Spanish cardiac catheterization and coronary intervention registry. 32nd official report of the Interventional Cardiology Association of the Spanish Society of Cardiology (1990-2022).

INTRODUCTION AND OBJECTIVES: This article presents the annual activity report of the Interventional Cardiology Association of the Spanish Society of Cardiology (ACI-SEC) for the year 2022. METHODS: All Spanish centers with catheterization laboratories were invited to participate. Data were collected online and were analyzed by an external company in collaboration with the members of the board of the ACI-SEC. RESULTS: A total of 111 centers participated. The number of diagnostic studies increased by 4.8% compared with 2021, while that of percutaneous coronary interventions (PCI) remained stable. PCIs on the left main coronary artery increased by 22%. The radial approach continued to be preferred for PCI (94.9%). There was an upsurge in the use of drug-eluting balloons, as well as in intracoronary imaging techniques, which were used in 14.7% of PCIs. The use of pressure wires also increased (6.3% vs 2021) as did plaque modification techniques. Primary PCI continued to grow and was the most frequent treatment (97%) in ST-segment elevation myocardial infarction. Most noncoronary procedures maintained their upward trend, particularly percutaneous aortic valve implantation, atrial appendage closure, mitral/tricuspid edge-to-edge therapy, renal denervation, and percutaneous treatment of pulmonary arterial disease. CONCLUSIONS: The Spanish cardiac catheterization and coronary intervention registry for 2022 reveals a rise in the complexity of coronary disease, along with a notable growth in procedures for valvular and nonvalvular structural heart disease.

Treatment with SGLT2 Inhibitors in Patients with Diabetes Mellitus and Extensive Coronary Artery Disease: Mortality and Cardiovascular Outcomes.

INTRODUCTION: Sodium-glucose type 2 cotransporter inhibitors (SGLT2-I) have shown solid benefits in reducing cardiovascular mortality and admissions for heart failure in patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease. However, no specific studies exist in patients with high-risk coronary artery disease (CAD). METHODS: Single-center, retrospective, observational study including patients with T2DM and a new diagnosis of extensive CAD (defined as left main disease or three main coronary vessel disease). Patients were recruited from 2015 until 2020, with a follow-up of at least 12 months. The primary outcome was to compare all-cause mortality in patients treated with or without SGLT2-I at discharge and adjusted by inverse probability of treatment weighting (IPTW) propensity score. RESULTS: A total of 420 patients were included: 104 (24.7%) were treated with SGLT2-I and 316 (75.3%) were not (non-SGLT2-I group). The presentation was acute coronary syndrome in 44.3%. The mean age was 71.2 ± 10.5 years. The mean left ventricular ejection fraction was 51.5 ± 12.5%, and the mean estimated glomerular filtration rate was 73.9 ± 22 ml/min. After a mean follow-up of 3 ± 1.6 years, all-cause mortality was 16.4%, and cardiovascular mortality was 9.5%. After IPTW, the risk of all-cause death was lower in the SGLT2-I group with a hazard ratio of 0.32 (95% confidence interval 0.12-0.81), p = 0.016. With regard to secondary outcomes, patients in the SGLT2-I group were associated with less renal function deterioration but an increase in unplanned revascularizations. CONCLUSIONS: In patients with T2DM and extensive CAD, treatment with SGLT2-I after discharge was associated with a reduced risk of all-cause death.

Vascular healing responses to paclitaxel coated balloons or everolimus eluting stents for the treatment of in-stent restenosis. Insights from optical coherence tomography.

BACKGROUND: Treatment of in-stent restenosis (ISR) remains a significant challenge. Current options include repeat stenting or drug-coated balloons. However, there is a paucity of data regarding vascular healing after these strategies. We, aimed to compare optical coherence tomography (OCT)-based vessel healing after treatment with paclitaxel-coated balloons (PCB) or everolimus-eluting stents (EES). METHODS: An OCT substudy (baseline and 6-9 months) of patients from RIBS IV and RIBS V, two prospective multicenter, randomized controlled clinical trials comparing PCB vs. EES in patients with ISR was performed. RESULTS: Sixty-four patients were included (30 PCB and 34 EES). There were no differences in the baseline or angiographic characteristics between groups. Both groups had the same proportion of drug-eluting and bare-metal stent (BMS) ISR. Baseline OCT analysis did not show differences in the qualitative characteristics of the ISR nor the restenotic tissue burden. Follow-up OCT showed a larger mean lumen area in the EES group (6.03 ± 1.5 vs. 5.24 ± 1.3 mm 2 ; P = 0.043) but no difference in angiographic restenosis ( P = 0.66). Percentage tissue coverage was higher with PCB vs. EES (26 ± 13 vs. 19 ± 11%; P = 0.031). EES-treated ISR more frequently had uncovered struts at follow-up [21 (72%) vs. 12 (44%); P = 0.034]. Tissue covering struts more frequently had a high backscatter structure after PCB [21 (78%) vs. 16 (55%); P = 0.07]. CONCLUSIONS: Compared with EES, ISR treated with PCB demonstrated more strut coverage with mainly high backscattering tissue. Larger OCT-defined neointimal proliferation in PCB-treated ISR did not translate into higher angiographic restenosis rates.

