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BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04137510.
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Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Trombosis , Humanos , Everolimus , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Polímeros , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Resultado del Tratamiento , Implantes Absorbibles , Sirolimus/efectos adversos , Infarto del Miocardio/tratamiento farmacológico , Stents/efectos adversos , Trombosis/etiologíaRESUMEN
Background and Objectives: The assessment of coronary microcirculation may facilitate risk stratification and treatment adjustment. The aim of this study was to evaluate patients' clinical presentation and treatment following coronary microcirculation assessment, as well as factors associated with an abnormal coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) values. Materials and Results: This retrospective analysis included 223 patients gathered from the national registry of invasive coronary microvascular testing collected between 2018 and 2023. Results: The frequency of coronary microcirculatory assessments in Poland has steadily increased since 2018. Patients with impaired IMR (≥25) were less burdened with comorbidities. Patients with normal IMR underwent revascularisation attempts more frequently (11.9% vs. 29.8%, p = 0.003). After microcirculation testing, calcium channel blockers (CCBs) and angiotensin-converting enzyme inhibitors were added more often for patients with IMR and CFR abnormalities, respectively, as compared to control groups. Moreover, patients with coronary microvascular dysfunction (CMD, defined as CFR and/or IMR abnormality), regardless of treatment choice following microcirculation assessment, were provided with trimetazidine (23.2%) and dihydropyridine CCBs (26.4%) more frequently than those without CMD who were treated conservatively (6.8%) and by revascularisation (4.2% with p = 0.002 and 0% with p < 0.001, respectively). Multivariable analysis revealed no association between angina symptoms and IMR or CFR impairment. Conclusions: The frequency of coronary microcirculatory assessments in Poland has steadily increased. Angina symptoms were not associated with either IMR or CFR impairment. After microcirculation assessment, patients with impaired microcirculation, expressed as either low CFR, high IMR or both, received additional pharmacotherapy treatment more often.
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Vasos Coronarios , Reserva del Flujo Fraccional Miocárdico , Humanos , Microcirculación , Resistencia Vascular , Estudios Retrospectivos , Sistema de Registros , Angiografía CoronariaRESUMEN
Background: The coronavirus disease-2019 (COVID-19) pandemic is surging across Poland, leading to many direct deaths and underestimated collateral damage. We aimed to compare the influence of the COVID-19 pandemic on hospital admissions and in-hospital mortality in larger vs. smaller cardiology departments (i.e., with ≥ 2000 vs. < 2000 hospitalizations per year in 2019). Methods: We performed a subanalysis of the COV-HF-SIRIO 6 multicenter retrospective study including all patients hospitalized in 24 cardiology departments in Poland between January 1, 2019 and December 31, 2020, focusing on patients with acute heart failure (AHF) and COVID-19. Results: Total number of hospitalizations was reduced by 29.2% in larger cardiology departments and by 27.3% in smaller cardiology departments in 2020 vs. 2019. While hospitalizations for AHF were reduced by 21.8% and 25.1%, respectively. The length of hospital stay due to AHF in 2020 was 9.6 days in larger cardiology departments and 6.6 days in smaller departments (p < 0.001). In-hospital mortality for AHF during the COVID-19 pandemic was significantly higher in larger vs. smaller cardiology departments (10.7% vs. 3.2%; p < 0.001). In-hospital mortality for concomitant AHF and COVID-19 was extremely high in larger and smaller cardiology departments accounting for 31.3% vs. 31.6%, respectively. Conclusions: During the COVID-19 pandemic longer hospitalizations and higher in-hospital mortality for AHF were observed in larger vs. smaller cardiology departments. Reduced hospital admissions and extremely high in-hospital mortality for concomitant AHF and COVID-19 were noted regardless of department size.
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BACKGROUND: Low operator and institutional volume are associated with poorer procedural and long-term clinical outcomes in the general population of patients treated with percutaneous coronary interventions (PCI). AIM: To assess the relationship between operator experience and procedural outcomes of patients treated with PCI and rotational atherectomy (RA). METHODS: Data for conducting the current analysis were obtained from the national registry of percutaneous coronary interventions (ORPKI) maintained in cooperation with the Association of Cardiovascular Interventions (AISN) of the Polish Cardiac Society. The study covers data from January 2014 to December 2020. RESULTS: During the investigated period, there were 162 active CathLabs, at which 747,033 PCI procedures were performed by 851 operators (377 RA operators [44.3%]). Of those, 5188 were PCI with RA procedures; average 30 ± 61 per site/7 years (Me: 3; Q1-Q3: 0-31); 6 ± 18 per operator/7 years (Me: 0; Q1-Q3: 0-3). Considering the number of RA procedures annually performed by individual operators during the analyzed 7 years, the first quartile totaled (Q1: < =2.57), the second (Q2: < =5.57), and the third (Q3: < =11.57), while the fourth quartile was (Q4: > 11.57). The maximum number of procedures was 39.86 annually per operator. We demonstrated, through a nonlinear relationship with annualized operator volume and risk-adjusted, that operators performing more PCI with RA per year (fourth quartile) have a lower number of the overall periprocedural complications (p = 0.019). CONCLUSIONS: High-volume RA operators are related to lower overall periprocedural complication occurrence in patients treated with RA in comparison to low-volume operators.
