Perioperative Management Of Patients On Dabigatran – a Prospective Cohort Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 3637-3637
Author(s):  
Sam Schulman ◽  
James Douketis ◽  
Rebecca Barty, MLT ◽  
Agnes Y.Y. Lee ◽  
Marc Carrier ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Research Funding ◽  
Perioperative Management ◽  
Vitamin K Antagonists ◽  
Bleeding Risk ◽  
Minor Bleeding ◽  
Off Label Use ◽  
Off Label

Abstract Background The risk of major bleeding in association with perioperative management of vitamin K antagonists is about 3% according to systematic reviews. We performed this study to evaluate the safety of perioperative management of dabigatran using a specified protocol. Methods Patients at least 18 years old, treated with dabigatran and planned for an invasive procedure were eligible for inclusion. The last dose of dabigatran before the procedure was at 24 h (creatinine clearance [CrCl] > 50 mL/min and standard bleeding risk), 48 h (CrCl 31-50 mL/h or increased bleeding risk) or 96 h (CrCl 31-50 mL/h and increased bleeding risk). Resumption was in the evening of the procedure with the first dose of 75 mg (hemostasis secured and low bleeding risk), postop day 1, 2 or 3, depending on the complexity of the surgery and consequences of a bleeding complication; all prespecified. Patients were followed for 30 days for major bleeding (primary outcome), minor bleeding, arterial thromboembolism and death and an independent committee adjudicated these events by. We calculated a sample size of 283 cases to exclude a doubling of major bleeding compared to historical warfarin with heparin bridging. The study was funded by Heart and Stroke Foundation Canada. Results We included 286 patients, mean age of 70.6 years (standard deviation, 11.7), 44 (15%) patients had CrCl 31-50 mL/min and 2 (0.7%) had 30 mL/min or less. The planned procedure was considered as “increased bleeding risk” in 102 (36%) patients. The last dose of dabigatran was at 24, 48 and 96 h before surgery in 160, 103 and 23 patients, respectively. Resumption with 75 mg the same day was in 139 patients. Major bleeding occurred in 3 patients (1.05%; 2 adjudicated so far); a 70-year-old male underwent ultrasound-guided drainage of abdomen and was readmitted after 17 days due to rectal bleeding and light headedness; the second patient, an 81-year-old male bled more than expected during the procedure of wide resection of myxosarcoma with free flap rotation and received blood transfusions during surgery, and a 69-year-old male bled 1200 mL during hip revision arthroplasty and received 3 units of red cells. Minor bleeding was observed in 9 adjudicated cases and reported in 10 additional, so far not adjudicated, cases. There were no strokes, systemic emboli, transient ischemic attacks, venous thromboembolic events or deaths. Three serious adverse events were reported (chest pain, congestive heart failure, wound infection) Conclusion With our protocol for perioperative management of dabigatran the risk of major bleeding compares favorably with historical data on vitamin K antagonists. Disclosures: Schulman: Bayer Healthcare: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria, Research Funding. Off Label Use: Dabigatran etexilate is an oral direct thrombin inhibitor approved for the prevention of stroke in patients with atrial fibrillation and (outside the US) for prevention of venous thromboembolism in patients undergoing total hip or knee replacement. This presentation includes discussion of the following off-label use of dabigatran: treatment of venous thromboembolism. Douketis:Boehringer Ingelheim: Consultancy, Honoraria. Lee:Boehringer Ingelheim: Honoraria. Heddle:CIHR: Research Funding; Canadian Blood Services: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Health Canada: Research Funding.

scholarly journals Bleeding and related mortality with NOACs and VKAs in newly diagnosed atrial fibrillation: results from the GARFIELD-AF registry

2021 ◽  
Vol 5 (4) ◽  
pp. 1081-1091
Author(s):  
Jean-Pierre Bassand ◽  
Saverio Virdone ◽  
Marc Badoz ◽  
Freek W. A. Verheugt ◽  
A. John Camm ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Bleeding Risk ◽  
Minor Bleeding ◽  
Newly Diagnosed ◽  
Risk Of Death ◽  
Major Bleed

