Tratamiento intervencionista de la embolia aguda de pulmón: resultados de un registro multicéntrico / Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry

Introduction and objectives Catheter-directed therapy (CDT) for acute pulmonary embolism (PE) is an emerging therapy that combines heterogeneous techniques. The aim of the study was to provide a nationwide contemporary snapshot of clinical practice and CDT-related outcomes. Methods This Investigator-initiated multicenter registry aimed to include consecutive patients with intermediate-high risk (IHR) or high-risk (HR), acute PE eligible for CDT. The primary outcome of the study was in-hospital all-cause death. Results A total of 253 patients were included, of whom 93 (36.8%) had HR-PE, and 160 (63.2%) had IHR-PE with a mean age of 62.3±15.1 years. Local thrombolysis was performed in 70.8% and aspiration thrombectomy in 51.8%, with 23.3% of patients receiving both. However, aspiration thrombectomy was favored in the HR-PE cohort (80.6% vs 35%; P<.001). Only 51 patients (20.2%) underwent CDT with specific PE devices. The success rate for CDT was 90.9% (98.1% of IHR-PE patients vs 78.5% of HR-PE patients, P<.001). In-hospital mortality was 15.5%, and was highly concentrated in the HR-PE patients (37.6%) and significantly lower in IHR-PE patients (2.5%), P<.001. Long-term (24-month) mortality was 40.2% in HR-PE patients vs 8.2% in IHR-PE patients (P<.001). Conclusions Despite the high success rate for CDT, in-hospital mortality in HR-PE is still high (37.6%) compared with very low IHR-PE mortality (2.5%) (AU)

Introducción y objetivos El emergente tratamiento por catéter (TPC) de la embolia pulmonar (EP) aguda combina técnicas heterogéneas. El objetivo del estudio es describir la práctica clínica contemporánea y los resultados relacionados con la TPC en un registro de ámbito nacional. Métodos Registro multicéntrico iniciado por investigador, destinado a incluir a pacientes con EP aguda consecutivos y en riesgo intermedio-alto (IAR) o alto riesgo (AR) elegibles para TPC. El resultado primario del estudio fue la muerte por cualquier causa en el hospital. Resultados Se incluyó en total a 253 pacientes, 93 (36,8%) con EP-AR y 160 (63,2%) con EP-IAR, de una media de edad de 62,3±15,1. Se realizó trombolisis local al 70,8% de los pacientes, trombectomía aspirativa al 51,8% y ambas al 23,3%. Sin embargo, la trombectomía por aspiración fue más frecuente en la cohorte de EP-AR (el 80,6 frente al 35%; p<0,001). Solo 51 pacientes (20,2%) se sometieron a TPC con dispositivos específicos de EP. El éxito de la TPC fue del 90,9% (el 98,1% de los casos de EP-IAR frente al 78,5% de los de EP-AR; p<0,001). La mortalidad hospitalaria fue del 15,5%, muy concentrada en los casos de EP-AR (37,6%) y significativamente menor entre los de EP-IAR (2,5%; p<0,001). La mortalidad a largo plazo (24 meses) fue del 40,2 en EP-AR frente al 8,2% en EP-IAR (p<0,001). Conclusiones A pesar del elevado éxito de la TPC, la mortalidad hospitalaria por EP-AR sigue siendo alta (37,6%) respeto a la muy baja mortalidad de la EP-IAR (2,5%) (AU)

Efectividad y seguridad de una estrategia de antiagregación plaquetaria simple tras cierre percutáneo de orejuela izquierda en pacientes con FA / Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness