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Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Aterectomía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/etiología , Enfermedad de la Arteria Coronaria/terapia , Mortalidad Hospitalaria , Hospitales de Alto Volumen , Hospitales de Bajo Volumen , Humanos , Intervención Coronaria Percutánea/efectos adversos , Sistema de Registros , Resultado del TratamientoRESUMEN
AIMS: The aim of this study was to determine the contemporary use of reperfusion therapy in the European Society of Cardiology (ESC) member and affiliated countries and adherence to ESC clinical practice guidelines in patients with ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: Prospective cohort (EURObservational Research Programme STEMI Registry) of hospitalized STEMI patients with symptom onset <24 h in 196 centres across 29 countries. A total of 11 462 patients were enrolled, for whom primary percutaneous coronary intervention (PCI) (total cohort frequency: 72.2%, country frequency range 0-100%), fibrinolysis (18.8%; 0-100%), and no reperfusion therapy (9.0%; 0-75%) were performed. Corresponding in-hospital mortality rates from any cause were 3.1%, 4.4%, and 14.1% and overall mortality was 4.4% (country range 2.5-5.9%). Achievement of quality indicators for reperfusion was reported for 92.7% (region range 84.8-97.5%) for the performance of reperfusion therapy of all patients with STEMI <12 h and 54.4% (region range 37.1-70.1%) for timely reperfusion. CONCLUSIONS: The use of reperfusion therapy for STEMI in the ESC member and affiliated countries was high. Primary PCI was the most frequently used treatment and associated total in-hospital mortality was below 5%. However, there was geographic variation in the use of primary PCI, which was associated with differences in in-hospital mortality.
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Cardiología , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Europa (Continente)/epidemiología , Hospitales , Humanos , Reperfusión Miocárdica , Estudios Prospectivos , Sistema de Registros , Infarto del Miocardio con Elevación del ST/terapia , Resultado del TratamientoRESUMEN
Ischemic stroke (IS) related to atherosclerosis of large arteries is one of the leading causes of mortality and disability in developed countries. Atherosclerotic internal carotid artery stenosis (ICAS) contributes to 20% of all cerebral ischemia cases. Nowadays, atherosclerosis prevention and treatment measures aim at controlling the atherosclerosis risk factors, or at the interventional (surgical or endovascular) management of mature occlusive lesions. There is a definite lack of the established circulating biomarkers which, once modulated, could prevent development of atherosclerosis, and consequently prevent the carotid-artery-related IS. Recent studies emphasize that microRNA (miRNA) are the emerging particles that could potentially play a pivotal role in this approach. There are some research studies on the association between the expression of small non-coding microRNAs with a carotid plaque development and vulnerability. However, the data remain inconsistent. In addition, all major studies on carotid atherosclerotic plaque were conducted on cell culture or animal models; very few were conducted on humans, whereas the accumulating evidence demonstrates that it cannot be automatically extrapolated to processes in humans. Therefore, this paper aims to review the current knowledge on how miRNA participate in the process of carotid plaque formation and rupture, as well as stroke occurrence. We discuss potential target miRNA that could be used as a prognostic or therapeutic tool.
