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BACKGROUND: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. METHODS: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. RESULTS: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. CONCLUSIONS: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.
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Fármacos Cardiovasculares , Materiales Biocompatibles Revestidos , Reestenosis Coronaria , Stents Liberadores de Fármacos , Sistema de Registros , Sirolimus , Humanos , Masculino , Femenino , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Anciano , Persona de Mediana Edad , Resultado del Tratamiento , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Reestenosis Coronaria/terapia , Factores de Tiempo , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Europa (Continente) , Infarto del Miocardio/mortalidad , Infarto del Miocardio/etiología , Catéteres Cardíacos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagenRESUMEN
Cardiovascular diseases (CVDs) remain the leading cause of death worldwide with coronary artery disease (CAD) being the first culprit in this group. In terms of CAD, not only its presence but also its severity plays a role in the patient's treatment and prognosis. CAD complexity can be assessed with the indicator named the SYNTAX score (SS). A higher SS is associated with major adverse cardiovascular event (MACE) occurrence in short- and long-term observations. Hence, the risk factors affecting CAD severity based on SS results may help lower the risk among patients with already developed CAD to reduce their impact on coronary atherosclerosis progression. The well-established risk factors of CAD are consistent with those associated with the coronary plaque burden. However, recently, it was shown that new indicators exist, which we present in this paper, that significantly contribute to CAD complexity such as inflammatory parameters, C-reactive protein (CRP), ratios based on blood smear results, and uric acid. Moreover, microbiota alteration, vitamin D deficiency, and obstructive sleep apnea (OSA) also predicted CAD severity. However, sometimes, certain indicators were revealed as significant only in terms of chronic coronary syndromes (CCSs) or specific acute coronary syndromes (ACSs). Importantly, there is a need to apply the interdisciplinary and translational approach to the novel CAD severity risk assessment to maximize the impact of secondary prevention among patients at risk of coronary atherosclerosis progression.
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Enfermedad de la Arteria Coronaria , Índice de Severidad de la Enfermedad , Enfermedad de la Arteria Coronaria/etiología , Humanos , Factores de Riesgo , Proteína C-Reactiva/metabolismo , Pronóstico , Apnea Obstructiva del Sueño/complicaciones , BiomarcadoresRESUMEN
BACKGROUND: The long-term outcomes for patients with in-stent restenosis (ISR) presenting with chronic coronary syndrome (CCS) are not well studied. AIMS: We aimed to investigate the outcomes for patients with drug-eluting stents (DES)-ISR and CCS undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB) or thin strut-DES. METHODS: A total of 846 consecutive patients from the Dragon-Registry with CCS and DES-ISR who underwent PCI with thin (strut thickness <100 µm) strut-DES (381 [45%]) or paclitaxel-DCB (465 [55%]) for DES-ISR were enrolled between February 2008 and October 2021. The median follow-up was 1006 (IQR 426-1770) days. The primary outcome was target lesion revascularization (TLR). Secondary outcomes were target vessel revascularization (TVR) and device-oriented composite endpoint (DOCE: cardiac death, TLR, or target vessel myocardial infarction [TV-MI]). RESULTS: Patients who received DES, compared with those who received DCB, had lower crude rates of TLR (hazard ratio [HR], 0.50 [95% CI, 0.34-0.74]; P <0.001), TVR (HR, 0.56 [95% CI, 0.39-0.86]; P <0.001), and DOCE (HR, 0.63 [95% CI, 0.45-0.88]; P = 0.007). The incidence of cardiac death and TV-MI were similar in both groups. After matching, the observed differences persisted in terms of TLR (HR, 0.54 [95% CI, 0.33-0.88]; P = 0.013), TVR (HR, 0.57 [95% CI, 0.41-0.80]; P = 0.009) and DOCE (HR, 0.65 [95% CI, 0.42-0.99]; P = 0.046) between the DES and DCB groups, respectively. CONCLUSIONS: In long-term follow-up of CCS patients undergoing PCI of ISR, the use of DES was associated with reduced rates of TLR, TVR, and DOCE compared with patients treated with DCB.
