Comparison of Positive Two-Step PF4-Polyvinylsulfonate Antigen Assay Results with Thrombotic Risk and Clinical Outcome among 182 Patients with Heparin-Induced Thrombocytopenia (HIT).

Abstract Background: Retrospective studies have reported a correlation of higher ELISA optical density (OD) values for H-PF4 antibodies with occurrence of thrombotic events in patients (pts) with HIT; often with variable prophylactic direct thrombin inhibitor (DTI) use. Objectives: To compare positive OD (≥0.4) values with thrombotic risk and clinical outcome in pts with clinically-suspected or confirmed HIT. Design: Retrospective cohort study. Setting: IRB-approved, CAMC HIT Registry. Patients: 182 HIT pts, age ≥18 yrs with OD values ≥0.40 (EIA, GTI) enrolled from 3/11/05 to 12/27/07. Age 64.5±13.4 yrs; M/F (107/75); caucasian (96.2%); CV surgery (n=120), medical (n=45), gen/vasc surgery (n=17); heparin use: therapeutic (n=160), prophylaxis (n=17), catheter flushes (n=5). Measurements: mean OD±SD; objectively confirmed thrombosis (venous, arterial); all-cause mortality; length of stay (LOS); DTI use; composite outcome (new thrombosis, death, amputation); thrombotic composite outcome (new thrombosis, death from new thrombosis, amputation). Results: At HIT diagnosis, prevalent thrombosis occurred in 82 pts and isolated HIT occurred in 100 pts. Thrombotic presentations (n) included: venous alone (DVT-27, PE-9, DVT + PE-5), arterial alone (single event-28, multiple events-5), and venous plus arterial (8). Prevalent thromboses were symptomatic in 65 pts (79.3%). Fourteen pts developed a new thrombosis; 5 of them had isolated HIT. A total of 87 pts (47.8%) had “ever” thrombosis. The OD of the 182 pts was 1.12±0.76 with a cumulative thrombotic rate of 52.4%, 75.6% and 90.3% in OD ranges of 0.40–0.89, 0.4–1.49 and 0.4–2.29, respectively. No significant difference in rates of prevalent thrombosis was observed in any of 3 categorizations of OD values (% thrombosis): 0.40–0.99 vs. ≥1.00 (42.3% vs. 41.7%; P=0.457), 0.40–1.09 vs. ≥1.10 (47.9% vs. 40.0%; P=0.307) and 0.40–1.19 vs. ≥ 1.20 (47.5% vs. 40.0%; P=0.337). Among pts with “ever” vs. “never” thrombosis, there was no significant difference in OD values (1.14±0.84 vs. 1.10±0.69; P=0.692). Among pts with a new thrombosis, the OD was 1.45±1.36 (min 0.43, max 5.53). The OD was numerically higher in pts with isolated HIT who developed a new thrombosis vs. pts with “never” thrombosis (2.23±2.05 vs. 1.10±0.69; P=0.285). Males developed a higher rate of thrombosis than females (56.1% vs. 36.0%; P=0.008). Surgical pts comprised a higher proportion of “ever” thrombosis than medical pts (54.7% vs. 26.7%); P=0.001). All-cause mortality was significantly higher in the “ever” vs. “never” thrombosis groups (16.1% vs. 5.3%; P=0.017); highest among pts with isolated HIT (80.0%) and prevalent thrombosis who developed a new thrombosis (55.6%). HIT as cause or possible cause of mortality in pts with “never” thrombosis (1.1%) was significantly lower than those with “ever” thrombosis (10.3%, P=0.007) and those with new thrombosis (57.1%, P<0.001). Composite and thrombotic composite outcomes were numerically higher in pts presenting with prevalent thrombosis vs. isolated HIT: 19.5% vs. 10.0% (P=0.068) and 14.6% vs. 6.0% (P=0.052). Among pts with “ever” vs. “never” thrombosis, there was no significant difference in rates of major bleeding (5.8% vs. 2.1%), amputation (2.3% vs. 0.0%), alternative anticoagulant therapy (99.0% vs. 94.7%), DTI use (96.6% vs. 94.7%) and mean LOS (28.1 d vs. 25.1 d). The mean duration of DTI use was longer in pts with “ever” vs. “never” thrombosis (16 d vs. 11.9 d; P=0.029) with a non-significant trend for a longer duration of DTI-warfarin overlap (7.4 d vs. 5.8 d; P=0.064). Conclusions: The occurrence of prevalent thrombosis was not significantly different in any of 3 categorizations of (+) OD values with thresholds at or above vs. lower than 1.0, 1.1 or 1.2. OD values, DTI use, rates of major bleeding and length of stay were similar among pts with “ever” vs. “never” thrombosis. Patients with “ever” thrombosis had significantly higher rates of all-cause and HIT-specific mortality. After HIT presentation, pts who developed a new thrombosis had the highest subpopulation OD values and mortality outcomes. Patients with isolated HIT who did not develop a new thrombosis (“never” thrombosis) had significantly lower rates of all-cause and HIT-specific mortality.