Abstract In atrial fibrillation (AF), lower risks of death and bleeding with non-vitamin-K oral anticoagulants (NOACs) were reported in meta-analyses of controlled trials, but whether these findings hold true in real-world practice remains uncertain. Risks of bleeding and death were assessed in 52 032 patients with newly diagnosed AF enrolled in GARFIELD-AF (Global Anticoagulant Registry in the FIELD–Atrial Fibrillation), a worldwide prospective registry. Baseline treatment was vitamin K antagonists (VKAs) with or without antiplatelet (AP) agents (VKA ± AP) (20 151; 39.3%), NOACs ± AP agents (14 103; 27.5%), AP agents only (10 748; 21.0%), or no antithrombotics (6219; 12.1%). One-year follow-up event rates (95% confidence interval [CI]) of minor, clinically relevant nonmajor (CRNM), and major bleedings were 2.29 (2.16-2.43), 1.10 (1.01-1.20), and 1.31 (1.21-1.41) per 100 patient-years, respectively. Bleeding risk was lower with NOACs than VKAs for any bleeding (hazard ratio (HR) [95% CI]), 0.85 [0.73-0.98]) or major bleeding (0.79 [0.60-1.04]). Compared with no bleeding, the risk of death was higher with minor bleeding (adjusted HR [aHR], 1.53 [1.07-2.19]), CRNM bleeding (aHR, 2.59 [1.80-3.73]), and major bleeding (aHR, 8.24 [6.76-10.04]). The all-cause mortality rate was lower with NOACs than with VKAs (aHR, 0.73 [0.62-0.85]). Forty-five percent (114) of all deaths occurred within 30 days, and 40% of these were from intracranial/intraspinal hemorrhage (ICH). The rates of any bleeding and all-cause death were lower with NOACs than with VKAs. Major bleeding was associated with the highest risk of death. CRNM bleeding and minor bleeding were associated with a higher risk of death compared to no bleeding. Death within 30 days after a major bleed was most frequently related to ICH. This trial was registered at www.clinicaltrials.gov as #NCT01090362.

Comparison of Bleeding Risk Scores in Elderly Patients Receiving Extended Anticoagulation with Vitamin K Antagonists for Venous Thromboembolism

2021 ◽  
Author(s):  
Andrea N. Frei ◽  
Odile Stalder ◽  
Andreas Limacher ◽  
Marie Méan ◽  
Christine Baumgartner ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Elderly Patients ◽  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Predictive Performance ◽  
Roc Curves ◽  
Bleeding Risk ◽  
Risk Scores ◽  
Likelihood Ratios ◽  
Risk Categories

Abstract Background In elderly patients with venous thromboembolism (VTE), the decision to extend anticoagulation beyond 3 months must be weighed against the bleeding risk. We compared the predictive performance of 10 clinical bleeding scores (VTE-BLEED, Seiler, Kuijer, Kearon, RIETE, ACCP, OBRI, HEMORR2HAGES, HAS-BLED, ATRIA) in elderly patients receiving extended anticoagulation for VTE. Methods In a multicenter Swiss cohort study, we analyzed 743 patients aged ≥65 years who received extended treatment with vitamin K antagonists after VTE. The outcomes were the time to a first major and clinically relevant bleeding. For each score, we classified patients into two bleeding risk categories (low/moderate vs. high). We calculated likelihood ratios and the area under the receiver operating characteristic (ROC) curve for each score. Results Over a median anticoagulation duration of 10.1 months, 45 patients (6.1%) had a first major and 127 (17.1%) a clinically relevant bleeding. The positive likelihood ratios for predicting major bleeding ranged from 0.69 (OBRI) to 2.56 (Seiler) and from 1.07 (ACCP) to 2.36 (Seiler) for clinically relevant bleeding. The areas under the ROC curves were poor to fair and varied between 0.47 (OBRI) and 0.70 (Seiler) for major and between 0.52 (OBRI) and 0.67 (HEMORR2HAGES) for clinically relevant bleeding. Conclusion The predictive performance of most clinical bleeding risk scores does not appear to be sufficiently high to identify elderly patients with VTE who are at high risk of bleeding and who may therefore not be suitable candidates for extended anticoagulation.

