Introduction and objectives: The ROLLER COASTR-EPIC22 trial randomized 171 patients with moderate-to-severe calcified coronary lesions to undergo percutaneous coronary intervention with rotational atherectomy, intravascular lithotripsy, or excimer laser. This trial and its 1-year follow-up demonstrated no significant differences among the 3 arms in terms of procedural success, complications and clinical outcomes. This subanalysis aimed to describe age-related outcomes among patients undergoing percutaneous coronary intervention with plaque-modification techniques. Methods: Of 171 patients (118 < 75 years; 53 >_ 75 years), we compared final stent expansion by optical coherence tomography using an intention-to-treat analysis. Secondary endpoints included minimum stent area, angiographic, procedural, and clinical success, in-hospital complications, 1-year all-cause mortality, and major adverse cardiovascular events (MACE), including cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. Results: Baseline characteristics and treatment allocation were similar among groups. Final stent expansion was 85 +/- 17.1 % in patients < 75 vs 84 +/- 18.9 % in those >_ 75 (P = .76). Minimum stent area, procedural success, and in-hospital complications were comparable. At 1 year, the >_ 75 cohort had significantly higher MACE (11.3% vs 1.7%; P = .01) and all-cause mortality (9.4% vs 0.9%; P = .01). Conclusions: Elderly patients achieved similar procedural outcomes as younger patients, but higher rates of MACE and all-cause mortality at 1-year follow-up.
Coronary calcification negatively affects the safety and effectiveness of percutaneous coronary intervention. There is a lack of randomized comparisons among different plaque modification techniques. The aim of this study was to compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis. Patients with moderate to severe calcified coronary lesions were randomly assigned to percutaneous coronary intervention with RA, IVL, or ELCA. The primary endpoint was the percentage of stent expansion by optical coherence tomography. An intention-to-treat, noninferiority analysis was conducted. A total of 171 patients (77.2% men [n = 132], mean age 70.9 ± 8.2 years) were enrolled, 57 in each treatment arm. Clinical presentation was chronic coronary syndrome in 64.3% of patients (n = 110) and acute coronary syndrome in 35.7% (n = 61). Severe angiographic calcification was observed in 82.5% of lesions (n = 141). Procedural success rate and final minimum stent area (RA, 5.5 ± 2.1 mm2; IVL, 5.4 ± 1.8 mm2; ELCA, 5.1 ± 1.8 mm2) were similar among the 3 arms. IVL proved to be noninferior to RA, with no differences in stent expansion (RA, 86.4% ± 14.1%; IVL, 85.6% ± 13.3%; P = 0.77). ELCA did not reach noninferiority in the intention-to-treat analysis. The rate of complications was low, with no significant differences in the 3 arms but numerically lower with IVL. In the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions, IVL was noninferior to RA in terms of stent expansion. ELCA did not reach this noninferiority margin compared with RA. No significant differences were observed among the 3 arms regarding minimum stent area, procedural success rate, and complications, which were numerically lower with IVL.
BACKGROUND:The ROLLER COASTR-EPIC22 was the first randomized trial to directly compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis. AIMS:The aim of this study is to report and compare its 1-year clinical outcomes. METHODS:The ROLLER COASTR-EPIC22 trial randomized 171 patients with angiographic moderate to severe calcified coronary lesions to PCI with RA (n = 57), IVL (n = 57), or ELCA (n = 57). A pre-specified analysis of clinical events at one year from the index PCI was conducted. The clinical endpoints analyzed at one year were the rate of major adverse cardiovascular events (MACE), defined as the occurrence of cardiac death, target vessel myocardial infarction (TV-MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis. Furthermore, the rate of all-cause mortality, non-fatal TV-MI, TVR, TLR, and stent thrombosis were analyzed separately. Kaplan-Meier analysis was performed to assess time-to-event outcomes. The adjudication of clinical events was conducted in accordance with the intention-to-treat principle. RESULTS:The mean age was 70.9 ± 8.2 years and 77.2% of the patients were men. Clinical presentation was acute coronary syndrome in 35.7% of patients and severe angiographic calcification was observed in 82.5% of lesions by the independent core laboratory unaware to the treatment arm. All patients showed criteria of severe calcification, either angiographic or at optical coherence tomography (OCT). At OCT evaluation, mean calcium arc was 300.8° ± 78.9°, maximum calcium thickness 1.17 ± 0.24 mm, calcification length 30.9 ± 12.9 mm and 30.5% of patients presented calcium nodules. Baseline characteristics were well balanced between groups. At one year, there were no significant differences in MACE incidence among the three arms (RA 5.3%, IVL 5.3%, ELCA 3.5%; p = 0.88). Furthermore, there were no significant differences in all-cause death between groups (p = 0.22), with no events in the IVL group (RA 5.3%, IVL 0%, ELCA 5.3%). No significant differences were observed among the 3 arms in the terms of TV-MI (RA 1.7, IVL 1.7, ELCA 0%; p = 0.61), TVR (RA 3.5%, IVL 5.3%, ELCA 1.7%; p = 0.59), TLR (RA 1.7%, IVL 1.7%, ELCA 1.7%; p = 1.00), or stent thrombosis (RA 1.7%, IVL 0%, ELCA 1.7; p = 0.61). CONCLUSIONS:This is the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions and reporting long-term clinical outcomes. At one year, no significant differences were observed among the three arms in the composite endpoint of one-year all-cause mortality, AMI, TVR, TLR and stent thrombosis. Similarly, no significant differences were found when analyzing the individual components of the endpoint separately.