Safety of coronary revascularization deferral based on fractional flow reserve and instantaneous wave-free ratio in patients with chronic kidney disease.

BACKGROUND: The safety of revascularization deferral according to pressure wire examination in patients with chronic kidney disease (CKD) has not been fully established. METHODS: From a retrospective cohort of 439 patients in whom revascularization was deferred after physiological assessment, we examined the incidence of patient-oriented composite endpoint (POCE: all-cause death, myocardial infarction [MI] and unplanned revascularization) in patients with CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m²) and without it. RESULTS: At 4 years of follow-up, the primary endpoint was met by 25.0% of patients with CKD and by 14.4% of patients without CKD (hazard ratio [HR] 1.56, 95% confidence interval [CI] 0.96-2.53, p = 0.071). The incidence of POCE was even higher in patients with an eGFR < 30 mL/min/1.73 m²: 43.8% (HR 3.10, 95% CI 1.08-8.92, p = 0.036). However, no differences were observed in the incidence of MI (4.2% vs. 4.4% in non-CKD), target vessel revascularization (5.8% vs. 5.9%), and target vessel MI (0.8% vs. 4.6%). CONCLUSIONS: Patients with CKD in whom pressure-wire evaluation led to deferral of coronary revascularization develop more POCE in the long term, compared to patients with normal renal function. However, the increase in POCE in patients with CKD was seldom related to deferred vessels, thus suggesting an epiphenomenon of an intrinsically higher cardiovascular risk of CKD patients.

Influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con reestenosis en el stent / Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis

Introducción y objetivos La neoateroesclerosis es una de las causas de la reestenosis en el stent (RS). Nuestro objetivo es evaluar la influencia de la neoateroesclerosis en el pronóstico y la respuesta al tratamiento de los pacientes con RS. Métodos Se trata de un análisis conjunto de los subestudios de tomografía de coherencia óptica (OCT) de los RIBS IV y V, 2 ensayos clínicos aleatorizados y multicéntricos que comparan el tratamiento con un balón recubierto con paclitaxel frente al stent liberador de everolimus en pacientes con RS. La evaluación con OCT se realizó basalmente y a los 6-9 meses. La neoateroesclerosis se definió en la OCT basal como una neoíntima con contenido calcificado o lipídico. Se evaluaron los resultados angiográficos y por OCT a los 6-9 meses y la aparición de eventos adversos cardiovasculares mayores a los 3 años de seguimiento en pacientes con y sin neoateroesclerosis tratados con balón recubierto con paclitaxel o stent liberador de everolimus. Resultados Se estudió mediante OCT a 64 pacientes en el momento del procedimiento. Se documentó neoateroesclerosis en 23 lesiones (36%). El seguimiento angiográfico a los 6-9 meses no mostró diferencias entre los pacientes con y sin neoateroesclerosis en reestenosis (5 [24%] frente a 6 [15%]; p=0,49), diámetro luminal mínimo (1,79±0,7 frente a 1,94±0,6 mm; p=0,41) o pérdida tardía (0,33±0,7 frente a 0,15±0,5; p=0,34). El seguimiento con OCT confirmó la ausencia de diferencias en los parámetros cuantitativos y las características del tejido de recubrimiento entre los 2 grupos. A los 3 años de seguimiento, la incidencia de eventos fue de 3 (13%) frente a 5 (12%) en los grupos con y sin neoateroesclerosis respectivamente (HR=0,94; IC95%, 0,22-3,93; p=0,93). Conclusiones En este estudio con una pequeña muestra de pacientes aleatorizados a tratamiento con balón recubierto con paclitaxel o stent liberador de everolimus por RS, ... (AU)

Introduction and objectives Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. Methods This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. Results Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). Conclusions In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR. (AU)

Clinical Profile and 30-Day Mortality of Invasively Managed Patients with Suspected Acute Coronary Syndrome During the COVID-19 Outbreak.

