RESUMEN
BACKGROUND: Angina pectoris can occur in up to 40% of patients following percutaneous coronary intervention (PCI). There is limited data assessing whether the type of stent implanted during revascularization can predict post-PCI angina symptoms. METHODS: In this study, data regarding revascularization characteristics including the stent type in patients admitted for PCI was collected. Prospective data including occurrence of angina and the presenting class, new onset ST-segment elevation myocardial infarction (STEMI), and other clinical outcomes were collected at 1, 3, and 6-month follow-up intervals. Univariable and multivariable logistic regression models were used to assess the potential predictors of angina symptoms at 6-month follow-up. RESULTS: A total of 787 patients (64.5% males) undergoing PCI with three stent types (Orsiro, Promus, and Xience) were included in the study. The occurrence of post PCI angina pectoris and new STEMI was similar among the stent types (p > 0.05). A linear association was found between the development of new STEMI (p = 0.018) and stroke (p = 0.003) and the worsening of angina class. The stent type was not a predictor of angina during the follow-up period. Other variables including dyslipidemia (odds ratio (OR) (95% CI), 1.51 (1.08; 2.10)), prior coronary artery disease (CAD) (OR (95% CI), 1.63 (1.02; 2.61)), and previous hospitalization (OR (95% CI), 2.10 (1.22; 3.63)) were independent predictors of angina. CONCLUSIONS: Although the type of stent may not have an association with the post-PCI angina, other predictors such as dyslipidemia and previous CAD and hospitalization may predict recurrence of cardiac angina. The class of angina severity may have a linear association with new-onset STEMI and stroke.
Asunto(s)
Angina de Pecho , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Diseño de Prótesis , Infarto del Miocardio con Elevación del ST , Stents , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Femenino , Persona de Mediana Edad , Angina de Pecho/terapia , Angina de Pecho/etiología , Angina de Pecho/diagnóstico , Factores de Riesgo , Anciano , Resultado del Tratamiento , Factores de Tiempo , Infarto del Miocardio con Elevación del ST/terapia , Infarto del Miocardio con Elevación del ST/diagnóstico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Medición de Riesgo , Estudios ProspectivosAsunto(s)
Implantes Absorbibles , Magnesio , Humanos , Resultado del Tratamiento , Andamios del Tejido , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Masculino , Diseño de Prótesis , Femenino , Persona de Mediana Edad , Stents Liberadores de FármacosRESUMEN
BACKGROUND: Percutaneous coronary intervention (PCI) has become one of the most commonly performed interventional life-saving procedures worldwide. Intravascular Imaging (intravascular ultrasound (IVUS) and optical coherence tomography (OCT)) have initially evolved to guide PCI compared with angiography. However, this technology is not universally employed in all PCI procedures, and there is ongoing controversy regarding its additional benefits to patient outcomes. We aim to estimate the efficacy and safety of imaging modalities during PCI, allowing pre-, per, and post-intervention assessment of coronary vascularization. METHODS: A systematic review and Bayesian network meta-analysis of randomized controlled trials (RCTs), which were retrieved from PubMed, WOS, SCOPUS, EMBASE, and CENTRAL through September 2023. We used R, version 4.2.0. Effect sizes will be presented as odds ratios with accompanying 95% credible intervals. PROSPERO ID: CRD42024507821. RESULTS: Our study, encompassing 36 RCTs with a total of 17,572 patients, revelead that compared to conventional angiography, IVUS significantly reduced the risk of major adverse cardiovascular events (MACE) (OR: 0.71 [95% CrI: 0.56 to 0.87]) but not OCT (OR: 0.91 [95% CrI: 0.62 to 1.39]), IVUS and OCT significantly reduced the risk of cardiac death (OR: 0.50 [95% CrI: 0.33 to 0.76]) and (OR: 0.55 [95% CrI: 0.31 to 0.98]), respectively, IVUS significantly reduced the risk of target vessel-related revascularization (OR: 0.60 [95% CrI: 0.48 to 0.75]) but not OCT (OR: 0.86 [95% CrI: 0.60 to 1.19]), IVUS and OCT significantly reduced the risk of stent thrombosis (OR: 0.50 [95% CrI: 0.28 to 0.92]) and (OR: 0.48 [95% CrI: 0.22 to 0.98]), respectively, IVUS significantly reduced the risk of re-stenosis (OR: 0.65 [95% CrI: 0.46 to 0.88]) but not OCT (OR: 0.55 [95% CrI: 0.15 to 1.99]), neither IVUS (OR: 0.97 [95% CrI: 0.71 to 1.38]) nor OCT (OR: 0.75 [95% CrI: 0.49 to 1.22]) were associated with statistically significant reductions in all-cause mortality, neither IVUS (OR: 0.70 [95% CrI: 0.45 to 1.32]) nor OCT (OR: 0.81 [95% CrI: 0.47 to 1.59]) were associated with statistically significant reductions in target vessel failure, neither IVUS (OR: 0.88 [95% CrI: 0.43 to 2.44]) nor OCT (OR: 0.81 [95% CrI: 0.37 to 2.04]) were associated with statistically significant reductions in target lesion failure, and neither IVUS (OR: 0.82 [95% CrI: 0.60 to 1.06]) nor OCT (OR: 0.84 [95% CrI: 0.59 to 1.19]) were associated with statistically significant reductions in myocardial infarction. CONCLUSION: Intravascular imaging-guided, including IVUS and OCT, improved the postinterventional outcomes of PCI, notably suggesting their advantage over traditional angiography with no significant difference between IVUS and OCT.
