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1.
Clinical Outcomes of Antithrombotic Strategies for Patients with Atrial Fibrillation After Percutaneous Coronary Intervention.
Gao, X, Ge, Z, Kong, X, Wang, Z, Zuo, G, Wang, F, Chen, S, Zhang, J
International heart journal. 2019;(3):546-553
Abstract
Antithrombotic strategies for patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI) remain challenging. This study aims to explore the best antithrombotic strategy for AF patients after PCI based on a network meta-analysis. This study was registered in PROSPERO (CRD42018093928). The PubMed, Cochrane, and EMBASE databases were searched to identify clinical trials concerning antithrombotic therapy for AF patients with PCI from inception to April 2018. Pairwise and network meta-analysis were conducted to compare clinical outcomes of different antithrombotic therapy. The primary endpoint was major bleeding. Fifteen studies including 16,382 patients were identified with follow-up ranging from 3 to 12 months. Non-vitamin K oral anticoagulants (NOAC) plus P2Y12 inhibitor ranked first with a reduced risk of major bleeding compared with vitamin K antagonist (VKA) plus dual antiplatelet therapy (OR: 0.57, 95% CI: 0.43-0.75) but with no significant difference compared with VKA plus single platelet therapy (OR: 0.85, 95% CI: 0.62-1.16). Similar thrombotic events were evident among these groups. Subgroup analysis showed that VKA plus aspirin exhibited a similar risk of major bleeding compared with VKA plus clopidogrel (OR: 0.94, 95% CI: 0.73-1.23) but was associated with increased risks of ischaemic stroke (OR: 2.10, 95% CI: 1.33-3.32) and all-cause death (OR: 1.77, 95% CI: 1.15-2.74) versus VKA plus clopidogrel. In AF patients undergoing PCI, NOAC plus P2Y12 inhibitor and VKA plus clopidogrel, but not VKA plus aspirin, were associated with reduced risk of major bleeding compared with the recommended VKA-based triple therapy, while thrombotic events were similar among these treatments.
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2.
Assessment of Condition and Medication Knowledge Gaps Among Atrial Fibrillation Patients: A Systematic Review and Meta-analysis.
Salmasi, S, De Vera, MA, Barry, A, Bansback, N, Harrison, M, Lynd, LD, Loewen, PS
The Annals of pharmacotherapy. 2019;(8):773-785
Abstract
Background: Patient education facilitates construction of a correct illness representation, improves beliefs about medications, and improves knowledge, factors that have been associated with better adherence. Objective: Our objective was to characterize the published literature about atrial fibrillation (AF) patients' disease and medication knowledge to identify knowledge gaps and misconceptions to inform AF patient education strategies. Methods: Following PRISMA guidelines, we searched PubMed, EMBASE, CINAHL, and PsychINFO from inception to May 2018 for studies that assessed AF patients' knowledge about their condition and medications. For quantitative studies, we extracted the proportion of participants who provided correct answers to the questions asked about their condition, medications, or risk of stroke. We classified data for related questions into knowledge domains. A random-effects meta-analysis was conducted for each knowledge domain. A domain was considered a knowledge gap if the pooled mean proportion of participants who demonstrated knowledge of it was ≤50%, regardless of CI. Qualitative data were summarized narratively. Results: A total of 21 studies were included. AF- and stroke-related knowledge gaps and misconceptions included the following: AF can be asymptomatic, AF can predispose to heart failure, women are at a higher risk of stroke, the definition of ischemic stroke, and patients' awareness of their diagnosis. Medication-related knowledge gaps were antithrombotic-drug interactions, antithrombotic-food interactions, vitamin K content of foods, the term INR (international normalized ratio) and its interpretation, and the required actions in case of a missed dose. Conclusion and Relevance: This systematic review identified several AF patient knowledge gaps about their condition and its treatment that can inform the development of AF patient education programs.
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3.
Dual versus triple antithrombotic therapy: is there a role for direct oral anticoagulants in arterial thrombosis?
