Impact of Primary Hemostasis Disorders on Late Major Bleeding Events among Anticoagulated Atrial Fibrillation Patients Treated by TAVR

Background: Bleeding events are among the striking complications following transcatheter aortic valve replacement (TAVR), and bleeding prediction models are crucially warranted. Several studies have highlighted that primary hemostasis disorders secondary to persistent loss of high-molecular-weight (HMW) multimers of the von Willebrand factor (vWF) and assessed by adenosine diphosphate closure time (CT-ADP) may be a strong predictor of late major/life-threatening bleeding complications (MLBCs). Pre-existing atrial fibrillation (AF) is a frequent comorbidity in TAVR patients and potentially associated with increased bleeding events after the procedure. Objectives: This study evaluated the impact of ongoing primary hemostasis disorders, as assessed by post-procedural CT-ADP > 180 s, on clinical events after TAVR among anticoagulated AF patients. Methods: An ongoing primary hemostasis disorder was defined by post-procedure CT-ADP > 180 s. Bleeding complications were assessed according to the Valve Academic Research Consortium-2 (VARC-2) criteria. The primary endpoint was the occurrence of late MLBCs at one-year follow-up. The secondary endpoint was a composite of mortality, stroke, myocardial infarction, and rehospitalization for heart failure. Results: In total, 384 TAVR patients were included in the analysis. Of these patients, 57 patients (14.8%) had a prolongated CT-ADP > 180 s. Increased MLBCs were observed in patients with CT-ADP > 180 s (35.1% versus 1.2%; p < 0.0001). Conversely, the occurrence of the composite endpoint did not differ between the groups. Multivariate analysis identified CT-ADP > 180 s (HR 28.93; 95% CI 9.74–85.95; p < 0.0001), bleeding history, paradoxical aortic stenosis (AS), and major vascular complications following TAVR as independent predictors of late MLBCs. Conclusion: Among patients with anticoagulated AF, a post-procedural CT-ADP > 180 s was identified as a strong independent predictor of late MLBCs. These findings suggest that persistent primary hemostasis disorders contribute to a higher risk of late bleeding events and should be considered for a tailored, risk-adjusted antithrombotic therapy after TAVR.

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Primary hemostatic disorders drive early and late major bleedings of patients with atrial fibrillation after transcatheter aortic valve replacement

European Heart Journal ◽

10.1093/eurheartj/ehab724.1631 ◽

2021 ◽

Vol 42 (Supplement_1) ◽

Author(s):

K Matsushita ◽

B Marchandot ◽

S Hess ◽

M Kibler ◽

C Sato ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cox Regression ◽

Academic Research ◽

Surrogate Marker ◽

Bleeding Complications ◽

Rank Test ◽

Bleeding Events ◽

Major Life ◽

Cox Regression Analysis ◽

The Impact

Abstract Introduction Patients with atrial fibrillation (AF) are likely to have multiple co-morbidities and receive anticoagulants after TAVR, which lead to a poor prognosis including bleeding events. Closure time adenosine diphosphate (CT-ADP) is a primary hemostasis point-of-care test used as a surrogate marker of high molecular weight (HMW) multimers defect of Von Willebrand factor (VWF). Our prior studies suggest that prolongation of CT-ADP (>180 seconds) after TAVR is a major determinant of early and late major/life-threatening bleeding complications (MLBCs). Purpose To evaluate the impact of post-procedural CT-ADP >180sec on bleeding events in AF patients. Methods We included 878 patients from our prospective TAVR registry between 2010 and 2019. Bleeding complications were assessed according to the VARC-2 (Valve Academic Research Consortium-2) criteria. Major adverse cardiac and cerebrovascular events (MACCE) was defined as a composite of all-cause death, myocardial infarction, stroke, and heart failure hospitalization within 1-year after TAVR. Ongoing primary haemostasis disorder was defined by post-procedure CT-ADP >180sec. Primary endpoint was the occurrence of MLBCs during the first year and the second endpoint was 1-year MACCE. Results Patients with AF had a higher incidence of all-cause mortality (15% vs. 8%, p=0.002), MACCE (29% vs. 20%, p=0.002), and MLBCs (20% vs. 12%, p=0.001) within 1-year compared to non-AF patients. When the cohort was split into 4 subgroups according to AF and CT-ADP >180sec, patients with AF and CT-ADP >180sec had the highest risk of MLBCs (log-rank test; p<0.001) (Figure). Multivariate Cox regression analysis confirmed that the patients with AF and CT-ADP >180sec had 4.6-fold higher risk of MLBCs within 1 year compared to non-AF patients with CT-ADP ≤180sec (hazard ratio: 4.60; 95% confidence interval: 2.18 - 9.68; p<0.001). Conclusion Among TAVR patients, AF with post-procedural CT-ADP >180 sec was identified as a strong independent predictor of MLBCs at 1-year follow-up. Our study suggest that persistent primary haemostasis disorders contribute to a higher risk of bleeding events particularly in AF patients and may be considered for a tailored and risk-adjusted antithrombotic therapy after TAVR. FUNDunding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Dr Matsushita received a grant from Edwards Lifesciences.

