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BACKGROUND: In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES: This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS: RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS: Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS: In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS.
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Implantes Absorbibles , Reestenosis Coronaria , Diseño de Prótesis , Humanos , Factores de Tiempo , Masculino , Resultado del Tratamiento , Femenino , Estudios Prospectivos , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/terapia , Persona de Mediana Edad , Anciano , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Stents , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION AND OBJECTIVES: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. METHODS: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. RESULTS: The study included 12 253 consecutive TAVI patients with a mean age of 81.2 ± 6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0 ± 7.0 vs 6.2 ± 6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P < .001) and cardiac tamponade (1.5% vs 0.6%; P = .009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P = .009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted odds ratio [OR], 1.01; 95% confidence interval [95%CI], 0.83-1.23; P = .902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P = .564) or at 1 year (11% vs 13%, adjusted HR, 0.94; [0.80-1.11]; P = .60). CONCLUSIONS: women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.
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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.
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Cardiología , Enfermedad de la Arteria Coronaria , Intervención Coronaria Percutánea , Humanos , Cateterismo Cardíaco , Sistema de RegistrosRESUMEN
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.
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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.
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Angioplastia Coronaria con Balón , Reestenosis Coronaria , Stents Liberadores de Fármacos , Humanos , Everolimus , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Reestenosis Coronaria/terapia , Paclitaxel , Tomografía de Coherencia Óptica , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/métodos , Estudios Prospectivos , Angiografía Coronaria , Metales , Resultado del Tratamiento , Stents , Constricción Patológica/tratamiento farmacológicoRESUMEN
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.
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Enfermedad de la Arteria Coronaria , Reserva del Flujo Fraccional Miocárdico , Infarto del Miocardio , Insuficiencia Renal Crónica , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Infarto del Miocardio/etiología , Revascularización Miocárdica/efectos adversos , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
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.
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Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/terapia , COVID-19/epidemiología , Brotes de Enfermedades , Síndrome Coronario Agudo/diagnóstico , Anciano , COVID-19/diagnóstico , COVID-19/terapia , Estudios de Cohortes , Femenino , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Revascularización Miocárdica , Intervención Coronaria Percutánea , Pronóstico , España , Volumen Sistólico , Tasa de SupervivenciaRESUMEN
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.
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Reestenosis Coronaria , Stents Liberadores de Fármacos , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico , Humanos , Paclitaxel , Pronóstico , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
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.
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Angioplastia Coronaria con Balón , Reestenosis Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Humanos , Neointima/diagnóstico por imagen , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
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.
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Reestenosis Coronaria/diagnóstico por imagen , Neointima/diagnóstico por imagen , Stents , Tomografía de Coherencia Óptica/métodos , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Diabetes Mellitus/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Factores de Riesgo , Factores de TiempoRESUMEN
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.
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Electrocardiografía , Medición de Riesgo/métodos , Infarto del Miocardio con Elevación del ST/epidemiología , Adulto , Factores de Edad , Femenino , Estudios de Seguimiento , Mortalidad Hospitalaria/tendencias , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , España/epidemiología , Tasa de Supervivencia/tendencias , Factores de TiempoRESUMEN
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 8.6â¯months. There was no statistically significant difference in the risk of target vessel revascularization (TVR) at 1â¯year (RR 1.15, 95% CI 0.60-2.19), but TVR was increased with DEB at 3â¯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 24.4â¯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.
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Angioplastia Coronaria con Balón/instrumentación , Catéteres Cardíacos , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Stents , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/fisiopatología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Reestenosis Coronaria/fisiopatología , Everolimus/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
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).
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Angioplastia Coronaria con Balón/instrumentación , Catéteres Cardíacos , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Everolimus/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Retratamiento , Factores de Riesgo , España , Factores de Tiempo , Resultado del TratamientoRESUMEN
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.
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Angiografía Coronaria , Estenosis Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Reserva del Flujo Fraccional Miocárdico , Microcirculación , Anciano , Cateterismo Cardíaco , Estenosis Coronaria/fisiopatología , Vasos Coronarios/fisiopatología , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Pronóstico , Sistema de Registros , Reproducibilidad de los Resultados , Estudios Retrospectivos , Seúl , Índice de Severidad de la EnfermedadAsunto(s)
Reestenosis Coronaria , Stents Liberadores de Fármacos , Everolimus , Humanos , Paclitaxel , StentsAsunto(s)
Reestenosis Coronaria , Implantes Absorbibles , Stents Liberadores de Fármacos , Humanos , StentsRESUMEN
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.
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Angioplastia Coronaria con Balón/efectos adversos , Reestenosis Coronaria/epidemiología , Stents Liberadores de Fármacos , Oclusión de Injerto Vascular/epidemiología , Ensayos Clínicos Controlados Aleatorios como Asunto , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico , Salud Global , Oclusión de Injerto Vascular/diagnóstico , Humanos , IncidenciaAsunto(s)
Reestenosis Coronaria/tratamiento farmacológico , Intervención Coronaria Percutánea , Cuidados Posoperatorios/métodos , Ticlopidina/uso terapéutico , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Inhibidores de Agregación Plaquetaria/uso terapéutico , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION AND OBJECTIVES: We assessed short- and long-term outcomes of primary angioplasty in ST-segment elevation myocardial infarction by comparing bifurcation culprit lesions (BCL) with non-BCL. METHODS: Observational study with a propensity score matched control group. Among 2746 consecutive ST-segment elevation myocardial infarction patients, we found 274 (10%) patients with BCL. The primary outcome was a composite endpoint including all-cause death, myocardial infarction, coronary artery bypass grafting or target vessel revascularization, assessed at 30-days and 5-years. RESULTS: Baseline characteristics showed no differences after propensity matching (1:1). In the BCL group, the most frequent strategy was provisional stenting of the main branch (84%). Compared with the non-BCL group, the procedures were technically more complex in the BCL group in terms of need for balloon dilatation (71% BCL vs 59% non-BCL; P = .003), longer procedural time (70 ± 29minutes BCL vs 62.8 ± 28.9minutes non-BCL; P = .004) and contrast use (256.2 ± 87.9mL BCL vs 221.1 ± 82.3mL non-BCL; P < .001). Main branch angiographic success was similar (93.4% BCL vs 93.8% non-BCL; P = .86). Thirty-day all-cause mortality was similar between groups: 4.7% BCL vs 5.1% non-BCL; P = .84. At the 5-year follow-up, there were no differences in all-cause death (12% BCL vs 13% non-BCL; P = .95) or the combined event (22% BCL vs 21% non-BCL; P = .43). CONCLUSIONS: Primary angioplasty of a BCL was technically more complex; however, main branch angiographic success was similar, and there were no differences in long-term prognosis compared with non-BCL patients.
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Vasos Coronarios/diagnóstico por imagen , Intervención Coronaria Percutánea , Puntaje de Propensión , Infarto del Miocardio con Elevación del ST/diagnóstico , Stents , Causas de Muerte , Angiografía Coronaria , Vasos Coronarios/cirugía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/cirugía , España/epidemiología , Tasa de Supervivencia/tendencias , Factores de TiempoRESUMEN
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 ± 10mmHg; P<.001), mean aortic gradient (EVR 7 ± 3 vs S3 11 ± 6mmHg; 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.