scholarly journals Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study: A Perioperative Management Plan for Patients with Atrial Fibrillation Who Are Receiving a Direct Oral Anticoagulant

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. LBA-5-LBA-5 ◽  
Author(s):  
James Douketis ◽  
Alex C. Spyropoulos ◽  
Joanne M Duncan ◽  
Marc Carrier ◽  
Gregoire Le Gal ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Major Bleeding ◽  
Research Funding ◽  
Perioperative Management ◽  
Elective Surgery ◽  
Bleeding Risk ◽  
Advisory Board ◽  
Advisory Committees ◽  
Arterial Thromboembolism ◽  
High Bleeding Risk

Abstract Introduction: The perioperative management of patients who are taking a direct oral anticoagulant (DOAC) for atrial fibrillation (AF) and require an elective surgery/procedure is uncertain. No studies have addressed the timing of perioperative DOAC interruption and resumption, and if perioperative heparin bridging and coagulation function testing are needed. The Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study hypothesized that a simple, standardized perioperative management strategy, based on DOAC-specific interruption and resumption intervals, that foregoes perioperative heparin bridging and coagulation function testing, is safe for patient care, with associated low rates of major bleeding (1%) and arterial thromboembolism (0.5%). We postulated that this management yields a high proportion of patients (>90%) with a minimal to no DOAC level at surgery/procedure. Methods: PAUSE is a prospective study with 3 parallel DOAC cohorts of patients with AF taking apixaban, dabigatran or rivaroxaban and requiring anticoagulant interruption for an elective surgery/procedure. Patients were managed using a standardized protocol based on DOAC pharmacokinetic properties, procedure-associated bleeding risk (Appendix 1) and creatinine clearance (CrCl). DOACs were interrupted for 1 day before and after surgery for a low bleed risk surgery and 2 days before and after a high bleed surgery; longer interruption was done in patients on dabigatran with a CrCl<50 mL/min (Figure 1). A blood sample was obtained just before the procedure to measure residual DOAC levels (Appendix 2). Heparin bridging and preoperative coagulation testing were not used to manage patients. Patient follow-up occurred weekly for 30 days post-procedure for the primary clinical outcomes of major bleeding and arterial thromboembolism (Appendix 3). The incidence (95% confidence interval [CI]) of clinical outcomes was determined for each DOAC cohort using an intention-to-treat (ITT) analysis (interrupted at least 1 DOAC dose) and per-protocol analysis (adhering to DOAC interruption and resumption protocol). Results: We enrolled 3007 patients from 23 sites in Canada, the U.S. and Europe (Appendix 4). The patient characteristics were (Figure 2): mean age 72.5 years; 66.1% male; 33.5% high bleeding risk surgery/procedure, with 1257 patients in the apixaban cohort, 668 in the dabigatran cohort and 1082 in the rivaroxaban cohort (Table 1). DOAC interruption and resumption intervals are shown in Table 2. The 30-day postoperative rate (95% CI) of major bleeding was 1.35% (0-2.00) in the apixaban cohort, 0.90% (0-1.73) in the dabigatran cohort and 1.85% (0-2.65) in the rivaroxaban cohort; the rate (95% CI) of arterial thromboembolism was 0.16% (0-0.48) in the apixaban cohort, 0.6% (0-1.33) in the dabigatran cohort and 0.37% (0-0.82) in the rivaroxaban cohort (Table 3). There were 2541 (84.5%) patients with preoperative DOAC levels measured: a level <50 ng/ml occurred in 90.5% of patients in the apixaban cohort, in 95.1% of the dabigatran cohort and in 96.8% of