Introduction and objectives The optimal antithrombotic strategy following left atrial appendage closure (LAAC) is poorly defined in patients with nonvalvular atrial fibrillation. We assessed the safety and effectiveness of a single antiplatelet treatment (SAPT) strategy after LAAC in a population at high risk of ischemic and bleeding events. Methods This single-center, observational, prospective study included a consecutive cohort of patients who underwent LAAC using the LAmbre device (Lifetech Scientific, China) and who were discharged with SAPT. The primary outcome was a composite of stroke, systemic embolism, and device-related thrombosis during follow-up. Secondary endpoints were cardiovascular mortality and major bleeding events (BARC ≥3a). Clinical follow-up was performed at 1, 6, and 12 months and subsequently on an annual basis. Transesophageal echocardiography was performed at 1 and 12 months of follow-up. Results The study comprised 74 patients. The median age was 77 [72-83] years and 43% were women. The cohort exhibited a high prevalence of comorbidities and cardiovascular risk factors. The median CHA2DS2-VASc and HAS-BLED scores were 4 [3-6] and 4 [4-5], respectively. The median length of follow-up was 2.5 years (188 patients-year). During follow-up, device-related thrombosis occurred in 3 patients (4%). Ischemic stroke occurred in 1 patient (1.3%, rate 0.5%/y), representing a 90.9% relative risk reduction compared with the risk predicted by CHA2DS2-VASc. Major bleeding events occurred in 12 patients (16%, 6.4%/y), with a relative risk reduction of 26.4% of that predicted by HAS-BLED. Cardiovascular-related mortality was observed in 2 patients (2.7%). Conclusions SAPT appears to be a safe and effective treatment following LAAC in patients at high ischemic and hemorrhagic risk. Further studies are needed to confirm our findings (AU)

Introducción y objetivos Se desconoce cuál es la terapia antitrombótica óptima tras el cierre percutáneo de la orejuela izquierda (CPOI) en pacientes con fibrilación auricular no valvular. El objetivo de este estudio es analizar la efectividad y la seguridad de un régimen de tratamiento antiagregante plaquetario simple (TAPS) tras el CPOI en una población con alto riesgo isquémico y hemorrágico. Métodos Estudio observacional prospectivo que incluyó una cohorte consecutiva de pacientes a los que se realizó CPOI con dispositivo LAmbre (Lifetech Scientific, China) y que recibieron TAPS al alta. El evento primario fue un combinado de ictus, embolia sistémica y trombosis del dispositivo. Los eventos secundarios fueron mortalidad cardiovascular y hemorragia mayor (BARC ≥ 3a). Se realizó seguimiento clínico al mes y a los 6 y 12 meses y cada año después. Se realizó ecocardiograma transesofágico al mes y a los 12 meses. Resultados Se incluyó a 74 pacientes (el 43% mujeres) con una mediana de edad de 77 [intervalo intercuartílico, 72-83] años, que presentaban gran comorbilidad y factores de riesgo cardiovascular. Los valores de CHA2DS2-VASc y HAS-BLED fueron una mediana de 4 [3-6] y 4 [4-5] respectivamente. Durante el seguimiento (mediana, 2,5 años), 3 pacientes (4%) presentaron trombosis del dispositivo. Uno sufrió ictus isquémico (1,3%, 0,5%/año), lo que supone, según la incidencia esperada por CHA2DS2-VASc, una reducción del riesgo relativo del 90,9%. Sufrieron eventos hemorrágicos 12 pacientes (16%; 6,4%/año), una tasa el 26,4% menor que el riesgo HAS-BLED predicho. Se produjo la muerte cardiovascular de 2 pacientes (2,7%). Conclusiones Una estrategia de TAPS tras el CPOI parece ser una opción efectiva y segura para los pacientes con altos riesgos isquémico y hemorrágico. Se necesitan más estudios que corroboren nuestros resultados (AU)

Single antiplatelet therapy after left atrial appendage closure in patients with AF: safety and effectiveness.

INTRODUCTION AND OBJECTIVES: The optimal antithrombotic strategy following left atrial appendage closure (LAAC) is poorly defined in patients with nonvalvular atrial fibrillation. We assessed the safety and effectiveness of a single antiplatelet treatment (SAPT) strategy after LAAC in a population at high risk of ischemic and bleeding events. METHODS: This single-center, observational, prospective study included a consecutive cohort of patients who underwent LAAC using the LAmbre device (Lifetech Scientific, China) and who were discharged with SAPT. The primary outcome was a composite of stroke, systemic embolism, and device-related thrombosis during follow-up. Secondary endpoints were cardiovascular mortality and major bleeding events (BARC ≥3a). Clinical follow-up was performed at 1, 6, and 12 months and subsequently on an annual basis. Transesophageal echocardiography was performed at 1 and 12 months of follow-up. RESULTS: The study comprised 74 patients. The median age was 77 [72-83] years and 43% were women. The cohort exhibited a high prevalence of comorbidities and cardiovascular risk factors. The median CHA2DS2-VASc and HAS-BLED scores were 4 [3-6] and 4 [4-5], respectively. The median length of follow-up was 2.5 years (188 patients-year). During follow-up, device-related thrombosis occurred in 3 patients (4%). Ischemic stroke occurred in 1 patient (1.3%, rate 0.5%/y), representing a 90.9% relative risk reduction compared with the risk predicted by CHA2DS2-VASc. Major bleeding events occurred in 12 patients (16%, 6.4%/y), with a relative risk reduction of 26.4% of that predicted by HAS-BLED. Cardiovascular-related mortality was observed in 2 patients (2.7%). CONCLUSIONS: SAPT appears to be a safe and effective treatment following LAAC in patients at high ischemic and hemorrhagic risk. Further studies are needed to confirm our findings.

