Incidence and clinical impact of inappropriate periprocedural and perioperative management of antiplatelet therapy.

BACKGROUND AND AIMS: There is little evidence on the impact of current recommendations on the use of antiplatelet therapy during the perioperative and periprocedural period in our setting. The aim of this study was to analyze the incidence and clinical impact of inappropriate use of antiplatelet therapy in a population of patients undergoing surgery or a diagnostic or therapeutic procedure in "real life" in Spain. METHODS: A prospective multicenter observational study of patients treated with antiplatelet agents requiring intervention was conducted. The incidence of thrombotic and hemorrhagic events at 30 days was analyzed according to peri-intervention management of antiplatelet therapy. RESULTS: We included 643 patients (31.9% women, 39.0% over 75 years of age), most of them (87.7%) receiving aspirin as antiplatelet therapy at a dose of 100mg/day. Indications for antiplatelet therapy were ischemic heart disease (44.9%), cerebrovascular disease (21.7%), and peripheral vascular disease (23.0%). Ischemic risk was low in 74.3%, while 51.6% had a low bleeding risk of the intervention. Periprocedural management was considered appropriate in 61.7% of cases. 30-day incidence of the combined primary endpoint of thrombotic events and major bleeding (12.1% versus 5.0%; p=0.002) and 30-day mortality (5.2% versus 1.5%; p=0.008) were significantly higher in patients with inappropriate periprocedural management of antiplatelet agents. CONCLUSIONS: Despite current recommendations for the use of antiplatelet drugs in the perioperative/periprocedural period, their implementation in the "real world" remains low. Inappropriate use is associated with an increased incidence of adverse events, both thrombotic and hemorrhagic.

Practical approach for atrial cardiomyopathy characterization in patients with atrial fibrillation.

Atrial fibrillation (AF) causes progressive structural and electrical changes in the atria that can be summarized within the general concept of atrial remodeling. In parallel, other clinical characteristics and comorbidities may also affect atrial tissue properties and make the atria susceptible to AF initiation and its long-term persistence. Overall, pathological atrial changes lead to atrial cardiomyopathy with important implications for rhythm control. Although there is general agreement on the role of the atrial substrate for successful rhythm control in AF, the current classification oversimplifies clinical management. The classification uses temporal criteria and does not establish a well-defined strategy to characterize the individual-specific degree of atrial cardiomyopathy. Better characterization of atrial cardiomyopathy may improve the decision-making process on the most appropriate therapeutic option. We review current scientific evidence and propose a practical characterization of the atrial substrate based on 3 evaluation steps starting with a clinical evaluation (step 1), then assess outpatient complementary data (step 2), and finally include information from advanced diagnostic tools (step 3). The information from each of the steps or a combination thereof can be used to classify AF patients in 4 stages of atrial cardiomyopathy, which we also use to estimate the success on effective rhythm control.

Should atrial fibrillation be considered a vascular disease? The need for a comprehensive vascular approach.

INTRODUCTION: Atrial fibrillation (AF) cannot be considered an isolated disease. Patients with AF should be managed using a comprehensive approach that is not limited to stroke prevention. AREAS COVERED: In this manuscript, the potential role of AF as a vascular disease that is managed as part of a holistic approach was reviewed. EXPERT OPINION: The residual risk of stroke in patients with AF reaches 1-2% annually, despite appropriate anticoagulation therapy. Additionally, patients with AF may develop cognitive impairment through stroke-independent pathways. Furthermore, patients with AF may have a higher risk of developing atherosclerotic vascular disease in various vascular beds and chronic kidney disease; conversely, patients with atherosclerotic disease may have an increased risk of developing AF. AF should be considered a truly systemic vascular disease, since it brings together several hemodynamic and systemic changes, including inflammation, oxidative stress, activation of the renin-angiotensin-aldosterone and sympathetic systems, as well as a prothrombotic state and endothelial dysfunction. In this regard, patients with AF should be treated based on a holistic approach that is not limited to oral anticoagulation but includes complete vascular protection.