The COVID-19 pandemic severely disrupted cardiovascular care during the spring of 2020 in Europe. Our study analyzed the clinical profile, COVID-19 impact, and 30-day prognosis of invasively managed patients with acute coronary syndrome (ACS) compared to a historical cohort.All invasively managed ACS patients from March 1st to April 30th, 2020 were compared to a cohort from the same timeframe of 2019 (n = 316). COVID-19 confirmed cases were defined by a positive SARS-CoV-2 polymerase chain reaction (PCR) test (CoV+). The primary outcome was all-cause 30-day mortality and multivariable predictors of this outcome.A 40.4% reduction in ACS patients was noted (198 cases in 2019 to 118 in 2020), and 11% of 2020 ACS patients were CoV+. Baseline characteristics were similar between groups. There were significantly more in-hospital patients with ACS (15.3% versus 6.1%, P = 0.007), and fewer patients were found to have a culprit lesion (58.5% versus 74.2%, P = 0.004) in 2020 compared to 2019. Thirty-day mortality in 2020 (7%) was not different from that in 2019 (4.2%), P = 0.294, but it was significantly higher in CoV+ patients (23.1%) compared to that in negative SARS-CoV-2 PCR test (CoV-) patients (5%), P = 0.047, in the 2020 group. In the multivariate analysis, CoV+ was an independent mortality predictor (OR = 9.8, 95% CI = 1.48-64.78), along with the left ventricular ejection fraction (LVEF) (OR = 0.91, 95% CI = 0.86-0.97), P = 0.0006.This study found increased 30-day mortality of invasively managed CoV+ ACS patients compared to that of CoV- patients during the 2020 COVID-19 spring outbreak. In the multivariable analysis, a SARS-CoV-2 positive test was independently associated with 30-day mortality. Further investigations of the underlying physiopathological relations between COVID-19 and ACS are warranted.

Influence of neoatherosclerosis on prognosis and treatment response in patients with in-stent restenosis.

INTRODUCTION AND OBJECTIVES: Neoatherosclerosis is one of the causes of in-stent restenosis (ISR). Our objective was to evaluate the influence of neoatherosclerosis on prognosis and treatment response in patients with ISR. METHODS: This is a pooled analysis of the optical coherence tomography (OCT)-substudies of 2 multicenter, randomized clinical trials, RIBS IV and V, comparing treatment with paclitaxel-coated balloon vs everolimus-eluting stent in patients with ISR. OCT evaluation was performed at baseline and at 6 to 9 months. Neoatherosclerosis was defined in baseline OCT as neointima with calcified or lipid content. We evaluated the angiographic and OCT results at 6 to 9 months and the occurrence of major adverse cardiovascular events at 3 years of follow-up in patients with and without neoatherosclerosis treated with paclitaxel-coated balloon or everolimus-eluting stents. RESULTS: Sixty-four patients underwent OCT at the time of the index procedure. Neoatherosclerosis was documented in 23 (36%) lesions. Angiographic follow-up at 6 to 9 months showed no differences in restenosis [5 (24%) vs 6 (15%) P=.49], minimum lumen diameter (1.79±0.7 vs 1.94±0.6mm; P=.41) or late loss (0.33±0.7 vs 0.15±0.5; P=.34) in patients with and without neoatherosclerosis, respectively. Follow-up OCT confirmed the absence of differences in quantitative parameters and the characteristics of tissue coverage between the 2 groups. At 3 years of follow-up, the major adverse cardiovascular events rate was 3 (13%) vs 5 (12%) in the neoatherosclerosis and nonneoatherosclerosis groups (HR, 0.94; 95%CI, 0.22-3.93; P=.93). CONCLUSIONS: In this limited study population, OCT-defined neoatherosclerosis did not seem to influence acute and long-term outcomes in patients randomized to paclitaxel-coated balloon or everolimus-eluting stents for ISR.

Clinical outcomes by optical characteristics of neointima and treatment modality in patients with coronary in-stent restenosis.