Catheter-directed therapy for acute pulmonary embolism: results of a multicenter national registry.

INTRODUCTION AND OBJECTIVES: Catheter-directed therapy (CDT) for acute pulmonary embolism (PE) is an emerging therapy that combines heterogeneous techniques. The aim of the study was to provide a nationwide contemporary snapshot of clinical practice and CDT-related outcomes. METHODS: This Investigator-initiated multicenter registry aimed to include consecutive patients with intermediate-high risk (IHR) or high-risk (HR), acute PE eligible for CDT. The primary outcome of the study was in-hospital all-cause death. RESULTS: A total of 253 patients were included, of whom 93 (36.8%) had HR-PE, and 160 (63.2%) had IHR-PE with a mean age of 62.3±15.1 years. Local thrombolysis was performed in 70.8% and aspiration thrombectomy in 51.8%, with 23.3% of patients receiving both. However, aspiration thrombectomy was favored in the HR-PE cohort (80.6% vs 35%; P<.001). Only 51 patients (20.2%) underwent CDT with specific PE devices. The success rate for CDT was 90.9% (98.1% of IHR-PE patients vs 78.5% of HR-PE patients, P<.001). In-hospital mortality was 15.5%, and was highly concentrated in the HR-PE patients (37.6%) and significantly lower in IHR-PE patients (2.5%), P<.001. Long-term (24-month) mortality was 40.2% in HR-PE patients vs 8.2% in IHR-PE patients (P<.001). CONCLUSIONS: Despite the high success rate for CDT, in-hospital mortality in HR-PE is still high (37.6%) compared with very low IHR-PE mortality (2.5%).

Real-World Multicenter Coronary Lithotripsy Registry: Long-Term Clinical Follow-Up.

OBJECTIVES: Coronary lithotripsy (CL) works by fracturing the calcified plaque, allowing mean area gain, enhancing vessel compliance, and facilitating stent deployment. This study reports the safety, effectiveness, and durability of the clinical benefit of CL at long-term follow-up of a real-world multicenter registry. METHODS: This was a prospective, multicenter, single-arm study that included consecutive patients with calcified lesions undergoing CL from August, 2018 to October, 2020 with a clinical follow-up of 20 months (interquartile range, 14.5-25). Exclusion criteria were a target lesion located in a vessel <2.5 mm and/or the presence of dissection prior to CL. The primary endpoint was the rate of major adverse cardiovascular event (MACE, defined as death or target-lesion revascularization [TLR] or myocardial infarction [MI]) at follow-up. RESULTS: This registry included 109 patients (128 lesions). The population was elderly (mean age, 74 years old), with high rates of diabetic patients (58%), renal insufficiency (32%), and multivessel disease (76%). Most of the lesions were predilated with semicompliant/noncompliant balloons (25 with cutting balloon). Rotational atherectomy was used in 20 lesions. On average, CL required the use of 1 balloon delivering a mean of 60 pulses. Twelve patients presented with ST-segment-elevation MI and a culprit calcified coronary lesion undergoing CL. Successful CL was achieved in 99% of cases. There were few procedural complications, with 30-day freedom from MACE rate of 98%. The MACE rate at long-term follow-up was 5.6%. CONCLUSION: This is the first real-world, multicenter registry that confirms the safety and long-term efficacy of percutaneous coronary intervention for calcified lesions using CL in an unselected and high-risk population with a low long-term follow-up MACE rate.

Procedural Results and One-Year Clinical Outcomes of Treatment of Bioresorbable Vascular Scaffolds Restenosis (from the RIBS VII Prospective Study).

Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032.

Coronary Endothelium-Dependent Vasomotor Function After Drug-Eluting Stent and Bioresorbable Scaffold Implantation.