Asunto(s)
Teorema de Bayes , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Metaanálisis en Red , Intervención Coronaria Percutánea , Valor Predictivo de las Pruebas , Ensayos Clínicos Controlados Aleatorios como Asunto , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Intervención Coronaria Percutánea/instrumentación , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/mortalidad , Resultado del Tratamiento , Factores de Riesgo , Medición de Riesgo , Femenino , Persona de Mediana Edad , Masculino , Anciano , Vasos Coronarios/diagnóstico por imagenRESUMEN
BACKGROUND: Recent observations in silico and in vivo reported that, during proximal optimisation technique, drug-eluting stents (DES) elongate, challenging conventional wisdom. The interaction between plaque morphology and radial expansion is well established, but little is known about the impact of plaque morphology on elongation. AIMS: We aimed to assess the longitudinal mechanical behaviour of contemporary DES in vivo and evaluate the relationship between post-percutaneous coronary intervention (PCI) stent elongation and lesion morphology, as assessed with optical coherence tomography (OCT). METHODS: Patients treated with OCT-guided PCI to left main or left anterior descending artery bifurcations, between July 2017 and March 2022, from the King's Optical coherence Database Analysis Compendium were included. Patients were excluded if there were overlapping stents, if they had undergone prior PCI, or if there was inadequate image quality. Lesions were characterised as fibrocalcific, fibrous or lipid-rich by pre-PCI OCT. Following stent post-dilatation, stent expansion and final stent length were assessed. The primary outcome was the percentage change in stent length from baseline. RESULTS: Of 501 eligible consecutive patients from this period, 116 were included. The median age was 66 years (interquartile range [IQR] 57-76), 31% were female, and 53.4% were treated for an acute coronary syndrome. A total of 50.0% of lesions were classified as fibrocalcific, 6.9% were fibrous, and 43.1% were lipid-rich. The change in relative stent length was 4.4% (IQR 1.0-8.9), with an increase of 3.1% (IQR 0.5-6.3) in fibrocalcific lesions, 3.3% (IQR 0.5-5.9) in fibrous lesions, and 6.4% (IQR 3.1-11.1) in lipid-rich plaque (p=0.006). In multivariate regression modelling, lipid-rich plaque was an independent predictor of stent elongation (odds ratio 3.689, 95% confidence interval: 1.604-8.484). CONCLUSIONS: Contemporary DES elongate following implantation and post-dilatation, and this is significantly mediated by plaque morphology. This is an important consideration when planning a strategy for DES implantation.
Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Placa Aterosclerótica , Tomografía de Coherencia Óptica , Humanos , Femenino , Tomografía de Coherencia Óptica/métodos , Masculino , Anciano , Persona de Mediana Edad , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Resultado del Tratamiento , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patologíaRESUMEN
BACKGROUND: The 12-month outcomes of BIOMAG-I - the first-in-human study investigating the third-generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) - showed promising results regarding clinical outcomes and late lumen loss. AIMS: The current study aimed to investigate vascular healing parameters assessed by optical coherence tomography (OCT) and intravascular ultrasound (IVUS), focusing on strut visibility, vessel and scaffold areas, and neointimal growth patterns. METHODS: This is a BIOMAG-I substudy including patients with available serial OCT and IVUS data. We conducted a frame-based analysis of OCT findings in conjunction with IVUS-derived vessel and scaffold areas, evaluating the qualitative and quantitative aspects of vascular healing. RESULTS: Among the 116 patients enrolled in this trial, 56 patients treated with DREAMS 3G were included in the analysis. At 12 months, OCT imaging revealed that 99.0% of the struts were invisible, and no malapposed struts were depicted. While the vessel area showed no significant difference between the timepoints, the minimum lumen area significantly decreased from post-percutaneous coronary intervention to 6 months (6.88 mm2 to 4.75 mm2; p<0.0001), but no significant changes were observed between 6 and 12 months. Protruding neointimal tissue (PNT) - a unique neointimal presentation observed following resorbable magnesium scaffold implantation - was observed in 89.3% of the study patients at 12 months, and its area exhibited a 47.4% decrease from 6 to 12 months. CONCLUSIONS: This imaging substudy revealed that, at 12-month follow-up, virtually all struts of the DREAMS 3G scaffold became invisible, without evident malapposition. The vascular healing response to DREAMS 3G implantation also appeared favourable up to 12 months, which is indicated by advanced strut degradation and spontaneous regressing PNT between 6 and 12 months.
Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Stents Liberadores de Fármacos , Magnesio , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Tomografía de Coherencia Óptica/métodos , Masculino , Femenino , Persona de Mediana Edad , Ultrasonografía Intervencional/métodos , Anciano , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/instrumentación , Vasos Coronarios/diagnóstico por imagen , Resultado del Tratamiento , Neointima , Andamios del TejidoAsunto(s)
Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Intervención Coronaria Percutánea/métodos , Tomografía de Coherencia Óptica/métodos , Ultrasonografía Intervencional/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapiaAsunto(s)
Intervención Coronaria Percutánea , Stents , Humanos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Diseño de PrótesisAsunto(s)
Implantes Absorbibles , Magnesio , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/efectos adversos , Tomografía de Coherencia Óptica/métodos , Angiografía Coronaria/métodos , Resultado del Tratamiento , Andamios del Tejido , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Masculino , Stents Liberadores de FármacosRESUMEN
Diabetic macroangiopathy is a leading cause of diabetes-related mortality worldwide. Both genetic and environmental factors, through a multitude of underlying molecular mechanisms, contribute to the pathogenesis of diabetic macroangiopathy. MicroRNAs (miRNAs), a class of non-coding RNAs known for their functional diversity and expression specificity, are increasingly recognized for their roles in the initiation and progression of diabetes and diabetic macroangiopathy. In this review, we will describe the biogenesis of miRNAs, and summarize their functions in diabetic macroangiopathy, including atherosclerosis, peripheral artery disease, coronary artery disease, and cerebrovascular disease, which are anticipated to provide new insights into future perspectives of miRNAs in basic, translational and clinical research, ultimately advancing the diagnosis, prevention, and treatment of diabetic macroangiopathy.
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Angiopatías Diabéticas , MicroARNs , Humanos , MicroARNs/genética , MicroARNs/metabolismo , Angiopatías Diabéticas/genética , Angiopatías Diabéticas/diagnóstico , Angiopatías Diabéticas/terapia , Animales , Regulación de la Expresión Génica , Marcadores Genéticos , Pronóstico , Transducción de Señal , Enfermedad de la Arteria Coronaria/genética , Enfermedad de la Arteria Coronaria/terapia , Enfermedad Arterial Periférica/genética , Enfermedad Arterial Periférica/terapia , Enfermedad Arterial Periférica/diagnósticoAsunto(s)
Intervención Coronaria Percutánea , Stents , Humanos , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/instrumentación , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Angiografía Coronaria/métodosAsunto(s)
Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica , Humanos , Tomografía de Coherencia Óptica/métodos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugíaAsunto(s)
Angioplastia Coronaria con Balón , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Resultado del Tratamiento , Masculino , Angiografía Coronaria , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugíaAsunto(s)
