scholarly journals Efficacy and Safety of Prothrombin Complex Concentrate in Patients Treated with Rivaroxaban or Apixaban Compared to Warfarin Presenting with Major Bleeding

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2535-2535
Author(s):  
Deepa Jayakody Arachchillage ◽  
Sharon Alavian ◽  
Jessica Griffin ◽  
Kamala Gurung ◽  
Richard Syzdlo ◽  
...  
Keyword(s):  
Vitamin K ◽  
Major Bleeding ◽  
Prothrombin Complex Concentrate ◽  
Vitamin K Antagonists ◽  
Left Ventricular ◽  
Factor Ix ◽  
Full Blood Count ◽  
Recurrent Bleeding ◽  
Efficacy And Safety ◽  
Educational Meeting

Abstract Introduction Bleeding is the major complication of anticoagulant therapy. Reversal of vitamin K antagonists (VKAs) in patients with major bleeding events (MBE) including intracranial haemorrhage (ICH) is achieved with prothrombin complex concentrate (PCC) and intravenous vitamin K. Administration of PCC or activated PCC is approved UK strategy for treating MBE associated with rivaroxaban or apixaban, pending approval of a specific reversal agent. In all cases there is concern regarding the incidence of thrombotic events. Methods In this respective review, the efficacy and safety of 4-factor PCCs for the management of MBE in 344 patients receiving rivaroxaban, apixaban or warfarin were compared from January 2016 to April 2018. All patients had full blood count, coagulation screen (INR for VKA) and biochemistry profile at presentation and prior to receiving PCC. Patients on rivaroxaban or apixaban had samples taken for drug level but did not wait for the results to administer PCC. Concomitant antiplatelet or nonsteroidal anti-inflammatory drugs, length of stay, thromboembolic events, re-bleeding at the same site and 30-day mortality were documented from medical records. Results Table 1: Baseline characteristics of the 344 patients Overall median (range) dose of PCC was 2000 units of Factor IX (500-5000). As expected, AF was more frequently the indication for apixaban and rivaroxaban (36/40, 90% and 29/40, 72.5%) than it was for warfarin (165/264, 62.5%). Patients with metallic heart valves or left ventricular thrombus received only warfarin. ICH was the most common indication for PCC in all three anticoagulant groups (137/344, 39.8%) followed by gastrointestinal bleeding (93/344, 27%). ICH was more frequently the indication for PCC in patients receiving rivaroxaban (25/40, 62.5%) and apixaban (21/40, 52.5%) compared to warfarin (91/264, 34.5%), p=0.003. Patients on warfarin more frequently received PCC for musculoskeletal bleeding (12.9%) compared to those on rivaroxaban (5%) and apixaban (5%), p=0.003. There were no differences in the other bleeding sites based on type of anticoagulant. No differences were observed in hemoglobin, platelet count and fibrinogen in patients based on type of anticoagulant or site of bleeding. Median (range) rivaroxaban and apixaban levels at time of receiving PCC were 230ng/ml (47-759) and 159ng/ml (45-255) respectively. Median INR pre- and post-PCC in patients on warfarin were 3.4 (1.9-15.4) and 1.2 (1.0-1.9) respectively. A significantly higher proportion of patients on apixaban (17/40, 42.5%) or rivaroxaban (14/40, 35%) received tranexamic acid compared to warfarin (51/264, 19.2%), p=0.001. Vitamin K was given to 227/264, 86% of patients on warfarin with median dose 5mg (range 1mg-10mg). There was no difference in number of red cell units, platelet or FFP used in the three anticoagulant groups. Overall 30-day mortality rate was 24.7% (85/344) and did not differ according to type of anticoagulant (p=0.17). Recurrent bleeding occurred in 18% overall, warfarin 15.8%, rivaroxaban 20% and apixaban 30.8%, p=0. 07. Recurrent thrombosis occurred in 4.1% (14/344) patients within 30 days of receiving PCC with no difference in three anticoagulant groups, p=0.83 (warfarin 4.2%, rivaroxaban 5.1% and apixaban 2.5%). Nearly half of the patients (48.1%), restarted anticoagulation in a median 13.5 days (6-44). Anticoagulation was restarted in a significantly higher proportion of patients on warfarin (138/264, 52.3%) compared to (10/40, 25%) on rivaroxaban and (13/40, 32.5%) on apixaban, p=0.001. In patients with ICH there were no differences in age or sex between groups. There were no differences in concomitant use of antiplatelet treatment, recurrent bleeding (overall 17.8%, warfarin 17.8%, rivaroxaban 20% and apixaban 15%, p=0.90) or 30-day mortality (overall 30-day mortality was 35%; warfarin 31.9%, rivaroxaban 44% and apixaban 38.1%, p=0.50). None of the patients with ICH on rivaroxaban or apixaban had thrombotic events and only 2/91 (2.2%) patients on warfarin had ischemic strokes within 30 days post PCC. Overall 30.6% of patients with ICH restarted anticoagulation with a median 15 days (10-42). In conclusion, there was no difference in the safety (thrombosis) and efficacy (30-day mortality and re-bleeding) in use of PCC to treat MBE in patients on warfarin, rivaroxaban and apixaban. Some differences may reflect indications for anticoagulation. Disclosures Jayakody Arachchillage: Octapharma: Other: Sponsored to attend an educational meeting; Mitsubishi Phama: Other: Sponsored to attend an educational meeting; Bayer: Other: Sponsored to attend educational meetings. Laffan:Roche: Consultancy, Speakers Bureau; Pfizer: Honoraria.