Background Early generation drug-eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium-dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device-related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable-polymer everolimus-eluting Xience (n=44), bioresorbable-polymer sirolimus-eluting Orsiro (n=35), polymer-free biolimus-eluting Biofreedom (n=24), bioactive endothelial-progenitor cell-capturing sirolimus-eluting Combo DES (n=25), polymer-based everolimus-eluting Absorb (n=44), and Mg-based sirolimus-eluting Magmaris BRS (n=34) underwent endothelium-dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow-up. Crude vasomotor responses of distal segments to low-dose acetylcholine (10-6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (-8.4%±12.6%) and durable-polymer DES had the most physiologic (-0.4%±11.8%; P=0.014). High-dose acetylcholine (10-4 mol/L) showed similar responses between groups (ranging from -10.8%±11.6% to -18.1%±15.4%; P=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable-polymer DES) to 2.5%±4.5% (bioactive DES; P=0.056). In multivariate models, endothelium-dependent vasomotor response was associated with age, bioresorbable-polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low-dose and 68.9% with high-dose acetylcholine, without differences between groups. Conclusions At follow-up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.

Primary Angioplasty of Calcified Coronary Lesions Using Coronary Lithotripsy in Acute ST-Segment Elevation Myocardial Infarction.

BACKGROUND: This study reports procedural and short-term clinical outcomes from a real-world series with the use of coronary lithotripsy in the context of primary angioplasty in ST-segment elevation myocardial infarction (STEMI). METHODS AND RESULTS: This was a prospective registry conducted at 2 hospitals, which included 10 patients who presented a culprit calcified lesion within acute STEMI and underwent coronary lithotripsy during primary angioplasty, between July 2019 and July 2020. Mean age was 69.2 ± 11.8 years, and there was a high proportion of hypertension (70%) and dyslipidemia (60%). All lesions (type B/C) were predilated with a semicompliant balloon. Coronary lithotripsy was performed in all cases once macroscopic thrombus was successfully retrieved by thrombus aspiration catheter. Before lithotripsy, rotational atherectomy was used in 1 case and cutting balloon was used in 2 cases. On average, coronary lithotripsy required the use of 1 lithotripsy balloon (range, 1-2) delivering a mean of 70 pulses. Two lithotripsy balloons were ruptured during lithotripsy therapy without any adverse event. Successful coronary lithotripsy was achieved in 90%. There were no periprocedural cardiac complications. CONCLUSIONS: Coronary lithotripsy seems to be a safe and effective technique in patients with STEMI and a culprit calcified lesion undergoing primary angioplasty for calcium modification in the absence of angiographic thrombus, and a suitable option to achieve adequate stent expansion and apposition.

Left Atrial Appendage Closure with a New Occluder Device: Efficacy, Safety and Mid-Term Performance.

The LAmbreTM device is a novel system designed for left atrial appendage closure (LAAC). First registries showed a high rate of device implantation success. However, few mid-term results are available. We present our 1- and 12-month follow-up results for this device. This prospective, single-center registry included consecutive patients with nonvalvular atrial fibrillation who underwent LAAC with the LAmbreTM device. Transesophageal echocardiography (TEE) was performed at 1-month follow-up. In total, 55 patients were included. The population was elderly (75 ± 9.4 years), with a high proportion of comorbidities. The mean CHA2DS2-VASc and HAS-BLED scores were 4.6 ± 1.6 and 3.9 ± 1.0, respectively. Previous history of a major bleeding event was present in 37 patients (67.3%). Procedural success was achieved in 54 patients (98.2%). Device success was achieved in 100% of patients in whom device implantation was attempted (54 patients). Major in-hospital device-related complications included mortality of one patient (1.8%) and pericardial tamponade in two patients (3.6%); the incidence of stroke was 0%. No thrombus or significant leaks (≥5 mm) were observed on 1-month TEE. At 12 months, adverse events were overall death (1.8%), transient ischemic attack/ischemic stroke (1.8%), and major bleeding events (Bleeding Academic Research Consortium (BARC) 3a and 3c; 11%). In this high-risk population, the LAmbreTM device seems to be a safe and effective option for LAAC with a remarkable mid-term performance.

Coronary endothelial and microvascular function distal to polymer-free and endothelial cell-capturing drug-eluting stents. The randomized FUNCOMBO trial.