the rivaroxaban cohort. Of 1007 patients having a high bleeding risk procedure, 832 (82.6%) had DOAC levels measured: 98.8% had a level <50 ng/mL (Table 4). Rates of major bleeding and arterial thromboembolism in the per protocol analysis were comparable to those of the ITT analysis (Table 5). Conclusions: In patients with AF who were taking a DOAC (apixaban, dabigatran, rivaroxaban) and required anticoagulant interruption for an elective surgery/procedure, using a standardized DOAC-specific perioperative management strategy was safe for patient care, with associated low rates of perioperative MB (<2%) and ATE (<1%). Further, a high proportion of patients (>90% overall; 98.8% at high bleeding risk) had a minimal or no residual DOAC level at the time of the surgery/procedure. PAUSE is the largest study, to date, that addresses how to manage the common problem of perioperative DOAC management. It is likely to have a practice-changing impact and will inform future practice guidelines in perioperative care. Study Funding: CIHR (313156) and the H&S Foundation of Canada (G-14-0006136). Aniara-Hyphen Biomed (assays). Acknowledgments: We thank Drs. Walter Ageno, David Garcia, Lehana Thabane, Wendt Lim, Lori Linkins, William Ristevski, and Demetrios J. Sahlas. Also, Kayla Lucier, Grace Wang, Tara McDougall, and HRLMP and CRLB. Supported by CanVector and REDCap. Disclosures Douketis: Bayer: Other: Advisory Board; Janssen: Consultancy; BMS: Other: Advisory Board; Biotie: Other: Advisory Board; Daiichi-Sankyo: Other: Advisory Board; Boehringer-Ingelheim: Consultancy, Other: Advisory Board, Research Funding; The Medicines Company: Other: Advisory Board; Sanofi: Consultancy, Other: Advisory Board; Astra-Zeneca: Other: Advisory Board; Portola: Other: Advisory Board; Pfizer: Other: Advisory Board. Spyropoulos:Janssen Scientific Affairs, LLC: Consultancy. Carrier:Bayer: Honoraria; Leo Pharma: Research Funding; Pfizer: Honoraria; BMS: Honoraria, Research Funding. Vanassche:Bayer: Consultancy; Boehringer Ingelheim: Consultancy; BMS/Pfizer: Consultancy. Verhamme:Bayer: Honoraria, Research Funding; Medtronic: Honoraria; Portola: Honoraria; Boehringer Ingelheim: Honoraria; Leo Pharma: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Daiichi-Sankyo: Honoraria, Research Funding; Pfizer: Honoraria, Research Funding. Shivakumar:Pfizer: Honoraria; Servier: Honoraria; Bayer: Honoraria; LEO Pharma: Honoraria. Gross:Pfizer: Honoraria; Bayer: Honoraria; LEO Pharma: Honoraria; Servier: Honoraria. Lee:Pfizer: Consultancy, Research Funding; BMS: Research Funding; Servier: Honoraria; LEO Pharma: Consultancy, Research Funding; Bayer: Consultancy, Honoraria. Le Templier:BMS-pfizer: Honoraria. Wu:Leo Pharma: Honoraria; Pfizer: Honoraria; BMS-Pfizer: Honoraria. Coppens:Bayer: Honoraria, Other: Non-financial support, Research Funding; CSL Behring: Honoraria, Other: non-financial support, Research Funding; Uniqure BV: Research Funding. Arnold:Bristol Myers Squibb: Research Funding; UCB: Consultancy; Amgen: Consultancy, Research Funding; UCB: Consultancy; Amgen: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Bristol Myers Squibb: Research Funding; Novartis: Consultancy, Research Funding. Caprini:Alexion Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees; Recovery Force: Consultancy; BMS: Membership on an entity's Board of Directors or advisory committees; Pfizor: Membership on an entity's Board of Directors or advisory committees; Janssen R&D: Membership on an entity's Board of Directors or advisory committees. Summer:Octapharma: Honoraria. Schulman:Daiichi-Sankyo: Honoraria; Bayer: Honoraria; Sanofi: Honoraria; Boehringer-Ingelheim: Honoraria, Research Funding.

