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Corresponding author: Dr Ali A. Youssef, Department of Cardiology, Suez Canal University, 4.5 Km the Ring Road, Ismailia, Egypt. Tel.: +201097797054; fax: +20643205208
Direct oral anticoagulants are frequently used to treat post-myocardial infarction (MI) left ventricular thrombus (LVT). This study was conducted to evaluate the efficacy and safety of use of apixaban, compared to the standard warfarin therapy, in post-MI LVT.
Methods
This open-label, randomized controlled trial included patients with post-acute or recent anterior wall MI with transthoracic echocardiography-confirmed LVT. Patients were randomized to receive either apixaban 5 mg twice daily or warfarin to achieve an international normalized ratio of 2-3, in addition to dual antiplatelet therapy. The primary endpoint was LVT resolution at 3 months, with a noninferiority margin of 95% for apixaban compared to warfarin. The secondary endpoint was major adverse cardiovascular events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification.
Results
Fifty patients were enrolled from 3 centres. The use of dual or single antiplatelet agents was similar in the 2 groups. The number of 1-, 3-, and 6-month LVT resolutions were 10 (40.0%), 19 (76.0%), and 23 (92.0%) in the apixaban group, and 14 (56%), 20 (80.0%), and 24 (96.0%) in the warfarin group, respectively, without significant differences (P < 0.036 for noninferiority at 3 months). Patients taking warfarin required longer hospital stays and more outpatient visits. Multivariate adjustment analysis revealed left ventricular aneurysm, larger baseline LVT area and lower left ventricular ejection fraction to be independent predictors of LVT persistence at 3 months. No MACE occurred in either group; 1 BARC-2 bleeding event occurred with warfarin.
Conclusions
Apixaban was not inferior to warfarin in the resolution of post-MI LVT.
Résumé
Contexte
Les anticoagulants oraux directs sont souvent utilisés pour traiter un thrombus du ventricule gauche (TVG) après un infarctus du myocarde (IM). Cette étude a été réalisée afin d’évaluer l’efficacité et l’innocuité de l’apixaban, comparativement au traitement de référence par la warfarine dans les cas de TVG consécutif à un IM.
Méthodologie
Cette étude en mode ouvert, contrôlée et à répartition aléatoire portait sur des patients ayant subi un IM aigu ou un IM récent de la paroi antérieure et présentant un TVG confirmé par échocardiographie transthoracique. Les patients ont été répartis aléatoirement pour recevoir l’apixaban à 5 mg deux fois par jour ou la warfarine en vue d’obtenir un ratio international normalisé de 2-3, en plus d’une bithérapie antiplaquettaire. Le critère d’évaluation principal était la résolution du TVG à trois mois, avec une marge de non-infériorité de 95 % pour l’apixaban comparativement à la warfarine. Le critère d’évaluation secondaire était la survenue d’événements cardiovasculaires indésirables majeurs ou de tout saignement associé, selon la classification du Bleeding Academic Research Consortium (BARC).
Résultats
Cinquante patients provenant de trois centres ont été sélectionnés. L’utilisation d’un seul ou de deux agents antiplaquettaires était similaire dans les deux groupes. Le nombre de résolutions du TVG à 1 mois, à 3 mois et à 6 mois était de 10 (40,0 %), 19 (76,0 %) et 23 (92,0 %) respectivement dans le groupe apixaban, et de 14 (56,0 %), 20 (80,0 %) et 24 (96,0 %) respectivement dans le groupe warfarine, sans différence significative (p < 0,036 pour la non-infériorité à 3 mois). Les patients qui prenaient de la warfarine ont dû être hospitalisés plus longtemps et consulter plus souvent en externe. L’analyse multivariée sur les ajustements a révélé que l’anévrisme du ventricule gauche, plus grande zone TVG de base et une faible fraction d’éjection du ventricule gauche étaient des facteurs prédictifs indépendants de la persistance du TVG à trois mois. Aucun événement cardiovasculaire indésirable majeur ne s’est produit dans les deux groupes; un saignement de classe 2 selon le BARC s’est produit dans le groupe prenant de la warfarine.
Conclusions
L’apixaban n’était pas inférieur à la warfarine dans la résolution du TVG après un IM.
The incidence of left ventricular (LV) thrombus (LVT) in patients with acute ST-elevation myocardial infarction (MI) has decreased significantly in the era of primary percutaneous coronary intervention, currently ranging from 1.5% to 6%, as opposed to 25% to 40% in the pre-thrombolytic era.
