Major Bleeding Outcomes for Admitted Immune Thrombocytopenia Patients with Platelets Less Than 10K: A Single Center Experience

Introduction Immune thrombocytopenia (ITP) is one of the most common causes of thrombocytopenia in adults. Majority of patients are asymptomatic or might have symptoms primarily related to mucocutaneous or minor bleeding events, while severe bleeding is uncommon. ITP patients who develop severe bleeding require urgent hospitalization, but asymptomatic/minor bleeding patients might be successfully treated as outpatient. In several occasions, the latter group of patients are admitted to the hospital to initiate treatment when their platelets are very low (i.e. less than 10K). In this study we aimed to evaluate the incidence of major bleeding and medical necessity for admitting this group to the hospital. Methods We conducted a retrospective chart review of 559 charts with an ICD code of ITP between March 2017 to March 2020. We excluded all patients who presented with a platelet above 10K, other co-existing hematological disorders or malignancies, first presentation with platelets less than 10K with no prior known history of ITP, and charts of patients who left against medical advice prior to initiation of treatment. The definition of major bleeding included intracranial hemorrhage, or any bleeding with more than 1 gm hemoglobin drop. Minor bleeding included epistaxis, gum bleeding, hematuria, vaginal or minor GI bleeding that didn't result in hemoglobin drop. We found a total of 66 ITP patients who were admitted to the hospital because of platelet count of less than 10K, of which 54 had minor or no bleeding episode, while 12 patients presented with major bleeding episode. Results Between the period of March 2017 to March 2020, a total of 66 patients with a known history of ITP were admitted to the hospital with platelet count of less than 10K, of which 54 patients (82%) had either only minor bleeding (n=10), or no evidence of bleeding (n=44) and 12 patients (18%) presented with major bleeding. The major bleeding events were distributed as follows: Hematuria due to kidney stone (n=1), traumatic ICH ((n=4), spontaneous ICH (n=1), and GI bleed (colon mass (n=1), erosive gastropathy(n=1), angiodysplasia (n=1), esophageal varices (n=2), and gastric ulcer (n=1)). None of the asymptomatic/minor bleeding patients developed any major bleeding event before, during or after hospitalization. The average LOS for asymptomatic/minor bleeding patients was 4.65 days (range 1-45 days), compared to 9.14 days (range 2-20 days) for patients with major bleeding. All the 12 patients (100%) with major bleeding received platelet transfusions during hospitalization, while 23 asymptomatic/minor bleeding patients (42%) received platelet transfusion. Discussion Major bleeding in patients with acute ITP is usually a clear indication for hospitalization, however there is lack of data to support admitting asymptomatic/minor bleeding ITP patients when platelets are less than 10K. Our data showed that no major bleeding event has developed in asymptomatic/minor bleeding patients at time of presentation, during hospitalization or after discharge. All 12 patients with major bleeding presented with a bleeding event that warranted their admission, of which 1 patient had spontaneous bleeding, while the rest had a clear medical reason for the major bleeding, which was likely exacerbated by thrombocytopenia. Since assessing the risk of bleeding is an important step in considering prophylactic platelet transfusion for those with platelets less than 10K, 42% of asymptomatic/minor bleeding patients received platelet transfusion during admission indicating that more than half didn't have high risk features. Inpatient hospitalization carries a high financial burden on both the patient and the healthcare system, increases the risk of hospital acquired infections and in-hospital complications. Asymptomatic/Minor bleeding patients in our study had average LOS of 4.65 days, and all were treated with regimens that can be given as an outpatient including steroids, IVIG, and in some occasions Rituximab and/or thrombopoietin stimulating agents increasing the cost of their hospital stay. Based on our observation, we are able to conclude that this particular group of patients would possibly benefit from close monitoring of signs and symptoms, labs, and treatment all in the outpatient setting. Further studies are needed to evaluate the cost effectiveness and long-term outcome in these patients. Disclosures No relevant conflicts of interest to declare.

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P3758Clinical characteristics and outcomes of atrial fibrillation patients with thrombocytopenia: the Fushimi AF Registry

European Heart Journal ◽

10.1093/eurheartj/ehz745.0610 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

K Ishigami ◽

Y Aono ◽

S Ikeda ◽

K Doi ◽

Y An ◽

...