Registro observacional prospectivo sobre la utilización del tratamiento antitrombótico durante el periodo perioperatorio y periprocedimiento en el «mundo real»: estudio REQXAA / Prospective observational registry of perioperative and periprocedural management of antithrombotic therapy in “real world”: the REQXAA study

Introducción y objetivos: Existe escasa evidencia acerca del impacto de las actuales recomendaciones sobre la utilización del tratamiento antitrombótico durante el periodo perioperatorio y periprocedimiento en el «mundo real». El objetivo de este estudio es analizar la utilización de los fármacos antitrombóticos en una población de pacientes que van a someterse a una cirugía/procedimiento, así como evaluar la implicación que tiene su retirada o mantenimiento en la incidencia de eventos adversos trombóticos y/o hemorrágicos. Métodos: Estudio observacional prospectivo, multicéntrico y multiespecialidad de pacientes en tratamiento antitrombótico que precisen alguna intervención. El objetivo principal fue la incidencia de eventos trombóticos y hemorrágicos a 30 días en función del uso periintervención de los fármacos antitrombóticos. Resultados: Se incluyó a un total de 1.266 pacientes (el 63,5% varones; media de edad, 72,6 años). El 48,6% de ellos se encontraban anticoagulados (la mayoría por fibrilación auricular; CHA2DS2-VASC, 3,7) y el 53,3%, antiagregados, con mayor frecuencia por cardiopatía isquémica. El 66,7% tenía un riesgo isquémico bajo y el 51,9%, un riesgo hemorrágico de la intervención bajo. El tratamiento antitrombótico periprocedimiento según las recomendaciones actuales fue idóneo únicamente en el 57,3% de los casos. Los pacientes con un uso inadecuado de los fármacos antitrombóticos periprocedimiento presentaron una incidencia de eventos adversos trombóticos y hemorrágicos significativamente mayor. Conclusiones: A pesar de las recomendaciones actuales acerca de la utilización de fármacos antitrombóticos en el periodo perioperatorio/periprocedimiento, su implementación en el «mundo real» continúa siendo baja. Un uso inadecuado se asocia con un aumento de la incidencia de eventos adversos, tanto trombóticos como hemorrágicos.(AU)

Introduction and objectives: There is scarce real-world evidence on the management of perioperative antithrombotic treatment according to current recommendations. The aim of this study was to analyze the management of antithrombotic treatment in patients undergoing surgery or another invasive intervention and to assess the consequences of this management on the occurrence thrombotic or bleeding events. Methods: This prospective, observational, multicenter and multispecialty study analyzed patients receiving antithrombotic therapy who underwent surgery or another invasive intervention. The primary endpoint was defined as the incidence of adverse (thrombotic and/or hemorrhagic) events after 30 days of follow-up with respect to management of perioperative antithrombotic drugs. Results: We included 1266 patients (male: 63.5%; mean age 72.6 years). Nearly half of the patients (48.6%) were under chronic anticoagulation therapy (mainly for atrial fibrillation; CHA2DS2-VASC: 3.7), while 53.3% of the patients were under chronic antiplatelet therapy (mainly for coronary artery disease). Low ischemic and hemorrhagic risk was found in 66.7% and 51.9%, respectively. Antithrombotic therapy management was in line with current recommendations in only 57.3% of the patients. Inappropriate management of antithrombotic therapy was an independent risk factor for both thrombotic and hemorrhagic events. Conclusions: The implementation of recommendations on the perioperative/periprocedural management of antithrombotic therapy in real-world patients is poor. Inappropriate management of antithrombotic treatment is associated with an increase in both thrombotic and hemorrhagic events.(AU)

Prospective observational registry of perioperative and periprocedural management of antithrombotic therapy in "real world": the REQXAA study.