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Aterosclerosis , Enfermedades de las Arterias Carótidas , Estenosis Carotídea , Accidente Cerebrovascular Isquémico , MicroARNs , Placa Aterosclerótica , Animales , Humanos , Aterosclerosis/metabolismo , Arterias Carótidas/metabolismo , Enfermedades de las Arterias Carótidas/genética , Enfermedades de las Arterias Carótidas/patología , Estenosis Carotídea/metabolismo , Accidente Cerebrovascular Isquémico/patología , MicroARNs/genética , Placa Aterosclerótica/metabolismo , Factores de RiesgoRESUMEN
There is little known about the prognostic value of serum microRNAs (miRs) in diabetic patients with symptomatic internal carotid artery disease (ICAS) who underwent stent supported angioplasty (PTA) for ICAS. The present study aimed to investigate expression levels of selected miRs for future major adverse cardiac and cerebral events (MACCE) as a marker in diabetic patients following ICAS-PTA. The expression levels of 11 chosen circulating serum miRs were compared in 37 diabetic patients with symptomatic ICAS and 64 control group patients with symptomatic ICAS, but free of diabetes. The prospective median follow-up of 84 months was performed for cardiovascular outcomes. Diabetic patients, as compared to control subjects, did not differ with respect to age (p = 0.159), distribution of gender (p = 0.375), hypertension (p = 0.872), hyperlipidemia (p = 0.203), smoking (p = 0.115), coronary heart disease (p = 0.182), lower extremities arterial disease (LEAD, p = 0.731), and miRs expressions except from lower miR-16-5p (p < 0.001). During the follow-up period, MACCE occurred in 16 (43.2%) diabetic and 26 (40.6%) non-diabetic patients (p = 0.624). On multivariate Cox analysis, hazard ratio (HR) and 95% Confidence Intervals (95%CI) for diabetic patients associated with MACCE were miR-134-5p (1.12; 1.05−1.21, p < 0.001), miR-499-5p (0.16; 0.02−1.32, p = 0.089), hs-CRP (1.14; 1.02−1.28; p = 0.022), prior myocardial infarction (8.56, 1.91−38.3, p = 0.004), LEAD (11.9; 2.99−47.9, p = 0.005), and RAS (20.2; 2.4−167.5, p = 0.005), while in non-diabetic subjects, only miR-16-5p (1.0006; 1.0001−1.0012, p = 0.016), miR-208b-3p (2.82; 0.91−8.71, p = 0.071), and hypertension (0.27, 0.08−0.95, p = 0.042) were associated with MACCE. Our study demonstrated that different circulating miRs may be prognostic for MACCE in diabetic versus non-diabetic patients with symptomatic ICAS. Higher expression levels of miR-134 were prognostic for MACCE in diabetic patients, while higher expression levels of miR-16 were prognostic in non-diabetic patients.
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Estenosis Carotídea , MicroARN Circulante , Diabetes Mellitus , Hipertensión , MicroARNs , Arterias Carótidas , Estenosis Carotídea/complicaciones , Estenosis Carotídea/cirugía , MicroARN Circulante/genética , Humanos , MicroARNs/genética , Estudios Prospectivos , Factores de Riesgo , Stents/efectos adversos , Resultado del TratamientoRESUMEN
BACKGROUND: The right phrenic nerve is vulnerable to injury (PNI) during cryoballoon ablation (CBA) isolation of the right pulmonary veins. The complication can be transient or persistent. The reported incidence of PNI fluctuates from 4.73% to 24.7% depending on changes over time, CBA generation, and selected protective methods. M e t h o d s: Through September 2019, a database search was performed on MEDLINE, EMBASE, and Cochrane Database. In the selected articles, the references were also extensively searched. The study provides a comprehensive meta-analysis of the overall prevalence of PNI, assesses the transient to persistent PNI ratio, the outcome of using compound motor action potentials (CMAP), and estimated average time to nerve recovery. R e s u l t s: From 2008 to 2019, 10,341 records from 48 trials were included. Out of 783 PNI retrieved from the studies, 589 (5.7%) and 194 (1.9%) were persistent. CMAP caused a significant reduction in the risk of persistent PNI from 2.3% to 1.1% (p = 0.05; odds ratio [OR] 2.13) in all CBA groups. The mean time to PNI recovery extended beyond the hospital discharge was significantly shorter in CMAP group at three months on average versus non CMAP at six months (p = 0.012). CMAP (in contrast to non-CMAP procedures) detects PNI earlier from 4 to 16 sec (p <0.05; I2 = 74.53%) and 3 to 9o (p <0.05; I2 = 97.24%) earlier. C o n c l u s i o n s: Right PNI extending beyond hospitalization is a relatively rare complication. CMAP use causes a significant decrease in the risk of prolonged injury and shortens the time to recovery.