Incidence of left ventricular thrombus in patients with acute ST-segment elevation myocardial infarction treated with percutaneous coronary intervention.
Incidence and predictors of early left ventricular thrombus after ST-elevation myocardial infarction in the contemporary era of primary percutaneous coronary intervention.
2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation of the European Society of Cardiology (ESC).
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelinesas.
These recommendations are based on relatively old practices, and on evidence derived from studies of limited power, when no alternatives to warfarin were available and the contemporary approach was significantly different. Direct oral anticoagulants (DOACs), including apixaban, are effective and safe, compared to warfarin, for nonvalvular atrial fibrillation.
Resolution of left ventricular postinfarction thrombi in patients undergoing percutaneous coronary intervention using rivaroxaban in addition to dual antiplatelet therapy.
and the medical literature has a significant gap in this vital area. In our randomized study, we compared the efficacy and safety of apixaban with that of warfarin for the resolution of post-MI LVT in contemporary practice.
Methods
Study design and population
This open-label randomized controlled study enrolled patients aged between 18 and 80 years with a history of either acute (within a week) or recent (within a month) anterior wall MI, with evident LVT on conventional transthoracic echocardiography. All patients were naïve to oral anticoagulants (OACs) and were considered stable for OAC administration and discharge. The study excluded patients with the following: other indications for OAC use (atrial fibrillation and pulmonary embolism); right ventricular thrombus or atrial thrombus; contraindications for OAC use
; history of confirmed stroke or further systemic embolization within the previous 6 months; high bleeding risk (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly (> 65 Years), Drugs/Alcohol Concomitantly [HAS-BLED] score ≥ 3); severe renal impairment (estimated glomerular filtration rate [eGFR] ≤ 15 mL/min per 1.72 m2); technically challenging echocardiography windows that hampered the assessment of actual LVT existence; and expected difficulties in strictly following the international normalized ratio (INR)
or fulfilling the study requirements. After obtaining consent from the patient, a clinical pharmacist used a computer application to generate a random sequence. The patient was allocated to one of the groups taking at least one dose of the assigned medications. The study was approved and overseen by the institutional research and ethics committee (IRB-2018-08; date of approval: August 18, 2018). Informed consent was obtained from all patients. The study data were reviewed on an ongoing basis to ensure the safety, validity, and integrity of the study participants. The study was registered at clinicaltrials.gov (NCT05208398).
The primary study endpoint was LVT resolution after 3 months of treatment. For apixaban to achieve noninferiority, it had to achieve ≥ 95% LVT resolution, compared with warfarin. The sample size was determined to be 25 cases for each arm, based on the OAC's reported average LVT resolution success rate of 90% at a 3-month follow-up in contemporary practice.
Two independent echocardiography experts analyzed each echocardiographic study. In cases of discordance regarding the existence of LVT at enrollment, the patient was not enrolled in the study. In cases of discordance regarding the resolution at follow-up, a third expert independently evaluated the echocardiographic study, and a consensus was reached to confirm the findings. LVT regression was defined as LVT area reduction of at least 25% reported by either or both experts. The experts reporting the echocardiographic studies were blinded to the treatment groups.
Echocardiographic assessment and thrombus evaluation
LVT was defined as an echo-dense mass distinct from the endocardium with well-defined edges adjacent to a hypokinetic, akinetic, or aneurysmal myocardial segment.
The LVT had to be visible in at least 2 views during the cardiac cycle. The LVT diameter (mm) and area (cm2) were assessed during each transthoracic echocardiogram without echo-contrast; the mean of 3 measures was considered to study LVT evolution over time. The location, shape, and mobility of the LVT were also determined. LVT mobility was considered when pedunculated, with at least part of it exhibiting independent movement. The echocardiographic assessment included LV ejection fraction (LVEF), LV volume, apical wall motion score index (WMSI), and the identification of an apical aneurysm. Echocardiography was performed at baseline, and at 1, 3, and 6 months. The medications were administered until LVT resolution was confirmed within a minimum of 3 months. We extended treatment for 6 months or more when LVT resolution could not be proven. In addition, a 6-month echocardiography study was routinely performed to assess for any LVT persistence or recurrence.