BACKGROUND: Drug-coated balloons (DCB) and drug-eluting stents (DES) represent the currently recommended treatments for in-stent restenosis (ISR). Optical coherence tomography (OCT) allows detailed neointimal characterisation which can guide treatment strategies. AIMS: The aims of this study were first, to assess the relation between neointimal pattern and clinical outcomes following in-stent restenosis (ISR) treatment, and second, to explore a potential interaction between neointimal pattern and treatment modality relative to clinical outcomes. METHODS: Patients undergoing OCT-guided treatment (DCB or DES) of ISR in three European centres were included. Based on the median of distribution of non-homogeneous neointima quadrants, patients were categorised into low and high inhomogeneity groups. RESULTS: A total of 197 patients (low inhomogeneity=100 and high inhomogeneity=97) were included. There were no significant differences in terms of major adverse cardiac events (MACE) (p=0.939) or target lesion revascularisation (TLR) (p=0.732) between the two groups. The exploratory analysis showed a significant interaction between neointimal pattern and treatment modality regarding MACE (pint=0.006) and TLR (pint=0.022). DES showed a significant advantage over DCB in the high (MACE: HR 0.26 [0.10-0.65], p=0.004; TLR: HR 0.28 [0.11-0.69], p=0.006), but not in the low inhomogeneity group (MACE: p=0.917; TLR: p=0.797). CONCLUSIONS: In patients with ISR treated with DCB or DES, there were no significant differences in terms of MACE or TLR between the low and high inhomogeneity groups. A significant interaction was observed between treatment modality and neointimal pattern with an advantage of DES over DCB in the high and no difference in the low inhomogeneity group. This warrants confirmation from prospective dedicated studies.

Qualitative and quantitative neointimal characterization by optical coherence tomography in patients presenting with in-stent restenosis.

AIMS: To describe optical coherence tomography (OCT) findings in patients with in-stent restenosis (ISR) and determine predictors of neointimal patterns and neoatherosclerosis. METHODS AND RESULTS: Patients undergoing OCT prior to PCI for ISR in three European centres were included. Analyses were performed in a core laboratory. Qualitative and quantitative [gray-scale signal intensity (GSI)] neointima analyses were performed on a per quadrant basis. A total of 107 patients were included. Predominantly homogeneous lesions included 4.5% (0.0-14.3) non-homogeneous quadrants, while predominantly non-homogeneous ones included 28.1% (20.3-37.5) homogeneous quadrants. Mean GSI values differed significantly between homogeneous [108.4 (92.5-123.6)], non-homogeneous [79.9 (61.2-95.9)], and neoatherosclerosis [88.3 (72.8-104.9)] quadrants (p < 0.001 for all comparisons). Stent underexpansion was observed in 48.5% and 61.1% of lesions, respectively (p = 0.225). Female sex and maximal neointimal thickness independently correlate with a non-homogeneous pattern, while angiographic pattern and diabetes mellitus inversely correlate with such pattern. Time from index stenting procedure was the only independent predictor of neoatherosclerosis. CONCLUSIONS: Different neointimal patterns coexist in a significant proportion of ISR lesions. GSI values differ significantly between neointimal categories. Neoatherosclerosis is a time-dependent phenomenon, displaying different time courses in DES compared to BMS, with earlier appearance in the former group. Stent underexpansion is a frequent finding in patients with ISR.

ST-Elevation Myocardial Infarction in Patients ≤35 Years of Age.

ST-elevation myocardial infarction (STEMI) in very young patients is an uncommon entity but with significant clinical meaning for the patient. These individuals may have different risk profiles and prognosis. Few reports have described epidemiology, clinical features, and long-term outcomes of these patients in the era of percutaneous coronary intervention, particularly of those ≤35. This observational study evaluates the clinical characteristics of patients <35 years with STEMI between January 2004 and September 2016 in 3 different centers. We gathered data and follow-up from the prospective database of the interventional cardiology department, medical history, and phone interviews. Over a total of 3,883 STEMI, we retrieved 61 patients ≤35. They were mainly male (88%), smokers (80%), and overweight (67%). Twenty-six percent were drug consumers. Only 2 patients (3%) were free of conventional risk factors. In-hospital mortality was 5% (3 deaths). They were followed-up for 5.9 ± 4.2 years with a total survival of 96.6% (2 deaths). Major adverse cardiovascular events incidence at the end of follow-up was only 17.2% (10 patients). STEMI in the young is a rare condition. These patients have several modifiable predisposing factors, a low clinical risk profile, and excellent short- and long-term prognosis with state-of-the-art treatment.

Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials.

OBJECTIVES: Individual randomized trials comparing drug-eluting balloons (DEB) versus everolimus-eluting stents (EES) for in-stent restenosis (ISR) were underpowered for clinical end-points. The objective of this study was to compare the clinical outcomes of DEB versus EES for any ISR. MATERIALS & METHODS: Electronic databases were searched for randomized trials which compared DEB versus EES for any ISR (i.e., drug eluting or bare metal stents). Summary estimate risk ratios (RRs) were constructed using a DerSimonian and Laird random effects model. RESULTS: Five trials with 962 patients were included. In-segment minimum lumen diameter (MLD) was lower with DEB (standardized mean difference -0.24, 95% confidence interval [CI] -0.46 - -0.01) on angiographic follow-up at a mean of 8.6 months. There was no statistically significant difference in the risk of target vessel revascularization (TVR) at 1 year (RR 1.15, 95% CI 0.60-2.19), but TVR was increased with DEB at 3 years (RR 1.87, 95% CI 1.15-3.03). The risk of target lesion revascularization (TLR) was statistically increased with DEB (RR 2.17, 95% CI 1.13-4.19) at a mean of 24.4 months. There was no difference in the risk of MI, stent thrombosis, cardiac mortality and all-cause mortality between both groups. CONCLUSION: In patients with any type of ISR, DEB was associated a similar risk of TVR at 1-year, but increased risk of TVR and TLR at longer follow-up, as compared with EES. The quality of evidence was moderate, suggesting the need for further randomized trials with longer follow-up to confirm the role of DEB in the management of ISR.

Monoterapia antiplaquetaria tras intervención coronaria percutánea. Resultados contemporáneos a largo plazo y comparación con la práctica habitual / Antiplatelet monotherapy after percutaneous coronary intervention. Contemporary long-term outcomes and matched comparison with routine clinical practice

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Lesión culpable bifurcada en infarto agudo de miocardio con elevación del segmento ST: éxito del procedimiento y pronóstico a 5 años comparado con lesión no bifurcada / Bifurcation culprit lesions in ST-segment elevation myocardial infarction: procedural success and 5-year outcome compared with nonbifurcation lesions

Introducción y objetivos: En el infarto agudo de miocardio con elevación del segmento ST, se compararon los resultados a corto y largo plazo de la angioplastia primaria de lesiones culpables bifurcadas (LCB) y no bifurcadas (LCNB). Métodos: Estudio observacional con grupo de control emparejado (1:1) por puntuación de propensión. En un total de 2.746 infartos agudos de miocardio con elevación del segmento ST consecutivos, se encontraron 274 casos de LCB (10%). El resultado principal es un combinado de muerte por cualquier causa, infarto, cirugía de revascularización coronaria o revascularización de vaso diana a 30 días y a 5 años. Resultados: No había diferencias clínicas entre los grupos emparejados (1:1). En el grupo de LCB, el tratamiento predominante fue un stent en la rama principal (84%). Respecto al grupo de LCNB, los procedimientos fueron más complejos en cuanto a dilatación con balón (el 71% de las LCB frente al 59% de las LCNB; p = 0,003), duración del procedimiento (70 ± 29 frente a 62,8 ± 28,9 min; p = 0,004) y consumo de contraste (256,2 ± 87,9 frente a 221,1 ± 82,3 ml; p < 0,001). El éxito angiográfico en la rama principal fue similar (el 93,4 frente al 93,8%; p = 0,86). La mortalidad a 30 días fue similar (el 4,7 frente al 5,1%; p = 0,84). A los 5 años de seguimiento, no había diferencias en mortalidad (el 12 frente al 13%; p = 0,95) ni en el objetivo combinado (el 22 frente al 21%; p = 0,43). Conclusiones: La angioplastia primaria de las LCB fue técnicamente más compleja, pero el éxito en la rama principal fue similar y no se hallaron diferencias en el pronóstico a largo plazo respecto a las LCNB