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Traumatismos de los Nervios Periféricos , Nervio Frénico , Humanos , Potenciales de Acción , Hospitalización , Oportunidad Relativa , Traumatismos de los Nervios Periféricos/etiología , Traumatismos de los Nervios Periféricos/prevención & controlRESUMEN
AIMS: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas of Interventional Cardiology has been developed to map interventional practice across European Society of Cardiology (ESC) member countries. Here we present the main findings of a 16-country survey in which we examine the national availability of interventional infrastructure, human resource, and procedure volumes. METHODS AND RESULTS: Sixteen ESC member countries participated in the EAPCI Atlas survey. Interventional data were collected by the National Cardiac Society of each participating country. An annual median of 5131 [interquartile range (IQR) 4013-5801] diagnostic heart procedures per million people were reported, ranging from <2500 in Egypt and Romania to >7000 in Turkey and Germany. Procedure rates showed significant correlation (r = 0.67, P = 0.013) with gross national income (GNI) per capita. An annual median of 2478 (IQR 1690-2633) percutaneous coronary interventions (PCIs) per million people were reported, ranging from <1000 in Egypt and Romania to >3000 in Switzerland, Poland, and Germany. Procedure rates showed significant correlation with GNI per capita (r = 0.62, P = 0.014). An annual median of 48.2 (IQR 29.1-105.2) transcatheter aortic valve implantation procedures per million people were performed, varying from <25 per million people in Egypt, Romania, Turkey, and Poland to >100 per million people in Denmark, France, Switzerland, and Germany. Procedure rates showed significant correlation with national GNI per capita (r = 0.92, P < 0.001). CONCLUSION: The first report from the EAPCI Atlas has shown considerable international heterogeneity in interventional cardiology procedure volumes. The heterogeneity showed association with national economic resource, a reflection no doubt of the technological costs of developing an interventional cardiology service.
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Cardiología , Intervención Coronaria Percutánea , Europa (Continente) , Francia , Alemania , Humanos , Polonia , SuizaRESUMEN
Atherosclerosis remains a large health and economic burden. Even though it has been studied for more than a century, its complex pathophysiology has not been elucidated. The relatively well-established contributors include: chronic inflammation in response to oxidized cholesterol, reactive oxygen species-induced damage and apoptosis. Recently, profilin 1, a regulator of actin dynamics emerged as a potential new player in the field. Profilin is abundant in stable atherosclerotic plaques and in thrombi extracted from infarct-related arteries in patients with acute myocardial infarction. The exact role of profilin in atherosclerosis and its complications, as well as its mechanisms of action, remain unknown. Here, we summarize several pathways in which profilin may act through mitochondria in a number of processes implicated in atherosclerosis.
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Aterosclerosis/metabolismo , Enfermedad de la Arteria Coronaria/metabolismo , Mitocondrias/metabolismo , Infarto del Miocardio/metabolismo , Profilinas/metabolismo , Sirtuina 3/metabolismo , Actinas/química , Enfermedad Aguda , Animales , Apoptosis , Humanos , Ratones , Placa Aterosclerótica/patología , Isoformas de Proteínas , Especies Reactivas de Oxígeno/metabolismo , Daño por Reperfusión/metabolismoRESUMEN
OBJECTIVE: Introduction: Index of microcirculatory resistance assessment is an invasive method of measuring coronary microcirculation function. Association between impaired microcirculatory function and higher rate of cardiovascular events was proven. Neutrophil-lymphocyte ratio and platelet-lymphocyte ratio seem to be a promising parameters to predict coronary microcirculatory disease in patients with chronic coronary syndrome. The aim: To determine neutrophil-lymphocyte ratio and platelet-lymphocyte ratio levels in patients with coronary microcirculatory disease and potential association with clinical outcome. PATIENTS AND METHODS: Material and methods: 82 consecutive patients with mean age of 67 years, 67% male, were tested for presence of coronary microcirculatory disease using index of microcirculatory resistance. Neutrophil-lymphocyte ratio and platelet-lymphocyte ratio were calculated based on admission full blood count. Follow-up with major adverse cardiac and cardiovascular events registration was performed (median 24 months). RESULTS: Results: The study showed significantly higher neutrophil-lymphocyte ratio and platelet-lymphocyte ratio in patients with coronary microcirculatory disease compared to control group (3.58±2.61 vs 2.54±1.09 and 164±87.9 vs 124±36.6 respectively). Higher level of platelet-lymphocyte ratio in patients with coronary microcirculatory disease results in worse MACCE-free survival. Optimal cut-off values of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio to detect coronary microcirculatory disease were 3.2 and 181.3, respectively. CONCLUSION: Conclusions: Higher neutrophil-lymphocyte ratio and platelet-lymphocyte ratio are associated with increased index of microcirculatory resistance value. Platelet-lymphocyte ratio may be used as a predictor of worse outcome in patients with coronary microcirculatory disease.