BACKGROUND:A new-generation coronary sirolimus eluting-stent(SES), whose novel characteristics are summarized in ultra-thin oval-shaped hydrodynamic struts (68 μm) and abluminal drug release with permanent fluoropolymer containing the platelet aggregation inhibitor triflusal, showed low target lesion failure(TLF) and absence of stent thrombosis(ST) at 1 year in a first-in-human study. Long-term clinical efficacy is unknown. We aim to investigate long-term clinical efficacy of this new SES in a real-world population undergoing PCI for native coronary artery. METHODS:VELAZQUEZ-EPIC26 is a prospective, observational and multicentre study of a large cohort undergoing PCI with the new SES (ihtDEStiny™). Primary endpoint was TLF at 2 years (composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization). Secondary clinical safety and efficacy endpoints included definitive or probable ST, target vessel failure (TVF), major adverse cardiac events (MACE), and BARC 3-5 bleeding. RESULTS:Between 2021 and 2023, 406 patients (mean age 65 ± 11 years, 75 % males, 26 % diabetes) were included. 519 SES were implanted over 482 target lesions. Mean stent diameter and length were 3.03 ± 0.49 mm and 22 ± 7,6 mm respectively. Procedural success rate was 97.3 %. TLF at 2 years was 2,2 % (n = 9). There were 3 cardiovascular deaths (0,7 %), none related to SES complications. 1 very late definite stent thrombosis was reported (0,2 %, n = 1). TVF, MACE and BARC 3-5 bleeding rates at years were 3 % (n = 12), 3,2 % (n = 13) and 3,5 % (n = 14) respectively. CONCLUSIONS:In a large real-world population undergoing PCI for native coronary artery, a new hydrodynamic ultra-thin strut SES with abluminal permanent fluoropolymer containing triflusal shows low TLF and very low ST rates at 2 years.
Background Coronary calcification negatively affects the safety and effectiveness of percutaneous coronary intervention. There is a lack of randomized comparisons among different plaque modification techniques. Objectives The aim of this study was to compare rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL) for the treatment of patients with calcified coronary stenosis. Methods Patients with moderate to severe calcified coronary lesions were randomly assigned to percutaneous coronary intervention with RA, IVL, or ELCA. The primary endpoint was the percentage of stent expansion by optical coherence tomography. An intention-to-treat, noninferiority analysis was conducted. Results A total of 171 patients (77.2% men [n = 132], mean age 70.9 ± 8.2 years) were enrolled, 57 in each treatment arm. Clinical presentation was chronic coronary syndrome in 64.3% of patients (n = 110) and acute coronary syndrome in 35.7% (n = 61). Severe angiographic calcification was observed in 82.5% of lesions (n = 141). Procedural success rate and final minimum stent area (RA, 5.5 ± 2.1 mm2; IVL, 5.4 ± 1.8 mm2; ELCA, 5.1 ± 1.8 mm2) were similar among the 3 arms. IVL proved to be noninferior to RA, with no differences in stent expansion (RA, 86.4% ± 14.1%; IVL, 85.6% ± 13.3%; P = 0.77). ELCA did not reach noninferiority in the intention-to-treat analysis. The rate of complications was low, with no significant differences in the 3 arms but numerically lower with IVL. Conclusions In the first randomized trial comparing RA, IVL, and ELCA for the treatment of patients with calcified coronary lesions, IVL was noninferior to RA in terms of stent expansion. ELCA did not reach this noninferiority margin compared with RA. No significant differences were observed among the 3 arms regarding minimum stent area, procedural success rate, and complications, which were numerically lower with IVL.