INTRODUCTION AND OBJECTIVES: The vasomotor function of new-generation drug-eluting stents designed to enhance stent healing and reendothelialization is unknown. This study aimed to compare the endothelial function of the infarct-related artery (IRA) treated with bioactive circulating endothelial progenitor cell-capturing sirolimus-eluting stents (COMBO) vs polymer-free biolimus-eluting stents (BioFreedom) in ST-segment elevation myocardial infarction patients at 6 months. Secondary objectives were to compare the microcirculatory function of the IRA and stent healing at 6 months. METHODS: Sixty patients were randomized to bioactive sirolimus-eluting stent vs polymer-free biolimus-eluting stents implantation. At 6 months, patients underwent coronary angiography with vasomotor, microcirculatory and optical coherence tomography examinations. Endothelial dysfunction of the distal coronary segment was defined as ≥ 4% vasoconstriction to intracoronary acetylcholine infusion. RESULTS: Endothelial dysfunction was similarly observed between groups (64.0% vs 62.5%, respectively; P=.913). Mean lumen diameter decreased by 16.0 ±20.2% vs 16.1 ±21.6% during acetylcholine infusion (P=.983). Microcirculatory function was similar in the 2 groups: coronary flow reserve was 3.23 ±1.77 vs 3.23±1.62 (P=.992) and the index of microcirculatory resistance was 24.8±16.8 vs 21.3±12.0 (P=.440). Optical coherence tomography findings were similar: uncovered struts (2.3% vs 3.2%; P=.466), malapposed struts (0.1% vs 0.3%; P=.519) and major evaginations (7.1% vs 5.6%; P=.708) were observed in few cases. CONCLUSIONS: Endothelial dysfunction of the IRA was frequent and was similarly observed with new-generation drug-eluting stents designed to enhance stent reendothelialization at 6 months. Endothelial dysfunction was observed despite almost preserved microcirculatory function and complete stent coverage. Larger and clinically powered studies are needed to assess the role of residual endothelial dysfunction in ST-segment elevation myocardial infarction patients. Registered in ClinicalTrials.gov: NCT04202172.

Litoplastia coronaria en lesiones calcificadas: registro multicéntrico de la práctica clínica / Coronary lithoplasty for calcified lesions: real-world multicenter registry

INTRODUCCIÓN Y OBJETIVOS: La litoplastia coronaria (LC) es una técnica con balón que se utiliza para tratar lesiones calcificadas graves. Este estudio describe la experiencia inicial del tratamiento de lesiones calcificadas con LC en una población no seleccionada y de alto riesgo. MÉTODOS: Registro prospectivo, multicéntrico, que incluyó consecutivamente todos los casos con lesiones coronarias calcificadas que se trataron con LC entre agosto de 2018 y agosto de 2019. Los criterios de exclusión fueron lesiones localizadas en vaso pequeño (< 2,5mm) y la presencia de disección previa a la LC. Un laboratorio central independiente realizó la angiografía coronaria cuantitativa y el análisis de la ecocardiografía intravascular/tomografía de coherencia óptica. RESULTADOS: Este registro incluyó a 57 pacientes (66 lesiones). Una población de edad avanzada (72,6±9,4 años) con alta proporción de pacientes diabéticos (56%), enfermedad renal crónica (35%) y enfermedad multivaso (84%). Todas las lesiones eran de tipo B/C. Se predilataron más del 75% de las lesiones con balones semidistensibles/no distensibles o cutting-balloon. Se utilizó rotablación antes de la litoplastia en 5 lesiones (7,6%). En promedio, la LC necesitó 1,17 balones de litoplastia y una media de 60 pulsos. El éxito de la LC se logró en el 98%. En el 13% de los casos, el balón de litoplastia se rompió durante el procedimiento. Hubo pocas complicaciones durante el procedimiento: 2 casos de disección significativa (ninguna relacionada con ruptura del balón de litoplastia), que se trataron con éxito mediante implante de stent farmacoactivo; 1 paciente presentó trombosis del stent 2 días después de someterse con éxito a la revascularización de la lesión objetivo. CONCLUSIONES: Este es un registro multicéntrico de la práctica clínica que respalda la factibilidad, la seguridad y la eficacia a corto plazo de la intervención coronaria percutánea para lesiones coronarias calcificadas utilizando la LC con resultados prometedores en una población no seleccionada y de alto riesgo

INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results

Coronary lithoplasty for calcified lesions: real-world multicenter registry.

INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.

Coronary vasomotor function and myocardial flow with bioresorbable vascular scaffolds or everolimus-eluting metallic stents: a randomised trial.