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Reestenosis Coronaria , Stents Liberadores de Fármacos , Paclitaxel , Sistema de Registros , Humanos , Masculino , Femenino , Paclitaxel/administración & dosificación , Paclitaxel/uso terapéutico , Persona de Mediana Edad , Anciano , Reestenosis Coronaria/etiología , Resultado del Tratamiento , Intervención Coronaria Percutánea , Angioplastia Coronaria con BalónRESUMEN
Introduction: Rotational atherectomy (RA) presents superior efficacy over traditional balloon angioplasty in managing calcified plaques, albeit being associated with a perceived heightened aggressiveness and increased risk of periprocedural complications. Aim: To assess the frequency and predictive factors of periprocedural myocardial infarction (MI) following RA. Material and methods: This was a retrospective observational study, encompassing 534 patients. The definition of periprocedural MI was consistent with the 4th universal definition of MI. Results: Periprocedural MI occurred in 45 (8%) patients. This subset tended to be older (74.6 ±8.2 vs. 72 ±9.3%; p = 0.04) with SYNTAX Score (SS) > 33 points (p = 0.01), alongside elevated rates of no/slow flow (p = 0.0003). These patients less often fulfilled the indication for RA, which is a non-dilatable lesion. The incidence of traditional risk factors was similar in both groups. Univariable logistic regression models revealed: male gender (OR = 0.54; p = 0.04), non-dilatable lesion (OR = 0.41; p = 0.01), prior coronary artery bypass grafting (CABG) (OR = 0.07; p = 0.01) as negative and SS > 33 (OR = 2.8; p = 0.02), older age (OR = 1.04; p = 0.04), no/slow flow (OR = 7.85; p = 0.002) as positive predictors. The multivariable model showed that occurrence of no/slow flow (OR = 6.7; p = 0.02), SS > 33 (OR = 2.95; p = 0.02), non-dilatable lesion (OR = 0.42; p = 0.02), and prior CABG (OR = 0.08; p = 0.02) were independent predictors of periprocedural MI. Conclusions: Periprocedural MI after RA was not an uncommon complication, occurring in nearly one-twelfth of patients. Our analysis implicated female gender, older age, and more severe coronary disease in its occurrence. As expected, the presence of no/slow flow amplified the risk of periprocedural MI, whereas prior CABG and non-dilatable lesions mitigated this risk.
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Percutaneous treatment of calcified coronary lesions is still a challenge in modern interventional cardiology practice. Coronary angiography is limited to the precise and quantitative assessment of calcium in coronary arteries. Intracoronary imaging (ICI) modalities, including optical coherence tomography (OCT) and intravascular ultrasound (IVUS), produce a very detailed image of calcifications and could help in proper percutaneous treatment. Intracoronary imaging indicates the need to use additional tools and improves the final effect of an intervention. Drawing on the already published literature, the authors focused on the qualification of patients to the procedure, conduct and result of interventional procedures involving calcified lesions supported by ICI. The article shows the advantages and disadvantages of both ICI methods in general and especially in calcified lesions. Currently available tools dedicated to dealing with coronary calcium and helping to meet optimal stent implantation criteria are also described. This article reviews the data on ICI implementation in daily clinical practice to improve the results of percutaneous interventions, and indicates further directions.
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In order to improve the percutaneous treatment of coronary artery calcifications (CAC) before stent implantation, methods such as rotational atherectomy (RA), orbital atherectomy (OA), and coronary intravascular lithotripsy (IVL) were invented. These techniques use different mechanisms of action and therefore have various short- and long-term outcomes. IVL employs sonic waves to modify CAC, whereas RA and OA use a rapidly rotating burr or crown. These methods have specific advantages and limitations, regarding their cost-efficiency, the movement of the device, their usefulness given the individual anatomy of both the lesion and the vessel, and the risk of specified complications. This study reviews the key findings of peer-reviewed articles available on Google Scholar with the keywords RA, OA, and IVL. Based on the collected data, successful stent delivery was assessed as 97.7% for OA, 92.4% for IVL, and 92.5% for RA, and 30-day prevalence of MACE (Major Adverse Cardiac Events) in OA-10.4%, IVL-7.2%, and RA-5%. There were no significant differences in the 1-year MACE. Compared to RA, OA and IVL are cost-effective approaches, but this is substantially dependent on the reimbursement system of the particular country. There is no standard method of CAC modification; therefore, a tailor-made approach is required.
