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5.
EuroIntervention ; 15(12): e1081-e1089, 2019 Dec 20.
Article in English | MEDLINE | ID: mdl-31310239

ABSTRACT

AIMS: The durable fluoroacrylate polymer-based sirolimus-eluting stent (Angiolite SES) has shown promising preclinical and clinical results regarding inflammatory vascular reaction and neointimal healing. We aimed to compare performance between the Angiolite SES and an everolimus-eluting stent (EES) in patients with coronary artery disease. METHODS AND RESULTS: The ANGIOLITE trial, a prospective, randomised, multicentre trial, compared the restenosis parameters of both stents in de novo coronary lesions. The primary endpoint was late lumen loss at six-month angiographic follow-up. In-stent healing was assessed by optical coherence tomography (OCT). The main clinical endpoint was target lesion failure (TLF) evaluated up to 24 months. A total of 223 patients were randomised 1:1 to EES or SES. At six months, in-stent late lumen loss was 0.08 mm (±0.38) for EES vs 0.04 mm (±0.39) for SES (difference=-0.04 mm, 95% CI: -0.15, 0.07, p for non-inferiority=0.002). By OCT, the rate of uncovered to total number of struts score >30% was comparable between the groups whereas neointimal thickness was reduced in the SES arm (9.0% [7.6, 10.6] vs 9.9% [8.5, 11.3], p=0.41; and 86.4 [81.6, 91.2] µm vs 72.1 [68.2, 76.0] µm, p<0.01, respectively). At 24 months, TLF occurred in eight patients (7.6% [3.3, 14.5]) in the EES arm and in seven patients (7.1% [2.9, 14.0]) in the SES arm (p=0.88). The definite/probable stent thrombosis rate was comparable between the groups (1.9% [0.2, 6.7] vs 1.0% [0.0, 5.5] EES vs SES, respectively; p=0.59). CONCLUSIONS: This trial demonstrates similar antirestenotic efficacy at midterm follow-up of the Angiolite SES vs an EES. Clinical endpoints were comparable between the groups at two-year follow-up. Visual summary. Main results of the ANGIOLITE trial.


Subject(s)
Coronary Artery Disease/surgery , Drug-Eluting Stents , Everolimus/therapeutic use , Percutaneous Coronary Intervention/methods , Sirolimus/therapeutic use , Absorbable Implants , Humans , Polymers/therapeutic use , Prospective Studies , Prosthesis Design , Treatment Outcome
6.
Rev. esp. cardiol. (Ed. impr.) ; 72(6): 449-455, jun. 2019. tab, graf
Article in Spanish | IBECS | ID: ibc-188405

ABSTRACT

Introducción y objetivos: Muchos pacientes con fibrilación auricular no valvular tienen contraindicados los anticoagulantes orales. El objetivo es estimar la incidencia de eventos tromboembólicos y hemorrágicos en pacientes con fibrilación auricular no valvular y cierre de la orejuela izquierda con seguimiento a largo plazo, y determinar los factores asociados con mayor mortalidad a largo plazo. Métodos: Cohorte prospectiva de pacientes reclutados desde 2009 a 2015. Se compararon los eventos tromboembólicos y hemorrágicos con los esperados según las escalas CHA2DS2-VASc y HAS-BLED. Se realizó un análisis multivariable para determinar las variables asociadas con la mortalidad. Resultados: Se reclutó a 598 pacientes (1.093 pacientes-año) con contraindicación de anticoagulantes (mediana de edad, 75,4 años). La tasa de éxito del cierre de la orejuela izquierda fue del 95,8%; 30 pacientes (5%) presentaron complicaciones. Las tasas de eventos (cada 100 pacientes-año) durante el seguimiento (media, 22,9 meses; mediana, 16,1 meses) fueron: muerte, 7,0%; ictus isquémico, 1,6% (frente al 8,5% esperado según CHA2DS2-VASc; p < 0,001); hemorragia intracraneal, 0,8%; hemorragia gastrointestinal, 3,2%, y hemorragia grave, 3,9% (frente al 6,3% esperado por HAS-BLED; p = 0,002). Estos resultados incluso mejoraron en el subgrupo de 176 pacientes con seguimiento > 24 meses (media, 46,6 meses; 683 pacientes-año) para las hemorragias graves, el 2,6% (frente al 6,3% esperado por HAS-BLED; p < 0,033). La edad (HR = 1,1), las hemorragias intracraneales (HR = 6,8) y el ictus (HR = 2,7) se asociaron con mayor mortalidad. Conclusiones: El cierre de la orejuela izquierda redujo significativamente las incidencias de ictus y de eventos hemorrágicos graves y el beneficio se mantuvo. La edad, las hemorragias intracraneales y el ictus se asociaron con mayor mortalidad