Aims The present analysis from the Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial aims to explore the significance of pre-admission physical activity and assess whether the benefits of physiology-guided complete revascularization apply consistently to sedentary and active older patients.Methods and results Patients aged 75 years or more with myocardial infarction (MI) and multivessel disease were randomized to receive physiology-guided complete revascularization or culprit-only strategy. The primary outcome was a composite of death, MI, stroke, or any revascularization within a year. Secondary endpoints included the composite of cardiovascular death or MI, as well as single components of the primary endpoint. Pre-admission physical activity was categorized into three groups: (i) absent (sedentary), (ii) light, and (iii) vigorous. Among 1445 patients, 692 (48%) were sedentary, whereas 560 (39%) and 193 (13%) performed light and vigorous physical activity, respectively. Patients engaging in light or vigorous pre-admission physical activity exhibited a reduced risk of the primary outcome compared with sedentary individuals [light hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.55-0.91 and vigorous HR 0.14, 95% CI 0.07-0.91, respectively]. These trends were also observed for death, cardiovascular death, or MI. When comparing physiology-guided complete revascularization vs. culprit-only strategy, no significant interaction was observed for primary and secondary endpoints when stratified by sedentary or active status.Conclusion In older patients with MI, pre-admission physical activity emerges as a robust and independent prognostic determinant. Physiology-guided complete revascularization stands out an effective strategy in reducing ischaemic adverse events, irrespective of pre-admission physical activity status.Clinical Trial Registration ClinicalTrials.gov NCT03772743. The Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial has shown that physiology-guided complete revascularization reduces ischaemic adverse events in older patients with myocardial infarction (MI) and multivessel disease. Older patients who engage in light or vigorous physical activity before hospitalization for MI have a reduced risk of the primary composite outcome of death, MI, stroke, or ischaemia-driven revascularization. These benefits extend to all secondary cardiovascular outcomes as well. In the present subanalysis of the FIRE trial, we find that the positive prognosis associated with physiology-guided complete revascularization holds true even for patients with a sedentary lifestyle. This means that this type of revascularization can effectively reduce ischaemic adverse events in older patients with MI and multivessel disease, regardless of their physical activity levels. Graphical Abstract
La atención del paciente con enfermedad cardiovascular por parte de cardiólogos ha demostrado mejores resultados en los distintos espectros. Sin embargo, la presencia de un cardiólogo de guardia es infrecuente en hospitales no terciarios. Se registraron consecutivamente los IAMCEST entre 2006 y 2016 en un centro de segundo nivel. Analizamos y comparamos 2 periodos: con red autonómica de atención al infarto sin guardia cardiológica (2006-2011) y un segundo periodo (2012-2016) con ambas medidas funcionando. Se incluyó a 1.524 pacientes, 47,2% tras el inicio de la guardia cardiológica. Se observó un aumento de la angioplastia primaria desde el inicio de la guardia de cardiología (34,3% al 75,7%, p < 0,001), así como una reducción del tiempo puerta balón en 64 minutos (220 [IQR, 167-290] a 156 [IQR, 130-197], p < 0,001). Esto se traduce en una menor estancia hospitalaria, así como en una reducción de las complicaciones durante la hospitalización, fundamentalmente la isquemia recurrente. Si bien se observa una tendencia a una menor mortalidad hospitalaria, la mortalidad durante el seguimiento no se modificó con la guardia de cardiología. La presencia de un cardiólogo de guardia aumenta el número de pacientes reperfundidos y acorta los tiempos hasta la misma. Esto se traduce en una reducción de las complicaciones hospitalarias, fundamentalmente la isquemia recurrente y la estancia media. Nuestros resultados avalan que la creación de la guardia cardiológica en hospitales no terciarios aporta beneficio adicional a la red de atención al paciente con IAMCEST. Identificador ClinicalTrials.gov: NCT02501070. The care of patients with cardiovascular disease by specialist in cardiology has shown better results in different spectrums. However, the presence of an on-call cardiologist is still rare in non-tertiary hospitals. STEMI was recorded consecutively between 2006 and 2016 in a second level center. We analyzed and compared two periods: regional heart attack care network without a cardiology guard (2006-2011) and a second period (2012-2016) with both measures working. 1524 patients were included, 47.2% after the start of cardiology shift. We observed an increase in primary angioplasty (34.3% to 75.7%, P < .001) as well as a reduction in door-to-balloon time of 64 minutes (220 [IQR, 167-290] to 156 [IQR, 130-197], P < .001). This translates into a shorter hospital stay as well as a reduction in complications during hospitalization, mainly recurrent ischemia. Although there is a trend towards lower hospital mortality, mortality during follow-up did not change with the cardiology guard. The presence of a cardiologist on call increases the number of patients reperfused, and shortens the time until it. This translates into a shorter hospital stay, as well as lower short-term mortality. Our results indicate that the creation of the cardiological guard brings additional benefit to the care network for patients with STEMI. ClinicalTrials.gov identifier: NCT02501070.