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PURPOSE: The normal healthy valve is devoid of inflammatory cells, however background of aortic stenosis (AS) may include inflammatory processes. Moreover, the link between hyperparathyroidism and heart failure is postulated. Simple whole blood analysis with indices is a beneficial tool in cardiovascular diseases' assessment. The purpose of the study was to evaluate correlation between parathyroid hormone (PTH) and simple blood parameters in severe AS. MATERIAL AND METHODS: The study included 62 patients with severe AS. Patients with inflammatory or autoimmune co-morbidities were excluded. Blood samples were collected, and clinical and demographic data were analyzed. RESULTS: The final study group comprised 55 patients (31 females, 56.4%; mean age 77.13 (SD 6.76)). In 23 patients (41.8%), PTH concentration was markedly increased. The study group was divided into two subgroups according to the PTH concentration. Patients from both groups did not differ significantly in terms of age and co-morbidities. PTH concentration correlated positively with monocyte-lymphocyte ratio (MLR) (p â= â0.008, Spearman rho 0.356) and platelet-lymphocyte ratio (PLR) (p â= â0.047, Spearman rho 0.269), creatinine level (p â= â0.001, Spearman rho 0.425) and glomerular filtration rate (GFR-MDRD) (p â= â0.009, Spearman rho -0.349). The multivariable logistic regression with backward analysis revealed MLR (p â= â0.029) and GFR (p â= â0.028) as independent significant predictors of abnormal PTH values. The receiver operator characteristics (ROC) curve was performed for the model of MLR and GFR-MDRD (AUC â= â0.777), yielding the sensitivity of 60.9% and specificity of 90.6%. CONCLUSIONS: PTH concentration correlates with monocyte-to-lymphocyte and platelet-to-lymphocyte ratios in calcified AS.
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Estenosis de la Válvula Aórtica , Monocitos , Femenino , Humanos , Anciano , Hormona Paratiroidea , Linfocitos , Plaquetas , Neutrófilos , Estenosis de la Válvula Aórtica/complicaciones , Estudios RetrospectivosAsunto(s)
Enfermedad de la Arteria Coronaria , Placa Aterosclerótica , Humanos , Volumen Sistólico , Placa Aterosclerótica/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Corazón , Angiografía Coronaria , Vasos CoronariosRESUMEN
BACKGROUND: It was hypothesized that the time-appropriate return to a resting heart rate (HR) after cessation of exercise could be a marker for predicting outcomes in patients with heart failure (HF). We aimed to evaluate the prognostic value of HR recovery in functional improvement among adults with severe aortic stenosis undergoing percutaneous aortic valve implantation (TAVI). METHODS: We performed a 6 min walk test (6MWT) in 93 individuals before TAVI and 3 months after the procedure. The change in walking distance was calculated. During the pre-TAVI 6MWT, we analyzed the differences between baseline HR, HR at the end of the test, and HR at the 1st, 2nd, and 3rd minute of recovery. RESULTS: After 3 months, 6MWT distances improved by 39 ± 63 m and reached a total of 322 ± 117 m. Multiple linear regression proved the differences between HR after 2 min of recovery and baseline HR in pre-TAVI after a 6MWT was the only significant predictor of waking distance improvement during follow-up. CONCLUSIONS: Our study suggests that analysis of HR recovery after a 6MWT may be a helpful and easy parameter to assess improvements in exercise capacity after TAVI. This simple method can help to identify patients in whom no significant benefit in functional improvement can be expected despite successful valve implantation.