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Safety and Effectiveness of Rivaroxaban Versus Low Molecular Weight Heparin for Treatment of Cancer-Associated Venous Thrombosis: A SEER-Medicare-Linked Data Analysis

Blood ◽

10.1182/blood-2019-128581 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 3673-3673

Author(s):

Christine G. Kohn ◽

Gary H. Lyman ◽

Nicole M. Kuderer ◽

Thomas J. Bunz ◽

Craig I. Coleman

Keyword(s):

Major Bleeding ◽

Research Funding ◽

Linked Data ◽

Factor Xa ◽

Low Molecular Weight ◽

Composite Outcome ◽

Recurrent Thrombosis ◽

Significant Difference ◽

All Cause Mortality ◽

Recurrent Vte

Introduction: Venous thromboembolism (VTE) affects ~20% of patients with cancer prior to death and may be present in up to half of cancer patients upon autopsy. International Society of Thrombosis and Haemostasis (ISTH) guidelines recommend oral factor Xa inhibitors for the acute treatment and secondary prevention of cancer-associated thrombosis (CAT) in patients considered low risk of bleeding and without a potential for drug-drug interactions with current systemic therapy. We sought to evaluate the effectiveness and safety of rivaroxaban versus a low molecular weight heparin (LMWH) for the treatment of CAT in routine practice. Methods: Using United States Surveillance, Epidemiology and End Results (SEER)-Medicare-linked data from 2013 to 2015, we identified adults diagnosed with lung, breast, pancreatic, prostate or ovarian cancer, having at ≥1 hospitalization or emergency department admission (index event) with a primary discharge diagnosis code for VTE (indicating VTE was the foremost reason for admission) , ≥12-months of continuous medical and prescription benefits prior to the index CAT and who received rivaroxaban or a LMWH as their first outpatient anticoagulant. Patients with primary or metastatic gastrointestinal cancers, stage 4 or worse chronic kidney disease or liver failure were excluded. Hazard ratios (HRs) and 95% confidence intervals (CIs) for the composite outcome of recurrent VTE or major bleeding, each of these outcomes alone as well as all-cause mortality in the subsequent 12-months were calculated using a multivariable Fine-Gray (competing risk) Cox regression model adjusted for baseline covariates and propensity score decile (c-index=0.76) estimated using generalized boosted models on the basis of 10,000 regression trees. Results: We included 259 rivaroxaban- and 559 LMWH-managed patients with CAT. The median age (25%, 75% range) of patients was 73 (68, 79) years, 62.5% were men and 43.6% had pulmonary embolism. The incident cancer diagnosis was made between 2010 and 2013 in 87.8% of patients. Primary cancer locations included lung (41.8%), breast (21.8%), pancreatic (12.1%), prostate (11.9%), ovarian (5.3%) and other (7.1%). Nearly all patients (96.5%) were diagnosed with stage 2 or 3 disease. During the 12-month follow-up period, the incidence of the composite of recurrent VTE or major bleeding was 13.8%, recurrent VTE alone occurred in 11.4% and major bleeding alone in 2.9% of patients and all-cause mortality occurred in 48.4%. No significant difference in patients' relative hazard of the experiencing the composite outcome (HR=0.86, 95%CI=0.52-1.41), recurrent VTE (HR=0.91, 95%CI=0.51-1.62), major bleeding (HR=0.90, 95%CI=0.29-2.83) or all-cause mortality (HR=0.86, 95%CI=0.62-1.21) were observed between the rivaroxaban and LMWH-managed cohorts. Conclusions: In this real-world study of rivaroxaban- and LMWH-managed CAT patients, no significant difference in patients' relative hazard of experiencing the composite outcome, recurrent thrombosis, major bleeding or all-cause mortality were observed between the two cohorts. These data are consistent with recommendation that the oral factor Xa inhibitor, rivaroxaban, is a reasonable alternative to LMWH for the treatment of CAT and prevention of recurrent thrombosis. Disclosures Lyman: Amgen Inc.: Other: Research support, Research Funding; Janssen Scientific Affairs, LLC: Research Funding; Generex Biotechnology: Membership on an entity's Board of Directors or advisory committees; G1 Therapeutics, Halozyme Therapeutics, Partners Healthcare, Hexal, Bristol-Myers Squibb, Helsinn Therapeutics, Amgen Inc., Pfizer, Agendia, Genomic Health, Inc.: Consultancy. Kuderer:Mylan: Consultancy, Other: Travel, Accommodations, Expenses; Celldex: Consultancy; Myriad Genetics: Consultancy; Coherus Biosciences: Consultancy, Other: Travel, Accommodations, Expenses; Pfizer: Consultancy; Halozyme: Consultancy; Janssen Scientific Affairs, LLC: Consultancy, Other: Travel, Accommodations, Expenses. Coleman:Bayer AG: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs LLC: Consultancy, Honoraria, Research Funding.