Treatment
We randomly assigned patients to treatment with apixaban (5 mg twice daily), the most studied DOAC,
or dose-adjusted warfarin, to achieve a target INR of 2.0 to 3.0 for the study duration. At the discretion of the treating physician, patients randomized to the warfarin group may have been treated with therapeutic heparin (subcutaneous enoxaparin or intravenous heparin infusion if hospitalized) until a therapeutic INR was achieved. Heparin bridging for patients randomized to warfarin, with a recently discovered MI at an outpatient follow-up visit, was decided at the treating physician's discretion. The use of anticoagulant therapy, clopidogrel, and low-dose aspirin, or triple antithrombotic therapy was based on the best available evidence.
Viewpoint: a proposal for a simple algorithm for managing oral anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation and coronary stents.
Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS).
Both groups received triple therapy for 1 month, and for a maximum of 3 months, unless the clinical condition or bleeding risk mandated the modification of this policy. Both groups were instructed on medication use at each visit. Clopidogrel was used throughout the study; aspirin was resumed once LVT resolution was confirmed, and OAC was discontinued (Fig. 1). The warfarin group was strictly followed by a dedicated anticoagulation clinic managed by a clinical pharmacist to ensure an INR between 2 and 3. The INR was re-estimated 4 days after the value had been < 1.5 or > 5, after a week if it had been 1.5-2 or 3.5-5, and in 2-3 weeks if it had been 3.0-3.5; otherwise, the INR was checked monthly. The clinical pharmacist in the anticoagulation clinic provided health education, closely monitored for any bleeding or significant out-of-range INR, and reviewed the medication (including apixaban tablets) to ensure adherence. The time-in-therapeutic range (TTR) was calculated using the Rosendaal method.
The study protocol included clinical assessment at enrollment visits and at 1-, 3-, and 6-month follow-up. In addition, the baseline characteristics of all patients were collected through a dedicated case report form. It included cardiovascular risk factors, medical history of significant bleeding or ischemic events, underlying diseases, and long-term use of anticoagulation therapy before LVT diagnosis. Oral anticoagulation was routinely given for 3 months
Incidence of left ventricular thrombus in patients with acute ST-segment elevation myocardial infarction treated with percutaneous coronary intervention.
and was discontinued when thrombus resolution had been confirmed at the 3-month visit. When LVT persisted beyond 3 months, anticoagulation was extended, and echocardiography was repeated at 6 months, which was the final study visit.
Endpoint definitions
The primary endpoint of the study was complete LVT resolution, defined by the disappearance of LVT on all echocardiographic views at the 3-month follow-up. LVT regression was considered when LVT area reduction of at least 25% was reported by either or both echocardiographic experts. LVT persistence was defined as increased thrombus dimension, stable thrombus size, or controversial minor thrombus regression at follow-up. In addition, the clinical outcomes during the observation period were evaluated, including major adverse cardiovascular events, defined as the composite of all-cause death, ischemic stroke or transient ischemic attack, MI or acute peripheral artery emboli, and any clinically relevant bleeding events (Bleeding Academic Research Consortium [BARC] score ≥ 2).
The baseline characteristics between the groups were compared using 1-way analysis of variance for continuous variables, and the χ2 test for categorical variables. In addition, univariate and multivariate Cox regression analyses were used to identify the independent correlates of total LVT persistence at 3 months. All baseline clinical and echocardiographic characteristics were included in the regression analysis. All tests had a 2-sided significance level of 5% and were performed using SAS software (version 9.2; SAS Institute, Cary, NC).