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Estenosis de la Válvula Aórtica , Válvula Aórtica , Adulto , Humanos , Prueba de Paso , Frecuencia Cardíaca/fisiología , Caminata/fisiología , Resultado del TratamientoAsunto(s)
Angioplastia Coronaria con Balón , Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Aterectomía Coronaria/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Factores de Riesgo , Resultado del Tratamiento , Enfermedad de la Arteria Coronaria/etiología , Angiografía Coronaria , Aterectomía/efectos adversosRESUMEN
Introduction: Data regarding the duration of dual antiplatelet therapy (DAPT) in patients with drug-eluting stent restenosis (DES-ISR) treated with percutaneous coronary intervention (PCI) and drug-eluting balloons (DEB) or DES are not unambiguous. Aim: To evaluate the relationship between long-term outcomes and the length of DAPT in patients treated with PCI due to DES-ISR with DEB or DES. Material and methods: Overall, a total of 1,367 consecutive patients with DES-ISR, who underwent PCI with DEB or DES between 2008 and 2019 entered the study. The mean length of the follow-up was 1,298.7 ±794 days. We assessed study endpoints according to the duration of DAPT (≤ 3 vs. > 3 and ≤ 6 vs. > 6 months) before and after propensity score matching (PSM): stroke, target lesion revascularisation (TLR), target vessel revascularisation (TVR), myocardial infarction (MI), death and device oriented composite endpoints (DOCE). Kaplan-Meier estimates were created to differentiate long-term outcomes. Results: Pairwise contrast analysis considering type of PCI (DES vs. DEB) and duration of DAPT (≤ 6 vs. > 6 months) before PSM revealed superiority of DES + DAPT > 6 months vs. DEB + DAPT > 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Also, DES + DAPT ≤ 6 months was found to be superior compared to DEB + DAPT ≤ 6 months for DOCE (p < 0.001), TVR (p = 0.02) and TLR (p = 0.01). Kaplan-Meier estimate analysis confirmed that DAPT > 6 months is related to a higher stroke rate (p = 0.01) when compared to ≤ 6 months. Conclusions: Treatment with DAPT in patients with DES-ISR is related to better long-term outcomes in the case of PCI with DES than DEB. DAPT > 6 months is related to the greater rate of strokes, independently of the type of treatment (DES and DEB) than DAPT ≤ 6 months.
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Background: Data regarding management of patients with unprotected left main coronary artery in-stent restenosis (LM-ISR) are scarce. Objectives: This study investigated the safety and effectiveness of percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) for the treatment of unprotected LM-ISR. Methods: Consecutive patients who underwent PCI or CABG for unprotected LM-ISR were enrolled. The primary endpoint was a composite of major adverse cardiac and cerebrovascular events (MACCE), defined as cardiac death, myocardial infarction (MI), target vessel revascularization (TVR), and stroke. Results: A total of 305 patients were enrolled, of which 203(66.6%) underwent PCI and 102(33.4%) underwent CABG. At 30-day follow-up, a lower risk of cardiac death was observed in the PCI group, compared with the CABG-treated group (2.1% vs. 7.1%, HR 3.48, 95%CI 1.01-11.8, p = 0.04). At a median of 3.5 years [interquartile range (IQR) 1.3-5.5] follow-up, MACCE occurred in 27.7% vs. 29.6% (HR 0.82, 95%CI 0.52-1.32, p = 0.43) in PCI- and CABG-treated patients, respectively. There were no significant differences between PCI and CABG in cardiac death (9.9% vs. 18.4%; HR 1.56, 95%CI 0.81-3.00, p = 0.18), MI (7.9% vs. 5.1%, HR 0.44, 95%CI 0.15-1.27, p = 0.13), or stroke (2.1% vs. 4.1%, HR 1.79, 95%CI 0.45-7.16, p = 0.41). TVR was more frequently needed in the PCI group (15.2% vs. 6.1%, HR 0.35, 95%CI 0.15-0.85, p = 0.02). Conclusions: This analysis of patients with LM-ISR revealed a lower incidence of cardiac death in PCI compared with CABG in short-term follow-up. During the long-term follow-up, no differences in MACCE were observed, but patients treated with CABG less often required TVR. Visual overview: A visual overview is available for this article. Registration: https://www.clinicaltrials.gov; Unique identifier: NCT04968977.