Cyclophilins are chaperone proteins that play important roles in signal transduction. Among them, cyclophilins A, B, C, and D were widely associated with inflammation and cardiovascular diseases. Cyclophilins A and C have been proposed as coronary artery disease biomarkers. However, less is known about their relationship with cardiovascular risk factors. Therefore, this study aimed to determine the association between cyclophilin A, B, C, and D and cardiovascular risk factors in coronary artery disease. Serum levels of cyclophilins were measured in 167 subjects (subdivided according to cardiovascular risk factors presence). This study reveals that cyclophilin A and C are elevated in patients regardless of the risk factors presence. Moreover, cyclophilin B is elevated in male patients with hypertension, type 2 diabetes, or high glucose levels. In addition, cyclophilins A, B, and C were significantly correlated with cardiovascular risk factors, but only cyclophilin B was associated with type 2 diabetes. The multivariate analysis strengthens the predictive value for coronary artery disease presence of cyclophilin A (>8.2 ng/mL) and cyclophilin C (>17.5 pg/mL) along with the cardiovascular risk factors tobacco, hypertension, dyslipidemia, and high glucose and cholesterol levels. Moreover, the risk of coronary artery disease is increased in presence of cyclophilin B levels above 63.26 pg/mL and with hypertension or dyslipidemia in male patients. Consequently, cyclophilins A and C serum levels are reinforced as useful coronary artery disease biomarkers, meanwhile, cyclophilin B is a valuable biomarker in the male population when patients are also suffering from hypertension or dyslipidemia.
RESUMEN Introducción y objetivos: La calcificación coronaria es uno de los principales factores que inciden negativamente en la seguridad y la eficacia del intervencionismo coronario percutáneo. Existen varias técnicas de modificación del calcio, pero falta evidencia de estudios aleatorizados sobre la terapia de elección en este escenario. Métodos: El ROLLERCOASTR es un estudio prospectivo, multicéntrico y aleatorizado, diseñado para comparar la seguridad y la eficacia de 3 técnicas de modificación de la placa en el contexto de calcificación coronaria moderada o grave: aterectomía rotacional (AR), aterectomía coronaria con láser láser excimer (ACLE) y litotricia intracoronaria (LIC). El objetivo primario es la expansión del stent evaluada mediante tomografía de coherencia óptica. Su análisis se hará por intención de tratar, con un α de 0,05 entre el grupo de referencia (AR) y cada uno de los otros grupos (ACLE y LIC). Se realizará también un análisis del objetivo primario por protocolo para mantener la coherencia. Si se confirma la hipótesis de no inferioridad, se realizará un análisis bilateral de superioridad. El comité de eventos clínicos y el laboratorio central independiente no conocerán la rama de tratamiento. Asumiendo un error α de 0,05, un error β de 0,2 (80% de potencia), un margen de irrelevancia (ε) del 7% y un 10% de pérdidas por dificultad de medición o imposibilidad de completar la intervención, se estima un tamaño de muestra de 56 casos en cada grupo. Los objetivos secundarios son el éxito del dispositivo, el éxito del procedimiento, la tasa de cruce entre técnicas y la presentación de eventos cardiovasculares adversos importantes al año de seguimiento. Conclusiones: El estudio ROLLERCOASTR evaluará y comparará la seguridad y la eficacia, en pacientes con estenosis coronaria calcificada, de 3 técnicas de modificación de placa: AR, ACLE y LIC. Este ensayo se ha registrado en Clinicaltrials.gov: NCT04181268.