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The safety of morphine use in acute coronary syndrome: a meta-analysis

Heart Asia ◽

10.1136/heartasia-2018-011142 ◽

2019 ◽

Vol 11 (1) ◽

pp. e011142 ◽

Cited By ~ 1

Author(s):

Rugheed Ghadban ◽

Tariq Enezate ◽

Joshua Payne ◽

Haytham Allaham ◽

Ahmad Halawa ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Major Bleeding ◽

Pain Control ◽

Controlled Trial ◽

Cochrane Central Register ◽

Minor Bleeding ◽

Coronary Syndrome ◽

Increased Risk ◽

Significant Difference ◽

All Cause Mortality

BackgroundMorphine is widely used for pain control in patients with acute coronary syndrome (ACS). Several studies have questioned the safety of morphine in this setting with a concern of interaction with and reduced efficacy of antiplatelet agents.ObjectiveThis study aims to systematically review the safety of morphine use in ACS.MethodsMEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were queried from inception through April 2018. Studies comparing morphine to nonmorphine use in ACS were included. Study endpoints included: in-hospital myocardial infarction (MI), all-cause mortality, stroke, major bleeding, minor bleeding and dyspnoea.ResultsA total of 64 323 patients with ACS were included from eight studies, seven of which were observational studies and one was a randomised controlled trial. The use of morphine was associated with increased risk of in-hospital recurrent MI (OR 1.30, 95% CI 1.18 to 1.43, p < 0.00001). There was, however, no significant difference in terms of all-cause mortality (OR 0.87, 95% CI 0.62 to 1.22, p = 0.44), stroke (OR 0.81, 95% CI 0.39 to 1.66, p = 0.57), major bleeding (OR 0.49, 95% CI 0.24 to 1.00, p = 0.05), minor bleeding (OR 0.98, 95% CI 0.41 to 2.34, p = 0.97), or dyspnoea (OR 0.55, 95% CI 0.16 to 1.83, p = 0.33).ConclusionThe use of morphine for pain control in ACS was associated with an increased risk of in-hospital recurrent MI. Randomised clinical trials are needed to further investigate the safety of morphine in ACS.

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Sepsis associated new onset atrial fibrillation; risk factors and long term outcomes

European Heart Journal ◽

10.1093/ehjci/ehaa946.0363 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

V Moosavi ◽

M Paymard ◽

R Ebrahimi ◽

T Harvey ◽

N Parkes ◽

...

Keyword(s):

Risk Factors ◽

Atrial Fibrillation ◽

Ischaemic Stroke ◽

Major Bleeding ◽

Rate Control ◽

Statistical Significance ◽

Significant Difference ◽

All Cause Mortality ◽

New Onset

Abstract Background Atrial fibrillation (AF) is commonly encountered in the setting of systemic inflammation or infection. The optimal management of AF in this cohort and their long-term AF-related clinical outcome are unknown. Purpose The aims of our study were to evaluate the traditional and non-traditional AF risk factors and long-term AF-related clinical outcomes in patients who were diagnosed with new onset AF in the setting of sepsis. Methods In this retrospective cohort study, we used the medical records to identify patients who were diagnosed with the new onset AF during hospitalization for sepsis at our centre between 2013 and 2017. The primary clinical outcomes included 24-month risk of ischaemic stroke, major bleeding (gastrointestinal or intracranial bleeding), the recurrence of AF and the all-cause mortality. The patients with known AF or those who died during the index admission were excluded from the analysis. Results 5598 patients were admitted to our hospital between 2013 and 2017 with sepsis. Of this cohort, 126 patients (mean age 69.7 years, 62.7% male) developed new onset AF during the index hospital admission (72.2% required ICU admission). 38 patients (30.1%) died during the initial hospitalisation while 88 patients (69.9%) were discharged from hospital (32% anticoagulated). 14 patients (16%) died within 24 months. Hypertension (59%), CKD (30%), diabetes (21%), and CCF (17%) were the most common risk factors. Mean CHA2DS2VASC score was 2.56±1.4 and mean HAS BLED score was 2.5±1.3. Mean CRP and WCC were 228±119 and 12.3±9.1 respectively. Comparing risk factors, only HASBLED score showed statistical significance on 24 months mortality (p=0.036, 95% CI 0.43–1.52). The composite incidence of all-cause mortality and ischaemic stroke was three times lower in anticoagulated patients compared with those who did not receive anticoagulation even though this did not reach statistical significance (7.1% v 21.6% respectively, p=0.07; RR=0.32; 95% CI=0.79–1.36). There was no statistically significant difference between the two groups for major bleeding events (3.5% v 3.3% respectively, p=0.68; RR=1.07; 95% CI=0.10–11.3). Rhythm and rate control therapies showed no significant difference on the composite outcome of all-cause mortality, ischaemic stroke and recurrence of AF (28.0% v 28.9%, p=0.92; RR=0.96, 95% CI=0.49–1.88), however, there was a trend towards less recurrence of AF in patients who received rate or rhythm control therapies (12% vs 18% respectively p=0.44; RR=0.67; 95% CI=0.24–1.85). Conclusions Our study suggests that anticoagulation therapy in patients with sepsis associated new onset AF may decrease composite of all-cause mortality and ischaemic stroke without increasing major bleeding risk. Rhythm and rate control strategies did not decrease all-cause mortality, ischaemic stroke or risk of recurrence of AF. These findings can provide benchmarks for design of randomized control trials. Funding Acknowledgement Type of funding source: None