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Enfermedad de la Arteria Coronaria , Estenosis Coronaria , Anciano , Femenino , Humanos , Recuento de Linfocitos , Linfocitos , Masculino , Microcirculación , Neutrófilos , Valor Predictivo de las Pruebas , Estudios RetrospectivosRESUMEN
OBJECTIVES: The aim of the study was to capture the evolution of neointima after implantation of a biodegradable polymer-coated, sirolimus-eluting, cobalt-chromium coronary stent system (BP-DES). BACKGROUND: Optical coherence tomography (OCT) suggests that in-stent neointimal morphology influences clinical outcomes after DES implantation. METHODS: Sixty patients treated with single BP-DES implantation were examined by quantitative coronary angiography (QCA) and OCT at 3, 6, and 12-month follow-up. RESULTS: Median late lumen loss by QCA (mm) was 0.04 (IQR 0, 0.08), 0.17 (IQR 0, 0.32), and 0.14 (IQR 0.07, 0.31) at 3, 6, and 12-month follow-up respectively (P = 0.03). OCT cross-section multilevel analysis showed uncovered struts in 3.90%, 1.78%, and 0.02% of struts respectively (P = 0.03). The corresponding malapposition rates were 0.12%, 0.04%, and 0%. Lipid-rich neointima was observed only at 12-month follow-up in one restenotic lesion (0.77% cross-sections) that was accountable for the only target vessel revascularization. The homogeneous pattern was prevalent at all three time points, but its incidence displayed an upward trend (3 months: 59%; 6 months: 71%; 12 months: 88%) despite no difference in neointimal volume between 6 and 12 months. Conversely, a trend could be observed of decreasing incidence of heterogeneous pattern as the follow-up length increased. CONCLUSIONS: In this study of a single-type BP-DES, the majority of stent struts were covered within 3 months from implantation. While the quantitative neointimal accumulation plateaued at 6 months with no further significant increase beyond 6 months, the neointima continued to evolve qualitatively and mature along with better strut coverage between 6 and 12 months after implantation.
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Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/cirugía , Stents Liberadores de Fármacos , Neointima , Intervención Coronaria Percutánea/instrumentación , Sirolimus/administración & dosificación , Tomografía de Coherencia Óptica , Anciano , Fármacos Cardiovasculares/efectos adversos , Aleaciones de Cromo , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Polonia , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Sirolimus/efectos adversos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Although P2Y12 antagonists are effective in patients with non-ST-segment elevation (NSTE) acute coronary syndromes, the effect of the timing of administration--before or after coronary angiography--is not known. We evaluated the effect of administering the P2Y12 antagonist prasugrel at the time of diagnosis versus administering it after the coronary angiography if percutaneous coronary intervention (PCI) was indicated. METHODS: We enrolled 4033 patients with NSTE acute coronary syndromes and a positive troponin level who were scheduled to undergo coronary angiography within 2 to 48 hours after randomization. Patients were randomly assigned to receive prasugrel (a 30-mg loading dose) before the angiography (pretreatment group) or placebo (control group). When PCI was indicated, an additional 30 mg of prasugrel was given in the pretreatment group at the time of PCI and 60 mg of prasugrel was given in the control group. RESULTS: The rate of the primary efficacy end point, a composite of death from cardiovascular causes, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor rescue therapy (glycoprotein IIb/IIIa bailout) through day 7, did not differ significantly between the two groups (hazard ratio with pretreatment, 1.02; 95% confidence interval [CI], 0.84 to 1.25; P=0.81). The rate of the key safety end point of all Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes, whether related or not related to coronary-artery bypass grafting (CABG), through day 7 was increased with pretreatment (hazard ratio, 1.90; 95% CI, 1.19 to 3.02; P=0.006). The rates of TIMI major bleeding and life-threatening bleeding not related to CABG were increased by a factor of 3 and 6, respectively. Pretreatment did not reduce the rate of the primary outcome among patients undergoing PCI (69% of the patients) but increased the rate of TIMI major bleeding at 7 days. All the results were confirmed at 30 days and in prespecified subgroups. CONCLUSIONS: Among patients with NSTE acute coronary syndromes who were scheduled to undergo catheterization, pretreatment with prasugrel did not reduce the rate of major ischemic events up to 30 days but increased the rate of major bleeding complications. (Funded by Daiichi Sankyo and Eli Lilly; ACCOAST ClinicalTrials.gov number, NCT01015287.).