Angioplastia Coronaria con Balón , Humanos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/métodos , Stents Liberadores de Fármacos , Resultado del Tratamiento , Vasos Coronarios/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Materiales Biocompatibles RevestidosAsunto(s)
Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Intervención Coronaria Percutánea/métodos , Enfermedad de la Arteria Coronaria/cirugía , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Puente de Arteria Coronaria/métodos , Angiografía Coronaria , Toma de Decisiones Clínicas , Resultado del Tratamiento , Índice de Severidad de la Enfermedad , Reserva del Flujo Fraccional MiocárdicoAsunto(s)
Microcirculación , Valor Predictivo de las Pruebas , Resistencia Vascular , Humanos , Resultado del Tratamiento , Masculino , Persona de Mediana Edad , Femenino , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/fisiopatología , Angina de Pecho/fisiopatología , Angina de Pecho/terapia , Angina de Pecho/diagnóstico , Circulación Coronaria , Anciano , Isquemia Miocárdica/fisiopatología , Isquemia Miocárdica/terapia , Isquemia Miocárdica/diagnóstico por imagen , Vasodilatadores/uso terapéutico , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/fisiopatologíaRESUMEN
BACKGROUND: Clopidogrel monotherapy improved clinical outcomes compared with aspirin monotherapy during a chronic maintenance period in patients who underwent coronary stenting in the HOST-EXAM (Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis-Extended Antiplatelet Monotherapy) trial. However, it is uncertain whether the beneficial effect of clopidogrel over aspirin is different according to the renal function. METHODS AND RESULTS: We conducted a post hoc analysis of the HOST-EXAM trial. Chronic kidney disease (CKD) was defined as baseline estimated glomerular filtration rate <60 mL/min per 1.73 m2. The primary end point was a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium bleeding type ≥3, during the 2-year follow up. Among the 5438 patients enrolled in the HOST-EXAM trial, 4844 patients (mean age, 63.3±10.6 years; 74.9% men) with a baseline creatinine value were analyzed in this study. A total of 508 (10.5%) patients had CKD, who were at higher risk of the primary end point compared with those without CKD (hazard ratio [HR], 2.01 [95% CI, 1.51-2.67]). Clopidogrel monotherapy was associated with a lower rate of the primary end point in both patients with CKD (HR, 0.74 [95% CI, 0.44-1.25]) and patients without CKD (HR, 0.71 [95% CI, 0.56-0.91]). No significant interaction was observed between the treatment effect and CKD status (P for interaction=0.889). CONCLUSIONS: During the chronic maintenance period after coronary stenting, the risk of thrombotic and bleeding events was significantly higher in patients with CKD compared with those without CKD. There was no statistical difference in the treatment effect of clopidogrel monotherapy in those with versus without CKD.
Asunto(s)
Aspirina , Clopidogrel , Intervención Coronaria Percutánea , Inhibidores de Agregación Plaquetaria , Insuficiencia Renal Crónica , Humanos , Clopidogrel/uso terapéutico , Clopidogrel/efectos adversos , Clopidogrel/administración & dosificación , Masculino , Femenino , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/fisiopatología , Insuficiencia Renal Crónica/terapia , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Aspirina/administración & dosificación , Aspirina/uso terapéutico , Aspirina/efectos adversos , Anciano , Hemorragia/inducido químicamente , Resultado del Tratamiento , Tasa de Filtración Glomerular , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/mortalidad , Stents , Factores de TiempoRESUMEN
BACKGROUND: Hospital- and physician-level variation for selection of percutaneous coronary intervention versus coronary artery bypass grafting (CABG) for patients with coronary artery disease has been associated with outcome differences. However, most studies excluded patients treated medically. METHODS AND RESULTS: From 2010 to 2019, adults with 3-vessel or left main coronary artery disease at 3 hospitals (A, B, C) in Alberta, Canada, were categorized by treatment with medical therapy, percutaneous coronary intervention, or CABG. Multilevel regression models determined the proportion of variation in treatment attributable to patient, physician, and hospital factors, and survival models assessed outcomes including death and major adverse cardiovascular events over 5 years. Of 22 580 patients (mean age, 67 years; 80% men): 6677 (29%) received medical management, 9171 (41%) percutaneous coronary intervention, and 6732 (30%) CABG. Hospital factors accounted for 10.8% of treatment variation. In adjusted models (site A as reference), patients at sites B and C had 49% (95% CI, 44%-53%) and 43% (95% CI, 37%-49%) lower rates of medical therapy, respectively, and 31% (95% CI, 24%-38%) and 32% (95% CI, 24%-40%) lower rates of CABG. During 5.0 years median follow-up, 3287 (14.6%) patients died, with no intersite mortality differences. There were no between-site differences in acute coronary syndromes or stroke; patients at sites B and C had 24% lower risk (95% CI, 13%-34% and 11%-35%, respectively) of heart failure hospitalization. CONCLUSIONS: Hospital-level variation in selection of percutaneous coronary intervention, CABG, or medical therapy for patients with complex coronary artery disease was not associated with differences in 5-year mortality rates. Research and quality improvement initiatives comparing revascularization practices should include medically managed patients.