Introducción y objetivos: En el infarto agudo de miocardio con elevación del segmento ST, se compararon los resultados a corto y largo plazo de la angioplastia primaria de lesiones culpables bifurcadas (LCB) y no bifurcadas (LCNB). Métodos: Estudio observacional con grupo de control emparejado (1:1) por puntuación de propensión. En un total de 2.746 infartos agudos de miocardio con elevación del segmento ST consecutivos, se encontraron 274 casos de LCB (10%). El resultado principal es un combinado de muerte por cualquier causa, infarto, cirugía de revascularización coronaria o revascularización de vaso diana a 30 días y a 5 años. Resultados: No había diferencias clínicas entre los grupos emparejados (1:1). En el grupo de LCB, el tratamiento predominante fue un stent en la rama principal (84%). Respecto al grupo de LCNB, los procedimientos fueron más complejos en cuanto a dilatación con balón (el 71% de las LCB frente al 59% de las LCNB; p = 0,003), duración del procedimiento (70 ± 29 frente a 62,8 ± 28,9 min; p = 0,004) y consumo de contraste (256,2 ± 87,9 frente a 221,1 ± 82,3 ml; p < 0,001). El éxito angiográfico en la rama principal fue similar (el 93,4 frente al 93,8%; p = 0,86). La mortalidad a 30 días fue similar (el 4,7 frente al 5,1%; p = 0,84). A los 5 años de seguimiento, no había diferencias en mortalidad (el 12 frente al 13%; p = 0,95) ni en el objetivo combinado (el 22 frente al 21%; p = 0,43). Conclusiones: La angioplastia primaria de las LCB fue técnicamente más compleja, pero el éxito en la rama principal fue similar y no se hallaron diferencias en el pronóstico a largo plazo respecto a las LCNB

Comparación de la hemodinámica valvular de la prótesis transcatéter con balón expandible SAPIEN 3 frente a la autoexpandible Evolut R: estudio de casos emparejados / Comparison of the hemodynamic performance of the balloon-expandable SAPIEN 3 versus self-expandable evolut R transcatheter valve: a case-matched study

Introducción y objetivos: Las válvulas SAPIEN 3 (S3) y Medtronic Evolut R (EVR) son prótesis transcatéter de segunda generación, diseñadas para reducir el grado de insuficiencia aórtica (IAo) paravalvular. El objetivo es comparar la hemodinámica valvular en un estudio de casos emparejados con análisis ecocardiográfico independiente. Métodos: De una población de 201 pacientes tratados con implante percutáneo de válvula aórtica, se emparejó a un total de 144 (S3, n = 80; EVR, n = 64) en función del diámetro del anillo y de la puntuación de calcio aórtico medidos por tomografía computarizada. Los ecocardiogramas de seguimiento basal, al mes y a los 6 meses se analizaron de manera independiente y centralizada. Resultados: No se observaron diferencias respecto a las características basales clínicas y ecocardiográficas. La prótesis EVR mostró un mejor perfil hemodinámico evaluado mediante gradiente aórtico máximo (EVR frente a S3, 13 ± 7 frente a 20 ± 10; p < 0,001), gradiente aórtico medio (7 ± 3 frente a 11 ± 6; p < 0,001) e índice de velocidad Doppler (0,65 ± 0,15 frente a 0,51 ± 0,16; p < 0,001). Por otro lado, la tasa de IAo paravalvular moderada-grave o de cualquier grado de IAo paravalvular (≥ leve) fue mayor en el grupo de EVR (el 11 y el 50%) que en el de S3 (el 2,5 y el 21%; p < 0,05), con mayor número de chorros regurgitantes (p < 0,001). Conclusiones: En una cohorte de casos emparejados tratados con implante percutáneo de válvula aórtica de segunda generación, la S3 se asoció con una menor tasa de IAo paravalvular y mayor gradiente transprotésico residual que con la EVR

Introduction and objectives: The SAPIEN 3 (S3) valve and the Medtronic Evolut R (EVR) are second-generation transcatheter valves, designed to further reduce the rate of paravalvular aortic regurgitation (AoR). The aim of this study was to compare the 2 devices in terms of valve performance in a case-matched study with independent echocardiographic analysis. Methods: Of a population of 201 patients who underwent transcatheter aortic valve implantation, 144 patients (S3, n = 80; EVR, n = 64) were matched according to aortic annulus diameter and aortic valve calcium score, as assessed by computed tomography. All echocardiographic examinations collected at baseline and at 1- and 6-month follow-up were centrally analyzed. Results: The 2 groups were well balanced in baseline clinical and echocardiographic characteristics. The EVR valve showed a better hemodynamic profile as assessed by peak aortic gradient (EVR 13 ± 7 vs S3 20 ± 10 mmHg; P < .001), mean aortic gradient (EVR 7 ± 3 vs S3 11 ± 6 mmHg; P < .001), and Doppler velocity index (EVR 0.65 ± 0.15 vs S3 0.51 ± 0.16; P < .001). The rate of moderate-severe or any paravalvular (≥ mild) AoR was higher in the EVR group (11% and 50%) than in the S3 group (2.5% and 21%; P < .05, respectively), with a larger number of paravalvular jets (P < .001). Conclusions: In a case-matched cohort of transcatheter aortic valve implantation patients, the S3 valve was associated with a lower rate of paravalvular AoR but also with a higher residual gradient than the EVR system