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Síndrome Coronario Agudo/tratamiento farmacológico , Angiografía Coronaria , Piperazinas/administración & dosificación , Premedicación , Antagonistas del Receptor Purinérgico P2Y/administración & dosificación , Tiofenos/administración & dosificación , Síndrome Coronario Agudo/terapia , Anciano , Puente de Arteria Coronaria , Método Doble Ciego , Femenino , Hemorragia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/tratamiento farmacológico , Intervención Coronaria Percutánea , Piperazinas/efectos adversos , Clorhidrato de Prasugrel , Antagonistas del Receptor Purinérgico P2Y/efectos adversos , Tiofenos/efectos adversosRESUMEN
OBJECTIVES: The aim of the study was to evaluate the healing process at 12 months after ABSORB™ bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND: There is currently no data on long-term BVS performance in the acute thrombotic setting. The underlying altered plaque pathomorphology may impact the neointima healing pattern, potentially making it different to that observed in stable coronary artery disease (CAD). METHODS: We have performed an angiographic and optical coherence tomography (OCT) 12-month follow-up of 19 STEMI patients who were treated with a BVS implantation (23 scaffolds). An independent core laboratory performed a paired analysis of the corresponding frames at baseline and follow-up. RESULTS: At 12 months, the OCT follow-up showed a decrease in the mean lumen area (8.29 ± 1.53 mm(2) vs. 6.82 ± 1.57 mm(2) , P < 0.001), but no significant change in the mean scaffold area (8.49 ± 1.53 mm(2) vs. 8.90 ± 1.51 mm(2) ). Significant decreases in malapposed strut ratio (4.9 ± 8.65% vs. 0.4 ± 1.55%, P < 0.001) and malapposition area (0.29 ± 0.60 mm(2) 0.08 ± 0.32 mm(2) , P = 0.002) were observed. A nonhomogenous proliferation of neointima was revealed with a symmetry index of 0.15 (0.08-0.27), a mean neointima thickness of 203 µm (183-249) and mean neointima area of 2.07 ± 0.51 mm(2) . The quantitative coronary angiography showed late lumen loss of 0.08 ± 0.23 mm and no significant change in the minimal lumen diameter (P = 0.11). There were no major adverse cardiovascular events (MACE), except for one nontarget vessel revascularization. CONCLUSIONS: The OCT revealed a favorable healing pattern after BVS implantation in a STEMI population.
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Implantes Absorbibles , Angiografía Coronaria/métodos , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/métodos , Tomografía de Coherencia Óptica/métodos , Anciano , Estudios de Cohortes , Stents Liberadores de Fármacos , Electrocardiografía/métodos , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Intervención Coronaria Percutánea/efectos adversos , Falla de Prótesis , Estudios Retrospectivos , Medición de Riesgo , Índice de Severidad de la Enfermedad , Estadísticas no Paramétricas , Factores de Tiempo , Andamios del Tejido , Resultado del Tratamiento , Grado de Desobstrucción Vascular/fisiologíaRESUMEN
BACKGROUND: Current STEMI guidelines recommend thrombectomy should be considered during primary PCI. Multiple data from randomized clinical trials, registries, and metanalysis have confirmed the efficacy of thrombectomy in terms of surrogate endpoints like better myocardial perfusion, less pronounced distal embolization, and conflicting results on lower all-cause mortality. Our aim was to analyze long-term outcome of STEMI patients treated with manual thrombectomy during primary PCI in a contemporary national registry. METHODS: There were 13 catheterization laboratories in Poland that enrolled patients in NRDES Registry. Patients were divided into two groups: those that were treated with manual thrombectomy for their primary PCI vs. those who were not. RESULTS: There were altogether 2,686 patients enrolled in the NRDES Registry of whom 1,763 were diagnosed with STEMI (66%). Aspiration thrombectomy was used in 673 of these cases (38%) and 1,090 (62%) patients were treated without thrombectomy during the index primary PCI. Overall mortality at 1 year was 11.03% in thrombectomy and 7.46% in no thrombectomy group respectively (P = 0.0292 which became insignificant after propensity score matching adjustment P = 0.613). Specific subgroup analyses revealed that there was no benefit from aspiration thrombectomy in neither subgroup. CONCLUSIONS: Manual aspiration thrombectomy in patients undergoing primary PCI for STEMI was not associated with improved long-term 1-year clinical outcome. Subgroup analysis did not reveal any specific setting in which thrombectomy would be clinically superior. © 2014 Wiley Periodicals, Inc.