INTRODUCTION AND OBJECTIVES: There is scarce real-world evidence on the management of perioperative antithrombotic treatment according to current recommendations. The aim of this study was to analyze the management of antithrombotic treatment in patients undergoing surgery or another invasive intervention and to assess the consequences of this management on the occurrence thrombotic or bleeding events. METHODS: This prospective, observational, multicenter and multispecialty study analyzed patients receiving antithrombotic therapy who underwent surgery or another invasive intervention. The primary endpoint was defined as the incidence of adverse (thrombotic and/or hemorrhagic) events after 30 days of follow-up with respect to management of perioperative antithrombotic drugs. RESULTS: We included 1266 patients (male: 63.5%; mean age 72.6 years). Nearly half of the patients (48.6%) were under chronic anticoagulation therapy (mainly for atrial fibrillation; CHA2DS2-VASC: 3.7), while 53.3% of the patients were under chronic antiplatelet therapy (mainly for coronary artery disease). Low ischemic and hemorrhagic risk was found in 66.7% and 51.9%, respectively. Antithrombotic therapy management was in line with current recommendations in only 57.3% of the patients. Inappropriate management of antithrombotic therapy was an independent risk factor for both thrombotic and hemorrhagic events. CONCLUSIONS: The implementation of recommendations on the perioperative/periprocedural management of antithrombotic therapy in real-world patients is poor. Inappropriate management of antithrombotic treatment is associated with an increase in both thrombotic and hemorrhagic events.

Effects of intravenous lysine acetylsalicylate versus oral aspirin on platelet responsiveness in patients with ST-segment elevation myocardial infarction: the ECCLIPSE-STEMI trial.

Prasugrel and ticagrelor, new P2Y12-ADP receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events in patients with an acute coronary syndrome. However, evidence is lacked about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared to oral aspirin. Recently, we demonstrated in healthy volunteers that the administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin. Loading dose of LA achieves platelet inhibition faster, and with less variability than aspirin. However, there are no data of this issue in patients with an ST-segment elevation myocardial infarction (STEMI). This is a prospective, randomized, multicenter, open platelet function study conducted in STEMI patients. Subjects were randomly assigned to receive a loading dose (LD) of intravenous LA 450 mg plus oral ticagrelor 180 mg, or LD of aspirin 300 mg plus ticagrelor 180 mg orally. Platelet function was evaluated at baseline, 30 min, 1 h, 4 h and 24 h using multiple electrode aggregometry and vasodilator-stimulated phosphoprotein phosphorylation (VASP). The primary endpoint of the study is the inhibition of platelet aggregation (IPA) after arachidonic acid (AA) 0.5 mM at 30 min. Secondary endpoints were the IPA at 1, 4, and 24 h after AA, and non-AA pathways through the sequence (ADP and TRAP). A total of 32 STEMI patients were randomized (16 LA, 16 aspirin). The inhibition of platelet aggregation after AA 0.5 mM at 30 min was greater in subjects treated with LA compared with aspirin: 166 vs. 412 respectively (p = 0.001). This differential effect was observed at 1 h (p = 0.01), but not at 4 and 24 h. Subjects treated with LA presented less variability and faster inhibition of platelet aggregation wit AA compared with aspirin. The administration of intravenous LA resulted in a significantly reduction of platelet reactivity compared to oral aspirin on ticagrelor inhibited platelets in patients with STEMI. Loading dose of LA achieves an earlier platelet inhibition, and with less variability than aspirin.Trial Registration: Unique identifier: NCT02929888; URL: http://www.clinicaltrials.gov.

Polypill Strategy in Secondary Cardiovascular Prevention.

BACKGROUND: A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODS: In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTS: A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. CONCLUSIONS: Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).

Role of telemedicine in the management of oral anticoagulation in atrial fibrillation: a practical clinical approach.

Compared with face-to-face consultations, telemedicine has many advantages, including more efficient use of healthcare resources, partial relief of the burden of care, reduced exposure to COVID-19, treatment adjustment, organization of more efficient healthcare circuits and patient empowerment. Ensuring optimal anticoagulation in atrial fibrillation patients is mandatory if we want to reduce the thromboembolic risk. Of note, telemedicine is an excellent option for the long-term management of atrial fibrillation patients. Moreover, direct oral anticoagulants may provide an added value in telemedicine (versus vitamin K antagonists), as it is not necessary to monitor anticoagulant effect or make continuous dosage adjustments. In this multidisciplinary consensus document, the role of telemedicine in anticoagulation of this population is discussed and practical recommendations are provided.

Antithrombotic Therapy in Elderly Patients with Acute Coronary Syndromes.