Incidencia y predictores de la reestenosis recurrente tras angioplastia con balón farmacoactivo en reestenosis de stents farmacoactivos: proyecto cooperativo ICARUS / Incidence and predictors of recurrent restenosis after drug-coated balloon angioplasty for restenosis of a drUg-eluting Stent: the ICARUS cooperation

Introducción y objetivos: No se ha estudiado bien la incidencia y los predictores de la reestenosis recurrente tras angioplastia con balón farmacoactivo (BFA) en reestenois de stents farmacoactivos (SFA). Nuestro objetivo es analizar la incidencia y los predictores de la reestenosis recurrente en los estudios aleatorizados en que se utilizaron BFA para el tratamiento de la reestenosis del SFA. Métodos: Los datos clínicos y anatómicos de los pacientes incluidos en 6 estudios aleatorizados sobre BFA para el tratamiento de reestenosis de SFA se analizaron en conjunto. Se asignó a todos los pacientes incluidos en este análisis a tratamiento con el BFA de paclitaxel SeQuent Please (B Braun; Melsungen, Alemania). El análisis se centró en los pacientes que tenían seguimiento angiográfico a los 6-9 meses. Se evaluó tanto la incidencia de reestenosis (definida como estenosis ≥ 50% del diámetro luminal en el análisis por segmento durante el seguimiento angiográfico tardío) como sus predictores clínicos y angiográficos. Resultados: Los datos de 546 pacientes se incluyeron en una única base de datos. De 484 pacientes (88,6%), con un total de 518 lesiones tratadas, se disponía de seguimiento angiográfico tardío, y se detectó recurrencia de reestenosis en 101 pacientes (20,8%). En el análisis multivariable, la longitud de la lesión (por cada incremento de 5 mm, OR = 1,58; IC95%, 1,10-2,26; p = 0,012) y el tamaño del vaso (por cada reducción de 0,5 mm, OR = 1,42; IC95%, 1,12-1,79; p = 0,003) se asociaron de manera independiente con la recurrencia de reestenosis. Conclusiones: Este estudio, el mayor disponible de pacientes tratados con BFA por reestenosis de SFA con seguimiento angiográfico tardío, demuestra que la recurrencia de reestenosis se produce en 1 de cada 5 de estos pacientes. Los predictores de la reestenosis recurrente son la longitud de la lesión y el tamaño del vaso

Introduction and objectives: The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and predictors of recurrent restenosis among participants in randomized controlled trials receiving DCB angioplasty for DES restenosis. Methods: The clinical and lesion data of individuals enrolled in 6 randomized controlled trials of DCB angioplasty for DES restenosis were pooled. All patients included in this report were assigned to receive paclitaxel-coated balloon angioplasty with the SeQuent Please DCB (B Braun, Melsungen, Germany). The current analysis focused on participants with available follow-up angiography at 6 to 9 months. The incidence of recurrent restenosis, defined as diameter restenosis ≥ 50% in the in-segment area at follow-up angiography, and its clinical and angiographic predictors were evaluated. Results: A total of 546 patients were combined in a single dataset. Angiographic follow-up at 6 to 9 months was available for 484 patients (88.6%) with 518 treated lesions. Recurrent restenosis was detected in 101 (20.8%) patients. On multivariable analysis, lesion length (OR, 1.58; 95%CI, 1.10-2.26; P = .012 for 5 mm increase) and vessel size (OR, 1.42; 95%, 1.12-1.79; P = .003 for 0.5 mm reduction) were independently associated with recurrent restenosis. Conclusions: In the largest cohort to date of individuals with angiographic surveillance after DCB angioplasty for DES restenosis, we demonstrated that recurrent restenosis occurs in approximately 1 out of 5 patients. Predictors of recurrent restenosis are increased lesion length and small vessel size

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

OBJECTIVES: This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). BACKGROUND: Treatment of patients with DES-ISR remains a challenge. METHODS: The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. RESULTS: A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. CONCLUSIONS: The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940).