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Trombosis Coronaria/terapia , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea , Trombectomía/métodos , Anciano , Distribución de Chi-Cuadrado , Angiografía Coronaria , Trombosis Coronaria/diagnóstico , Trombosis Coronaria/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Oportunidad Relativa , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Polonia , Puntaje de Propensión , Sistema de Registros , Factores de Riesgo , Succión , Trombectomía/efectos adversos , Trombectomía/mortalidad , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: To analyze long-term outcome of ST-Elevation Myocardial Infarction (STEMI) and non-STEMI (NSTEMI) patients treated with Drug Eluting Stents (DES) stents with regard to mortality and stent thrombosis rates based on the national Polish PCI registry database. BACKGROUND: Only a few studies suggested potential trend towards lower mortality in STEMI patients treated with DES. Current European Society of Cardiology STEMI guidelines recommend DES use only with one restriction to suspected patient poor compliance or contraindication to dual antiplatelet therapy. METHODS: Thirteen high-volume interventional cardiology centers in Poland enrolled patients in National Registry of Drug Eluting Stents (NRDES) Registry from October 2010 till October 2011. RESULTS: There were 2686 patients enrolled in NRDES Registry. Eighty five patients (3%) had both DES and BMS implanted at index PCI procedure and were excluded from further analysis. A subpopulation of STEMI (1709; 66%) and NSTEMI (892; 34%) patients was selected for BMS vs DES comparison. A significant difference in favor of DES group for 1-year mortality was found in STEMI subgroup (P < 0.0001-unadjusted and P = 0.0497 after propensity score adjustment). No such differences were noticed for NSTEMI subgroup or stent thrombosis comparisons. CONCLUSIONS: A strong selection bias for DES stents was observed with regard to demographic and angiographic characteristics in both STEMI and NSTEMI. DES implantation was associated with similar ischemic outcome to BMS at 1-year follow-up. STEMI patients with DES presented a trend towards lower long-term mortality at 1 year in comparison to BMS.
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Stents Liberadores de Fármacos , Metales , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/instrumentación , Stents , Anciano , Angiografía Coronaria , Reestenosis Coronaria/etiología , Reestenosis Coronaria/mortalidad , Trombosis Coronaria/etiología , Trombosis Coronaria/mortalidad , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Inhibidores de Agregación Plaquetaria/uso terapéutico , Polonia , Puntaje de Propensión , Sistema de Registros , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The study aimed to compare pre- and postoperative resting as well as postprocedural resting and exertional right ventricular speckle-tracking echocardiographic parameters at a mid-term follow-up after left ventricular assist device (LVAD) implantation. METHODS: Patients with implanted third-generation LVADs with hydrodynamic bearings were prospectively enrolled (NCT05063006). Myocardial deformation was evaluated before pump implantation and at least three months after the procedure, both at rest and during exercise. RESULTS: We included 22 patients, 7.3 months (IQR, 4.7-10.2) after the surgery. The mean age was 58.4 ± 7 years, 95.5% were men, and 45.5% had dilated cardiomyopathy. The RV strain analysis was feasible in all subjects both at rest and during exercise. The RV free wall strain (RVFWS) worsened from -13% (IQR, -17.3 to -10.9) to -11.3% (IQR, -12.9 to -6; p = 0.033) after LVAD implantation with a particular decline in the apical RV segment [-11.3% (IQR, -16.4 to -6.2) vs -7.8% (IQR, -11.7 to -3.9; p = 0.012)]. The RV four-chamber longitudinal strain (RV4CSL) remained unchanged [-8.5% (IQR, -10.8 to -6.9) vs -7.3% (IQR, -9.8 to -4.7; p = 0.184)]. Neither RVFWS (-11.3% (IQR, -12.9 to -6) vs -9.9% (IQR, -13.5 to -7.5; p = 0.077) nor RV4CSL [-7.3% (IQR, -9.8 to -4.7) vs -7.9% (IQR, -9.8 to -6.3; p = 0.548)] changed during the exercise test. CONCLUSIONS: In patients who are pump-supported, the right ventricular free wall strain tends to worsen after LVAD implantation and remains unchanged during a cycle ergometer stress test.