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Platelet Count ◽

Major Bleeding ◽

Bleeding Event ◽

Bleeding Events ◽

Major Bleeding Event ◽

Entire Cohort ◽

Severe Group ◽

The Mean

Abstract Background Thrombocytopenia is sometimes found in routine blood tests and is reported as a risk factor of major bleeding events and incidence of all-cause death after percutaneous coronary intervention. However, the influence of thrombocytopenia on clinical outcomes in patients with atrial fibrillation (AF) remains unknown. Purpose We aimed to investigate relationship between baseline platelet count and clinical outcomes such as all-cause death, hospitalization for heart failure, and the major bleeding event in AF patients. Methods The Fushimi AF Registry was designed to enroll all of the AF patients in Fushimi-ku, Kyoto. Fushimi-ku is densely populated with a total population of 283,000 and is assumed to represent a typical urban community in Japan. Follow-up data with baseline platelet counts were available in 4,179 patients from March 2011 to November 2018. We divided the entire cohort into 3 groups according to baseline platelet level: No thrombocytopenia (≥150,000/μL, n=3,323), Mild thrombocytopenia (100,000–149,999/μL, n=707), and Moderate/severe thrombocytopenia (≤99,999/μL, n=149). Results In the entire cohort, the mean age was 73 years, 40% were women, and the mean body weight and body mass index was 59 kg and 23.1 kg/m2, and the median platelet count were 192,000/μL (interquartile range 156,000 to 232,000/μL), respectively. Compared to No thrombocytopenia, patients with thrombocytopenia were older (No vs. Mild vs. Moderate/severe; 73.3 years vs. 76.5 years vs. 75.8 years, p<0.0001), more likely to have heart failure (27.0% vs. 32.8% vs. 41.6%, p<0.0001), more likely to have chronic renal disease (35.7% vs. 42.6% vs. 57.7%, p<0.0001), and had higher CHADS2 score (2.05 vs. 2.17 vs. 2.34, p=0.0039) and CHA2DS2-VASc score (3.40 vs. 3.52 vs. 3.71, p=0.0416). Patients with thrombocytopenia had lower hemoglobin (13.0 vs. 12.8 vs. 11.6, p<0.0001) than No thrombocytopenia. However, prevalence of previous major bleeding events was comparable between three groups (4.66% vs. 4.67% vs. 5.37%, p=0.92) On Kaplan-Meier analysis, the incidence of all-cause death was higher in Mild group (hazard ratio [HR] 1.51; 95% confidence interval [CI] 1.28–1.77) and Moderate/severe group (HR 2.97; 95% CI 2.28–3.80) than No group (Figure 1). The incidence of hospitalization for heart failure was higher in Mild group (HR 1.62; 95% CI 1.31–1.99) and Moderate/severe group (HR 2.64; 95% CI 1.76–3.81) than No group (Figure 2). The incidence of major bleeding event was higher in Mild group (HR 1.46; 95% CI 1.11–1.91) and Moderate/severe group (HR 2.45; 95% CI 1.41–3.91) than No group (Figure 3). Conclusion Thrombocytopenia in AF patients was associated with higher incidence of all-cause death, hospitalization for heart failure, and major bleeding event in the Fushimi AF Registry. Acknowledgement/Funding Pfizer, Bristol-Myers Squibb, Boehringer Ingelheim, Bayer Healthcare,and Daiichi-Sankyo

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A phase I feasability study of concurrent fondaparinux (F) with carboplatin (Crb) and paclitaxel (P) for metastatic non-small cell lung cancer (NSCLC): An analysis of coagulation/angiogenic biomarker (CABM) kinetics.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.e19143 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. e19143-e19143

Author(s):

David James Mooney ◽

Debi Miley ◽

Mary Jerome ◽

Stefan C. Grant ◽

Francisco Robert

Keyword(s):