Garcia-Ropero, A, Santos-Gallego, CG, Zafar, MU, Badimon, JJ
Drugs of today (Barcelona, Spain : 1998). 2019;(3):197-214
Abstract
The number of patients receiving dual antiplatelet therapy with an additional indication for long-term oral anticoagulation has substantially increased over time. This population is facing an unacceptable risk of bleeding events, particularly among elderly individuals, who are especially vulnerable to complications. Further strategies to minimize this bleeding risk, including various drug combinations, different dosage regimens and even numerous attempts to find the appropriate duration of the treatment, have been evaluated in a multitude of randomized control trials. Moreover, the recent incorporation of the direct oral anticoagulants (DOACs) to the therapeutic armamentarium may represent an alternative to treat such patients, since they have demonstrated to be noninferior to the classic vitamin K antagonists and with lower bleeding rates. The aim of this review is to summarize the most recent literature on the use of DOACs in patients with an indication for dual antiplatelet therapy (mostly subjects with coronary artery disease) and also an established indication for chronic anticoagulation (chiefly individuals with nonvalvular atrial fibrillation). The role of DOACs in ischemic heart disease alone is also discussed.
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The changing face of venous thromboembolism management in England.
Ramagopalan, SV, Carroll, R, Ulvestad, M, Mehmud, F, Alikhan, R
Future cardiology. 2019;(3):183-185
Abstract
Aim: Venous thromboembolism (VTE), which comprises deep vein thrombosis and pulmonary embolism, poses a global disease burden. Vitamin K antagonists have traditionally been the mainstay of treatment; however, the non-vitamin K oral anticoagulants (NOACs) are emerging as an alternative. The relative use of these treatment classes in the real world is unknown. Patients & methods: We performed a retrospective study using data from the UK Clinical Practice Research Datalink to understand VTE treatment patterns. Results: NOACs have unseated vitamin K antagonist as the main form of VTE patient treatment in England. Conclusion: The data highlight how comfortable physicians have become in using NOACs to treat VTE in England and it is likely that the increasing use of NOACs will continue.
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5.
Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial.
Vranckx, P, Valgimigli, M, Eckardt, L, Tijssen, J, Lewalter, T, Gargiulo, G, Batushkin, V, Campo, G, Lysak, Z, Vakaliuk, I, et al
Lancet (London, England). 2019;(10206):1335-1343
Abstract
BACKGROUND We aimed to assess the safety of edoxaban in combination with P2Y12 inhibition in patients with atrial fibrillation who had percutaneous coronary intervention (PCI). METHODS ENTRUST-AF PCI was a randomised, multicentre, open-label, non-inferiority phase 3b trial with masked outcome evaluation, done at 186 sites in 18 countries. Patients had atrial fibrillation requiring oral anticoagulation, were aged at least 18 years, and had a successful PCI for stable coronary artery disease or acute coronary syndrome. Participants were randomly assigned (1:1) from 4 h to 5 days after PCI using concealed, stratified, and blocked web-based central randomisation to either edoxaban (60 mg once daily) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist (VKA) in combination with a P2Y12 inhibitor and aspirin (100 mg once daily, for 1-12 months). The edoxaban dose was reduced to 30 mg per day if one or more factors (creatinine clearance 15-50 mL/min, bodyweight ≤60 kg, or concomitant use of specified potent P-glycoprotein inhibitors) were present. The primary endpoint was a composite of major or clinically relevant non-major (CRNM) bleeding within 12 months. The primary analysis was done in the intention-to-treat population and safety was assessed in all patients who received at least one dose of their assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02866175, is closed to new participants, and follow-up is completed. FINDINGS From Feb 24, 2017, through May 7, 2018, 1506 patients were enrolled and randomly assigned to the edoxaban regimen (n=751) or VKA regimen (n=755). Median time from PCI to randomisation was 45·1 h (IQR 22·2-76·2). Major or CRNM bleeding events occurred in 128 (17%) of 751 patients (annualised event rate 20·7%) with the edoxaban regimen and 152 (20%) of 755 patients (annualised event rate 25·6%) patients with the VKA regimen; hazard ratio 0·83 (95% CI 0·65-1·05; p=0·0010 for non-inferiority, margin hazard ratio 1·20; p=0·1154 for superiority). INTERPRETATION In patients with atrial fibrillation who had PCI, the edoxaban-based regimen was non-inferior for bleeding compared with the VKA-based regimen, without significant differences in ischaemic events. FUNDING Daiichi Sankyo.