Introduction and objectives: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. Methods: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. Results: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). Conclusions: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality


Subject(s)
Humans , Male , Female , Aged , Atrial Appendage/surgery , Vascular Closure Devices/statistics & numerical data , Heart Septal Defects, Atrial/surgery , Atrial Fibrillation/complications , Long Term Adverse Effects/prevention & control , Diseases Registries/statistics & numerical data , Atrial Fibrillation/drug therapy , Anticoagulants/adverse effects , Prospective Studies , Thromboembolism/epidemiology , Hemorrhage/epidemiology , Stroke/prevention & control , Indicators of Morbidity and Mortality , Contraindications, Drug
7.
Rev Esp Cardiol (Engl Ed) ; 72(6): 449-455, 2019 Jun.
Article in English, Spanish | MEDLINE | ID: mdl-29754808

ABSTRACT

INTRODUCTION AND OBJECTIVES: Many patients with nonvalvular atrial fibrillation are still left without protection due to a contraindication for anticoagulants. This study aimed to establish the occurrence of stroke and major bleeding events in patients with nonvalvular atrial fibrillation and left atrial appendage closure with long-term follow-up and to explore the factors associated with higher long-term mortality. METHODS: Analysis of a multicenter single cohort prospectively recruited from 2009 to 2015. Thromboembolic and bleeding events were compared with those expected from CHA2DS2-VASc and HAS-BLED scores. Multivariate analysis examined variables associated with mortality during follow-up. RESULTS: A total of 598 patients (1093 patient-years) with a contraindication for anticoagulants were recruited (median 75.4 years). The success rate of left atrial appendage closure device implantation was 95.8%. Thirty patients (5%) experienced periprocedural complications. The rate of events (per 100 patient-years) during follow-up (mean 22.9 months; median 16.1 months) was as follows: death 7.0%; ischemic stroke 1.6% (vs 8.5% expected according to CHA2DS2-VASc; P < .001); intracranial hemorrhage 0.8%; gastrointestinal bleeding 3.2%; severe bleeding 3.9% (vs 6.3% expected by HAS-BLED, P = .002). These results were improved in the subgroup of 176 patients with follow-up > 24 months (mean follow-up 46.6 months, 683 patient-years) for severe bleeding 2.6% (vs 6.3% expected by HAS-BLED, P < .033). The factors significantly associated with higher mortality were age (HR, 1.1), intracranial hemorrhage (HR, 6.8), and stroke during follow-up (HR, 2.7). CONCLUSIONS: Left atrial appendage closure significantly reduced the incidence of stroke and bleeding events and the benefit was maintained. Intracranial hemorrhage, age and stroke were associated with higher mortality.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cardiac Surgical Procedures/methods , Registries , Septal Occluder Device , Stroke/prevention & control , Aged , Aged, 80 and over , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Echocardiography, Transesophageal , Female , Follow-Up Studies , Humans , Incidence , Male , Portugal/epidemiology , Prospective Studies , Spain/epidemiology , Stroke/epidemiology , Stroke/etiology , Time Factors , Treatment Outcome
8.
Arch Cardiovasc Dis ; 110(4): 234-241, 2017 Apr.
Article in English | MEDLINE | ID: mdl-28082243