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Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source

Stroke ◽

10.1161/strokeaha.120.031891 ◽

2021 ◽

Vol 52 (3) ◽

pp. 1069-1073

Author(s):

Shinichiro Uchiyama ◽

Kazunori Toyoda ◽

Byung-Chul Lee ◽

Chia-Wei Liou ◽

Lawrence Ka Sing Wong ◽

...

Keyword(s):

East Asia ◽

Major Bleeding ◽

Recurrent Stroke ◽

East Asian ◽

Hazard Ratio ◽

Embolic Stroke ◽

Thrombin Inhibitor ◽

Asian Patients ◽

Significant Difference ◽

East Asian Patients

Background and Purpose: We assessed the outcomes of dabigatran versus aspirin in a prespecified subgroup analysis of East Asian patients with embolic stroke of undetermined source in the RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source). Methods: Patients with a recent embolic stroke of undetermined source were randomized to dabigatran (150 or 110 mg BID) or aspirin (100 mg QD). The primary efficacy outcome was recurrent stroke; the primary safety outcome was major bleeding. The East Asia cohort was compared with patients from all other countries (non-East Asia cohort). Results: Overall, 988 of 5390 patients (18%) were randomized in East Asia. During a median follow-up of 18.8 months, there was no statistically significant difference in recurrent stroke (hazard ratio, 0.65 [95% CI, 0.41–1.03]) or major bleeding (hazard ratio, 1.04 [95% CI, 0.57–1.91]) in East Asian patients receiving dabigatran versus aspirin. Death from any cause occurred more often in the dabigatran versus the aspirin group (hazard ratio, 3.98 [95% CI, 1.32–12.01]). Conclusions: The treatment effect of dabigatran versus aspirin was consistent between cohorts, with no apparent superiority for dabigatran over aspirin in preventing recurrent stroke in patients with embolic stroke of undetermined source. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239120.

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Anticoagulation in Cancer Patients with Atrial Fibrillation and Grade 3-4 Thrombocytopenia

Blood ◽

10.1182/blood-2021-150782 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4272-4272

Author(s):

Genady Drozdinsky ◽

Noam Arad ◽

Galia Spectre ◽

Nir Livneh ◽

Itamar Poran ◽

...

Keyword(s):