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Ischemic and Bleeding Events of Ticagrelor Monotherapy in Korean Patients With and Without Diabetes Mellitus: Insights From the TICO Trial

Frontiers in Pharmacology ◽

10.3389/fphar.2020.620906 ◽

2021 ◽

Vol 11 ◽

Author(s):

Kyeong Ho Yun ◽

Jae Young Cho ◽

Seung Yul Lee ◽

Sang Jae Rhee ◽

Byeong Keuk Kim ◽

...

Keyword(s):

Diabetes Mellitus ◽

Myocardial Infarction ◽

Academic Research ◽

Bleeding Complications ◽

Diabetic Patients ◽

Bleeding Events ◽

Coronary Syndrome ◽

Patients With Diabetes ◽

The Impact ◽

Ischemic Events

Background: Ticagrelor monotherapy after 3 months dual antiplatelet therapy (DAPT) with aspirin and ticagrelor can reduce bleeding without increasing ischemic events after percutaneous coronary intervention (PCI). However, the impact of this approach among the patient with diabetes remains unknown.Methods: This was a sub-analysis of the Ticagrelor Monotherapy after 3 months in the Patients Treated with New Generation Sirolimus Eluting Stent for Acute Coronary Syndrome (TICO) trial. After successful PCI, the patients were randomly assigned to ticagrelor monotherapy after 3-months DPAT or to ticagrelor-based 12-months DAPT. We compared ischemic events and bleeding events between the patients with diabetes and without diabetes for 12 months. Ischemic events were defined as death, myocardial infarction, ischemic stroke, transient ischemic attack, stent thrombosis, and any revascularizations. Bleeding events were defined according to the Thrombolysis in Myocardial Infarction (TIMI) criteria and Bleeding Academic Research Consortium (BARC) definition.Results: Between August 2015 and October 2018, 3,056 patients were enrolled in the TICO trial, of which 835 (27.3%) had diabetes mellitus. Diabetes mellitus was associated with all evaluated ischemic and bleeding events. No significant differences in any ischemic events were observed in patients with diabetes between ticagrelor monotherapy after 3-months DAPT and ticagrelor-based 12-months DAPT (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.45–1.52, p = 0.540). In patients with diabetes, the overall incidence of bleeding complications during the 12-months follow-up period did not differ between the two treatment groups (HR 0.83, 95% CI 1.48–1.43, p = 0.505). However, ticagrelor monotherapy was significantly reduced both any TIMI bleeding and BARC three or five bleeding events in diabetes patients in the 3-months landmark analysis, after 3-months DAPT period (HR 0.20, 95% CI 0.07–0.59, p = 0.003).Conclusion: In diabetic patients, ticagrelor monotherapy showed a lower incidence of bleeding complications after 3-months DAPT period, without increasing ischemic complications, compared with ticagrelor-based 12-months DAPT (ClinicalTrials.gov Identifier: NCT02494895).

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Aspirin I.V. Loading during Elective Percutaneous Coronary Intervention

Pharmacology ◽

10.1159/000517994 ◽

2021 ◽

pp. 1-5

Author(s):

David Naguib ◽

Carolin Helten ◽

Saif Zako ◽

Philipp Mourikis ◽

René M’Pembele ◽

...