the Efficacy and Safety of Prothrombin Complex Concentrate In Patients Requiring Urgent Reversal of Warfarin, A Retrospective Canadian Experience

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 3344-3344
Author(s):  
Cindy Varga ◽  
Stella Papadoukakis ◽  
Stephen N. Caplan ◽  
Susan R. Kahn ◽  
Mark Blostein
Keyword(s):  
Adverse Events ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Conflicts Of Interest ◽  
Oral Anticoagulant Therapy ◽  
Care Center ◽  
Vitamin K Antagonists ◽  
Tertiary Care ◽  
Factor Ix ◽  
Efficacy And Safety

Abstract Abstract 3344 Background: Major bleeding remains the most frequent adverse effect of oral anticoagulant therapy. A rapid method of reversal is required for patients on warfarin who suffer acute bleeding or require emergency surgery. Octaplex is a prothrombin complex concentrate recently recommended for use by the National Advisory Committee for Blood and Blood Products of Canada (Canadian Blood Services) at a dose of 1000 IU of factor IX activity. It ensures rapid INR correction by providing vitamin K-dependent factors without a large volume load. The main goal of this study was to investigate both the efficacy and safety of Octaplex use in a tertiary care center in Quebec, Canada. Materials and Methods: A retrospective review was conducted on the charts of patients who received Octaplex for urgent warfarin reversal between 1 January 2009 and 31 October 2009. Data collected included INRs pre and post Octaplex administration, and documentation of any adverse events. Results: We identified 146 occasions when Octaplex was administered for urgent INR reversal. A total of 118 patients were included in the study with a median age of 77. The three most frequent indications for Octaplex were: 1) gastrointestinal bleeding, 2) intracranial hemorrhage, and 3) pre-procedural INR reversal. The majority of patients (90.7%) were treated with Octaplex at a dose of 1000 IU of factor IX activity, with a range of 500 IU to 5000 IU. The average mean pre-and post INRs were 4.00 and 1.65, respectively. Overall, 89.8% (130/146) of patients corrected to an INR < 2.0, of which 51.5% (67/130) corrected to an INR < 1.5. Although 8.2% (12/146) of patients were considered to have a poor response (post INR > 2.1), these patients tended to have a higher mean pre-INR value (5.28 vs. 2.69) and still achieved important absolute drops in INR (range 1.1–9.3, mean 2.91). Only 4 patients (2.7%) did not experience a reversal of their INR. Seventeen patients received second doses of Octaplex, 70.6% (12/17) of whom achieved a post INR < 1.5 and 94.1% (16/17) achieved a post INR < 2.0. There were 8 reported thrombotic events amongst 118 patients: 3 myocardial infarctions, 3 DVTs, 1 ischemic limb and 1 intracardiac clot. All patients with these adverse events had other co-morbities that could have also contributed to these toxicities. Conclusion: Octaplex is efficient and appears to be safe in the urgent reversal of INR in patients taking vitamin K antagonists. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Efficacy and Safety of a 4-Factor Prothrombin Complex Concentrate in Patients on Vitamin K Antagonists Presenting With Major Bleeding