Influence of Microcirculatory Dysfunction on Angiography-Based Functional Assessment of Coronary Stenoses.

OBJECTIVES: The authors sought to evaluate the influence of coronary microcirculatory dysfunction (CMD) on the diagnostic performance of the quantitative flow ratio (QFR). BACKGROUND: Functional angiographic assessment of coronary stenoses based on fluid dynamics, such as QFR, constitutes an attractive alternative to fractional flow reserve (FFR). However, it is unknown whether CMD affects the reliability of angiography-based functional indices. METHODS: FFR and the index of microcirculatory resistance (IMR) were measured in 300 vessels (248 patients) as part of a multicenter international registry. QFR was calculated at a blinded core laboratory. Vessels were classified into 2 groups according to microcirculatory status: low IMR (<23 U), and high IMR (≥23 U, CMD). The impact of CMD on the diagnostic performance of QFR, as well as on incremental value of QFR over quantitative angiography, was assessed using FFR as reference. RESULTS: Percent diameter stenosis (%DS) and FFR were similar in low- and high-IMR groups (%DS 51 ± 12% vs. 53 ± 11%; p = 0.16; FFR 0.80 ± 0.11 vs. 0.81 ± 0.11; p = 0.23, respectively). In the overall cohort, classification agreement (CA) between QFR and FFR and diagnostic efficiency of QFR (area under the receiver-operating characteristics curve [AUC]) were high (CA: 88%; AUC: 0.93 [95% confidence interval (CI): 0.90 to 0.96]). However, when assessed according to microcirculatory status, a significantly lower CA and AUC of QFR were found in the high-IMR group as compared with the low-IMR group (CA: 76% vs. 92%; p < 0.001; AUC: 0.88 [95% CI: 0.79 to 0.94] vs. 0.96 [95% CI: 0.92 to 0.98]; p < 0.05). Compared with angiographic assessment, QFR increased by 0.20 (p < 0.001) and by 0.16 (p < 0.001) the AUC of %DS in low- and high-IMR groups, respectively. Independent predictors of misclassification between QFR and FFR were high IMR and acute coronary syndrome. CONCLUSIONS: CMD decreases the diagnostic performance of QFR. However, even in the presence of CMD, QFR remains superior to angiography alone in ascertaining functional stenosis severity.

Incidence and predictors of reCurrent restenosis after drug-coated balloon Angioplasty for Restenosis of a drUg-eluting Stent: The ICARUS Cooperation.

INTRODUCTION AND OBJECTIVES: The incidence and predictors of recurrent restenosis after drug-coated balloon (DCB) angioplasty for drug-eluting stent (DES) restenosis remain poorly studied. We sought to evaluate the incidence and predictors of recurrent restenosis among participants in randomized controlled trials receiving DCB angioplasty for DES restenosis. METHODS: The clinical and lesion data of individuals enrolled in 6 randomized controlled trials of DCB angioplasty for DES restenosis were pooled. All patients included in this report were assigned to receive paclitaxel-coated balloon angioplasty with the SeQuent Please DCB (B Braun, Melsungen, Germany). The current analysis focused on participants with available follow-up angiography at 6 to 9 months. The incidence of recurrent restenosis, defined as diameter restenosis ≥ 50% in the in-segment area at follow-up angiography, and its clinical and angiographic predictors were evaluated. RESULTS: A total of 546 patients were combined in a single dataset. Angiographic follow-up at 6 to 9 months was available for 484 patients (88.6%) with 518 treated lesions. Recurrent restenosis was detected in 101 (20.8%) patients. On multivariable analysis, lesion length (OR, 1.58; 95%CI, 1.10-2.26; P=.012 for 5mm increase) and vessel size (OR, 1.42; 95%, 1.12-1.79; P=.003 for 0.5mm reduction) were independently associated with recurrent restenosis. CONCLUSIONS: In the largest cohort to date of individuals with angiographic surveillance after DCB angioplasty for DES restenosis, we demonstrated that recurrent restenosis occurs in approximately 1 out of 5 patients. Predictors of recurrent restenosis are increased lesion length and small vessel size.