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6.
A Pilot Randomized Controlled Trial Testing the Feasibility and Acceptability of a SystemCHANGE Intervention to Improve Medication Adherence in Older Adult Stroke Survivors.
Wessol, JL, Russell, CL, Olds, KE
The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses. 2019;(5):259-265
Abstract
BACKGROUND Adhering to an antithrombotic medication regimen is essential to reducing recurrent stroke in adult stroke survivors. The purpose of this study was to evaluate the feasibility and acceptability of the SystemCHANGE (SC) and attention control (AC) intervention in older adult, nonadherent ischemic stroke patients. METHODS A pilot randomized controlled trial was conducted to determine the feasibility and acceptability of an SC versus AC intervention in older adult, nonadherent stroke survivors in the management of antithrombotic medication. Participants were masked to group assignment. Stroke survivors 50 years or older, taking at least 1 once-a-day antithrombotic medication, were recruited from a Midwest Comprehensive Stroke Center-affiliated neurology office. They were screened electronically using the Medication Event Monitoring System for 2 months to determine baseline medication adherence. Nonadherent stroke survivors (medication adherence < 0.97) were randomized to SC or AC intervention and monitored for 3 months. SC focused on redesigning the interpersonal environmental system and daily routines. The AC group was provided education materials on stroke that consisted of stroke risk factor reduction, stroke facts, rehabilitation, and nutrition with the primary investigator. Participation and intervention experience interviews were evaluated for themes. RESULTS Thirty participants were recruited: median age was 64 years, 46.7% of them were male, and they took an average of 7.77 (SD, 3.191; range, 3-15) prescribed medications. The number of over-the-counter medications taken (excluding aspirin) on a regular basis averaged 1.9 (SD, 0.8; range, 1-4). Two participants were nonadherent and were randomized to the 2 arms. Both participants had positive feedback and were not inconvenienced by their participation in the study. Neither participant voiced concerns about the intervention, survey demands, time requirement, or completing the surveys on the primary investigator's laptop. CONCLUSION The SC and AC intervention protocols were feasible and acceptable to the participants in this study. Additional pilot testing is needed to further evaluate the intervention and its effect on medication adherence in this population.
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Association between antithrombotic treatment and outcomes at 1-year follow-up in patients with atrial fibrillation: the EORP-AF General Long-Term Registry.
Boriani, G, Proietti, M, Laroche, C, Fauchier, L, Marin, F, Nabauer, M, Potpara, T, Dan, GA, Kalarus, Z, Tavazzi, L, et al
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. 2019;(7):1013-1022
Abstract
AIMS: In recent years, stroke prevention in patients with atrial fibrillation (AF) has radically changed, with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs). Contemporary European data on AF thromboprophylaxis are needed. METHODS AND RESULTS We report 1-year follow-up data from the EURObservational Research Programme in Atrial Fibrillation (EORP-AF) General Long-Term Registry. Outcomes were assessed according to antithrombotic therapy. At 1-year follow-up, 9663 (88.0%) patients had available data for analysis: 586 (6.1%) were not treated with any antithrombotic; 681 (7.0%) with antiplatelets only; 4066 (42.1%) with vitamin K antagonist (VKA) only; 3167 (32.8%) with NOACs only; and 1163 (12.0%) with antiplatelet and oral anticoagulant. At 1-year follow-up, there was a low rate of stroke (0.7%) and any thromboembolic event (TE) (1.2%), while haemorrhagic events occurred in 222 patients (2.3%). Cardiovascular (CV) death and all-cause death occurred in 3.9% and 5.2% of patients, respectively. Cumulative survival for all the three main outcomes considered was highest amongst patients treated only with NOACs (P < 0.0001). Multivariable-adjusted Cox regression analysis found that VKA or NOACs use was independently associated with a lower risk for any TE/acute coronary syndrome/CV death, while all treatments were independently associated with a lower risk for CV death and all-cause death. CONCLUSION The 1-year follow-up of EORP-AF General Long-Term Registry reported a low occurrence of thromboembolic and haemorrhagic events, although mortality was high. Both VKA and NOACs were associated with a lower risk of all main adverse outcomes. All treatments were associated with a lower risk for CV death and all-cause death.