AIMS: The aim of this study was to compare the hyperaemic flow and vasomotor response to endothelium-dependent stimuli between bioresorbable vascular scaffolds (BVS) and metallic everolimus-eluting stents (EES) at 13 months. METHODS AND RESULTS: Seventy non-diabetic patients aiming to achieve complete revascularisation were randomised 1:1 to BVS or EES implantation. At 13 months, invasive coronary angiography was performed using intracoronary pressure and Doppler ultrasound measurements at rest and maximal hyperaemia. A vasomotor test to endothelium-dependent (acetylcholine) and independent (nitroglycerine) stimuli and optical coherence tomography (OCT) were also performed. Fifty-nine patients (30 BVS and 29 EES) underwent 13-month examination. Doppler ultrasound average peak velocity (49.0±17.5 vs 49.3±18.3 cm/sec; p=0.95), coronary blood flow (97.4±53.5 vs 88.3±46.7 ml/min; p=0.51), coronary flow reserve (2.6±0.9 vs 2.7±0.8; p=0.84) and fractional flow reserve (0.92±0.06 vs 0.94±0.04; p=0.17) were similar between the groups. The vasomotor test showed vasoconstriction response to acetylcholine in 75.6% proximal and 72.2% distal peri-scaffold segments without differences between study devices. BVS had larger in-scaffold vasoconstriction than EES (60.0% vs 27.6%; p=0.01) despite similar neointima response as assessed by OCT. CONCLUSIONS: BVS and EES had similar microcirculatory response to hyperaemia and predominant vasoconstrictive response in the peri-scaffold segments to endothelium-dependent stimuli. However, BVS exhibited larger vasoconstriction to endothelium-dependent stimuli in the scaffold segment.

Estratificación basal de riesgo en pacientes mayores de 75 años con infarto y shock cardiogénico referidos para angioplastia primaria / Baseline risk stratification of patients older than 75 years with infarction and cardiogenic shock undergoing primary angioplasty

Introducción y objetivos: Los pacientes mayores de 75 años con infarto agudo de miocardio con elevación del segmento ST sometidos a angioplastia primaria en situación de shock cardiogénico sufren una gran mortalidad. La identificación previa al procedimento de variables predictoras de la posterior mortalidad sería muy útil para guiar la toma de decisiones. Métodos: Análisis del registro multicéntrico de angioplastia primaria en pacientes mayores de 75 años (ESTROFA MI+75), que incluye a 3.576 pacientes. Se analizaron las características y la evolución clínica del subgrupo con shock cardiogénico para identificar predictores de supervivencia a 1 año tras la angioplastia y elaborar un índice pronóstico. Se validó el índice en una cohorte independiente. Resultados: Se incluyó a 332 pacientes. Los predictores basales independientes fueron: la localización anterior (HR=2,8; IC95%, 1,4-6,0; p=0,005), una fracción de eyección<40% (HR=2,3; IC95%, 1,14-4,50; p=0,018) y un tiempo entre el inicio de los síntomas y la angioplastia >6 h (HR=3,2; IC95%, 1,6-7,5; p=0,001). Se diseñó un índice basado en estas variables (índice «6-ANT-40»). La supervivencia a 1 año fue del 54,5% de aquellos con índice 0, el 32,3% con índice 1, el 27,4% con índice 2 y el 17% con índice 3 (p=0,004, estadístico C=0,70). En una cohorte independiente de 124 pacientes, las supervivencias a 1 año fueron del 64,5, el 40,0, el 28,9 y el 22,2% respectivamente (p=0,008; estadístico C=0,68). Conclusiones: Un índice basado en simples variables clínicas previas al procedimiento (localización anterior, fracción de eyección<40%, demora >6 h) permite estimar la supervivencia tras una angioplastia primaria de los pacientes mayores con shock cardiogénico, y así ayudar en la toma de decisiones