Major Bleeding ◽

Metastatic Cancer ◽

Bleeding Event ◽

Stage Iv ◽

Endothelial Damage ◽

Minor Bleeding ◽

Bleeding Events ◽

Thrombotic Risk ◽

Increased Risk ◽

Angiogenic Biomarkers

e19143 Background: There is an association between risk of thrombosis and metastatic cancer. Chemotherapy (C) also independently increases thrombotic risk. This increased risk is multifactorial, including endothelial damage and release of angiogenic cytokines. We hypothesized that adding anticoagulation to C may decrease thrombotic risk and also, potentially, have anti-tumor effect. Methods: The primary aim of this study was to determine the tolerability and safety (bleeding events) of the combination of F with 21-day cycle chemotherapy (Crb AUC 6 + P 200 mg/m2) in two cohorts of untreated patients (pts) with stage IV NSCLC. The secondary objectives were to determine incidence of venous thrombosis (VT), changes in CABM parameters during treatment, and clinical efficacy endpoints. Two cohorts of pts received F from cycles 2-4 with Crb+P. Cohort A received 2.5 mg F daily from cycle 2-4. Cohort B received 7.5 mg of F on day 1, 2 of cycle 2-4 and 2.5 mg F on day 3-21. Results: Clinical data from 19 evaluable pts are as follows: median age 55 years, 63% male, and 32% adenocarcinoma. There was no major bleeding event (BE) in either cohort, and 5 pts had a minor BE. There was no VT. Median time to progression was 5 months (3.8-6.2 months), and overall survival was 10 months (4.3-15.6 months). Baseline values of sensitive markers of activated coagulation (D-Dimer, Thrombin Anti-Thrombin Complex) were above the normal range in most patients. These biomarkers tended to increase during the first cycle (without F); whereas the same markers decreased during the second cycle (with F). A reduction of the angiogenic biomarkers during therapy was observed with VEGF, TGF-β1, and Angiopoietin-1. Conclusions: Concurrent treatment with F and chemotherapy for metastatic NSCLC is feasible with no major bleeding and little minor bleeding. During chemotherapy, coagulant and angiogenic biomarkers tended to increase, perhaps suggesting an increase in thrombogenic state. When F was added, these markers trended downward, suggesting that the proangiogenic state associated with cancer may be significantly altered by anticoagulation. Clinical trial information: NCT00476216.

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LO94: Evaluation of stroke and bleeding outcomes among patients managed in the emergency department for newly diagnosed atrial fibrillation

CJEM ◽

10.1017/cem.2020.148 ◽

2020 ◽

Vol 22 (S1) ◽

pp. S41-S42

Author(s):

S. Niaz ◽

C. Kirwan ◽

N. Clayton ◽

M. Mercuri ◽

K. de Wit

Keyword(s):

Atrial Fibrillation ◽

Emergency Department ◽

Major Bleeding ◽

Bleeding Event ◽

National Guidelines ◽

Bleeding Events ◽

Chads2 Score ◽

Major Bleeding Event ◽

Ischemic Attack ◽

New Diagnosis

Introduction: Atrial Fibrillation (AF) is the most common arrhythmia seen in patients presenting to the emergency department (ED). AF increases the risk of ischemic stroke which can be mitigated by anticoagulant prescription. National guidelines advise that emergency physicians initiate anticoagulation when AF is first diagnosed. We aimed to evaluate the 90-day incidence of stroke and major bleeding among emergency patients discharged home with a new diagnosis of AF. Methods: This was a health records review of patients diagnosed with AF in two EDs. We included patients ≥ age 18, with a new diagnosis of AF who were discharged from the ED, between 1st May 2014 and 1st May 2017. Using a structure review we collected data on CHADS65 and CHADS2 scores, contraindications to direct oral anticoagulant (DOAC) prescription and initiation of anticoagulation in the ED. Patient charts were reviewed for the diagnosis of stroke, transient ischemic attack (TIA), ischemic gut, ischemic limb or other systemic embolism within 90 days of the index ED presentation. We extracted data on major bleeding events within 90 days, defined by the International Society of Thrombosis and Haemostasis criteria. All data were extracted in duplicate for validation. Results: We identified 399 patients fulfilling the inclusion criteria, median age 68 (IQR 57-79), 213 (53%) male. 11 patients were already prescribed an anticoagulant for another indication and 19 had a contraindication to prescription of a DOAC. 48/299 (16%) CHADS65 positive patients were initiated on an anticoagulant, 3 of whom had a contra-indication to initiation of anticoagulation in the ED (1 dual antiplatelet therapy, 2 liver cirrhosis). 1/100 CHADS65 negative patients was initiated on anticoagulation. The median CHADS2 score was 1 (IQR 0-2). Among the 49 patients initiated on anticoagulation, 3 patients had a stroke/TIA within 90 days, 6.1% (95% CI; 2.1-16.5%). There were no bleeding events 0.0% (95% CI; 0.0-7.3%). Among the 350 patients who were not initiated on anticoagulation in the ED, 4 patients had a stroke/TIA 1.1% (95% CI; 1.1-2.9%) within 90 days and 2 patients had a major bleeding event. Conclusion: Prescription of anticoagulation for new diagnoses of AF was under-utilized in these EDs. The 90-day stroke/TIA rate was high, even among those given an anticoagulant prescription in the ED. No patient had an anticoagulant-associated bleeding event.