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Association Between Antithrombotic Medication Use After Bioprosthetic Aortic Valve Replacement and Outcomes in the Veterans Health Administration System.
Bravata, DM, Coffing, JM, Kansagara, D, Myers, J, Murphy, L, Homoya, BJ, Perkins, AJ, Snow, K, Quin, JA, Zhang, Y, et al
JAMA surgery. 2019;(2):e184679
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Abstract
IMPORTANCE The recommendations about antithrombotic medication use after bioprosthetic aortic valve replacement (bAVR) vary. OBJECTIVES To describe the post-bAVR antithrombotic medication practice across the Veterans Health Administration (VHA) and to assess the association between antithrombotic strategies and post-bAVR outcomes. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study. Multivariable modeling with propensity scores was conducted to adjust for differences in patient characteristics across the 3 most common antithrombotic medication strategies (aspirin plus warfarin sodium, aspirin only, and dual antiplatelets). Text mining of notes was used to identify the patients with bAVR (fiscal years 2005-2015). MAIN OUTCOMES AND MEASURES This study used VHA and non-VHA outpatient pharmacy data and text notes to classify the following antithrombotic medications prescribed within 1 week after discharge from the bAVR hospitalization: aspirin plus warfarin, aspirin only, dual antiplatelets, no antithrombotics, other only, and warfarin only. The 90-day outcomes included all-cause mortality, thromboembolism risk, and bleeding events. Outcomes were identified using primary diagnosis codes from emergency department visits or hospital admissions. RESULTS The cohort included 9060 veterans with bAVR at 47 facilities (mean [SD] age, 69.3 [8.8] years; 98.6% male). The number of bAVR procedures per year increased from 610 in fiscal year 2005 to 1072 in fiscal year 2015. The most commonly prescribed antithrombotic strategy was aspirin only (4240 [46.8%]), followed by aspirin plus warfarin (1638 [18.1%]), no antithrombotics (1451 [16.0%]), dual antiplatelets (1010 [11.1%]), warfarin only (439 [4.8%]), and other only (282 [3.1%]). Facility variation in antithrombotic prescription patterns was observed. During the 90-day post-bAVR period, adverse events were uncommon, including all-cause mortality in 127 (1.4%), thromboembolism risk in 142 (1.6%), and bleeding events in 149 (1.6%). No differences in 90-day mortality or thromboembolism were identified across the 3 antithrombotic medication groups in either the unadjusted or adjusted models. Patients receiving the combination of aspirin plus warfarin had higher odds of bleeding than patients receiving aspirin only in the unadjusted analysis (odds ratio, 2.58; 95% CI, 1.71-3.89) and after full risk adjustment (adjusted odds ratio, 1.92; 95% CI, 1.17-3.14). CONCLUSIONS AND RELEVANCE These data demonstrate that bAVR procedures are increasingly being performed in VHA facilities and that aspirin only was the most commonly used antithrombotic medication strategy after bAVR. The risk-adjusted results suggest that the combination of aspirin plus warfarin does not improve either all-cause mortality or thromboembolism risk but increases the risk of bleeding events compared with aspirin only.