Keyword(s):

Pilot Study ◽

Light Transmission ◽

Platelet Reactivity ◽

Coronary Intervention ◽

Bleeding Complications ◽

Loading Dose ◽

Bleeding Events ◽

Elective Percutaneous Coronary Intervention ◽

Percutaneous Coronary ◽

The Impact

Additional loading dose of acetylsalicylic acid (ASA) during percutaneous coronary interventions (PCIs) despite permanent oral ASA medication is frequently applicated. The impact on platelet reactivity and clinical events is not known. In this pilot study, we aimed to analyze high on-treatment platelet reactivity (HTPR) to aspirin in patients undergoing elective PCI. Platelet reactivity was measured using light-transmission aggregometry in 100 patients on permanent low-dose ASA medication undergoing elective PCI. Platelet reactivity measured by arachidonic acid-induced maximum of aggregation (MoA) in patients with versus without additional peri-procedural ASA loading (500 mg i.v.) was compared. HTPR was defined as MoA >20% for ASA. Major adverse cerebro- and cardiovascular events (MACCEs) and bleeding events were evaluated during hospital course. HTPR rate was similar in both groups (HTPR to ASA: loading vs. control 6% vs. 16%, odds ratio [OR] = 0.33, 95% confidence interval [CI] 0.08–1.35, <i>p</i> = 0.12). In-hospital MACCEs were not different between groups (MACCE: loading vs. control: 0 vs. 0 patient, OR = 1.32, 95% CI 0.03–67.95, <i>p</i> = 0.89). Thrombolysis in myocardial infarction minimal bleedings were numerically higher in patients without ASA loading dose. In this pharmacodynamic pilot study, additional ASA loading did not reduce HTPR to ASA. Furthermore, ASA loading did not increase in-hospital MACCE and bleeding complications.

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A Systematic Review of Anticoagulation Strategies for Patients With Atrial Fibrillation in Critical Care.

Thrombosis and Haemostasis ◽

10.1055/a-1477-3760 ◽

2021 ◽

Author(s):

Alexandra Jayne Nelson ◽

Brian W Johnston ◽

Alicia Achiaa Charlotte Waite ◽

Gedeon Lemma ◽

Ingeborg Dorothea Welters

Keyword(s):

Atrial Fibrillation ◽

Critical Care ◽

Critically Ill ◽

Major Bleeding ◽

Critically Ill Patients ◽

Thromboembolic Events ◽

Bleeding Events ◽

Major Bleeding Events ◽

The Impact ◽

Anticoagulated Patients

Background. Atrial fibrillation (AF) is the most common cardiac arrhythmia in critically ill patients. There is a paucity of data assessing the impact of anticoagulation strategies on clinical outcomes for general critical care patients with AF. Our aim was to assess the existing literature to evaluate the effectiveness of anticoagulation strategies used in critical care for AF. Methodology. A systematic literature search was conducted using MEDLINE, EMBASE, CENTRAL and PubMed databases. Studies reporting anticoagulation strategies for AF in adults admitted to a general critical care setting were assessed for inclusion. Results. Four studies were selected for data extraction. A total of 44087 patients were identified with AF, of which 17.8-49.4% received anticoagulation. The reported incidence of thromboembolic events was 0-1.4% for anticoagulated patients, and 0-1.3% in non-anticoagulated patients. Major bleeding events were reported in three studies and occurred in 7.2-8.6% of the anticoagulated patients and up to 7.1% of the non-anticoagulated patients. Conclusions. There was an increased incidence of major bleeding events in anticoagulated patients with AF in critical care compared to non-anticoagulated patients. There was no significant difference in the incidence of reported thromboembolic events within studies, between patients who did and did not receive anticoagulation. However, the outcomes reported within studies were not standardised, therefore, the generalisability of our results to the general critical care population remains unclear. Further data is required to facilitate an evidence-based assessment of the risks and benefits of anticoagulation for critically ill patients with AF.

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Abstract 15073: Best Anticoagulation Strategy for Stroke Prophylaxis in Atrial Fibrillation Patients With Amyloidosis

Circulation ◽

10.1161/circ.142.suppl_3.15073 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Sanghamitra Mohanty ◽

CHINTAN G TRIVEDI ◽

Joseph Gallinghouse ◽

Domenico G Della Rocca ◽

Carola Gianni ◽

...