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Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial

Circulation ◽

10.1161/circulationaha.119.041346 ◽

2019 ◽

Vol 140 (22) ◽

pp. 1792-1801 ◽

Cited By ~ 2

Author(s):

Brian A. Bergmark ◽

Pieter W. Kamphuisen ◽

Stephen D. Wiviott ◽

Christian T. Ruff ◽

Elliott M. Antman ◽

...

Keyword(s):

Atrial Fibrillation ◽

At Risk ◽

Major Bleeding ◽

Bleeding Event ◽

Cox Proportional Hazards ◽

Severe Bleeding ◽

Bleeding Events ◽

Unique Identifier ◽

Clinical Trial Registration ◽

Relative Safety

Background: Numerous scales exist for the classification of major bleeding events. Limited data compare the most commonly used bleeding scales within a single at-risk cohort of patients with atrial fibrillation. Here, we analyze bleeding outcomes according to the ISTH (International Society on Thrombosis and Hemostasis), TIMI (Thrombolysis in Myocardial Infarction), GUSTO (Global Usage of Strategies to Open Occluded Arteries), and BARC (Bleeding Academic Research Consortium) bleeding scales in the ENGAGE AF (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation)–TIMI 48 trial (NCT00781391) of edoxaban versus warfarin. Methods: A total of 21 105 patients with atrial fibrillation at risk for stroke (CHADS 2 score ≥2) were enrolled in the ENGAGE AF-TIMI 48 trial comparing warfarin with a higher- (60/30 mg daily) or lower- (30/15 mg daily) dose edoxaban regimen. Median follow-up was 2.8 years. Bleeding events occurring among on-treatment patients were examined. Annualized event rates were calculated by the ISTH, TIMI, GUSTO, and BARC scales and compared across treatment arms. Cox proportional hazards for a first bleeding event of each type were calculated for higher-dose edoxaban regimen vs warfarin and lower-dose edoxaban regimen versus warfarin. Results: A total of 10 311 bleeding events were reported. In a comparison of the most severe events in each scale, ISTH major bleeding was the most common (n=1289), followed by TIMI major (n=548), GUSTO severe/life-threatening (n=347), and BARC 3c+5 (n=276) bleeding. Lower bleeding risk with edoxaban compared with warfarin was seen regardless of bleeding scale (higher-dose edoxaban regimen range: hazard ratio [HR], 0.47 [95% CI, 0.35–0.62] for BARC 3c+5 versus HR, 0.80 [95% CI, 0.71–0.91] for ISTH major; lower-dose edoxaban regimen range: HR, 0.32 [95% CI, 0.23–0.45] for BARC 3c+5 versus HR, 0.47 [95% CI, 0.41–0.55] for ISTH major). Furthermore, a gradient of more pronounced risk reduction with edoxaban was observed with greater severity of first bleeding event (higher-dose edoxaban regimen: HR, 0.47 [95% CI, 0.35–0.62] for BARC 3c+5 bleeds versus HR, 0.86 [95% CI, 0.81–0.91] for any BARC bleed; lower-dose edoxaban regimen: HR, 0.32 [95% CI, 0.23–0.45] for BARC 3c+5 bleeds versus HR, 0.68 [95% CI, 0.63–0.72] for any BARC bleed). The direction of this trend was consistent for both gastrointestinal bleeding and nongastrointestinal bleeding. Conclusions: Among patients with atrial fibrillation at risk for stroke, there was a >4-fold difference in the frequency of the most severe bleeding events across commonly used bleeding scales. Furthermore, the relative safety of edoxaban compared with warfarin tended to increase with greater severity of bleeding. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT00781391.