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Insuficiencia Cardíaca , Corazón Auxiliar , Disfunción Ventricular Derecha , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ecocardiografía/métodos , Corazón Auxiliar/efectos adversos , Estudios Retrospectivos , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/etiología , Función Ventricular Izquierda , Función Ventricular DerechaRESUMEN
INTRODUCTION: Ischemia and non-obstructive coronary arteries (INOCA) remains a significant clinical issue. Recent guidelines underscore the importance of comprehensive coronary physiology assessments to make specific diagnoses and implement tailored treatment strategies. OBJECTIVES: The primary objective was to implement the comprehensive invasive diagnostics. The secondary objective was to determine the pathomechanism of INOCA in consecutive adult patients with symptomatic chronic coronary syndrome, non-invasive evidence of myocardial ischemia, and non-obstructive coronary artery disease included in the prospective MOSAIC-COR registry, and therefore, to define new INOCA subgroups. PATIENTS AND METHODS: All patients underwent comprehensive coronary physiological assessments, including resting full-cycle ratio (RFR), fractional flow reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) using a pressure wire and thermodilution method. Coronary artery reactivity was assessed with acetylcholine in a provocative test. RESULTS: A total of 173 patients were enrolled (median age 66 years, 66% female). A high prevalence of typical cardiovascular risk factors was registered. According to physiological assessment, patients were divided into the following subgroups: epicardial vasospastic angina (EVSA) (19%), microvascular vasospastic angina (MVSA) (19%), coronary microcirculatory disease (CMD) (11%), EVSA+CMD (21%), MVSA+CMD (18%), and non-coronary disorder (12%). The diagnosis of MVSA and MVSA+CMD had a higher representation of females (76% and 94%, respectively). CONCLUSIONS: Patients diagnosed with INOCA in the MOSAIC-COR registry exhibit significant symptomatology and a high prevalence of typical cardiovascular risk factors. Myocardial ischemia in this population may be generated by various pathomechanisms which may overlap.
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BACKGROUND: The coexistence of mitral regurgitation (MR) and severe aortic stenosis (AS) has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). Herein, the aim was to assess the etiology and degree of MR in an unselected TAVI population and investigate the impact of MR reduction at mid-term follow-up. METHODS: Patients subjected to TAVI as a treatment for severe AS in a single center were retrospectively analyzed. The primary endpoint was the MR reduction after TAVI. The secondary endpoint was all-cause mortality and heart failure hospitalization at a 3-year follow-up. RESULTS: Patients undergoing TAVI (n = 283) in the years 2017-2019 were screened for the presence of hemodynamically significant MR. Sixty-nine subjects (24.4%) with severe (16, 23.2%) and moderate (53, 76.8%) MR were included. The primary MR was predominant (39 subjects, 56.5%). The median age of the patients was 82 years. MR improved in 25 patients (36.2%, p < 0.001). Baseline severe MR was more prone to reduce (8 subjects, 50%) than moderate (17 subjects, 32.1%, p = 0.04). The primary MR improved in 14 patients (35.9%), while secondary in 11 patients (36.7%, p = 1). Patients showing MR reduction had lower mortality (8 vs. 29.55%, p = 0.047) and were less frequently hospitalized (20 vs. 45.45%, p = 0.03) at 3-year follow-up. CONCLUSIONS: Hemodynamically significant MR improves after TAVI regardless of its etiology. Moreover, MR reduction after TAVI is associated with better clinical outcomes.
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BACKGROUND: Notwithstanding readily available revascularization, significant advancements in mechanical circulatory support, and pharmacological progress, cardiogenic shock (CS) secondary to unprotected left main culprit lesion-related acute myocardial infarction (ULMCL-related AMI) is associated with very high mortality. In this population, chronic total occlusion (CTO) is relatively frequent. AIMS: This study sought to assess the association between the presence of CTO and 12-month mortality in patients with CS due to ULMCL-related AMI. RESULTS: The study included consecutive patients admitted for AMI-related CS with ULMCL who underwent percutaneous coronary intervention (PCI) and were enrolled in the prospective Polish Registry of Acute Coronary Syndromes (PL-ACS) between January 2017 and December 2021. The patients were stratified into two groups based on the presence of at least one CTO. The primary endpoint was all-cause death at 12 months. Of the 250 included patients, 60 (24%) patients had one or more CTOs of a major coronary artery (+CTO), and in 190 (76%) patients, the presence of CTO was not observed (-CTO). The 12-month mortality rates for the +CTO and -CTO patients were 85% and 69.8%, respectively (P log-rank = 0.03). After multivariable adjustment for differences in the baseline characteristics, the presence of CTO remained significantly associated with higher 12-month mortality (hazard ratio, 1.423; 95% CI, 1.027-1.973; P = 0.034). CONCLUSIONS: Our analysis showed that in patients with CS due to ULMCL-related AMI treated with PCI, the presence of CTO is associated with worse 12-month prognosis.