The treatment of acute coronary syndrome (ACS) in elderly patients continues to be a challenge because of the characteS.G.B.ristics of this population and the lack of data and specific recommendations. This review summarizes the current evidence about critical points of oral antithrombotic therapy in elderly patients. To this end, we discuss the peculiarities and differences reported referring to dual antiplatelet therapy (DAPT) in ACS management in elderly patients and what might be the best option considering these population characteristics. Furthermore, we analyze antithrombotic strategies in patients with atrial fibrillation (AF), with a particular focus on those cases that also present coronary artery disease (CAD). It is imperative to deepen our knowledge regarding the management of these challenging patients through real-world data and specifically designed geriatric studies to help resolve the questions remaining in their disease management.

Direct Oral Anticoagulants versus Warfarin in Octogenarians with Nonvalvular Atrial Fibrillation: A Systematic Review and Meta-Analysis.

Direct oral anticoagulants (DOACs) have been demonstrated to be more effective and safer than vitamin-K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (AF). This meta-analysis aims to assess the effect of DOACS vs. VKA in patients ≥ 80 and AF. Primary endpoints were stroke or systemic embolism and all-cause death. Secondary endpoints included major bleeding, intracranial bleeding, and gastrointestinal bleeding. A random-effects model was selected due to significant heterogeneity. A total of 147,067 patients from 16 studies were included, 71,913 (48.90%) treated with DOACs and 75,154 with VKA (51.10%). The stroke rate was significantly lower in DOACs group compared with warfarin group (Relative risk (RR): 0.72; 95% confidence interval (CI): 0.63-0.82; p < 0.001). All-cause mortality was significantly lower in DOACs group compared with warfarin group (RR: 0.82; 95% CI: 0.70-0.96; p = 0.012). Compared to warfarin, DOACs were not associated with reductions in major bleeding (RR: 0.85, 95% CI 0.69-1.04; p = 0.108) or gastrointestinal bleeding risk (RR: 1.08, 95% CI 0.76-1.53; p = 0.678) but a 43% reduction of intracranial bleeding (RR: 0.47, IC 95% 0.36-0.60; p < 0.001) was observed. Our meta-analysis demonstrates that DOACs are effective and safe with statistical superiority when compared with warfarin in octogenarians with AF.

Endovascular treatment of coronary subclavian steal syndrome: a case series highlighting the diagnostic usefulness of a multimodality imaging approach.

BACKGROUND: Coronary subclavian steal syndrome (CSSS) is an uncommon complication observed in patients after coronary artery bypass surgery with left internal mammary artery (LIMA) grafts. It is defined as coronary ischaemia due to reversal flow from the LIMA to the left subclavian artery (SA) when a proximal left SA stenosis is present. In practice, the entire clinical spectrum of ischaemic heart disease, ranging from asymptomatic patients to acute myocardial infarction, may be encountered. CASE SUMMARY: Three cases of CSSS recently detected at our hospital are being described. Two patients presented with an acute coronary syndrome, so diagnosis was suspected based on coronary angiography findings, as retrograde blood flow from LIMA to the distal SA was present. Myocardial ischaemia was documented by myocardial perfusion scintigraphy in one case. The third patient was asymptomatic and CSSS was suspected during physical examination and confirmed by computed tomography (CT). Endovascular intervention with balloon-expandable stent implantation of the stenotic SA was performed by vascular surgeons in all patients. No periprocedural complications occurred, and complete resolution of symptoms was achieved. DISCUSSION: In CSSS, subclavian angiography is the standard diagnostic test. However, other diagnostic techniques may be valuable to better clarify this challenging diagnosis. In the herein small series, the usefulness of a multimodality imaging approach including Doppler ultrasound, myocardial perfusion scintigraphy, and CT is well demonstrated. Furthermore, this study endorses the safety and utility of endovascular treatment in different clinical scenarios, including asymptomatic patients.

Percutaneous mitral valve repair with MitraClip device in hemodynamically unstable patients: A systematic review.