Management and outcome of major bleeding in patients receiving vitamin K antagonists for venous thromboembolism

2018 ◽  
Vol 171 ◽  
pp. 74-80 ◽  
Author(s):  
Farès Moustafa ◽  
Alexander Stehouwer ◽  
Pieter Kamphuisen ◽  
Joan Carles Sahuquillo ◽  
Ángel Sampériz ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists

P690Incidence of events between vitamin K antagonists and direct oral anticoagulants in patients with cancer

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
A Pardo Sanz ◽  
L M Rincon ◽  
G De Lara ◽  
A Tamayo ◽  
L C Belarte ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Bleeding Risk ◽  
Systemic Embolism ◽  
Bleeding Events ◽  
Patients With Cancer

Abstract Background Balance between embolic and bleeding risk is challenging in patients with cancer. There is a lack of specific recommendations for the use of antithrombotic therapy in oncologic patients with atrial fibrillation (AF). We aimed to evaluate the effectiveness and safety of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) within patients with breast cancer. We also compared the embolic and bleeding risk, the preventive management and the incidence of events between patients with and without cancer. Methods It is an ambispective observational multicentric study that analysed patients with non-valvular AF treated in Oncology and Cardiology Departments in Spain in the period 2011–2018. A total of 1237 female patients with AF were enrolled: 637 with breast cancer and 599 without cancer. The incidence of thromboembolic and major bleeding events according to the antithrombotic strategy with VKAs or DOACs was evaluated in the cohort of 637 patients with cancer. Analysis were conducted using SPSS software V.22.0 and R V.3.5.1, with a two-tailed significance value of 0.05. Results Mean follow-up was 3.1 years. Both groups were similar in age, CHA2DS2-VASc and HASB-LED scores. There was no evidence that the incidence of ischemic stroke/systemic embolism differed between patients with cancer treated with AVK and DOAC after CHA2DS2-VASc adjustment: HR 0.91 (95% CI, 0.42–1.99). In addition, no significant differences in the incidence of major bleeding events were found between DOACs and VKA after adjustment for HAS-BLED score: HR 1.53 (95% CI, 0.93–2.53) (Figure 3). Gastrointestinal bleeding was the main source of haemorrhages in both groups (45% of bleedings among patients treated with DOACs and, 37% in VKAs group). Metastatic disease or active chemotherapy were studied as potential covariates but none of them posed any relevant change in the result. Kaplan-Meier analysis Conclusions Cancer patients treated with DOACs did not differ versus those treated with VKAs with regards to stroke or systemic embolism in a model adjusted for CHA2DS2-VASc. Neither significant differences were found for bleeding events in a model adjusted for baseline HASBLED.

Selection, management, and outcome of vitamin K antagonist-treated patients with atrial fibrillation not switched to novel oral anticoagulants

2015 ◽  
Vol 114 (11) ◽  
pp. 1076-1084 ◽  
Author(s):  
Franziska Michalski ◽  
Luise Tittl ◽  
Sebastian Werth ◽  
Ulrike Hänsel ◽  
Sven Pannach ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Case Fatality ◽  
Bleeding Risk ◽  
Vitamin K Antagonist ◽  
Bleeding Complications ◽  
Treatment Rate