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Soluble glycoprotein VI is a predictor of major bleeding in patients with suspected heparin-induced thrombocytopenia

Blood Advances ◽

10.1182/bloodadvances.2020002861 ◽

2020 ◽

Vol 4 (18) ◽

pp. 4327-4332 ◽

Cited By ~ 1

Author(s):

Allyson M. Pishko ◽

Robert K. Andrews ◽

Elizabeth E. Gardiner ◽

Daniel S. Lefler ◽

Adam Cuker

Keyword(s):

Major Bleeding ◽

Platelet Transfusion ◽

Bleeding Event ◽

Bleeding Risk ◽

Enzyme Linked Immunosorbent Assay ◽

Sample Collection ◽

Bleeding Events ◽

Heparin Induced Thrombocytopenia ◽

Glycoprotein Vi ◽

Major Bleeding Events

Abstract We have shown that patients with suspected heparin-induced thrombocytopenia (HIT) have a high incidence of major bleeding. Recent studies have implicated elevated soluble glycoprotein VI (sGPVI) levels as a potential risk factor for bleeding. We sought to determine if elevated sGPVI plasma levels are associated with major bleeding events in patients with suspected HIT. We used a cohort of 310 hospitalized adult patients with suspected HIT who had a blood sample collected at the time HIT was suspected. Plasma sGPVI levels were measured by using enzyme-linked immunosorbent assay. Patients were excluded who had received a platelet transfusion within 1 day of sample collection because of the high levels of sGPVI in platelet concentrates. We assessed the association of sGPVI (high vs low) with International Society on Thrombosis and Haemostasis major bleeding events by multivariable logistic regression, adjusting for other known risk factors for bleeding. Fifty-four patients were excluded due to recent platelet transfusion, leaving 256 patients for analysis. Eighty-nine (34.8%) patients had a major bleeding event. Median sGPVI levels were significantly elevated in patients with major bleeding events compared with those without major bleeding events (49.09 vs 31.93 ng/mL; P < .001). An sGPVI level >43 ng/mL was independently associated with major bleeding after adjustment for critical illness, sepsis, cardiopulmonary bypass surgery, and degree of thrombocytopenia (adjusted odds ratio, 2.81; 95% confidence interval, 1.51-5.23). Our findings suggest that sGPVI is associated with major bleeding in hospitalized patients with suspected HIT. sGPVI may be a novel biomarker to predict bleeding risk in patients with suspected HIT.

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Assessment of Predicted Rate and Associated Factors of Dabigatran-induced Bleeding Events in Malaysian Patients with Non-Valvular Atrial Fibrillation

Journal of Pharmacy & Pharmaceutical Sciences ◽

10.18433/j3tp9q ◽

2017 ◽

Vol 20 (1) ◽

pp. 365 ◽

Cited By ~ 1

Author(s):

Semira Abdi Beshir ◽

Lok Bin Yap ◽

Szyuin Sim ◽

Kok Han Chee ◽

Yoke Lin Lo

Keyword(s):

