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1.
Int J Cardiol ; 416: 132510, 2024 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-39222885

RESUMEN

BACKGROUND: Despite a large body of evidence supporting the use of intravascular imaging (IVI) to guide percutaneous coronary intervention (PCI), concerns exist about its universal recommendation. The selective use of IVI to guide PCI of complex lesions and patients is perceived as a rational approach. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Embase, PubMed, and Cochrane were systematically searched for RCTs that compared IVI-guided PCI with angiography-guided PCI in high-risk patients and complex coronary anatomies. The primary outcome was major adverse cardiac events (MACE). A random-effects model was used to calculate the risk ratios (RRs) with 95 % confidence intervals (CIs). RESULTS: A total of 15 RCTs with 14,109 patients were included and followed for a weighted mean duration of 15.8 months. IVI-guided PCI was associated with a decrease in the risk of MACE (RR: 0.65; 95 % CI: 0.56-0.77; p < 0.01), target vessel failure (TVF) (RR: 0.66; 95 % CI: 0.52-0.84; p < 0.01), all-cause mortality (RR: 0.71; 95 % CI: 0.55-0.91; p < 0.01), cardiovascular mortality (RR: 0.47; 95 % CI: 0.34-0.65; p < 0.01), stent thrombosis (RR: 0.55; 95 % CI: 0.38-0.79; p < 0.01), myocardial infarction (RR: 0.81; 95 % CI: 0.67-0.98; p = 0.03), and repeated revascularizations (RR: 0.70; 95 % CI: 0.58-0.85; p < 0.01) compared with angiography. There was no significant difference in procedure-related complications (RR: 1.03; 95 % CI: 0.75-1.42; p = 0.84) between groups. CONCLUSIONS: Compared with angiographic guidance alone, IVI-guided PCI of complex lesions and high-risk patients significantly reduced all-cause and cardiovascular mortality, MACE, TVF, stent thrombosis, myocardial infarction, and repeat revascularization.


Asunto(s)
Angiografía Coronaria , Intervención Coronaria Percutánea , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Intervención Coronaria Percutánea/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Ultrasonografía Intervencional/métodos
2.
J Soc Cardiovasc Angiogr Interv ; 3(6): 102046, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-39132594

RESUMEN

Background: Approximately 30% to 50% of patients who are referred for diagnostic coronary angiography are found to have no obstructive coronary artery disease (CAD). Ischemia and nonobstructive coronary arteries (INOCA) is increasingly recognized and encompasses coronary microvascular dysfunction, vasospastic angina, symptomatic myocardial bridging, and other vasomotor disorders. However, the prevalence of these disorders and whether underlying atherosclerotic plaque burden and morphology affect the long-term outcomes of each physiologic phenotype is unknown. Methods: The DISCOVER INOCA registry is ongoing at 8 centers in the United States and plans to enroll 500 patients with ischemic heart disease referred for angiography undergoing coronary function testing (CFT). All participants will complete patient-reported outcome measures and undergo protocol-guided angiography, acetylcholine provocation, coronary thermodilution, and intravascular imaging. Follow-up assessments occur at 30 days, 6 months, 1 year, and annually for 5 years. The primary short-term end point is the prevalence of INOCA phenotypes based on physiology and the degree of atherosclerosis based on intravascular ultrasound or optical coherence tomography (intravascular imaging). The primary long-term end point is the incidence of major adverse cardiovascular events, defined as a composite of cardiovascular death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization at a follow-up of 5 years. At the time of this publication, 100 participants have been enrolled. Conclusions: DISCOVER INOCA is the first prospective study of INOCA patients to integrate anatomic and physiologic measures of disease and correlate them with long-term outcomes. DISCOVER INOCA will report on the prevalence of INOCA phenotypes, the safety of comprehensive invasive CFT, and the impact of testing on diagnoses and medical therapy. Symptoms and cardiovascular adverse events at long-term follow-up will be determined in patients with no obstructive CAD undergoing angiography.