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Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Masculino , Femenino , Anciano , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/estadística & datos numéricos , Intervención Coronaria Percutánea/mortalidad , Puente de Arteria Coronaria/estadística & datos numéricos , Puente de Arteria Coronaria/mortalidad , Alberta/epidemiología , Persona de Mediana Edad , Toma de Decisiones Clínicas , Resultado del Tratamiento , Pautas de la Práctica en Medicina/tendencias , Hospitales/estadística & datos numéricos , Factores de RiesgoRESUMEN
Intravascular ultrasound and optical coherence tomography are used with increasing frequency for the care of coronary patients and in research studies. These imaging tools can identify culprit lesions in acute coronary syndromes, assess coronary stenosis severity, guide percutaneous coronary intervention (PCI), and detect vulnerable plaques and patients. However, they have significant limitations that have stimulated the development of multimodality intracoronary imaging catheters, which provide improvements in assessing vessel wall pathology and guiding PCI. Prototypes combining 2 or even 3 imaging probes with complementary attributes have been developed, and several multimodality systems have already been used in patients, with near-infrared spectroscopy intravascular ultrasound-based studies showing promising results for the identification of high-risk plaques. Moreover, postmortem histology studies have documented that hybrid imaging catheters can enable more accurate characterization of plaque morphology than standalone imaging. This review describes the evolution in the field of hybrid intracoronary imaging; presents the available multimodality catheters; and discusses their potential role in PCI guidance, vulnerable plaque detection, and the assessment of endovascular devices and emerging pharmacotherapies targeting atherosclerosis.
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Enfermedad de la Arteria Coronaria , Vasos Coronarios , Imagen Multimodal , Intervención Coronaria Percutánea , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Intervención Coronaria Percutánea/instrumentación , Diseño de Equipo , Catéteres Cardíacos , Difusión de Innovaciones , Cateterismo Cardíaco/instrumentación , Espectroscopía Infrarroja Corta , AnimalesRESUMEN
BACKGROUND: Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year. METHODS: This investigator-initiated, multicentre, randomised, open-label, superiority trial conducted at 20 hospitals in South Korea enrolled patients aged 19-85 years for whom PCI with drug-eluting stents was clinically indicated. After diagnostic angiography, clinical and angiographic findings were assessed to identify patients who met the criterion of having one or more complex lesions. Patients were randomly assigned 1:1 to receive PCI with OCT guidance (OCT-guidance group) or angiography guidance without OCT (angiography-guidance group). Web-response permuted-block randomisation (mixed blocks of four or six) was used at each participating site to allocate patients. The allocation sequence was computer-generated by an external programmer who was not involved in the rest of the trial. Outcome assessors were masked to group assignment. Patients, follow-up health-care providers, and data analysers were not masked. PCI was done according to conventional standard methods with everolimus-eluting stents. The primary endpoint was major adverse cardiac events (a composite of cardiac death, myocardial infarction, stent thrombosis, or ischaemia-driven target-vessel revascularisation), 1 year after PCI. The primary analysis was done in the intention-to-treat population. The margin used to establish superiority was 1·0 as a hazard ratio. This trial is registered with ClinicalTrials.gov (NCT03625908) and is completed. FINDINGS: Between Jan 9, 2019, and Sept 22, 2022, 1604 patients requiring PCI with drug-eluting stents for complex lesions were randomly assigned to receive either OCT-guided PCI (n=803) or angiography-guided PCI (n=801). 1290 (80%) of 1604 patients were male and 314 (20%) were female. The median age of patients at randomisation was 64 years (IQR 57-70). 1588 (99%) patients completed 1-year follow-up. The primary endpoint occurred in 37 (5%) of 803 patients in the OCT-guided PCI group and 59 (7%) of 801 patients in the angiography-guided PCI group (absolute difference -2·8% [95% CI -5·1 to -0·4]; hazard ratio 0·62 [95% CI 0·41 to 0·93]; p=0·023). Rates of stroke, bleeding events, and contrast-induced nephropathy were not significantly different across the two groups. INTERPRETATION: Among patients who required drug-eluting stent implantation for complex lesions, OCT guidance resulted in a lower incidence of major adverse cardiac events at 1 year compared with angiography guidance. These findings indicate the existence of a therapeutic benefit of OCT as an intravascular imaging technique for PCI guidance in patients with complex coronary lesions. FUNDING: Abbott Vascular and Cardiovascular Research Center. TRANSLATION: For the Korean translation of the abstract see Supplementary Materials section.