Heart Failure ◽

Atrial Fibrillation ◽

Congestive Heart Failure ◽

Major Bleeding ◽

Bleeding Event ◽

Minor Bleeding ◽

Bleeding Events ◽

Laboratory Test Results ◽

Major Bleeding Events

Purpose: To assess the predicted rate and the factors associated with bleeding events among patients with non-valvular atrial fibrillation (NVAF) receiving dabigatran therapy. Methods: This retrospective cohort study includes adult patients of two tertiary hospitals in Malaysia. Potential study subjects were identified using pharmacy supply database or novel oral anticoagulant (NOAC) registry. Demographics, clinical data and laboratory test results were extracted from the medical records of the patients or electronic databases. The main outcome measure is the occurrence of a bleeding event. Bleeding events were classified into major bleeding, clinically relevant non-major bleeding, or minor bleeding, according to the International Society on Thrombosis and Haemostasis criteria. We consider clinically relevant non-major bleeding events or major bleeding events as clinically relevant bleeding events. An occurrence of any bleeding event was recorded from the initiation of NOAC therapy until the death of a patient, or the date of permanent discontinuation of NOAC use, or the last day of data collection. The predicted rate of dabigatran-induced bleeding events per 100 patient-years was estimated. Results: During a median follow-up period of 18 months, 73 patients experienced 90 bleeding events. Among these patients, 25 including 4 fatal cases, experienced major bleeding events. The predicted rate per 100 patient-years of follow-up of any bleeding events was 9.0 [95% CI 6.9 to 11.1]; clinically relevant bleeding events 6.0 [95% CI 4.8 to 8.3], and major bleeding events 3.0 [95% CI 1.9 to 4.2]. The independent risk factor for clinically relevant bleeding events is prior bleeding. While prior bleeding or congestive heart failure is linked with major bleeding events. Conclusions: The predicted rate for dabigatran-induced major bleeding episodes is low but these adverse events carry a high fatality risk. Preventive measures should target older patients who have prior bleeding or congestive heart failure. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

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Bleeding Complications in Patients on New Oral Anticoagulants for Venous Thromboembolism in Kenya

10.21203/rs.3.rs-166168/v1 ◽

2021 ◽

Author(s):

ANTONINA OBAYO ◽

Mzee Ngunga ◽

Jasmit Shah ◽

Ahmed Sokwala ◽

Anders Barasa

Keyword(s):

Venous Thromboembolism ◽

Major Bleeding ◽

Oral Anticoagulants ◽

Bleeding Event ◽

Bleeding Complications ◽

Minor Bleeding ◽

Bleeding Events ◽

Tertiary Referral Hospital ◽

Telephone Interviews ◽

Major Bleed

Abstract Background: The purpose of this study is to determine the rates of bleeding associated with NOAC use. Methods: Patients diagnosed with venous thromboembolism (VTE) and treated with NOACs at a tertiary referral hospital in Kenya from January 2014 to December 2019 were recruited. They were followed up from commencement of oral anticoagulation to completion of therapy, the first major bleed, clinically relevant non-major bleed (CRNM), or minor bleeding. Data on bleeding was obtained from the hospital database and through telephone interviews. Unadjusted rates of the first major bleeding event or clinically relevant non-major bleeding (CRNM) were calculated as the number of bleeding events per 100 patient-years Results: Two hundred forty-three patients with VTE were recruited. 222(91.4%) were initiated on rivaroxaban, 12(4.9%) on dabigatran, 9(3.7%) on apixaban with a median follow-up of 213(119,477) days. The median age of the patients was 57(45, 71) years. A total of 64 bleeding events were identified in 41(16.9%) patients, 18.8 % were major, 17.2 % were clinically relevant non-major (CRNM), and 64.1 % were minor. The incidence rate for bleeding events was 22.1 per 100 patient-years. Gastrointestinal (GIT) bleeding was the most common major bleeding site. There were more females with bleeding events (70.7%) compared to males. Conclusions: In our cohort, most bleeding events were minor, with the GIT being the most common site of major bleeding and menorrhagia being the commonest cause of bleeding. Females had more major and CRNM than men.

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The Effect of BMI and Gender on Bleeding Events when Rivaroxaban Is Administered for Thromboprophylaxis Following Total Hip and Total Knee Arthroplasty

Seminars in Thrombosis and Hemostasis ◽

10.1055/s-0038-1676319 ◽

2018 ◽

Vol 45 (02) ◽

pp. 180-186 ◽

Cited By ~ 3

Author(s):

Eugene Krauss ◽

Nancy Dengler ◽

Barry Simonson ◽

Kathleen Altner ◽

Madison Daly ◽

...

Keyword(s):