Circulation ◽  
2013 ◽  
Vol 128 (11) ◽  
pp. 1234-1243 ◽  
Author(s):  
Ravi Sarode ◽  
Truman J. Milling ◽  
Majed A. Refaai ◽  
Antoinette Mangione ◽  
Astrid Schneider ◽  
...  
Keyword(s):  
Vitamin K ◽  
Major Bleeding ◽  
Prothrombin Complex Concentrate ◽  
Vitamin K Antagonists ◽  
Efficacy And Safety

scholarly journals Direct oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation and cancer a meta-analysis

2020 ◽  
Author(s):  
Marco Valerio Mariani ◽  
Michele Magnocavallo ◽  
Martina Straito ◽  
Agostino Piro ◽  
Paolo Severino ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Vitamin K ◽  
Major Bleeding ◽  
Meta Analysis ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Significant Risk ◽  
Bleeding Complications ◽  
Efficacy And Safety

Abstract Background Direct oral anticoagulants (DOACs) are recommended as first-line anticoagulants in patients with atrial fibrillation (AF). However, in patients with cancer and AF the efficacy and safety of DOACs are not well established. Objective We performed a meta-analysis comparing available data regarding the efficacy and safety of DOACs vs vitamin K antagonists (VKAs) in cancer patients with non-valvular AF. Methods An online search of Pubmed and EMBASE libraries (from inception to May, 1 2020) was performed, in addition to manual screening. Nine studies were considered eligible for the meta-analysis involving 46,424 DOACs users and 182,797 VKA users. Results The use of DOACs was associated with reduced risks of systemic embolism or any stroke (RR 0.65; 95% CI 0.52–0.81; p 0.001), ischemic stroke (RR 0.84; 95% CI 0.74–0.95; p 0.007) and hemorrhagic stroke (RR 0.61; 95% CI 0.52–0.71; p 0.00001) as compared to VKA group. DOAC use was associated with significantly reduced risks of major bleeding (RR 0.68; 95% CI 0.50–0.92; p 0.01) and intracranial or gastrointestinal bleeding (RR 0.64; 95% CI 0.47–0.88; p 0.006). Compared to VKA, DOACs provided a non-statistically significant risk reduction of the outcomes major bleeding or non-major clinically relevant bleeding (RR 0.94; 95% CI 0.78–1.13; p 0.50) and any bleeding (RR 0.91; 95% CI 0.78–1.06; p 0.24). Conclusions In comparison to VKA, DOACs were associated with a significant reduction of the rates of thromboembolic events and major bleeding complications in patients with AF and cancer. Further studies are needed to confirm our results.

Efficacy and Safety of Direct Oral Anticoagulants Versus Vitamin K Antagonists in the Treatment of Left Ventricular Thrombus

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Cameron Burmeister ◽  
Azizullah Beran ◽  
Mohammed Mhanna ◽  
Sami Ghazaleh ◽  
Jeremy C. Tomcho ◽  
...  
Keyword(s):  
Vitamin K ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Left Ventricular ◽  
Left Ventricular Thrombus ◽  
Efficacy And Safety ◽  
Ventricular Thrombus

scholarly journals Management Strategies for Vitamin K Antagonists Reversal in Patients With Major Bleeding

2016 ◽  
Vol 23 (1) ◽  
pp. 40-44 ◽  
Author(s):  
Enrico Bernardi ◽  
Davide Imberti ◽  
Annamaria Ferrari
Keyword(s):  
Vitamin K ◽  
Major Bleeding ◽  
Prothrombin Complex Concentrate ◽  
Telephone Survey ◽  
Vitamin K Antagonists ◽  
Management Strategies ◽  
Public Hospitals ◽  
Computer Assisted ◽  
Emergency Physicians ◽  
National Guidelines