ABSTRACT

BACKGROUND: Current guideline recommendations encourage culprit vessel only percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease. However, recent studies have shown a better clinical outcome in patients who receive multivessel PCI. AIM: To measure and compare clinical outcomes between partial revascularization (PR) versus complete revascularization (CR) in patients with STEMI and multivessel disease who underwent a cardiac rehabilitation programme. METHODS: We retrospectively reviewed the medical records of 282 patients with STEMI and multivessel disease who received PR or CR and were subsequently enrolled in a cardiac rehabilitation programme between July 2006 and November 2013 at La Paz University Hospital. The incidences of cardiovascular events, new PCI, hospital admissions for cardiovascular reasons and mortality were compared between the PR and CR groups. RESULTS: Overall, 143 patients received PR and 139 received CR. Baseline characteristics were similar in both groups, except for mean age (59.3 vs. 56.7 years; P=0.02), diabetes mellitus prevalence (34.3% vs. 20.1%; P=0.01) and number of arteries with stenosis (2.6 vs. 2.3; P=0.001). During the mean follow-up of 48.0±25.9 months, a cardiovascular event occurred in 23 (16.1%) PR patients and 20 (14.4%) CR patients, with no statistically significant differences in the early (hazard ratio: 0.61, 95% confidence interval: 0.19-1.89) or late (hazard ratio: 1.40, 95% confidence interval: 0.62-3.14) follow-up periods. Cox regression, adjusted for age, sex, presence of diabetes mellitus and number of affected coronary vessels, showed no difference in new cardiovascular event risk. CONCLUSIONS: There were no statistical differences in clinical outcomes between PR and CR among patients who received cardiac rehabilitation.


Subject(s)
Cardiac Rehabilitation/methods , Coronary Artery Disease/therapy , Coronary Stenosis/therapy , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/therapy , Aged , Cardiac Rehabilitation/adverse effects , Cardiac Rehabilitation/mortality , Chi-Square Distribution , Coronary Artery Disease/complications , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Stenosis/complications , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/mortality , Female , Hospitals, University , Humans , Kaplan-Meier Estimate , Linear Models , Male , Medical Records , Middle Aged , Patient Readmission , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Proportional Hazards Models , Retreatment , Retrospective Studies , Risk Factors , ST Elevation Myocardial Infarction/diagnostic imaging , ST Elevation Myocardial Infarction/etiology , ST Elevation Myocardial Infarction/mortality , Severity of Illness Index , Spain , Time Factors , Treatment Outcome
9.
Rev Port Cardiol ; 35(11): 617.e1-617.e7, 2016 Nov.
Article in English, Portuguese | MEDLINE | ID: mdl-27693110

ABSTRACT

Mitral stenosis (MS) is frequently associated with the development of atrial fibrillation (AF) as a consequence of hemodynamic and inflammatory changes in the left atrium. Both conditions predispose to thrombus formation, with frequent involvement of the left atrial appendage (LAA), and consequent increase in the incidence of systemic thromboembolic events. Percutaneous mitral valvuloplasty (PMV) reduces the risk of thromboembolism in patients with significant mitral stenosis. Percutaneous LAA closure is also associated with a reduction in thromboembolic risk in patients with AF, but there are no data regarding the use of this technique in patients with significant mitral valve disease. We report the case of a 57-year-old-woman with significant MS and permanent AF, in New York Heart Association functional class II, who despite adequate oral anticoagulation with acenocoumarol, presented several clinical episodes of systemic thromboembolism in the last four years. It was decided to perform a combined percutaneous procedure, including both PMV and percutaneous LAA closure with the Amplatzer Cardiac Plug device. No significant acute complications occurred and the patient was discharged on indefinite treatment with acenocoumarol associated with aspirin 100 mg/d for three months. After a one-year follow-up, there have been no new embolic episodes or other complications.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Mitral Valve Stenosis/surgery , Septal Occluder Device , Thromboembolism/prevention & control , Acenocoumarol/therapeutic use , Anticoagulants/therapeutic use , Atrial Fibrillation/complications , Cardiac Surgical Procedures , Combined Modality Therapy/methods , Female , Humans , Middle Aged , Mitral Valve Stenosis/complications , Mitral Valve Stenosis/diagnostic imaging , Thromboembolism/etiology , Treatment Outcome
10.
Med. clín (Ed. impr.) ; 138(5): e1-e5, mar. 2012.
Article in Spanish | IBECS | ID: ibc-98079