Background and objectives: Patients older than 75 years with ST-segment elevation myocardial infarction undergoing primary angioplasty in cardiogenic shock have high mortality. Identification of preprocedural predictors of short- and long-term mortality could be useful to guide decision-making and further interventions. Methods: We analyzed a nationwide registry of primary angioplasty in the elderly (ESTROFA MI+75) comprising 3576 patients. The characteristics and outcomes of the subgroup of patients in cardiogenic shock were analyzed to identify associated factors and prognostic predictors in order to derive a baseline risk prediction score for 1-year mortality. The score was validated in an independent cohort. Results: A total of 332 patients were included. Baseline independent predictors of mortality were anterior myocardial infarction (HR 2.8, 95%CI, 1.4-6.0; P=.005), ejection fraction<40% (HR 2.3, 95%CI, 1.14-4.50; P=.018), and time from symptom onset to angioplasty >6hours (HR 3.2, 95%CI, 1.6-7.5; P=.001). A score was designed that included these predictive factors (score "6-ANT-40"). Survival at 1 year was 54.5% for patients with score 0, 32.3% for score 1, 27.4% for score 2 and 17% for score 3 (P=.004, c-statistic 0.70). The score was validated in an independent cohort of 124 patients, showing 1-year survival rates of 64.5%, 40.0%, 28.9%, and 22.2%, respectively (P=.008, c-statistic 0.68). Conclusions: A preprocedural score based on 3 simple clinical variables (anterior location, ejection fraction<40%, and delay time >6 hours) may be used to estimate survival after primary angioplasty in elderly patients with cardiogenic shock and to guide preinterventional decision-making

Baseline Risk Stratification of Patients Older Than 75 Years With Infarction and Cardiogenic Shock Undergoing Primary Angioplasty.

BACKGROUND AND OBJECTIVES: Patients older than 75 years with ST-segment elevation myocardial infarction undergoing primary angioplasty in cardiogenic shock have high mortality. Identification of preprocedural predictors of short- and long-term mortality could be useful to guide decision-making and further interventions. METHODS: We analyzed a nationwide registry of primary angioplasty in the elderly (ESTROFA MI+75) comprising 3576 patients. The characteristics and outcomes of the subgroup of patients in cardiogenic shock were analyzed to identify associated factors and prognostic predictors in order to derive a baseline risk prediction score for 1-year mortality. The score was validated in an independent cohort. RESULTS: A total of 332 patients were included. Baseline independent predictors of mortality were anterior myocardial infarction (HR 2.8, 95%CI, 1.4-6.0 P=.005), ejection fraction<40% (HR 2.3, 95%CI, 1.14-4.50 P=.018), and time from symptom onset to angioplasty >6hours (HR 3.2, 95%CI, 1.6-7.5; P=.001). A score was designed that included these predictive factors (score "6-ANT-40"). Survival at 1 year was 54.5% for patients with score 0, 32.3% for score 1, 27.4% for score 2 and 17% for score 3 (P=.004, c-statistic 0.70). The score was validated in an independent cohort of 124 patients, showing 1-year survival rates of 64.5%, 40.0%, 28.9%, and 22.2%, respectively (P=.008, c-statistic 0.68). CONCLUSIONS: A preprocedural score based on 3 simple clinical variables (anterior location, ejection fraction<40%, and delay time >6 hours) may be used to estimate survival after primary angioplasty in elderly patients with cardiogenic shock and to guide preinterventional decision-making.

Hallazgos por IVUS en trombosis de stent tardía y muy tardía. Comparación entre stents metálicos y farmacoactivos / IVUS findings in late and very late stent thrombosis. A comparison between bare-metal and drug-eluting stents

Introducción y objetivos: La trombosis de stent (TS) es una complicación grave tras la angioplastia coronaria, y la ecografía intravascular es una herramienta capaz de discernir las causas. El objetivo es comparar los hallazgos por ecografía intravascular entre stents metálicos (SM) y stents farmacoactivos (SFA) en pacientes con TS tardía (de 31 días a 1 año) o muy tardía (>1año). Métodos: Se incluyó a 114 pacientes (el 45,5% con SM y el 54,5% con SFA) de un total de 250 consecutivos con TS tardía o muy tardía en 7 hospitales españoles. Se realizó una ecografía intravascular, que se analizó posteriormente para detectar la presencia de malaposición, infraexpansión y neoateroesclerosis. Resultados: El tiempo hasta la TS fue de 4,0 años en los SM y 3,4 años en los SFA (p = 0,04). La malaposición fue similar en ambos grupos (el 36,5 frente al 46,8%; p = 0,18), aunque numéricamente menor en los SM con trombosis muy tardía (el 26,6 frente al 48,0%; p = 0,07). La infraexpansión se observó de manera similar en ambos grupos (el 13,5 frente al 11,3%; p = 0,47). La neoateroesclerosis solo se observó en TS muy tardías y fue más prevalente en los SM (22,9%) que en los SFA (6,0%; p = 0,02). A los 2,9 años de seguimiento, las muertes cardiacas eran 0 frente a 6,9% respectivamente (p = 0,06) y las recurrencias de TS se produjeron en el 4,0 frente al 5,2% (p = 0,60). Conclusiones: La malaposición es el hallazgo más frecuente en los pacientes con TS tardía y muy tardía, más prevalente en los SFA con TS muy tardías. Sin embargo, la neoateroesclerosis se observó únicamente en pacientes con TS muy tardías, y principalmente en SM