BACKGROUND: Very few data exist on percutaneous mitral valve repair (PMVr) in unstable patients with concomitant moderate-severe mitral regurgitation (MR). The purpose of this systematic review was to evaluate baseline characteristics, management and clinical outcomes of critically ill patients undergoing PMVr with MitraClip. METHODS: We conducted a systematic review of the published data on MitraClip from its first use in 2003 to December 2020. Studies referring to critically ill patients in cardiogenic shock or acute refractory pulmonary edema were included. A total of 40 publications including 254 patients with significant MR (Grade 4 in 91%) were included. RESULTS: Mean age was 70 ± 12 years with mean Euroscore II and STS of 21 ± 13 and 20.5 ± 16, respectively. Clinical presentation was with cardiogenic shock and acute myocardial infarction in 72.8 and 60.0% of patients, respectively. Device success was achieved in 238 (93.7%) patients with a significant reduction in MR (Grade ≤ 2 in 91.8%, p < .001). The median weaning time from the procedure, to discontinuation of mechanical circulatory or respiratory support, was 2 days (IQR 1-4), with an in-hospital mortality and non-fatal complication rate of 12.6 and 9.1%, respectively. Kaplan-Meier curves estimated an overall mortality rate of 39.1% at 12-month follow-up, with persistent reduction in MR severity for survivors (Grade ≤ 2 in 81.3%) and one case of mitral valve reintervention. CONCLUSIONS: Percutaneous mitral valve repair with MitraClip device is a technically feasible and potentially viable management option in high-risk patients with cardiogenic shock or refractory pulmonary edema and concomitant moderate-severe MR. Prospective trials are required to confirm these findings, and definitively determine the value of MitraClip in hemodynamically unstable patients.

Comparing extracorporeal shock wave lithotripsy and ureteroscopy laser lithotripsy for treatment of urinary stones smaller than 2 cm: a cost-utility analysis in the Spanish clinical setting.

PURPOSE: To analyze the efficiency and cost-utility profile of ureteroscopy versus shock wave lithotripsy for treatment of reno-ureteral stones smaller than 2 cm. METHODS: Patients treated for urinary stones smaller than 2 cm were included in this study (n = 750) and divided into two groups based on technique of treatment. To assess the cost-utility profile a sample of 48 patients (50% of each group) was evaluated. Quality of life survey (Euroqol 5QD-3L) before-after treatment was applied, Markov model was designed to calculate quality of life in each status of the patients (stone or stone-free with and without double-J stent) and to estimate the incremental cost-utility. Monte carlo simulation was conducted for a probabilistic sensitivity analysis. Chi-square was used for comparing qualitative variables and T student's for continuous variables. RESULTS: Shock wave lithotripsy group had 408 (54.4%) and ureteroscopy group had 342 (45.6%) patients. Of them, 56.3% were treated for renal stones and 43.7% for ureteral stones. Ureteroscopy produced slightly higher overall quality of patients' life, but produced a significant higher overall cost per quality-adjusted life year (QALY) than shock wave lithotripsy, exceeding the cost-utility threshold (20,000€/QALY). Sensitivity analysis confirmed results in 93.65% of cases. Difference was maintained in subgroup analysis (ureteral vs renal stones). CONCLUSIONS: Results suggest that in our clinical setting shock wave lithotripsy has better cost-utility profile than ureteroscopy for treatment of reno-ureteral stones less than 2 cm, but excluding waiting times, in ideal clinical setting, ureteroscopy would have better cost-utility profile than shock wave lithotripsy.

Performance of the heart team approach in daily clinical practice in high-risk patients with aortic stenosis.

OBJECTIVE: The heart team (HT) approach plays a key role in selecting the optimal treatment strategy for patients with aortic stenosis (AS). However, little is known about the HT decision process and its impact on outcomes. The aim of this study was to identify the factors associated with the HT decision and evaluate clinical outcomes according to the treatment choice. METHODS: The study included a total of 286 consecutive patients with AS referred for discussion in the weekly HT meeting in a cardiovascular institute over 2 years. Patients were stratified according to the selected therapeutic approach: medical treatment (MT), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. Baseline characteristics involved in making a therapeutic choice were identified and a decision-making tree was built using classification and regression tree methodology. RESULTS: Based on HT discussion, 53 patients were assigned to SAVR, 210 to TAVR, and 23 to MT. Older patients (≥88 years old) were mainly assigned to TAVR or MT according to the logistic EuroSCORE (