Results
We screened 72 patients with provisional eligibility at 3 participating centres. Fifty patients with post-MI LVT were enrolled and completed the follow-up in the study; all patients had anterior wall MI with apical or apical-septal LVT. They were randomized to receive either warfarin or apixaban (Fig. 2). The first patient underwent randomization in September 2018, and the last patient completed follow-up in July 2021. We excluded 2 patients randomized to the warfarin group, and 1 randomized to the apixaban group, because the treating physician allocated them a different OAC. This site was closed early in the course of the study because of the violation of Good Clinical Practice in the consent process. The baseline demographic characteristics did not show significant differences, including in the history of acute or recent MI, creatinine and hemoglobin levels, and HAS-BLED score (Table 1). In the apixaban group, 11 patients (44.0%) were admitted with a diagnosis of acute MI, compared to 10 (40.0%) in the warfarin group (P = nonsignificant). The remaining patients in both groups were diagnosed with LVT beyond a week or at a routine 1-month outpatient follow-up. The median time from MI to echocardiogram was 2 days (interquartile range: 1.3-2.8) in patients with acute MI, and 32 days (interquartile range: 28.4-35.8) in patients with recent MI; the 2 groups were not statistically different. Two patients in the apixaban group and 3 in the warfarin group had a history of lytic therapy for acute MI. Neither group showed a significant difference in percutaneous coronary intervention rate. One-month dual antiplatelet therapy (aspirin and clopidogrel) was administered to 18 and 17 patients in the apixaban and warfarin groups, respectively. The use of heparin or enoxaparin was more common in the warfarin group than in the apixaban group (21 [84.0 %] vs 16 [64.0 %], P = 0.028). The warfarin group needed more-frequent outpatient visits, and significantly longer hospital stays, than the apixaban group (5.3 ± 4.3 days vs 2.1 ± 2.7 days, P = 0.042). The baseline echocardiographic parameters (Table 2) showed comparable results, including the severity of LV systolic dysfunction, LVEF (26.4% ± 6.1% vs 27.3% ± 9.2%, apixaban vs warfarin), the LV chamber volumes, apical WMSI (2.88 ± 0.25 vs 2.85 ± 0.39, apixaban vs warfarin), and LV apical aneurysm (14 [56.0%] vs 13 [52.0%], apixaban vs warfarin). Both groups had similar LVT characteristics, including its dimensions and the area involved. Furthermore, the high-risk features did not differ significantly between the apixaban and warfarin groups, such as mobility (12 [48.0%] vs 11 [44.0%] patients), and fresh or protruding thrombus (22 [88.0%] vs 21 [84.0%] patients).
Figure 2Study screening, randomization, and follow-up.
All patients in both groups completed the predetermined study period of 6 months of institutional follow-up. None of the patients demonstrated stroke, transient ischemic attack, or other systemic embolisms, new MI, death from any cause, unscheduled hospitalization, or clinical evidence of bleeding during this period. The 3-month hemoglobin level was confirmed in 20 (80.0%) and 19 (76.0%) patients in the apixaban and warfarin groups (13.3 ± 2.6 vs 13.2 ± 2.5 gm/dL), respectively. One patient in the warfarin group (on triple therapy) had a 2.3 gm/dL drop of hemoglobin at 1-month follow-up (BARC score: 2).
He did not observe stool color changes or any other apparent source of bleeding, and the INR was within an acceptable range. Therefore, we discontinued aspirin and increased the proton pump inhibitor dose. His hemoglobin level improved at the next follow-up, and warfarin and clopidogrel were continued. All study patients completed up to 6 months of the initially allocated OAC medication without crossover. In the apixaban group, all patients received 5 mg of apixaban twice daily. Aspirin was discontinued in 5 patients after 1-2 weeks and in 17 patients after the first month; 3 patients continued triple therapy for up to 3 months. Apixaban was halted in 19 patients with LVT resolution at 3 months, and dual antiplatelet therapy was resumed. In the warfarin group, aspirin was withheld in 5 patients after 1-2 weeks, and in 16 patients after the first month; it was continued in 4 patients until the third month. Warfarin was halted in 20 patients with LVT resolution at 3 months, and dual antiplatelet therapy was resumed. During the remainder of the study period, clopidogrel and the anticoagulant were continued in both groups until the study ended at 6 months (see graphical abstract). The INR time of the warfarin group within the TTR was 73%.
Efficacy endpoints
Apixaban was noninferior to warfarin in LVT resolution, with no statistical difference in resolution rates (Table 3; Fig. 3). At the 1-month follow-up, 10 patients (40.0%) in the apixaban group had LVT resolution, 13 (52.0%) had LVT regression, and 2 had persistent LVT. At 1-month follow-up, 14 patients (56.0%) had LVT resolution in the warfarin group, 10 (40.0%) had LVT regression, and one had persistent LVT. At 3 months, 19 patients (76.0%) in the apixaban group had LVT resolution, 5 (20.0%) had LVT regression, and 1 had persistent LVT. In the warfarin group, by contrast, 20 patients (80%) had LVT resolution, and 5 (20.0%) had LVT regression. Apixaban achieved 95% relative success in LVT resolution at 3 months, compared with warfarin (P < 0.036 for noninferiority). By 6 months, 23 (92.0%) and 24 (96.0%) patients in the apixaban and warfarin groups, respectively, had complete LVT resolution. No patient in whom the OAC was stopped after LVT resolution at 3-month follow-up had evident echocardiographic recurrence at 6 months.