Atrial Fibrillation ◽

Acute Leukemia ◽

Cancer Patients ◽

Major Bleeding ◽

Cumulative Incidence ◽

Competing Risk ◽

Newly Diagnosed ◽

Thrombotic Risk ◽

Significant Difference ◽

Grade 3

Abstract Introduction: Atrial fibrillation (AF) is not uncommon in cancer patients with grade 3-4 thrombocytopenia (platelets <50x10 9/L). The risk of bleeding appears to outweigh the risk of thrombosis in acute leukemia patients. There are no published data regarding management of anticoagulation (AC) and rates of bleeding and thrombosis in other cancer types. Aim: To assess AC management and incidence of bleeding and thrombosis in thrombocytopenic cancer patients with AF. Methods: Single-center retrospective cohort study. The study included adults with active cancer, grade 3-4 thrombocytopenia (platelets <50x10 9/L) and AF with CHA 2DS 2-VASc ≥1, irrespective of AC status prior index. Patients with acute leukemia were excluded. Patients were indexed when platelets <50x10 9/L. AC management was classified as either "No-AC", if AC was withheld (i.e., stopped or not started) at index, or "Continue-AC", if AC was continued. Arterial thromboembolism (ATE; ischemic stroke, transient ischemic attack or systemic embolism) and ISTH-defined major bleeding were recorded over 30 days. The 30-day cumulative incidence of composite and individual outcomes with corresponding 95% confidence intervals (CI) was calculated for each management group (death as competing risk). A Cox proportional hazards model was used to calculate hazard ratios (HR) and corresponding 95% CI for outcomes between the No-AC and Continue-AC groups, with death as a competing risk (Fine and Gray model). Results: The eligibility criteria were met by 131 patients. At study index, AC was not given in 90 (69%) patients and continued in 41 (31%). Table 1 shows patient characteristics overall and stratified for management. The median age was 80 years )IQR 70-82) and 55 (42%) were females. Most patients were inpatients at index (70%) and had newly diagnosed cancer (70%). 64% had solid malignancy, and the remainder had hematological malignancy. The majority (92%) had AF prior to study index, while 8% had AF newly diagnosed at index. The median CHA 2DS 2-VASc score was 4 [IQR 3-5] and 18% had a prior stroke. Median platelet counts were 42 x 10 9/L at index and the median HASBLED score was 5 [3-5]. Only 44% of the No-AC group were receiving AC prior index, compared with 95% in the Continue-AC group, at shorter median duration. The type of prior AC differed between groups. Antiplatelet therapy (54%) and major bleeding prior index (13%) were more frequent in the No-AC group. There was a median [IQR] of 4 [0-60] and 4 [1-26] days of grade 3-4 thrombocytopenia in the No-AC and Continue-AC groups, respectively. Platelet nadirs (x10 9/L) were numerically higher in the No-AC group (31 [3-50] vs. 21 [6-50]; p=0.09). A median [IQR] of 12 [6-17.25] and 10 [5-12] platelet transfusions were given to 29 (32.2%) patients in the No-AC group and 11 (26.8%) in the Continue-AC group, respectively (p>0.2). In the Continue-AC group, AC was subsequently held in 12/41 (29%) and dose-reduced in 4/41 (10%) during the 30 days post-index. The 30-day cumulative incidence [95% CI] of the composite outcome (major bleeding or ATE) was 10% [4.88-17.27] in the No-AC group and 4.88% [0.86-14.7] in the Continue-AC group (HR 2.142 [0.47-9.609]). The 30-day cumulative incidence of ATE (Figure 1A) was 3.33% [0.88-8.66] in the No-AC group (n=3), and 4.88% [0.85-14.7] in the Continue-AC group (n=2), corresponding with a HR of 0.70 [0.12-4.10]. The 30-day cumulative incidence of major bleeding (Figure 1B) was 7.8% [3.40-14.52] in the No-AC group, and 2.44% [0.18-11.22] in the Continue-AC group (HR 3.29 [0.42-26.04]). The 30-day overall survival was 64.4% in the No-AC and 73.2% in the Continue-AC groups (HR 1.39 (95% CI 0.7-2.76). Conclusions: In a cohort of cancer patients with grade 3-4 thrombocytopenia (<50x10 9/L) and AF (median CHA 2DS 2-VASc = 4), the majority had anticoagulation held. Baseline thrombotic and bleeding risk factors were generally balanced, but a higher rate of prior bleeding and lower rates of anticoagulation prior index in the No-AC group, suggest confounding by indication. No statistically significant difference in outcomes was detected between management groups, but 95% CI's were wide. The high bleeding and low ATE incidence in the No-AC group suggests that holding AC during time-limited periods of grade 3-4 thrombocytopenia may be a reasonable approach in many cancer patients with AF. Continuing AC should be investigated in a subset of patients with lower bleeding and higher thrombotic risk. Figure 1 Figure 1. Disclosures Falanga: Pfizer: Honoraria; Bayer: Honoraria; Sanofi: Honoraria; Leo Pharma: Honoraria. ten Cate: Bayer AG: Other; Pfizer: Other; LEO Pharma: Other; Gideon Pharmaceuticals: Other; Alveron Pharma: Other. Leader: Bayer: Honoraria; Leo Pharma: Honoraria; Novartis: Honoraria; Pfizer: Consultancy, Honoraria; Sanofi: Honoraria.

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Clopidogrel versus Ticagrelor for Secondary Prevention after Coronary Artery Bypass Grafting

Journal of Clinical Medicine ◽

10.3390/jcm8010104 ◽

2019 ◽

Vol 8 (1) ◽

pp. 104 ◽

Cited By ~ 3

Author(s):

Hyoung Chang ◽

Hee Kim ◽

Jae Yoo ◽

Dong Kim ◽

Kwang Cho

Keyword(s):