Keyword(s):

Atrial Fibrillation ◽

Oral Anticoagulants ◽

Bleeding Complications ◽

Considerable Proportion ◽

Medical Procedure ◽

Bleeding Events ◽

Full Dose ◽

Half Dose ◽

Group 2 ◽

Group 1

Background: A considerable proportion of elderly patients are known to have coexistent atrial fibrillation (AF) and amyloidosis. Both conditions increase stroke risk. Objective: We evaluated the best anticoagulation strategy in a series of AF patients with amyloidosis. Methods: Consecutive AF patients with coexistent amyloidosis undergoing catheter ablation at our center were included in the analysis. Based on the stroke-prophylaxis approach they were divided into 2 groups; group 1: left atrial appendage occlusion (LAAO) with Watchman and group 2: oral anticoagulation. Following LAAO, all patients remained on full dose non-vitamin K oral anticoagulants (NOAC) for 45 days. Transesophageal echocardiogram (TEE) was performed at 45 days to assess completeness of closure. If the occlusion was complete, patients were kept on aspirin, 81 mg/day for long-term. In case of leak or dense ‘smoke’ in the left atrium (LA) or enlarged LA, they were prescribed half-dose NOAC. NOACs included dabigatran, apixaban, endoxaban and rivaroxaban. Group 2 patients remained on full-dose NOAC during the whole study period (1 year). All patients were prospectively followed up for 1 year. Results: A total of 87 patients were included in the analysis; group 1: 56 and group 2: 31 . CHA 2 DS 2 -VASc score was comparable between the groups (gr. 1: 3.7±1.6 and gr. 2: 3.2±1.7, p=0.18). The most commonly used NOACs were apixaban (45, 51.7%) and rivaroxaban (34, 39%). After the 45-day TEE, 34 patients from group 1 remained on baby-aspirin and 22 on half-dose NOAC. Of the 22, 12 patients had leaks <5 mm, 6 had large LA (mean diameter 5.2±1.4 cm) and 4 patients had dense LA smoke. At 1-year follow-up, 3 stroke and 1 transient ischemic attack were reported in group 1 on baby-aspirin (4/34, 11.8%). No stroke or bleeding complications occurred in the 22 patients on half-dose NOAC. In group 2 patients on full-dose OAC, a total of 5 (5/31, 16.1%) bleeding events (1 subdural hematoma and 4 GI bleedings) were recorded. Additionally, a stroke was reported that happened during brief discontinuation of OAC for another medical procedure. Conclusion: In our series of patients with coexistent AF and amyloidosis, half-dose NOAC following LAA occlusion procedure was observed to be the safest stroke-prophylaxis strategy.

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Vascular Complications in Patients with Hepatocellular Carcinoma Treated with Sorafenib

Cancers ◽

10.3390/cancers12102961 ◽

2020 ◽

Vol 12 (10) ◽

pp. 2961 ◽

Cited By ~ 2

Author(s):

Katharina Pomej ◽

Bernhard Scheiner ◽

Dabin Park ◽

David Bauer ◽

Lorenz Balcar ◽

...

Keyword(s):

Hepatocellular Carcinoma ◽

Cardiovascular Risk ◽

Treatment Option ◽

Multivariable Analysis ◽

Vascular Complications ◽

Bleeding Complications ◽

Bleeding Events ◽

Increased Risk ◽

Venous Thromboembolic Events ◽

Venous Thromboembolic

VEGF(R)-targeted therapies are associated with an increased risk of thromboembolism and bleeding, which might be pronounced in patients with increased cardiovascular risk. Nevertheless, sorafenib represents an important treatment option in patients with hepatocellular carcinoma (HCC). We retrospectively investigated the risk of arterial/venous thromboembolic and bleeding events in 252 patients treated with sorafenib for HCC between 05/2006 and 03/2020 at the Medical University of Vienna. Cardiovascular risk was assessed using Framingham score. Eight patients (3.2%) experienced 11 arterial/venous thromboembolic events. Only two patients (0.8%) developed arterial thromboembolism even though cardiovascular risk was low, intermediate, and high in 15 (8.7%), 104 (60%), and 54 (31.2%) of 173 assessable patients. Median overall survival (OS) was shorter in the high risk vs. low/intermediate risk group 7.4 (95% CI: 3.4–11.3) vs. 10.0 (95% CI: 6.8–13.2 months) and independently associated with OS in multivariable analysis HR: 1.53 (95% CI: 1.07–2.19; p = 0.019). Forty-eight (19%) patients experienced a bleeding, most commonly gastrointestinal bleeding (14%) followed by epistaxis (4.7%). Advanced liver dysfunction was not associated with an increased incidence of bleeding/venous thromboembolism. Sorafenib represents a safe treatment option even in patients with increased cardiovascular risk. Bleeding complications were comparable with previous reports, even though patients with more advanced liver disease were included.