Table 3Primary outcome of the study
LV thrombus
Apixaban
Warfarin
P
n (of 25)
%
n (of 25)
%
1 month
0.165
Persistent
2
8.0
1
4.0
Regression
13
52.0
10
40.0
Resolution
10
40.0
14
56.0
3 months
0.303
Persistent
1
4.0
0
0
Regression
5
20.0
5
20.0
Resolution
19
76.0
20
80.0
6 months
0.366
Regression
2
8.0
1
4.0
Resolution
23
92.0
24
96.0
P values are for left ventricular (LV) thrombus resolution.
Figure 3Left ventricular thrombus resolution. Each group consisted of 25 patients, and left ventricular thrombus (LVT) resolution was not statistically different between the treatment groups. The numerically higher resolution at 1 month can be explained by the parenteral use of anticoagulants in the warfarin group and optimal compliance during hospitalization and soon after discharge. NS, nonsignificant.
Multivariate adjustment analysis (Table 4) revealed that the presence of LV aneurysm (hazard ratio [HR]: 1.65; 95% confidence interval [CI]: 1.03 to 1.87; P < 0.024), a larger baseline LV thrombus area (HR: 1.63; 95% CI: 1.32 to 2.74; P < 0.031), and lower LVEF (HR: 1.39; 95% CI: 1.02 to 2.54; P < 0.043) were independent predictors of LVT persistence at 3 months.
Table 4Multivariate analyses of the left ventricular thrombus (LVT) persistence predictors after 3 months of anticoagulation therapy
In this prospective randomized controlled study, which is the largest to date, of patients with LVT after acute or recent MI, apixaban was not inferior to warfarin for LVT resolution, at all times of evaluation. Guidelines routinely recommend the use of warfarin for patients with post-MI LVT.
2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation of the European Society of Cardiology (ESC).
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelinesas.
These recommendations are based on long-term experience and older studies that lack the optimal level of evidence. Several studies, including registries,
Resolution of left ventricular postinfarction thrombi in patients undergoing percutaneous coronary intervention using rivaroxaban in addition to dual antiplatelet therapy.
have supported the use of DOACs for post-MI LVT. Our study provides additional evidence, as a small randomized controlled clinical trial, of the benefit of DOACs in patients with LVT after acute or recent MI.
All guidelines agree on the echocardiographic evaluation of LVT at 3 months.
2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation of the European Society of Cardiology (ESC).
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelinesas.
Rationale and design of a prospective multi-center randomized trial of EARLY treatment by rivaroxaban versus warfarin in ST-segment elevation MYOcardial infarction with Left Ventricular Thrombus (EARLY-MYO-LVT trial).
Rationale and design of a prospective multi-center randomized trial of EARLY treatment by rivaroxaban versus warfarin in ST-segment elevation MYOcardial infarction with Left Ventricular Thrombus (EARLY-MYO-LVT trial).
After a month of triple therapy in the current study, and an additional 2 months of OAC and clopidogrel, nearly 20% of the patients did not achieve full LVT resolution; however, no incidence of stroke or peripheral embolization occurred.
Contrary to the absence of clinical events in our study, other studies have reported a higher risk of clinical complications in real life.
At 1 month, the numerically higher, statistically nonsignificant LVT resolution in the warfarin group might reflect the effect of extended parenteral anticoagulation use, strict compliance, and longer hospital stay with well-achieved TTR. The OAC regimen was not a predictor of LVT resolution at 3 months. The presence of an LV aneurysm, a larger LVT area, and a lower LVEF were independent predictors of a lower LVT resolution rate. This finding is comparable to the results of several prior studies
Incidence of left ventricular thrombus in patients with acute ST-segment elevation myocardial infarction treated with percutaneous coronary intervention.
; this finding provides support for the overall safety of choosing either therapy in contemporary practice with concomitant antiplatelet administration. However, these findings should be cautiously considered, owing to the short follow-up period, small sample size, short triple therapy use, and close follow-up of this study. In a large atrial fibrillation study, use of apixaban showed less bleeding, including intracranial hemorrhage, than use of warfarin.
We achieved a well-controlled warfarin therapy with a high TTR ( > 70%) of INR and only 1 case of clinically relevant bleeding. The type of anticoagulant therapy used was not independently associated with cardiovascular events in a recent study,
consistent with our findings. Our study enrolled relatively younger patients and those in whom achievement of better INR was more feasible, with a strict INR protocol; these factors might have favoured the warfarin group. Studies have shown less efficacy and an increased risk of warfarin use with a TTR < 50%.