Overall Survival ◽

Coronary Artery ◽

Coronary Artery Bypass Grafting ◽

Propensity Score ◽

Major Bleeding ◽

Dual Antiplatelet Therapy ◽

Artery Bypass ◽

Bypass Grafting ◽

Composite Outcome ◽

Significant Difference

We sought to evaluate the outcomes of postoperative three-month dual antiplatelet therapy in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) following off-pump coronary artery bypass grafting (OPCAB) with exclusively arterial grafts. Between 2013–2016, dual antiplatelet therapy (DAPT) with either aspirin + clopidogrel (ASA + CPD group, n = 100) or aspirin + ticagrelor (ASA + TCG group, n = 169) was prescribed postoperatively in 269 NSTE-ACS patients after total arterial OPCAB. Patients with indications for other oral anticoagulants were excluded from the study. Three-month DAPT was completed in 259 patients (96%); ASA + CPD group (n = 94) vs. ASA + TCG group (n = 165). A one-to-one propensity score matching was performed. Unadjusted comparison between the groups showed no significant difference in overall survival (P = 0.253) and composite outcome of major adverse cerebrovascular and cardiovascular event (MACCE) and major bleeding (P = 0.276). The rate of freedom from composite outcome at one year in the ASA + CPD and ASA + TCG groups was 91 ± 3% and 93 ± 2%, respectively. In multivariable analysis, being in the ASA + TCG group did not increase the risk of the composite outcome of MACCE and major bleeding (P = 0.972, hazard ratio: 1.0, 95% confidence interval: 0.4–2.3). Propensity score-matched comparison (76 pairs) showed no significant difference in the overall survival (P = 0.423) and composite outcome between the groups (P = 0.442). In the setting of exclusive arterial grafting, post-OPCAB three-month DAPT showed acceptable outcomes in patients with NSTE-ACS. There was no significant difference in overall survival or composite outcome of MACCE and major bleeding between the ASA + CPD and ASA + TCG groups.

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Anticoagulants for the treatment of venous thromboembolism in patients with cancer: An updated pairwise and network meta-analysis of randomized trials.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e14692 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e14692-e14692

Author(s):

Shima Sidahmed ◽

Ahmed Abdalla ◽

Babikir Kheiri ◽

Areeg Bala ◽

Mohammed Salih ◽

...

Keyword(s):

Venous Thromboembolism ◽

Cancer Patients ◽

Vitamin K ◽

Major Bleeding ◽

Metastatic Cancer ◽

Meta Analysis ◽

Number Needed To Treat ◽

Cancer Type ◽

Significant Difference ◽

All Cause Mortality

e14692 Background: Cancer-associated venous thromboembolism (VTE) is common. Although low molecular weight heparin (LMWH) is the standard therapy in this setting, little is known with regard to non-vitamin K antagonist oral anticoagulants (NOACs). Therefore, we thought about evaluating the safety and efficacy of various anticoagulants in this vulnerable population. Methods: Electronic database search was conducted to identify randomized clinical trials (RCTs) that compared LMWH, NOACs, and/or vitamin-K-antagonists (VKA) in cancer patients. We performed frequentist direct and Bayesian network meta-analysis using random-effects model to calculate odds ratios (ORs), 95% confidence intervals (CIs), and 95% credible intervals (CrIs). The primary outcome was VTE (pulmonary embolism and deep-vein thrombosis) recurrence. Secondary outcomes were major bleeding and all-cause mortality. Results: We identified 13 RCTs with 6,595 total patients (mean age 62.4 ± 12.2; 50.4% female; 17.7% hematological malignancies; and 6 months median follow-up). The most common cancer type was colorectal and 48% of the population had metastatic cancer at baseline. NOACs were associated with significantly reduced VTE recurrence compared with VKA (OR = 0.58; 95% CI = 0.40-0.83; P < 0.01; number needed to treat [NNT] = 40) and LMWH (OR = 0.46; 95% CI = 0.25-0.85; P = 0.01; NNT = 20). LMHW was associated with significantly reduced VTE recurrence compared with VKA (OR = 0.52; 95% CI = 0.39-0.71; P < 0.01; NNT = 18). NOACs were associated with significantly reduced major bleeding compared with VKA (OR = 0.56; 95% CI = 0.35-0.91; P = 0.02; NNT = 64). There was no significant difference identified between the anticoagulant groups in regard to all-cause mortality. Conclusions: Among cancer patients with VTE, NOACs were associated with significantly reduced VTE recurrence compared to LMWH and VKA, and significantly reduced major bleeding compared with VKA. LMWH was associated with significantly reduced VTE recurrence compared with VKA.

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Clinical Features and Outcomes in Patients with Heparin-Induced Thrombocytopenia (HIT): Report of the CAMC HIT Registry.