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Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI

European Heart Journal - Cardiovascular Pharmacotherapy ◽

10.1093/ehjcvp/pvaa135 ◽

2020 ◽

Author(s):

Francesco Costa ◽

Marco Valgimigli ◽

Philippe Gabriel Steg ◽

Deepak L Bhatt ◽

Stefan H Hohnloser ◽

...

Keyword(s):

Atrial Fibrillation ◽

Antithrombotic Therapy ◽

Bleeding Risk ◽

Coronary Intervention ◽

Bleeding Complications ◽

Event Analysis ◽

Increased Risk ◽

Safety Endpoint ◽

High Bleeding Risk ◽

The Impact

Abstract Aims Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg b.i.d., clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT. Methods and results A score ≥25 points qualified high bleeding risk (HBR). Comparisons were made for the primary safety endpoint International Society of Thrombosis and Haemostasis major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thrombo-embolic events, or unplanned revascularization, analysed by time-to-event analysis. PRECISE-DAPT was available in 2336/2725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR [hazard ratio (HR) 0.42, 95% confidence interval (CI) 0.31–0.57] and HBR (HR 0.70, 95% CI 0.52–0.94), with a greater magnitude of benefit among non-HBR (Pint = 0.02). Dual antithrombotic therapy with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95% CI 0.45–0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95% CI 0.63–1.34; Pint = 0.08). The risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint = 0.45 and Pint = 0.56, respectively). Conclusions PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications and may help clinicians identifying the antithrombotic regimen intensity with the best benefit–risk ratio in an individual patient.

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Reticulated Platelets in Medicine: Current Evidence and Further Perspectives

Journal of Clinical Medicine ◽

10.3390/jcm9113737 ◽

2020 ◽

Vol 9 (11) ◽

pp. 3737

Author(s):

Noé Corpataux ◽

Kilian Franke ◽

Alexander Kille ◽

Christian Marc Valina ◽

Franz-Josef Neumann ◽

...

Keyword(s):

Atrial Fibrillation ◽

Current Evidence ◽

Bleeding Events ◽

P2y12 Inhibitors ◽

Coronary Syndrome ◽

Reticulated Platelets ◽

Cardiovascular Patients ◽

Clinical Scenarios ◽

Recurrent Atrial Fibrillation ◽

The Impact

Reticulated platelets (RPs) are young thrombocytes, newly released from the bone marrow. The identification and quantification of these cells remained difficult for decades due to a lack of standardized preanalytical and analytical methods. With the introduction of automated hematology analyzers in clinical routine, the determination of RPs, either as a total count or as a fraction, became more reliable, faster and more affordable. Currently, RPs are the focus of research in multiple clinical settings. In cardiovascular medicine, recent studies have focused on the relationship between RPs, coronary artery disease (CAD) and clinical outcomes, as well as the impact of RPs on the effects of antiplatelet therapy. Cohort studies showed increased levels of RPs in patients with acute coronary syndrome (ACS) or cardioembolic stroke. In patients with ACS, increased levels of RPs were also associated with an increased incidence of major ischemic cardiovascular events during follow-up. Further studies showed an association of levels of RPs with the antiplatelet response to less-potent P2Y12 inhibitors. In patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation, levels of RPs differed significantly depending on the achieved rhythm (sinus rhythm vs. recurrent atrial fibrillation). Levels of RPs appear to also be predictive for bleeding events in patients with various hematological diagnoses. Although no causal relationship has so far been proven, RP values have been associated with a large number of pathologies and clinical scenarios. This review summarizes the current evidence with regard to RPs and their potential diagnostic and prognostic value for noncardiovascular patients and for cardiovascular patients in particular. It describes further perspectives on how the testing of these cells might improve the treatment of cardiovascular patients.

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P3745Differences in short-term outcome between early- and new-generation TAVR devices

European Heart Journal ◽

10.1093/eurheartj/ehz745.0597 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

V Veulemans ◽

K Klein ◽

O Maier ◽

G Wolff ◽

A Polzin ◽

...

