◽

Amol D. Dhamane ◽

Theodore Lee ◽

Lisa Rosenblatt ◽

...

Keyword(s):

Chronic Kidney Disease ◽

Venous Thromboembolism ◽

Kidney Disease ◽

Lower Risk ◽

Treatment Effects ◽

Interaction Analysis ◽

Oral Anticoagulants ◽

Cohort Analysis ◽

Ckd Stage ◽

Recurrent Vte

AbstractThere has been limited evidence reported about the outcomes of oral anticoagulants among patients with venous thromboembolism (VTE) and chronic kidney disease (CKD), especially those with stage V/end-stage renal disease (ESRD). This retrospective cohort analysis of five U.S. claims databases evaluated the risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB) for apixaban versus warfarin among VTE patients diagnosed with CKD, including ESRD. Inverse probability treatment weighting (IPTW) was used to balance patient characteristics between treatment cohorts. Hazard ratios (HRs) were calculated for recurrent VTE, MB, and CRNMB among patients with CKD who experienced an index VTE. An interaction analysis was conducted to evaluate treatment effects across different stages of CKD. A total of 29,790 VTE patients with CKD were selected for analyses, of whom 10,669 (35.8%) initiated apixaban and 19,121 (64.2%) initiated warfarin. Among IPTW-balanced patient cohorts, the apixaban group had significantly lower risk of recurrent VTE (HR: 0.78; 95% confidence interval [CI]: 0.66–0.92), MB (HR: 0.76; 95% CI: 0.65–0.88), and CRNMB (HR: 0.86; 95% CI: 0.80–0.93) than the warfarin group. When stratified by CKD stage (stage I/II: 8.2%; stage III: 49.4%; stage IV: 12.8%; stage V/ESRD: 12.0%; stage unspecified: 17.6%), no significant interaction was observed for effects of apixaban versus warfarin on recurrent VTE or MB. In summary, apixaban was associated with a significantly lower risk of recurrent VTE and MB than warfarin among VTE patients with CKD. CKD stages did not have significant impact on treatment effects for recurrent VTE and MB.

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The Risk of Recurrent Venous Thromboembolism in Patients with and without Factor V Leiden

Thrombosis and Haemostasis ◽

10.1055/s-0038-1656023 ◽

1997 ◽

Vol 77 (04) ◽

pp. 624-628 ◽

Cited By ~ 139

Author(s):

Sabine Eichinger ◽

Ingrid Pabinger ◽

Andreas Stümpfien ◽

Mirko Hirschl ◽

Christine Bialonczyk ◽

...

Keyword(s):

Oral Anticoagulant Therapy ◽

Oral Anticoagulants ◽

Factor V Leiden ◽

Multicenter Trial ◽

Observation Time ◽

Antiphospholipid Antibody ◽

Antiphospholipid Antibody Syndrome ◽

Factor V ◽

Increased Risk ◽

Recurrent Vte

SummaryThromboprophylaxis with oral anticoagulants up to six months is established in patients after a first venous thromboembolic event (VTE). The risk of recurrent VTE is still considerable thereafter, and it is uncertain whether some patients might benefit from extended anticoagulation. We performed a prospective, multicenter trial (4 thrombosis centers) and evaluated in 380 patients with a first or recurrent VTE (patients with a deficiency of antithrombin, protein C, protein S or plasminogen; cancer; or an antiphospholipid antibody syndrome were excluded) the risk of recurrence after discontinuation of secondary thromboprophylaxis with oral anticoagulants. It was the aim of the study to evaluate whether patients with factor V Leiden are at an increased risk of recurrent VTE. 112 (29.5%) patients were carriers of factor V Leiden (26.9% heterozygous, 2.6% homozygous). After a median observation time of 19.3 months the overall recurrence rate of VTE was 9.9%. Recurrent deep vein thrombosis and/or pulmonary embolism occurred in 26 of 268 patients without factor V Leiden (9.7%) and in 10 of 112 patients with factor V Leiden (8.9%). The probability of recurrent VTE two years after discontinuation of oral anticoagulants was 12.4% (95% Cl 7.8-17) in patients without factor V Leiden and was 10.6% (95% Cl 3.8-17.4) in carriers of the mutation. This difference was statistically not significant. Patients with factor V Leiden are not at a higher risk of recurrent VTE within two years after discontinuation of oral anticoagulants than patients without factor V Leiden. Balancing the risk of recurrent VTE and bleeding from oral. anticoagulants, patients with factor V Leiden are not likely to benefit from oral anticoagulant therapy extended beyond six months.

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