Blood ◽

10.1182/blood.v104.11.2069.2069 ◽

2004 ◽

Vol 104 (11) ◽

pp. 2069-2069 ◽

Cited By ~ 2

Author(s):

James N. Frame ◽

Elaine Davis ◽

Joan Reed ◽

Ying Wang ◽

Mary Emmett

Keyword(s):

Cardiac Surgery ◽

Clinical Features ◽

Academic Medical Center ◽

Tertiary Care ◽

Hospital Length Of Stay ◽

Thrombin Inhibitor ◽

Graft Occlusion ◽

Composite Outcome ◽

Platelet Counts ◽

Specific Mortality

Abstract In 2001, our tertiary-care academic medical center implemented a HIT Task Force to develop quality improvement (QI) initiatives for HIT (Blood. 102:2766a, 2003). From these initiatives, a CAMC IRB-approved HIT Registry was developed. We present, from inpatient (IP) Registry data, a retrospective analysis of the clinical features/outcomes of patients (pts) reported/identified with clinical HIT from Jan 1999 to June 2003. IP medical records for case selection were identified from archival pharmacy records, the laboratory records of HIT antibody (Ab) assays, and case-reporting. Demographic features, co-morbid conditions, HIT-cohorts, HIT frequency in open heart surgery (OHS) pts, platelet counts (baseline; time HIT 1st suspected, nadir), thromboembolic complications (TEC), HIT Ab testing (H-PF4 ELISA;HIPA), agents utilized for HIT treatment, mean hospital length of stay (LOS), individual/composite outcomes of new TEC, amputations, and all-cause or HIT-specific mortality are presented. Clinical HIT was identified or recorded in 285 pts: 1999: 35, ‘00: 66, ‘01:63, ‘02:67, 1–6.30.03: 54. The median age was 68 yrs (range, 26–90). M/F (%): 47/53. Co-morbidities included coronary artery disease (68%), hyperlipidemia (49%), diabetes mellitus (40%), renal failure (4.6%), active malignancy (2.5%). The median/mean time from initiating heparin (H) to HIT recognition was 8.7/5.0 days. Median platelet counts (mm3) at baseline/time HIT was 1st suspected/HIT nadir were 208,000/72,000/53,000. A H-PF4 or HIPA assay was (+) in 80% (228). HIT cohorts included OHS (187; 66%), medical admission (69; 24%), & non-cardiac surgery (29; 10%) pts. HIT was identified following IP discharge (D/C) in 19% (35/187) of OHS and 10% (3/29) of non-cardiac surgery pts. The OHS HIT frequency among total OHS pts was: 1.8% (187/10,529). TEC at HIT presentation was 43% (123) and included (> 1 event/pt may have occurred): DVT (101), PE (17), graft occlusion (17), MI (10), venous gangrene (4), TIA (4). A new TEC occurred in 14% (41). Anticoagulant therapy for HIT was administered in 88% of Registry pts: r-hirudin (56%), Argatroban (26%) and danaparoid (6%). The mean duration of direct thrombin inhibitor (DTI) therapy/warfarin overlap with a DTI was 8.9 days /4.5 days. Warfarin was administered at D/C in 78% (176/225) pts. The HIT-admission mean LOS was 21days. The all-cause/HIT-specific mortality was 21% (60)/14% (39). Major bleeding /amputation occurred in 9.0%/2.4%. The composite outcome of new TEC, amputation and all-cause death was 26% (75/285). This report is among the largest reported hospital experiences. HIT was identified most frequently after OHS. Delayed HIT after hospital D/C occurred in 13%. Outcomes comparable to prior reports include time to HIT development, clinical HIT Ab detection, OHS HIT frequency, baseline/new TEC, alternative anticoagulant use, all-cause mortality and the composite outcome. QI initiatives arising from this analysis emphasize initiating DTI therapy when HIT 1st suspected and warfarin when platelets are sufficiently recovered; incorporating a prospective tool for scoring the likelihood of HIT; detailed analyses of the delayed-onset HIT cohort and assessing the financial impact of HIT in hospitalized pts.

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An indirect comparison of dabigatran, rivaroxaban and apixaban for atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th12-02-0093 ◽

2012 ◽

Vol 108 (09) ◽

pp. 476-484 ◽

Cited By ~ 107

Author(s):

Jack Ansell ◽

Simon Mantha

Keyword(s):