Keyword(s):

Aortic Regurgitation ◽

Lower Incidence ◽

Academic Research ◽

Pacemaker Implantation ◽

Vascular Complications ◽

Permanent Pacemaker ◽

Bleeding Events ◽

Term Outcome ◽

Pacemaker Therapy ◽

New Generation

Abstract Background For transcatheter aortic valve replacement (TAVR) morbidity- and outcome relevant factors like paravalvular aortic regurgitation, vascular access complications and the need for permanent pacemaker implantation remain key challenges. New-generation devices for TAVR have been optimized to improve clinical outcome. Purpose We aimed to address safety and effectiveness of new-generation TAVR devices compared with earlier generations in a single centre study. Methods We compared 30 days outcome of the new-generation repositionable MER (n=614) and MEP (n=90) and the balloon-expandable ES3 (n=414) valve with the last-generation self-expandable MCV (n=270) and the balloon-expandable SXT (n=103) in patients treated with TAVR between 2009 and 2018. TAVR endpoints and adverse events were defined according to the Valve Academic Research Consortium-2. Results Logistic EuroSCORE I as predictor for risk stratification and 30-day mortality was comparable between both cohorts (27.3%±2.9 new vs 23.0%±1.4 early; p=n.s.). Compared to early-generation devices (MCV/SXT), new-generation devices (MER/MEP/ES3) had significantly higher primary device success (98.9% new vs 96.8% early; p=0.0089), lower incidence of new renal replacement therapy (2.6% new vs 6.2% early; p=0.0028), new permanent pacemaker therapy for conduction disturbances (12.8% new vs 17.0% early; p=0.0394), and disabling bleeding (1.4% new vs 4.0% early; p=0.0040). No difference could be observed concerning incidence of moderate-to-severe paravalvular leakage (4.2% new vs 5.0% early; p=n.s.), stroke (3.3% new vs 2.1% early; p=n.s.), major vascular complications (2.8% new vs 3.5% early; p=n.s.) and 30-day mortality (2.7% new vs 4.4% early; p=n.s). Conclusion Data from the retrospective analysis indicate higher primary device success and lower incidence of renal replacement, pacemaker therapy and disabling bleeding events in new-generation devices, although praised “hot-item” advantages like paravalvular leackage/aortic regurgitation, vascular complications and mortality remain unacknowledged.

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Association between Renal Function and Bleeding Risk for Dabigatran after Switching from Warfarin

American Journal of Nephrology ◽

10.1159/000446848 ◽

2016 ◽

Vol 44 (1) ◽

pp. 11-18 ◽

Cited By ~ 3

Author(s):

Roberto S. Kalil ◽

Peter J. Kaboli ◽

Xin Liu ◽

Mary Vaughan-Sarrazin

Keyword(s):

Renal Function ◽

Healthcare Providers ◽

Bleeding Risk ◽

Bleeding Complications ◽

Close Monitoring ◽

Gi Bleeding ◽

Bleeding Events ◽

National Patient ◽

Study Population ◽

The Impact

Background: There is a higher risk of gastrointestinal (GI) bleeding in patients treated with dabigatran versus warfarin. We analyzed the impact of renal function on the relative risk of bleeding in patients converted to dabigatran. Methods: Patients aged ≥65 years who received anticoagulation with warfarin for a minimum of 6 months and subsequently converted to dabigatran or remained on warfarin were studied. Data sources included VA National Patient Care, and VA Decision Support System National Pharmacy and Laboratory. Each patient who converted to dabigatran 150 mg twice daily was matched by propensity score with 2 patients on warfarin who did not convert. Outcomes included rates of hospital admission for GI or other major bleeding and mortality, stratified by estimated glomerular filtration rate (eGFR). Results: Study population included 864 patients who converted and 1,710 patients who did not convert to dabigatran. In patients with eGFR 50-80 ml/min/1.73 m², the hazard of GI bleeding in patients who initiated dabigatran was nearly 3 times higher, (4.1 vs. 1.3 per 100 patient years; hazards ratio 2.94; 95% CI 1.24-7.02; p = 0.015), compared to patients who remained on warfarin. There were relatively few patients with eGFR <50 or >80 ml/min/1.73 m2, and relatively few bleeding events outside the GI tract. Conclusions: Prescribing healthcare providers should exercise caution and close monitoring for bleeding complications when converting from warfarin to dabigatran, even in patients with renal function in the range considered safe for dabigatran use as per current recommendations.

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