5.
Cardiovasc. revasc. med ; 59: 60-66, fev.2024. ilus, tab
Artículo en Inglés | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1527062

RESUMEN

BACKGROUND: Landmark trials showed that invasive pressure measurement (Fractional Flow Reserve, FFR) was a better guide to coronary stenting than visual assessment. However, present-day interventionists have benefited from extensive research and personal experience of mapping anatomy to hemodynamics. AIMS: To determine if visual assessment of the angiogram performs as well as invasive measurement of coronary physiology. METHODS: 25 interventional cardiologists independently visually assessed the single vessel coronary disease of 200 randomized participants in The Objective Randomized Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina trial (ORBITA). They gave a visual prediction of the FFR and Instantaneous Wave-free Ratio (iFR), denoted vFFR and viFR respectively. Each judged each lesion on 2 occasions, so that every lesion had 50 vFFR, and 50 viFR assessments. The group consensus visual estimates (vFFR-group and viFR-group) and individual cardiologists' visual estimates (vFFR-individual and viFR-individual) were tested alongside invasively measured FFR and iFR for their ability to predict the placebo-controlled reduction in stress echo ischemia with stenting. RESULTS: Placebo-controlled ischemia improvement with stenting was predicted by vFFR-group (p < 0.0001) and viFR-group (p < 0.0001), vFFR-individual (p < 0.0001) and viFR-individual (p < 0.0001). There were no significant differences between the predictive performance of the group visual estimates and their invasive counterparts: p = 0.53 for vFFR vs FFR and p = 0.56 for viFR vs iFR. CONCLUSION: Visual assessment of the angiogram by contemporary experts, provides significant additional information on the amount of ischaemia which can be relieved by placebo-controlled stenting in single vessel coronary artery disease.


Asunto(s)
Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Reserva del Flujo Fraccional Miocárdico , Índice de Severidad de la Enfermedad , Estenosis Coronaria
6.
J Am Heart Assoc ; 13(2): e031111, 2024 Jan 16.
Artículo en Inglés | MEDLINE | ID: mdl-38214263

RESUMEN

BACKGROUND: Despite the initial evidence supporting the utility of intravascular imaging to guide percutaneous coronary intervention (PCI), adoption remains low. Recent new trial data have become available. An updated study-level meta-analysis comparing intravascular imaging to angiography to guide PCI was performed. This study aimed to evaluate the clinical outcomes of intravascular imaging-guided PCI compared with angiography-guided PCI. METHODS AND RESULTS: A random-effects meta-analysis was performed on the basis of the intention-to-treat principle. The primary outcomes were major adverse cardiac events, cardiac death, and all-cause death. Mixed-effects meta-regression was performed to investigate the impact of complex PCI on the primary outcomes. A total of 16 trials with 7814 patients were included. The weighted mean follow-up duration was 28.8 months. Intravascular imaging led to a lower risk of major adverse cardiac events (relative risk [RR], 0.67 [95% CI, 0.55-0.82]; P<0.001), cardiac death (RR, 0.49 [95% CI, 0.34-0.71]; P<0.001), stent thrombosis (RR, 0.63 [95% CI, 0.40-0.99]; P=0.046), target-lesion revascularization (RR, 0.67 [95% CI, 0.49-0.91]; P=0.01), and target-vessel revascularization (RR, 0.60 [95% CI, 0.45-0.80]; P<0.001). In complex lesion subsets, the point estimate for imaging-guided PCI compared with angiography-guided PCI for all-cause death was a RR of 0.75 (95% CI, 0.55-1.02; P=0.07). CONCLUSIONS: In patients undergoing PCI, intravascular imaging is associated with reductions in major adverse cardiac events, cardiac death, stent thrombosis, target-lesion revascularization, and target-vessel revascularization. The magnitude of benefit is large and consistent across all included studies. There may also be benefits in all-cause death, particularly in complex lesion subsets. These results support the use of intravascular imaging as standard of care and updates of clinical guidelines.


Asunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Trombosis , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Ultrasonografía Intervencional/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto , Trombosis/etiología , Resultado del Tratamiento , Muerte
7.
Cardiovasc Revasc Med ; 59: 60-66, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37612169

RESUMEN

BACKGROUND: Landmark trials showed that invasive pressure measurement (Fractional Flow Reserve, FFR) was a better guide to coronary stenting than visual assessment. However, present-day interventionists have benefited from extensive research and personal experience of mapping anatomy to hemodynamics. AIMS: To determine if visual assessment of the angiogram performs as well as invasive measurement of coronary physiology. METHODS: 25 interventional cardiologists independently visually assessed the single vessel coronary disease of 200 randomized participants in The Objective Randomized Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina trial (ORBITA). They gave a visual prediction of the FFR and Instantaneous Wave-free Ratio (iFR), denoted vFFR and viFR respectively. Each judged each lesion on 2 occasions, so that every lesion had 50 vFFR, and 50 viFR assessments. The group consensus visual estimates (vFFR-group and viFR-group) and individual cardiologists' visual estimates (vFFR-individual and viFR-individual) were tested alongside invasively measured FFR and iFR for their ability to predict the placebo-controlled reduction in stress echo ischemia with stenting. RESULTS: Placebo-controlled ischemia improvement with stenting was predicted by vFFR-group (p < 0.0001) and viFR-group (p < 0.0001), vFFR-individual (p < 0.0001) and viFR-individual (p < 0.0001). There were no significant differences between the predictive performance of the group visual estimates and their invasive counterparts: p = 0.53 for vFFR vs FFR and p = 0.56 for viFR vs iFR. CONCLUSION: Visual assessment of the angiogram by contemporary experts, provides significant additional information on the amount of ischaemia which can be relieved by placebo-controlled stenting in single vessel coronary artery disease.


Asunto(s)
Cardiólogos , Enfermedad de la Arteria Coronaria , Estenosis Coronaria , Reserva del Flujo Fraccional Miocárdico , Humanos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Isquemia , Valor Predictivo de las Pruebas , Índice de Severidad de la Enfermedad
9.
J Cardiovasc Comput Tomogr ; 17(6): 401-406, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37679247

RESUMEN

BACKGROUND: Coronary CT angiography (CCTA) is a first-line noninvasive imaging modality for evaluating coronary artery disease (CAD). Recent advances in CCTA technology enabled semi-automated detection of coronary arteries and atherosclerosis. However, there have been to date no large-scale validation studies of automated assessment of coronary atherosclerosis phenotype and coronary artery dimensions by artificial intelligence (AI) compared to current standard invasive imaging. METHODS: INVICTUS registry is a multicenter, retrospective, and prospective study designed to evaluate the dimensions of coronary arteries, as well as the characteristic, volume, and phenotype of coronary atherosclerosis by CCTA, compared with the invasive imaging modalities including intravascular ultrasound (IVUS), near-infrared spectroscopy (NIRS)-IVUS and optical coherence tomography (OCT). All patients clinically underwent both CCTA and invasive imaging modalities within three months. RESULTS: Patients data are sent to the core-laboratories to analyze for stenosis severity, plaque characteristics and volume. The variables for CCTA are measured using an AI-based automated software and assessed independently with the variables measured at the imaging core laboratories for IVUS, NIRS-IVUS, and OCT in a blind fashion. CONCLUSION: The INVICTUS registry will provide new insights into the diagnostic value of CCTA for determining coronary atherosclerosis phenotype and coronary artery dimensions compared to IVUS, NIRS-IVUS, and OCT. Our findings will potentially shed new light on precision medicine informed by an AI-based coronary CTA assessment of coronary atherosclerosis burden, composition, and severity. (ClinicalTrials.gov: NCT04066062).


Asunto(s)
Enfermedad de la Arteria Coronaria , Placa Aterosclerótica , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Angiografía por Tomografía Computarizada , Tomografía de Coherencia Óptica , Inteligencia Artificial , Estudios Prospectivos , Estudios Retrospectivos , Ultrasonografía Intervencional/métodos , Valor Predictivo de las Pruebas , Angiografía Coronaria/métodos , Vasos Coronarios/diagnóstico por imagen
10.
J Invasive Cardiol ; 35(6): E281-E290, 2023 06.
Artículo en Inglés | MEDLINE | ID: mdl-37220640

RESUMEN

BACKGROUND: Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). AIMS: We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS: This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs. iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS: A total of 2,268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs. low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P =.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs. 29 (2.6%) in the low-osmolarity group (P =.4). CONCLUSION: Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.