Objective: Emergency physicians frequently deal with patients on vitamin K antagonists (VKAs) suffering major bleeding events, and rapid reversal of anticoagulation in this setting is of paramount importance. In Italy, given the absence of specific national guidelines, local policies are likely to differ, possibly impacting on clinical outcomes. We decided to perform a telephone survey among Italian emergency physicians to evaluate management strategies for VKAs reversal in patients with major bleeding. Methods: We conducted a computer-assisted, 10-minute telephone survey of 15 questions, focusing on the local prevalence, assessment, and management strategies of major and intracranial hemorrhage (ICH) occurring in patients on VKAs. We planned to interview a sample of 320 Italian emergency physicians. Institutions from all geographic areas of Italy were to participate in the survey. Results: Of the 320 physicians contacted, 150 (47%) completed the survey, 95% being employed in public hospitals. Focusing on ICH, only 29% of the responders stated they would reverse anticoagulation irrespective of the international normalized ratio value, and only 27% would use prothrombin-complex concentrate as first-line agent. In patients needing urgent neurosurgical operation, less than 50% would administer prothrombin-complex concentrate before surgery. Conclusion: The average knowledge of management strategies for reversal of anticoagulation displayed by Italian emergency physicians appears to be unsatisfactory. The need for an extensive educational program and for the implementation of specific guidelines, possibly endorsed by Scientific Societies, cannot be underemphasized.

P6454Antithrombotic therapy and cardiovascular events in patients with left ventricular thrombus

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
B Lattuca ◽  
N Bouziri ◽  
J J Portal ◽  
J Zhou ◽  
M Zeitouni ◽  
...  
Keyword(s):  
High Risk ◽  
Vitamin K ◽  
Predictive Factors ◽  
Major Bleeding ◽  
Ischemic Cardiomyopathy ◽  
Vitamin K Antagonists ◽  
Anticoagulation Therapy ◽  
Left Ventricular ◽  
Ventricular Thrombus

Abstract Background Left Ventricular Thrombus (LVT) is associated with a high risk of thromboembolic complications such as stroke. Contemporary data are lacking on the management, prognosis and treatment of LVT, particularly with the emergence of the non-vitamin K antagonist anticoagulants (NOACs). Purpose To study the time and predictive factors associated with thrombus regression on treatment and its association with survival, embolic and bleeding complications. Methods From January 2011 to January 2018, a computerized case sensitive search of LVT was performed on 90 065 consecutive echocardiogram reports. All patients with a confirmed LVT were included in this analysis after imaging review by two independent experts. Repeated echocardiographic data, treatment management and clinical outcomes were collected during follow-up. Major adverse cardiac events (MACE), defined as the composite of death, ischemic stroke or transient ischemic attack (TIA), myocardial infarction (MI) or embolic peripheral artery occlusion were analyzed as well as major bleeding events (BARC ≥3) and the predictive factors and impact of LVT regression. Results We identified 174 patients with a suspected LVT of whom 159 had confirmed LVT on two different cardiac imaging exams. Ischemic cardiomyopathy was the main cause of LVT (n=125, 78.6%) including 56 (35.2%) patients with an acute ST segment elevation MI. The mean left ventricular ejection fraction was 31.9±12.5% with predominant (98.1%) apical location of the LVT. Anticoagulation therapy was achieved with vitamin K antagonists, NOACs and parenteral heparins in 48.7%, 22.8% and 27.8% of patients, respectively. Concomitant antiplatelet therapy was prescribed in 67.9% of patients. Total LVT regression was reached in two third of patients (62.3%, n=99) within a median time of 103 [32–392] days. Independent predictors of total LVT regression were an ischemic cardiomyopathy (HR: 0.36 [0.19–0.70], p=0.002), a larger baseline thrombus area (HR=0.66 [0.45–0.96], p<0.031) and a prolonged anticoagulation therapy over 3 months (HR=0.11 [0.05–0.22], p<0.0001). During a median follow-up of 632 [187–1126] days, MACE occurred in 59 (37.1%) patients with a 18.9% rate of mortality and 13.2% of major bleeding. Patients with a total LVT regression had a non-significant lower rate of MACE as compared with patients without total LVT regression (35.4% vs. 40.0%; HR=0.71 [0.42–1.21]; p=0.20), and a significant lower rate of mortality (15.2% vs. 25.0%; HR=0.48 [0.23–0.98]; p=0.039). Occurence of mortality (A) and MACE (B) Conclusions The prognosis of LVT remains severe with a high risk of major cardiovascular event and mortality. Total LVT regression, mostly reached in 3 months, can be obtained with both vitamin K antagonists and NOACs and is associated with a better prognosis.

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