Venous Thromboembolism ◽

Major Bleeding ◽

Total Joint Arthroplasty ◽

Bleeding Event ◽

Joint Arthroplasty ◽

Morbidly Obese ◽

Bleeding Events ◽

Major Bleeding Event ◽

Major Bleeding Events ◽

And Gender

AbstractRivaroxaban is approved in Europe and the United States for thromboprophylaxis following total joint arthroplasty. As the rate of obesity increases, confirming safety and efficacy in this patient population is paramount. This retrospective chart review assessed the efficacy and safety of rivaroxaban between two body mass index (BMI) groups: normal or overweight (< 30 kg/m2) and obese or morbidly obese (≥30 kg/m2). Safety outcome was a major bleeding event, defined as a decrease in hemoglobin of at least 2 g/dL from postoperative day 1(POD 1) to discharge or a blood transfusion of at least two units. Efficacy outcome was venous thromboembolism within 35 days postoperatively. There were 68 (68/1,241; 5.48%) major bleeding events. There was no significant association between major bleeding events and BMI in the univariable analysis (p < 0.36). However, after adjusting for other factors in the multivariable model, there was a significant interaction between BMI and gender (p < 0.001). Among males, the incidence of major bleeding events was three times greater in obese/morbidly obese subjects as compared with normal/overweight male subjects (odds ratio [OR]: 3.09, 95% confidence interval [CI]: 1.25, 7.62). Among females, incidence of having a major bleeding event was almost two times greater in normal/overweight subjects as compared with obese/morbidly obese female subjects (OR: 2.17, 95% CI: 1.10, 4.35). Incidence of venous thromboembolism was 0.4% in each group. The authors' study results highlight a previously unexplored association between BMI and gender-dependent differences in bleeding outcomes when rivaroxaban is used for thromboprophylaxis following total joint arthroplasty.

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478 Clinical outcomes of patients at very high stroke risk undergoing watchman implantation

European Heart Journal Supplements ◽

10.1093/eurheartj/suab134.052 ◽

2021 ◽

Vol 23 (Supplement_G) ◽

Author(s):

Michele Magnocavallo ◽

Domenico Giovanni Della Rocca ◽

Carlo Lavalle ◽

Gianni Carola ◽

Sa Mohanty ◽

...

Keyword(s):

Major Bleeding ◽

Stroke Risk ◽

Bleeding Event ◽

Minor Bleeding ◽

Bleeding Events ◽

Related Complication ◽

Watchman Device ◽

Major Bleeding Events ◽

Very High

Abstract Aims Left atrial appendage occlusion (LAAO) with the Watchman device is an effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation at high thromboembolic risk. We sought to evaluate the safety and effectiveness of LAAO for stroke and bleeding prevention in patients at very high stroke risk. Methods and results Data were extracted from a prospective database of 488 AF patients who underwent LAA closure with a Watchman device. Periprocedural complications, thromboembolic (TE), and bleeding event rates among patients with a CHA2DS2-VASc ≥ 5 were reported. Predicted annual rates of TE or major bleeding events were compared to the annualized observed risk of the population. Overall, 209 patients with a CHA2DS2-VASc ≥5 (CHA2DS2-VASc: 6.0 ± 1.0; HAS-BLED: 3.7 ± 1.1) were included in the study. The mean age was 78 ± 6 years and 52.2% (n = 109) were males. Watchman implantation was successful in all patients. Overall procedure-related complication rate was 3.3% (n = 7). Two major complications were observed (1.0%): one pericardial tamponade requiring surgery and one major bleeding event at 3 days post-procedure. The incidence of minor complications was 2.3% (n = 5). Specifically, two patients experienced a pericardial effusion that required drainage and three had a groin hematoma. During a mean follow-up duration of 12 ± 5 months (193 pt/years), six TE events (2.9%/annualized rate: 3.1%) were documented after a median of 6.3 months (IQR: 2.2–9.6). Based on the estimated annual TE risk according to the CHA2DS2-VASc score (8.5%), the % risk reduction after LAAO was 63.5%. Four major bleeding events [1.9% (median time to event: 2.1 months; IQR: 1.0–3.4)] and five minor bleeding events occurred (2.5%) during follow-up. Compared to the expected rate of bleeding events as assessed by the HAS-BLED of the population (8.03%), LAAO led to a 42% reduction of bleeding risk. Conclusions In a population at very high TE risk, LAAO with the Watchman device was a safe and effective approach, and led to a 63.5% of stroke risk.