Asunto(s)
Ácido Yoxáglico , Enfermedades Renales , Anciano , Humanos , Medios de Contraste/efectos adversos , Angiografía Coronaria/efectos adversos , Angiografía Coronaria/métodos , Creatinina , Ácido Yoxáglico/efectos adversos , Enfermedades Renales/inducido químicamente , Factores de Riesgo , Ácidos Triyodobenzoicos/efectos adversos
11.
J Thromb Haemost ; 21(8): 2213-2222, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-37230416

RESUMEN

BACKGROUND: Patients hospitalized with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease. OBJECTIVES: To investigate the efficacy of an acute coronary syndrome regimen in patients hospitalized with COVID-19 and coronary disease risk factors. METHODS: A randomized controlled, open-label trial across acute hospitals (United Kingdom and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28 days. Primary efficacy and safety outcomes were 30-day mortality and bleeding. The key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, or death). RESULTS: Three hundred twenty patients from 9 centers were randomized. The trial terminated early due to low recruitment. At 30 days, there was no significant difference in mortality (intervention vs control, 11.5% vs 15%; unadjusted odds ratio [OR], 0.73; 95% CI, 0.38-1.41; p = .355). Significant bleeds were infrequent and were not significantly different between the arms (intervention vs control, 1.9% vs 1.9%; p > .999). Using a Bayesian Markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (OR, 1.46; 95% credible interval [CrI], 0.88-2.37; Pr [beta > 0], 93%; adjusted OR, 1.50; 95% CrI, 0.91-2.45; Pr [beta > 0], 95%) and median time to discharge to home was 2 days shorter (95% CrI, -4 to 0; 2% probability that it was worse). CONCLUSION: Acute coronary syndrome treatment regimen was associated with a reduction in the length of hospital stay without an excess in major bleeding. A larger trial is needed to evaluate mortality.


Asunto(s)
Síndrome Coronario Agudo , COVID-19 , Humanos , SARS-CoV-2 , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/tratamiento farmacológico , Teorema de Bayes , Aspirina/uso terapéutico , Hemorragia/inducido químicamente , Hemorragia/tratamiento farmacológico , Resultado del Tratamiento
12.
J. invasive cardiol ; 35(6): e281 e290, May 2023. graf, ilus, tab
Artículo en Inglés | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1437590

RESUMEN

BACKGROUND. Despite the potential benefits of percutaneous procedures for the assessment and treatment of coronary artery disease, these interventions require the use of iodine contrast, which might lead to contrast-induced nephropathy (CIN) and increased risk of dialysis and major adverse cardiac events (MACE). Aims. We sought to compare two different iodine contrasts (low vs. iso-osmolar) for the prevention of CIN among high-risk patients. METHODS. This is a single-center, randomized (1:1) trial comparing consecutive patients at high risk for CIN referred to percutaneous coronary diagnostic and/or therapeutic procedures with low (ioxaglate) vs iso-osmolarity (iodixanol) iodine contrast. High risk was defined by the presence of at least one of the following conditions: age >70 years, diabetes mellitus, non-dialytic chronic kidney disease, chronic heart failure, cardiogenic shock, and acute coronary syndrome (ACS). The primary endpoint was the occurrence of CIN, defined as a >25% relative increase and/or >0.5 mg/dL absolute increase in creatinine (Cr) levels compared with baseline between the 2nd and 5th day after contrast media administration. RESULTS. A total of 2268 patients were enrolled. Mean age was 67 years. Diabetes mellitus (53%), non-dialytic chronic kidney disease (31%), and ACS (39%) were highly prevalent. The mean volume of contrast media was 89 ml ± 48.6. CIN occurred in 15% of all patients, with no significant difference regarding the type of contrast used (iso = 15.2% vs low = 15.1%, P>.99). Differences were not observed in specific subgroups such as diabetics, elderly, and ACS patients. At 30-day follow-up, 13 patients in the iso-osmolarity group and 11 in low-osmolarity group required dialysis (P=.8). There were 37 (3.3%) deaths in the iso-osmolarity cohort vs 29 (2.6%) in the low-osmolarity group (P=.4). CONCLUSION. Among patients at high risk for CIN, the incidence of this complication was 15%, and independent of the use of low- or iso-osmolar contrast.