Atrial Fibrillation ◽

Major Bleeding ◽

Odds Ratio ◽

Past History ◽

Randomised Trial ◽

Indirect Comparison ◽

Thrombin Inhibitor ◽

Systemic Embolism ◽

Chads2 Score ◽

Significant Difference

SummaryNew oral anticoagulant drugs are emerging as alternatives to warfarin for the prevention of stroke in patients with non-valvular atrial fibrillation. Two agents are direct factor Xa inhibitors (rivaroxaban and apixaban), and the third is a direct thrombin inhibitor (dabigatran). They have been separately compared to warfarin in large randomised trials. Our objective was to indirectly compare the three agents to each other for major efficacy and safety outcomes. Studies were assessed for comparability and the odds ratios of selected outcomes for each anticoagulant versus one another were estimated indirectly. The three cohorts differed significantly in terms of CHADS2 score and the number of individuals with a past history of stroke, transient ischemic attack or systemic embolism. The estimated odds ratio of stroke or systemic embolism was 1.35 for rivaroxaban vs dabigatran 150 mg (p=0.04), 0.97 for rivaroxaban versus dabigatran 110 mg (p=0.81), 1.22 for apixaban versus dabigatran 150 mg (p=0.18), 0.88 for apixaban versus dabigatran 110 mg (p=0.34) and 0.90 for apixaban versus rivaroxaban (p=0.43). The estimated odds ratio of major bleeding was 1.10 for rivaroxaban versus dabigatran 150 mg (p=0.36), 1.28 for rivaroxaban versus dabigatran 110 mg (p=0.02), 0.74 for apixaban versus dabigatran 150 mg (p=0.004), 0.87 for apixaban versus dabigatran 110 mg (p=0.17) and 0.68 for apixaban versus rivaroxaban (p<0.001). In conclusion, the available data indicate no significant difference in efficacy between dabigatran 150 mg and apixaban for the prevention of stroke or systemic embolism in patients with non-valvular atrial fibrillation. It appears however that apixaban is associated with less major bleeding than dabigatran 150 mg or rivaroxaban and that rivaroxaban is less effective than dabigatran 150 mg in preventing stroke or systemic embolism. Such an indirect comparison should be used only to generate hypotheses which need to be tested in a dedicated randomised trial comparing the three drugs directly.

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Thromboembolic Outcomes of Hospitalized COVID-19 Patients in the 90-Day Post-Discharge Period: Early Data from the Northwell CORE-19 Registry

Blood ◽

10.1182/blood-2020-141901 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 33-34

Author(s):

Dimitrios Giannis ◽

Steven L. Allen ◽

Anne Davidson ◽

Galina S. Marder ◽

Sarah Flint ◽

...

Keyword(s):

Major Bleeding ◽

Small Sample ◽

Hospitalized Patients ◽

Hospital Treatment ◽

Common Data Model ◽

Thromboembolic Events ◽

Post Discharge ◽

Thrombotic Risk ◽

Venous Thromboembolic Events ◽

All Cause Mortality

Introduction Thromboembolic outcomes have emerged as an important issue in sick hospitalized patients with COVID-19. Multiple pathogenetic mechanisms for thrombosis have been implicated, including endothelial dysfunction, increased von Willebrand factor (vWF), interleukin-6 release, and activation of/interaction between macrophages, monocytes, endothelial cells, platelets and lymphocytes. The actual rate of arterial and venous thromboembolic events (ATE and VTE) in hospitalized patients with COVID-19, especially in the immediate post-hospital discharge period, has not been fully elucidated, with most of the data derived from retrospective studies with small sample sizes. Methods Against this background, we have designed and implemented an ongoing prospective registry (CORE-19) consisting of 11,249 consecutive hospitalized patients with COVID-19 from March 1st 2020 through May 31st 2020 using data derived from the Northwell Health System and the COVID-19 Research Consortium to study through 90-days post-discharge the rate of VTE and ATE, major bleeding, all-cause mortality, and other complications. We are capturing data of interest including demographic characteristics, co-morbidities, relevant medications, hospital setting, in-hospital treatment, thromboprophylaxis usage, key laboratory parameters, and 90-day thromboembolic and other key outcomes. A unified data repository (datamart) of hospitalized COVID-19 patients across multiple datasets from electronic health records, health informatics exchange, a dedicated radiology database, and a standardized data collection tool in REDCap, that includes telephonic calls up to 90 days post-discharge, is being implemented. A common data model (CDM) is utilized to ensure semantic interoperability between data originating from disparate sources. Northwell Health protocols stipulate the use of post-discharge low-molecular weight heparin, direct oral anticoagulants, or baby aspirin in hospitalized COVID-19 patients with high thrombotic risk features. Results Our cohort as of August 7, 2020 consists of complete follow up in 4,100 patients with a mean age of 61.0 years (SD: 17.0) with 54.7% males (Table 1). Preliminary data show an all-cause mortality rate of 4.29%, an overall thromboembolic rate of 3.51% (2.41% VTE and 1.10% ATE), a major bleeding rate of 1.61%, and a rehospitalization rate of 12.85%. Of patients with either DVT or PE post-discharge, 13.43% (9/67) died. The full dataset, including risk factors, comorbidities, key in-hospital and post-discharge medications including anticoagulant and antiplatelet agents, will be available at the time of presentation to the ASH congress. Conclusion Our ongoing registry is a large prospective study evaluating the rate of overall thromboembolic complications and all-cause mortality in hospitalized COVID-19 patients through 90 days post discharge. Current rates of thromboembolic events signify the importance of post-discharge surveillance and, potentially, post-discharge extended thromboprophylaxis, in this acutely ill medical population. Disclosures Allen: Bristol Myers Squibb: Current equity holder in publicly-traded company. Spyropoulos:Janssen, Boehringer Ingelheim, Bayer, BMS, Portola, ATLAS Group: Consultancy; Janssen, Boehringer Ingelheim: Research Funding.

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