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The Risk of Major Bleeding in Patients with Suspected Heparin-Induced Thrombocytopenia (HIT)

Blood ◽

10.1182/blood-2018-99-112200 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 377-377

Author(s):

Allyson Pishko ◽

Daniel Lefler ◽

Phyllis Gimotty ◽

James Guevara ◽

Adam Cuker

Keyword(s):

Laboratory Test ◽

Major Bleeding ◽

Laboratory Testing ◽

Research Funding ◽

Bleeding Event ◽

Bleeding Events ◽

Chi Square ◽

Heparin Induced Thrombocytopenia ◽

Major Bleeding Event ◽

Empiric Treatment

Abstract Introduction: Without prompt treatment, heparin-induced thrombocytopenia (HIT) is associated with a daily rate of life- and limb-threatening thrombosis of 6.1%. Current recommendations are to empirically treat a patient with an intermediate or high pre-test likelihood of HIT with a non-heparin (alternative) anticoagulant while awaiting HIT laboratory test results. The real-world bleeding rates of empiric treatment with an alternative anticoagulant in patients with suspected HIT have not been well-described. We assessed the rates of major bleeding in a prospective cohort of patients with suspected HIT. Because HIT is generally considered a prothrombotic and not a prohemorrhagic disorder, we hypothesized that major bleeding would be less common in alternative anticoagulant-treated patients with HIT than in treated patients who were ultimately determined not to have HIT. Methods: From June 2012 to January 2015, we enrolled 310 patients with suspected HIT at the Hospital of the University of Pennsylvania and an affiliated community hospital. All patients underwent HIT laboratory testing with a poly-specific PF4/heparin ELISA and in-house serotonin release assay. Patients were adjudicated to be HIT-positive or HIT-negative by an independent adjudication panel of HIT experts based on clinical course and results of HIT laboratory testing. We retrospectively reviewed the electronic health record to assess for the presence of a major bleeding event from the time of suspicion of HIT until hospital discharge or death. Major bleeding events were defined by International Society on Thrombosis and Haemostasis (ISTH) criteria (fall in hemoglobin ≥2 g/dL, transfusion of ≥2 units of packed red blood cells, fatal bleed, bleed occurring in a critical organ and/or requiring a repeat surgical intervention). Secondary outcomes of progressive or new thrombosis following suspicion of HIT testing, in-hospital and 30-day mortality were also assessed. Patients were considered to be treated for suspicion for HIT if they received an alternative anticoagulant following a HIT laboratory test order. The demographics and clinical features of patients defined by adjudicated HIT status were compared using the Wilcoxon test and chi-square tests for continuous and for categorical variables, respectively. The proportion of bleeding and thrombotic events were compared between groups using a chi-square test. All analyses were performed using Stata v14.2. Results:The demographics of our cohort by adjudicated HIT status are displayed in Table 1. 44 patients in the cohort were adjudicated to be HIT-positive and 266 were adjudicated HIT-negative. 42/44 (95.5%) HIT-positive patients and 116 of 266 (43.6%) HIT-negative patients received an alternative anticoagulant. Of those who were empirically treated with an alternative anticoagulant, the median duration of treatment was 3 days (IQR 2-5.5) in HIT-negative patients, compared with 11.5 days (IQR 6-16) in the HIT-positive group (p=0.001). The majority of treated patients received argatroban (88.0% of HIT-positive patients and 76.7% of HIT-negative patients). In those patients who received an alternative anticoagulant, a major bleeding event occurred in 40.9% of HIT positive patients and 44.8% HIT negative patients (p=0.45).The majority of major bleeding events met ISTH criteria based on hemoglobin fall or blood transfusion (Table 2). New or progressive thrombosis following suspicion for HIT was more common in HIT-positive patients (35.7%) than in patients who were HIT-negative and treated (15.5%) or not treated (11.3%) (p=0.001) (Table3). Conclusions: Contrary to our hypothesis, HIT was not protective against bleeding. A similar proportion of HIT-positive patients had ISTH major bleeding compared with HIT-negative patients treated with an alternative anticoagulant. The current paradigm for empiric treatment of patients with suspected HIT may need to be reconsidered in light of our findings of greater than expected bleeding associated with treatment. Limitations of our study include relatively small size, recruitment from a single health system, and predominant use of a single alternative anticoagulant (argatroban). Further studies are needed to determine whether our results apply to other centers and other alternative anticoagulants. Disclosures Pishko: Novo Nordisk: Research Funding. Cuker:Synergy: Consultancy; Genzyme: Consultancy; Kedrion: Membership on an entity's Board of Directors or advisory committees; Spark Therapeutics: Research Funding.

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