13.
JACC Case Rep ; 14: 101832, 2023 May 17.
Artículo en Inglés | MEDLINE | ID: mdl-37077873

RESUMEN

We present a case of a young man with complete atrioventricular block and aneurysm of the right sinus of Valsalva penetrating the interventricular septum and causing severe aortic regurgitation. Chest trauma and inflammatory or infectious diseases are potential causes. Bentall-de Bono surgical repair was performed. Anatomopathologic analysis demonstrated fibrosis, hyalinization, and extensive myxoid material. (Level of Difficulty: Beginner.).

14.
J. thromb. haemost ; 21: 2213-2222, Apr. 2023. graf, ilus, tab
Artículo en Inglés | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1435649

RESUMEN

BACKGROUND: patients hospitalised with covid-19 suffer thrombotic complications. risk factors for poor outcomes are shared with coronary artery disease. Objectives: to investigate efficacy of an acute coronary syndrome regimen in patients hospitalised with covid-19 and coronary disease risk factors. PATIENTS/METHODS: a randomised controlled open-label trial across acute hospitals (uk and brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28-days. primary efficacy and safety outcomes were 30-day mortality and bleeding. the key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, death). RESULTS: 320 patients from 9 centres were randomised. the trial terminated early due to low recruitment. at 30 days there was no significant difference in mortality (intervention: 11.5% vs control: 15%, unadjusted or 0.73, 95%ci 0.38 to 1.41, p=0.355). significant bleeds were infrequent and not significantly different between the arms (intervention: 1.9% vs control 1.9%, p>0.999). using a bayesian markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (or 1.46, 95% cri 0.88 to 95 2.37, pr(beta>0) =93%; adjusted or 1.50, 95% cri 0.91 to 2.45, pr(beta>0) =95%) and median time to discharge home was two days shorter (95% cri -4 to 0, 2% probability that it was worse). CONCLUSIONS: acute coronary syndrome treatment regimen was associated with a 99 reduction in the length of hospital stay without an excess in major bleeding. a larger trial is needed to evaluate mortality.


Asunto(s)
Síndrome Coronario Agudo , COVID-19
15.
JACC. Case reports ; 14Apr. 2023. ilus
Artículo en Inglés | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1427644

RESUMEN

ABSTRACT: We present a case of a young man with complete atrioventricular block and aneurysm of the right sinus of Valsalva penetrating the interventricular septum and causing severe aortic regurgitation. Chest trauma and inflammatory or infectious diseases are potential causes. Bentall-de Bono surgical repair was performed. Anatomopathologic analysis demonstrated fibrosis, hyalinization, and extensive myxoid material. (Level of Difficulty: Beginner.).


Asunto(s)
Aneurisma de la Aorta , Marcapaso Artificial , Seno Aórtico , Tomografía Computarizada por Rayos X , Ecocardiografía , Ventrículos Cardíacos
16.
J Invasive Cardiol ; 35(5): E225-E233, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36920890

RESUMEN

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. AIMS: We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS: This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.


Asunto(s)
Enfermedad de la Arteria Coronaria , Diabetes Mellitus Tipo 2 , Stents Liberadores de Fármacos , Humanos , Masculino , Persona de Mediana Edad , Femenino , Enfermedad de la Arteria Coronaria/terapia , Tomografía de Coherencia Óptica/métodos , Estudios Prospectivos , Resultado del Tratamiento , Diseño de Prótesis , Stents , Polímeros
17.
J. invasive cardiol ; 35(5)May. 2023. ilus, graf, tab
Artículo en Inglés | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1426378

RESUMEN

BACKGROUND: Although first-generation drug-eluting stent (DES) devices have effectively achieved their main goal of reducing restenosis, their safety has been limited by suboptimal polymer biocompatibility, delayed stent endothelialization, and local drug toxicity, which ultimately prompted the development of new-generation DES options carrying biocompatible or even biodegradable polymers. Aims. We sought to assess the vessel-healing pattern of the novel sirolimus-eluting Inspiron DES (Scitech Medical) using serial optical coherence tomography (OCT) and assuming the hypothesis that this thin-strut (75-µm), biodegradable-polymer DES promotes a faster healing, with very early strut coverage. METHODS. This is a prospective, multicenter, open-label, single-arm study enrolling 68 patients who underwent percutaneous coronary intervention guided by OCT. These patients were consecutively assigned into 3 groups. The first group had its OCT imaging follow-up performed at 3 months, the second group at 2 months, and the third group at 1 month. RESULTS: Mean age was 59.5 years, 70.6% were male, 41.2% had type 2 diabetes, and 29.4% presented with acute coronary syndrome. A total of 72 lesions were treated and 1.06 stents were implanted per patient. OCT assessment of the stents at 1, 2, and 3 months showed a strut coverage of 90.41%, 93.96%, and 97.21%, respectively (P=.04). CONCLUSION: The Inspiron DES showed an early strut healing pattern, with >90% of the struts covered by neointima within the first month and with almost all struts covered by the third month.