SummaryAtrial fibrillation (AF) patients treated with well-controlled vitamin K antagonists (VKAs) may benefit less from non-vitamin K antagonist oral anticoagulants (NOACs) because they are supposed to be at low risk of thromboembolic and bleeding complications. However, little is known about the selection, management, and outcome of such “stable” VKA patients in current practice. We assessed characteristics, VKA persistence and 12 months' outcome of AF patients selected for VKA continuation. On March 1, 2013, the Dresden NOAC registry opened recruitment of patients continuing on VKA for sites that had been actively recruiting AF patients treated with NOACs in the prior 18 months. Patient characteristics were compared with those of NOAC patients from the same sites. Four hundred twenty-seven VKA patients had a significantly lower bleeding risk profile compared with 706 patients selected for NOAC treatment. For VKA, international normalised ratio time-in-therapeutic range before enrolment was 71% and increased to 75% during a mean follow-up of 15 months. Rates of stroke/transient ischaemic attack/systemic embolism were 1.3/100 patient-years (intention-to-treat) and 0.94/100 patient-years (as-treated). On-treatment rate of ISTH major bleeding was 4.15/100 patient-years (95% CI 2.60–6.29) with a case-fatality rate of 16.3% (all-cause mortality at day 90 after major bleeding). In conclusion, in daily care, AF patients selected for VKA therapy are healthier than those treated with NOAC, demonstrate a high quality of anticoagulant control and very low stroke rates. However, despite adequate patient selection and INR control, the risk of major VKA bleeding is unacceptably high and bleeding outcome is poor.

scholarly journals Major bleeding risk assessment in atrial fibrillation patients taking vitamin K antagonists

2015 ◽  
Vol 35 (2) ◽  
pp. 99-103
Author(s):  
Fernando Pivatto ◽  
André Luís Ferreira da Silva ◽  
Indira Valente Bezerra ◽  
Leonardo Martins Pires ◽  
Luís Carlos Amon ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Risk Assessment ◽  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Bleeding Risk

Tendency towards Minor Bleeding in Women Is Associated with a Reduced Risk for Major Bleeding, without Apparent Differences in Level of Anticoagulation during Treatment with Vitamin K Antagonist.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 889-889
Author(s):  
Nic J.G.M. Veeger ◽  
Margriet Piersma-Wichers ◽  
Jan van der Meer
Keyword(s):  
Vitamin K ◽  
Major Bleeding ◽  
Vitamin K Antagonists ◽  
Secondary Prophylaxis ◽  
Incidence Rates ◽  
Target Range ◽  
Minor Bleeding ◽  
Bleeding Tendency ◽  
Men And Women ◽  
Reduced Risk

Abstract Easy bruising is frequently found in healthy women. This mild bleeding tendency may be enhanced by treatment with vitamin K antagonists. This may result in more intense monitoring of the level of anticoagulation (INR) to improve the individual time within target range (ITTR) and consequently to reduce the risk of major bleeding. We performed a retrospective study in 6758 consecutive patients receiving vitamin K antagonists for primary or secondary prophylaxis of venous or arterial thrombosis (mean age 67, 51% male and 189762 INRs in 6681 person-years) to evaluate differences in gender on the occurrence of minor and major bleeding, as well as the ITTR. The incidence rates (IR, per 100 person-years) of minor and major bleeding were assessed and survival analysis performed to obtain adjusted hazard ratios (HR, 95%CI) for major bleeding in men versus women with or without prior minor bleeding, controlling for significant patient characteristics. Minor bleeding occurred more frequently in women than men (IR=33.2 versus 21.1, respectively; HR=1.5, 95%CI 1.4–1.7, p<0.001), whereas major bleeding showed a tendency towards a higher incidence in men (IR=1.6 versus 2.0; HR=1.3, 95%CI 0.9–1.8, p=0.20). Figure Figure However, in women with prior minor bleeding, the incidence of major bleeding was low (IR=1.3, 95% CI 0.7–2.1), when compared to men with minor bleeding (3.3, 95%C 2.2–4.7) (HR =2.7, 95% CI 1.4–5.0, p=0.002). Men and women without prior minor bleeding had comparable incidences of major bleeding (IR 1.8, 95% CI 1.3–2.5, and 1.5, 95% CI 1.1–2.1, respectively), but both were higher than in women with prior minor bleeding (HR 1.4 (0.8–2.5, p=0.30 and 1.2 (0.7–2.2, p=0.55)). These differences were even more pronounced in patients at high risk of major bleeding due to a strongly reduced ITTR (ITTR below 30%, lowest quartile). Considering the actually achieved level of anticoagulation, there were no differences between men and women with or without prior minor bleeding that could explain the reduced risk of major bleeding in women with prior minor bleeding. With 42% to 43%, the ITTR was comparable, as was the time spend above INR 5.0 (6% to 7%). In conclusion, more frequent minor bleeding in women was associated with a reduced incidence of major bleeding, whereas in men, such a reversed association was not present. Differences in intensity of INR monitoring in patients with or without minor bleeding and as a result in actual level of anticoagulation, could not be demonstrated.