ABSTRACT

A pesar del creciente número tanto de alternativas terapéuticas disponibles para el tratamiento de la diabetes como de revisiones y guías de práctica clínica generales, en el caso de contextos específicos como la cardiología intervencionista se encuentra una ausencia de pautas terapéuticas claras e inequívocas. En esta guía de actuación clínica se propone un algoritmo consensuado, basado tanto en la revisión crítica de la evidencia de ensayos clínicos recientes como en criterios subjetivos derivados de la experiencia clínica y conocimiento colectivos, para orientar en la elección de las alternativas más adecuadas en esta situación clínica del manejo del control glucémico de pacientes con diabetes tipo 1 y 2 que van a ser sometidos a procedimientos de cardiología intervencionista en el laboratorio de hemodinámica (AU)


Despite the growing number of therapeutic alternatives available as well as general reviews and treatment guidelines for the treatment of diabetes, physicians are often left without a clear pathway of therapy to follow in specific clinical contexts such as interventional cardiology. The present document proposes a consensus treatment algorithm, based both on a critical appraisal of evidence from recent clinical trials and on value judgements supported by the authors’ collective clinical knowledge and experience, in an attempt to guide practitioners when choosing the most appropriate alternatives in the context of glycemic management in type 1 and 2 diabetic patients scheduled to undergo interventional cardiology procedures in a haemodynamic laboratory (AU)


Subject(s)
Humans , Diabetes Mellitus , Cardiac Surgical Procedures/methods , Glucose Metabolism Disorders/prevention & control , Glycemic Index , Monitoring, Physiologic , Intraoperative Complications/prevention & control
11.
Med Clin (Barc) ; 138(5): 207.e1-5, 2012 Mar 03.
Article in Spanish | MEDLINE | ID: mdl-22093406

ABSTRACT

Despite the growing number of therapeutic alternatives available as well as general reviews and treatment guidelines for the treatment of diabetes, physicians are often left without a clear pathway of therapy to follow in specific clinical contexts such as interventional cardiology. The present document proposes a consensus treatment algorithm, based both on a critical appraisal of evidence from recent clinical trials and on value judgements supported by the authors' collective clinical knowledge and experience, in an attempt to guide practitioners when choosing the most appropriate alternatives in the context of glycemic management in type 1 and 2 diabetic patients scheduled to undergo interventional cardiology procedures in a haemodynamic laboratory.


Subject(s)
Blood Glucose/analysis , Cardiac Surgical Procedures , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/therapeutic use , Acidosis, Lactic/chemically induced , Acidosis, Lactic/prevention & control , Algorithms , Contrast Media/adverse effects , Contrast Media/pharmacokinetics , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/complications , Disease Management , Humans , Hyperglycemia/etiology , Hyperglycemia/prevention & control , Hypoglycemia/chemically induced , Hypoglycemia/prevention & control , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Insulin/administration & dosage , Insulin/adverse effects , Insulin/therapeutic use , Intraoperative Complications/prevention & control , Iodine Compounds/adverse effects , Iodine Compounds/pharmacokinetics , Kidney Diseases/complications , Myocardial Ischemia/complications , Myocardial Ischemia/surgery , Postoperative Complications/prevention & control
12.
Echocardiography ; 27(1): 84-6, 2010 Jan.
Article in English | MEDLINE | ID: mdl-20030688

ABSTRACT

We describe a preliminary clinical experience with 3D transesophageal echocardiography (3D TEE) in an 84-year-old man with severe aortic stenosis and multiple comorbidity, who underwent percutaneous aortic valve implantation. Although 3D TEE monitoring is not a standard procedure during aortic valve replacement procedure (PAVR), when used in combination with conventional 2D-TEE contributes to improving adequate patient selection and provides more accurate information to the interventional cardiologist during positioning, deployment, and early function of the prosthesis.


Subject(s)
Aortic Valve Stenosis/surgery , Echocardiography, Three-Dimensional/methods , Echocardiography, Transesophageal/methods , Heart Valve Prosthesis Implantation/methods , Surgery, Computer-Assisted/methods , Aged, 80 and over , Humans , Male , Treatment Outcome
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