Asunto(s)
Tomografía de Coherencia Óptica , Síndrome Coronario Agudo , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea
18.
Rev Cardiovasc Med ; 24(8): 221, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39076703

RESUMEN

Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( DynamX ® Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting. Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had de novo lesions in coronary arteries measuring between 2.5 and 3.5 mm in diameter and ≤ 24 mm in length. Clinical follow-up was performed up to 36 months. This analysis includes the intention-to-treat population and is based on data available. The preclinical studies include optical coherence tomography (OCT) analyses of 5 DynamX Bioadaptors implanted in 3 mini Yucatan pigs (at 3, 12 and 24 months), and assessment of smooth muscle cell gene expression profile in 8 pigs of which each was implanted with the DynamX Bioadaptor and the Xience drug-eluting stent. To assess the gene expression profile by quantitative real-time polymerase chain reaction, animals were sacrificed at 3, 6, 9 and 12 months. Results: Target lesion failure at 36 months was 8.7% (4/46), consisting of one clinically-driven target lesion revascularization and 3 cardiac deaths (all site-reported to be unrelated to the device or procedure). There were no additional target vessel revascularization and no definite or probable scaffold thrombosis. Preclinical data confirmed late lumen enlargement (from 7.02 ± 1.31 mm 2 at baseline to 8.46 ± 1.31 mm 2 at 24 months) and identified an increased expression of contractile genes around 9 months compared to a conventional drug-eluting stent. Conclusions: The DynamX Bioadaptor demonstrated very good 36-month clinical outcomes, highlighted by the absence of target-vessel myocardial infarction and definite or probable device thrombosis, and only one target lesion revascularization up to 36 months. These data are supported by preclinical studies that showed late lumen enlargement by OCT and an increased expression of contractile genes around 9 months compared to conventional drug-eluting stents, indicating faster vessel healing. Larger clinical studies are necessary to compare outcomes against contemporary drug-eluting stents. Clinical Trial Registration: https://clinicaltrials.gov/: NCT03429894.

19.
J. Transcatheter Interv ; 31: A202208, 2023. graf, ilus, tab
Artículo en Inglés, Portugués | LILACS, CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1412824

RESUMEN

A fisiologia coronariana tornou-se o padrão de tratamento para avaliar o significado funcional da doença aterosclerótica coronariana. Ela permite identificar isquemia miocárdica em nível de vaso, discriminar os padrões funcionais da doença aterosclerótica e orientar a necessidade de revascularização; complementar o planejamento da intervenção coronária percutânea e confirmar o sucesso funcional dessa última. Em uma edição anterior do Journal of Transcatheter Interventions, apresentamos uma revisão abrangente sobre o fluxo fracionado de reserva do miocárdio. Apesar do robusto corpo de evidências que apoiam seu uso, a aceitação clínica do fluxo fracionado de reserva é variável e excessivamente baixa em muitas áreas do mundo. O aumento percebido no tempo do procedimento, o uso de agentes hiperêmicos com seus correspondentes custos e desconforto do paciente, e a dificuldade de interpretação dos resultados em determinadas situações anatômicas contribuíram para a adoção limitada do método. A introdução do índice de fluxo instantâneo no período livre de ondas superou a maioria dessas limitações. Apoiada por uma validação técnica sólida e dados de desfechos clínicos, o índice de fluxo instantâneo no período livre de ondas recebeu as mesmas indicações clínicas que o fluxo fracionado de reserva nas recomendações mais recentes das diretrizes. Isso foi seguido pela introdução de outros índices pressóricos não hiperêmicos, já comercialmente disponíveis. Neste artigo, revisamos as bases fisiológicas que justificam o uso de índices pressóricos não hiperêmicos, sua validação técnica e clínica e dados de desfechos clínicos, além de discutirmos suas aplicações em situações anatômicas específicas, com exemplos de casos dos autores, sempre que aplicável.