The average actual practice TTR in the study centres was approximately 52%. The high-value TTR in our study required dedication, several study-related visits, and indirectly higher costs that are difficult to achieve in real life. The convenience of use and availability of medications and services will impact the choice of therapeutic approach. Our study showed significantly shorter hospital stays and fewer outpatient visits related to LVT treatment with apixaban. Given the noninferiority of apixaban in LVT resolution, its relative safety in our study and others,
and the usual difficulty in ensuring that patients with good TTR continue using warfarin in regular life, apixaban and probably other DOACSs should be considered reasonable alternatives to warfarin for treating post-MI LVT. Our study forms a basis for further larger-scale randomized studies
Rationale and design of a prospective multi-center randomized trial of EARLY treatment by rivaroxaban versus warfarin in ST-segment elevation MYOcardial infarction with Left Ventricular Thrombus (EARLY-MYO-LVT trial).
2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation of the European Society of Cardiology (ESC).
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelinesas.
Apixaban versus warfarin in patients with left ventricular thrombus: a pilot prospective randomized outcome blinded study investigating size reduction or resolution of left ventricular thrombus.
add complementary evidence to this unmet knowledge gap. In addition, echocardiography has known limitations for LVT detection; however, it remains the standard screening imaging modality, and LVT resolution on echocardiography ensures the discontinuation of OAC therapy.
2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation of the European Society of Cardiology (ESC).
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelinesas.
Rationale and design of a prospective multi-center randomized trial of EARLY treatment by rivaroxaban versus warfarin in ST-segment elevation MYOcardial infarction with Left Ventricular Thrombus (EARLY-MYO-LVT trial).
Furthermore, 3 randomized patients (5.4%) were excluded early on from the study, due to protocol violation; they were allocated to the opposite study group due to a local treating physician’s concern. Patient safety and study integrity were not affected by this protocol. Finally, the study results cannot be extrapolated to older and sicker patients and are not powered to assess the clinical outcome.
Conclusion
In this prospective randomized, open-label controlled clinical trial, apixaban was not inferior to warfarin in terms of LVT resolution after acute or recent MI.
Acknowledgements
The authors appreciate the efforts of our research coordinators, Resmi George and Josephine-Grace Chua, who helped complete this work.
Funding Sources
The authors have no funding sources to declare.
Disclosures
The authors have no conflicts of interest to disclose.
References
Weinsaft J.W.
Kim J.
Medicherla C.B.
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Echocardiographic algorithm for post-myocardial infarction LV thrombus: a gatekeeper for thrombus evaluation by delayed enhancement CMR.
J Am Coll Cardiol Cardiovasc Imaging.2016; 9: 505-515
Incidence of left ventricular thrombus in patients with acute ST-segment elevation myocardial infarction treated with percutaneous coronary intervention.
Incidence and predictors of early left ventricular thrombus after ST-elevation myocardial infarction in the contemporary era of primary percutaneous coronary intervention.
2017 ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the Management of Acute Myocardial Infarction in Patients Presenting with ST-segment Elevation of the European Society of Cardiology (ESC).
2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelinesas.
Resolution of left ventricular postinfarction thrombi in patients undergoing percutaneous coronary intervention using rivaroxaban in addition to dual antiplatelet therapy.
Viewpoint: a proposal for a simple algorithm for managing oral anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation and coronary stents.
Management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous coronary or valve interventions: a joint consensus document of the European Society of Cardiology Working Group on Thrombosis, European Heart Rhythm Association (EHRA), European Association of Percutaneous Cardiovascular Interventions (EAPCI) and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS) and Asia-Pacific Heart Rhythm Society (APHRS).
Rationale and design of a prospective multi-center randomized trial of EARLY treatment by rivaroxaban versus warfarin in ST-segment elevation MYOcardial infarction with Left Ventricular Thrombus (EARLY-MYO-LVT trial).
Apixaban versus warfarin in patients with left ventricular thrombus: a pilot prospective randomized outcome blinded study investigating size reduction or resolution of left ventricular thrombus.
Ethics Statement: The study was approved and overseen by the institutional research and ethics committee (No: IRB-2018-08; date of approval: August 18, 2018). Informed consent was obtained from all patients. The study data were reviewed on an ongoing basis to ensure the safety, validity, and integrity of the study participants.
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