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[Figure: see text].
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Angioplastia Coronaria con Balón , Reestenosis Coronaria , Stents Liberadores de Fármacos , Preparaciones Farmacéuticas , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Reestenosis Coronaria/terapia , Humanos , Diseño de Prótesis , Sistema de Registros , Stents , Resultado del TratamientoAsunto(s)
Bioprótesis , Prótesis Valvulares Cardíacas , Laceraciones , Pectinidae , Reemplazo de la Válvula Aórtica Transcatéter , Animales , Válvula Aórtica/cirugía , Vasos Coronarios/cirugía , Humanos , Enfermedad Iatrogénica/prevención & control , Polonia , Diseño de Prótesis , Resultado del TratamientoRESUMEN
BACKGROUND: The aim of the study was to assess anatomical and procedural predictors of clinical and procedural failure of rotational atherectomy (RA) in an all-comers population.MethodsâandâResults:A total of 534 consecutive patients who underwent RA were included in a double-center observational study. The primary composite endpoint consisted of: rota-wire introduction failure, burr-passage failure, periprocedural complications and procedure-related major adverse events. The second primary endpoint included rota-wire introduction failure and burr-passage failure. The primary endpoint occurred in 76 (14.2%) patients and the second primary endpoint occurred in 64 (12%) Periprocedural complications occurred in 23 (4.3%) and procedure-related adverse events in 23 (4.3%) patients. Multivariable analysis revealed angulation on lesion ≤90° (HR=2.18, 95% CI: 1.21-3.94, P=0.0096) and sequential lesion (HR=1.89, 95% CI: 1.01-3.54, P=0.046) as independent predictors of no clinical success of RA. Multivariable analysis revealed again that angulation on lesion ≤90° (HR=2.26, 95% CI: 1.16-4.40, P=0.02) and sequential lesion (HR=3.77, 95% CI: 1.64-8.69, P<0.01) as independent predictors of no procedural success of RA. CONCLUSIONS: The presence of an acute angulation on lesion and sequential lesion are independent determinants of clinical and procedural failure of RA. Further research is necessary to establish a score predicting RA failure, which can help in preproceduralrisk stratification of patients undergoing complex percutaneous coronary intervention with RA.
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Aterectomía Coronaria , Enfermedad de la Arteria Coronaria , Calcificación Vascular , Aterectomía Coronaria/efectos adversos , Angiografía Coronaria , Humanos , Intervención Coronaria Percutánea , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
INTRODUCTION: Few studies assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008. Effects of the Valve for Life Initiative in the country have not been reported. OBJECTIVE: The aim of the study was to investigate TAVI adoption and practice in Poland in the years 2008 to 2019. PATIENTS AND METHODS: The Polish Interventional Cardiology TAVI Survey (PICTS) analyzed reports of TAVI activity in all 23 TAVI centers. It consisted of 94 questions and encompassed the following topics: 1) characteristics of centers; 2) the annual number of TAVI procedures in the years 2008 to 2019; 3) pre-, intra-, and postprocedural management of patients; and 4) a list of TAVI team members. It was obligatory to answer all questions. The registry survey was published online. RESULTS: Since 2008, 102 certified operators have performed a total of 6910 procedures. In 2019, the annual number of TAVI reached 1550 (40.38 implants per 1 000 000 inhabitants). Among patients aged 65 years and older, TAVI penetration rate was 18.65% in 2019. Inoperable and high-risk patients were treated in all centers, while 18 also treated medium- and 5 treated low-risk individuals. The rate of transfemoral implantations increased to 93.5% of all procedures. CONCLUSIONS: The survey highlighted a slow increase in the rate of TAVI adoption in Poland. We found a significant treatment gap in patients with severe aortic stenosis. Remarkable regional variations in TAVI experience exist among Polish TAVI centers. Further multinational cooperation is warranted to tackle the identified limitations in access to this life-saving procedure.