Coronary physiology has become the standard of care to assess the functional significance of coronary atherosclerotic disease. It allows for identification of myocardial ischemia on a vessel level, discrimination of the functional patterns of atherosclerotic disease, guidance for the need of revascularization, complements the planning of percutaneous coronary intervention and verification of the functional success of percutaneous coronary intervention. On a previous issue of the Journal of Transcatheter Interventions, we presented a comprehensive review about fractional flow reserve. Despite the robust body of evidence supporting its use, the clinical use of fractional flow reserve is variable, and unreasonably low in many areas around the globe. The perceived increase in procedure time, the use of hyperemic agents with its related costs and patient discomfort, and difficulty in interpreting results in certain anatomical scenarios have contributed to the limited adoption of fractional flow reserve. The introduction of instantaneous wave-free ratio overcame most of these limitations. Supported by sound technical validation, and clinical outcomes data, instantaneous wave-free ratio received the same clinical indications as fractional flow reserve in the most recent guidelines recommendations. This was followed by the introduction of other non- hyperemic pressure ratios for commercial use. In the current manuscript we review the physiological basis that supports the use of non-hyperemic pressure ratios, their technical and clinical validation, clinical outcomes data, and discuss its applications on specific anatomic scenarios, with examples of cases from the authors, whenever applicable.


Asunto(s)
Reserva del Flujo Fraccional Miocárdico , Intervención Coronaria Percutánea , Nivel de Atención
20.
São Paulo; s.n; 20221208.
No convencional en Portugués | CONASS, Sec. Est. Saúde SP, SESSP-IDPCPROD, Sec. Est. Saúde SP | ID: biblio-1442486

RESUMEN

INTRODUÇÃO E/OU FUNDAMENTOS: Anomalias congênitas da origem ou trajeto das coronárias podem necessitar correção cirúrgica. Outras cardiopatias congênitas requerem translocação das coronárias na cirurgia corretiva (ex: transposição das grandes artérias [TGA]). Compressão extrínseca, acotovelamentos, retração cicatricial entre outros podem causar insuficiência coronária (ICo) no pós-operatório (PO) precoce ou tardio. O manejo terapêutico destas situações não é bem estabelecido na literatura. Objetivo é relatar nossa experiência com a angioplastia coronária nestes pacientes e seus desfechos. MÉTODOS: Estudo observacional de pacientes previamente operados de cardiopatias congênitas que necessitaram de reimplante de uma ou 2 coronárias. ICo foi suspeitada clinicamente e confirmada por angiografia, ultra-som (US) ou angiotomografia coronária (TC). Confirmada a obstrução, procedeu-se com implante de stent eluído seguido de reavaliação clínica, métodos de imagem intra-coronário e exames de rastreamento para ICo. Dupla antiagregação foi mantida por 3 meses e o AAS indefinidamente. RESULTADOS E CONCLUSÕES: Quatro pacientes (lactente, criança, adolescente e adulto jovem) previamente operados (TGA [n=2], origem anômala da coronária esquerda [CE], trajeto maligno da CE) foram submetidos com sucesso a angioplastia com stent. No caso da TGA do lactente, o procedimento foi realizado por via carotídea em ECMO no PO precoce. Neste, o stent foi implantado no tronco da coronária direita. Nos 3 casos eletivos com angina estável no PO tardio, mecanismos diversos de estenose foram observados no US e/ou na TC. Nestes, os stents foram implantados via femoral no tronco da coronária esquerda. Não houve complicações dos procedimentos. Stents compatíveis com o diâmetro de coronária do adulto foram usados. Todos os pacientes apresentaram melhora clínica e laboratorial imediata e se mantiveram sem ICo no seguimento. O lactente permaneceu com acinesia na parede inferior. CONCLUSÕES: A angioplastia coronária deve ser considerada no manejo de pacientes com cardiopatias congênitas que necessitaram de reimplante das coronárias e que apresentam ICo precoce ou tardia. Nesta experiência inicial, o procedimento se mostrou factível, seguro e eficaz.


Asunto(s)
Angioplastia Coronaria con Balón , Cardiopatías Congénitas/cirugía
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