Introduction and objectives: Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year). Methods: Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis. Results: The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60). Conclusions: Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS

Multivessel disease in patients over 75years old with ST elevated myocardial infarction. Current management strategies and related clinical outcomes in the ESTROFA MI+75 nation-wide registry.

BACKGROUND: In elderly patients with ST elevated myocardial infarction (STEMI) and multivessel disease (MVD the outcomes related with different revascularization strategies are not well known. METHODS: Subgroup-analysis of a nation-wide registry of primary angioplasty in the elderly (ESTROFA MI+75) with 3576 patients over 75years old from 31 centers. Patients with MVD were analyzed to describe treatment approaches and 2years outcomes. RESULTS: Of 1830 (51%) with MVD, 847 (46%) underwent multivessel revascularization either in acute (51%), staged (44%) or both procedures (5%). Patients with previous myocardial infarction and those receiving drug-eluting stents or IIb-IIIa inhibitors were more prone to be revascularized, whereas older patients, females and those with Killip III-IV, renal failure and higher ejection fraction were less likely. Survival free of cardiac death and infarction at 2years was better for those undergoing multivessel PCI (85.8% vs. 80.4%, p<0.0008), regardless of Killip class. Multivessel PCI was protective of cardiac death and infarction (HR 0.60, 95% CI 0.40-0.89; p=0.011). Complete revascularization made no difference in outcomes among those patients undergoing multivessel PCI. The best prognosis corresponded to those undergoing multivessel PCI in staged procedures (p<0.001). A propensity score matching analysis (514 patients in each group) yielded similar results. CONCLUSIONS: In elderly patients with STEMI and MVD, multivessel PCI was related with better outcomes especially after staged procedures. Among those undergoing multivessel PCI, anatomically defined completeness of revascularization had not prognostic influence. SUMMARY: We sought to investigate the revascularization strategies applied and their prognostic implications in patients aged over 75years with ST elevated myocardial infarction showing multivessel disease. Of 1830 patients, 847 (46%) underwent multivessel PCI either in acute (51%), staged (44%) or both procedures (5%). Multivessel PCI was independent predictor of cardiac death and infarction with the best prognosis corresponding to those undergoing staged procedures.

IVUS Findings in Late and Very Late Stent Thrombosis. A Comparison Between Bare-metal and Drug-eluting Stents.

INTRODUCTION AND OBJECTIVES: Stent thrombosis (ST) is a life-threatening complication after stent implantation. Intravascular ultrasound is able to discern most causes of ST. The aim of this study was to compare intravascular ultrasound findings between bare-metal stents (BMS) and drug-eluting stents (DES) in patients with late (31 days to 1 year) or very late ST (> 1 year). METHODS: Of 250 consecutive patients with late or very late ST in 7 Spanish institutions, 114 patients (45.5% BMS and 54.5% DES) were imaged with intravascular ultrasound. Off-line intravascular ultrasound analysis was performed to assess malapposition, underexpansion, and neoatherosclerosis. RESULTS: The median time from stent implantation to ST was 4.0 years with BMS and 3.4 years with DES (P = .04). Isolated malapposition was similarly observed in both groups (36.5% vs 46.8%; P = .18) but was numerically lower with BMS (26.6% vs 48.0%; P = .07) in patients with very late ST. Isolated underexpansion was similarly observed in both groups (13.5% vs 11.3%; P = .47). Isolated neoatherosclerosis occurred only in patients with very late ST and was more prevalent with BMS (22.9%) than with DES (6.0%); P = .02. At 2.9 years' follow-up, there were 0% and 6.9% cardiac deaths, respectively (P = .06) and recurrent ST occurred in 4.0% and 5.2% of patients, respectively (P = .60). CONCLUSIONS: Malapposition was the most common finding in patients with late and very late ST and is more prevalent with DES in very late ST. In contrast, neoatherosclerosis was exclusively observed in patients with very late ST and mainly with BMS.