Bleeding Incidence Among Patients With Venous Thromboembolism: A Large US Insurance Database Analysis

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2916-2916 ◽  
Author(s):  
Xianchen Liu ◽  
Lin Xie ◽  
Hemant Phatak ◽  
Jack Mardekian ◽  
Wilson Tan ◽  
...  
Keyword(s):  
Heart Disease ◽  
Venous Thromboembolism ◽  
Major Bleeding ◽  
Research Funding ◽  
Index Date ◽  
Bleeding Risk ◽  
Employment Equity ◽  
History Of ◽  
Equity Ownership ◽  
Insurance Database

Abstract Introduction It is crucial to assess clinical benefit and bleeding risk when selecting an anticoagulant for patients with venous thromboembolism (VTE). This study examined the incidence of major bleeding and non-major bleeding and clinical predictors of major bleeding among patients with VTE in the usual clinical practice setting. Methods VTE patients aged ≥18 years were identified from the Truven Health MarketScan commercial or Medicare supplemental insurance database. Index date was defined as the first VTE diagnosis between 07/01/2006 – 12/31/2011. Patients were required to have ≥2 VTE outpatient diagnoses within a 3-week window or have 1 VTE diagnosis in an inpatient setting, have a continuous health plan enrollment for 6 months prior to the index date (baseline), and have no VTE diagnosis in the baseline period. Major bleeding was defined as any bleeding that resulted in hospitalization or blood transfusion; all other bleeds were non-major bleeding. Patients were followed until major bleeding/non-major bleeding, death, disenrollment, or end of study. Multivariate Cox regression was used to examine factors associated with major bleeding. Results Of 267,655 eligible patients, 182,972 patients were with deep vein thrombosis (DVT) only (68.4%), 69,169 with pulmonary embolism (PE) only (25.8%); and 15,514 with both (5.8%). Mean age was 61.5 years, and 53.1% were female. Mean follow-up period was 17.3 months (median=12.1). The annual incidence of major bleeding and non-major bleeding were 3.9% and 20.1%, respectively. The median time to major bleeding from index VTE diagnosis was 2.2 months. Major risk factors at baseline for major bleeding (Risk increase>20%) were history of major bleeding (HR=10.78, 95%CI=10.30-11.28) and non-major bleeding (HR=1.61, 95%CI=1.54-1.68), chemotherapy (HR=1.27, 95%CI=1.20-1.35), age ≥65 vs.≤40 years (HR=1.27, 95%CI=1.18-1.37), alcohol abuse (HR=1.26, 95%CI=1.16-1.38), cancer (HR=1.25, 95%CI=1.19-1.31), and heart disease (HR=1.23, 95%CI=1.18-1.28) (Table). Baseline hormone therapy (HR=0.74, 95%CI=0.68-0.80) and pregnancy (HR=0.59, 95%CI=0.46-0.74) were associated with reduced risk for major bleeding. Conclusions Major and non-major bleeding were common in patients with VTE. Multiple factors, especially history of bleeding, age≥65 years, alcohol abuse, cancer and heart disease, were associated with increased risk for major bleeding. Further research needs to examine bleeding risk associated with anticoagulant therapy. Disclosures: Liu: Pfizer: Employment, Equity Ownership. Xie:StatInMed: Employment, Research Funding. Phatak:BMS: Employment, Equity Ownership. Mardekian:Pfizer: Employment, Equity Ownership. Tan:Pfizer: Employment, Equity Ownership. Baser:StatInMed: Employment, Research Funding. Ramacciotti:BMS: Employment, Equity Ownership.

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