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Triple versus double antithrombotic therapy in patients with atrial fibrillation and stent implantation: a meta‑analysis of randomized trials.
Grajek, S, Olasińska-Wiśniewska, A, Michalak, M, Ritter, SS
Kardiologia polska. 2019;(9):837-845
Abstract
BACKGROUND Appropriate double (DT) and triple (TT) antithrombotic therapy in patients with atrial fibrillation and stent implantation is unclear. AIM: The aim of the study was to perform a meta‑analysis of studies comparing DT and TT in patients with atrial fibrillation and stent implantation. METHODS Of the 450 reports, 5 randomized trials were included in the meta‑analysis: WOEST, ISAR‑REACT, PIONEER AF‑PCI, RE‑DUAL PCI, and AUGUSTUS, with a total of 9931 patients. RESULTS Treatment efficacy, as assessed by the incidence of major adverse cardiac events, did not differ significantly between both therapeutic strategies: 8.98% for DT vs 8.71% for TT (odds ratio [OR], 1.02; 95% CI, 0.86-1.21). The incidence of hemorrhagic complications was significantly lower in patients treated with DT than TT (13.1% and 21.0%, respectively; OR, 0.57; 95% CI, 0.47-0.70). In over 90% of patients, DT included clopidogrel along with an oral anticoagulant (non-vitamin K antagonist oral anticoagulant or vitamin K antagonist). CONCLUSIONS The results of our meta‑analysis are clearly in line with the current trend of the fastest possible reduction in the use of TT in favor of DT. Almost half lower risk of hemorrhagic complications during DT compared with TT, with similar efficacy of the 2 strategies, provides an argument for the wider use of DT in patients with AF and stent implantation.
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10.
Leaf-Inspired Authentically Complex Microvascular Networks for Deciphering Biological Transport Process.
Miali, ME, Colasuonno, M, Surdo, S, Palomba, R, Pereira, R, Rondanina, E, Diaspro, A, Pascazio, G, Decuzzi, P
ACS applied materials & interfaces. 2019;(35):31627-31637
Abstract
The vascular transport of molecules, cells, and nanoconstructs is a fundamental biophysical process impacting tissue regeneration, delivery of nutrients and therapeutic agents, and the response of the immune system to external pathogens. This process is often studied in single-channel microfluidic devices lacking the complex tridimensional organization of vascular networks. Here, soft lithography is employed to replicate the vein system of a Hedera elix leaf on a polydimethilsiloxane (PDMS) template. The replica is then sealed and connected to an external pumping system to realize an authentically complex microvascular network. This satisfies energy minimization criteria by Murray's law and comprises a network of channels ranging in size from capillaries (∼50 μm) to large arterioles and venules (∼400 μm). Micro-PIV (micro-particle image velocimetry) analysis is employed to characterize flow conditions in terms of streamlines, fluid velocity, and flow rates. To demonstrate the ability to reproduce physiologically relevant transport processes, two different applications are demonstrated: vascular deposition of tumor cells and lysis of blood clots. To this end, conditions are identified to culture cells within the microvasculature and realize a confluent endothelial monolayer. Then, the vascular deposition of circulating breast (MDA-MB 231) cancer cells is documented throughout the network under physiologically relevant flow conditions. Firm cell adhesion mostly occurs in channels with low mean blood velocity. As a second application, blood clots are formed within the chip by mixing whole blood with a thrombin solution. After demonstrating the blood clot stability, tissue plasminogen activator (tPA) and tPA-carrying nanoconstructs (tPA-DPNs) are employed as thrombolytics. In agreement with previous data, clot dissolution is equally induced by tPA and tPA-DPNs. The proposed leaf-inspired chip can be efficiently used to study a variety of vascular transport processes in complex microvascular networks, where geometry and flow conditions can be modulated and monitored throughout the experimental campaign.