In-hospital Outcomes of Rotational Atherectomy in ST-Elevation Myocardial Infarction: Results From the Multicentre ROTA-STEMI Network.

BACKGROUND: Although the use of rotational atherectomy (RA) is off-label in the setting of ST-elevation myocardial infarction (STEMI), it can be the only option in severely calcified culprit lesions to achieve procedural success. We sought to investigate the safety and feasibility of RA during primary percutaneous coronary intervention (PPCI). METHODS: This was a retrospective observational study of patients who underwent RA during PPCI from 12 European centres. The main outcomes were procedural success (defined as successful stent implantation with final thrombolysis in myocardial infarction [TIMI] flow 3 and residual stenosis < 30%) and in-hospital mortality. A comparison of patients presenting with and without shock was performed. RESULTS: In 104 patients with RA during STEMI, the mean age was 72.8 ± 9.1 years, and 35% presented with cardiogenic shock. Bailout RA was performed in 76.9% of cases. Mean burr size was 1.42 ± 0.21 mm. Procedural success was achieved in 86.5% of cases, with no difference between shocked and nonshocked patients (94.4% vs 82.4%; P = 0.13). In-hospital stent thrombosis occurred in 0.96%, perforation in 1.9% and burr entrapment in 2.9% of cases. In spite of equally high procedural success, in-hospital mortality was higher in shocked (50%) compared with nonshocked patients (1.5%; P < 0.0001). CONCLUSIONS: Patients presenting with STEMI requiring RA, represent a high-risk population, frequently presenting with cardiogenic shock. In this analysis of selected patients, RA was performed as a bailout strategy in the majority, and, as such, RA seems to be feasible with a high procedural success rate. In the absence of cardiogenic shock, RA-facilitated PCI seems to be associated with low in-hospital mortality.

Prognosis of cardiogenic shock secondary to culprit left main coronary artery lesion-related myocardial infarction.

AIMS: This study aimed to assess, in patients with cardiogenic shock secondary to unprotected left main coronary artery-related myocardial infarction (ULMCA-related AMICS), the incidence and predictors of no recovery of left ventricular function during the admission. METHODS AND RESULTS: This was an observational study conducted at two tertiary care centres (2012-20). The main outcome measured was death or requirement for heart transplantation (HT) or left ventricular assist devices (LVAD) during the admission. A total of 70 patients were included. Percutaneous coronary intervention (PCI) was successful in 53/70 patients (75.7%). The combined endpoint of death or requirement of HT or LVAD during the admission occurred in 41/70 patients (58.6%). The highest incidence of the primary endpoint was observed among patients with profound shock and occluded left main coronary artery (LMCA) (20/23, 87%, P < 0.001). Although a successful PCI reduced the incidence of the event in the whole cohort (51.9% vs. 82.4% in failed PCI, P = 0.026), this association was not observed among this last group of complex patients (86.7% vs. 87.5% in failed PCI, P = 0.731). The predictive model included left ventricular ejection fraction, baseline ULMCA Thrombolysis In Myocardial Infarction flow, and severity of shock and showed an optimal ability for predicting death or requirements for HT or LVAD during the admission (area under the curve 0.865, P < 0.001). CONCLUSIONS: ULMCA-related AMICS was associated with a high in-hospital mortality or need for HT or LVAD. Prognosis was especially poor among patients with profound shock and baseline occluded LMCA, with a low probability of recovery regardless of successful PCI.

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.

Amphilimus- Versus Everolimus-Eluting Stents in Patients With Diabetes Mellitus: 5-Year Follow-Up of the RESERVOIR Trial.

The amphilimus-eluting stent (AES) is a thin-strut polymer-free stent that releases sirolimus formulated with a carrier from abluminal grooves. The RESERVOIR trial compared AES vs everolimus-eluting stents (EES) in patients with diabetes mellitus (DM) and showed non-inferior neointimal hyperplasia suppression at 9 months follow-up. The aim of this study was to assess comparative clinical outcomes at 5 years. The endpoints analyzed for this extended follow-up were target-vessel failure (TVF), target-vessel revascularization (TVR) and target-lesion revascularization (TLR). At 5-years, AES vs EES had similar risk of TVF (HR 0.54, 95% CI 0.20-1.47, p = 0.23), TVR (HR 0.36, 95% CI 0.12-1.14, p = 0.08) and TLR (HR 0.43, 95%CI 0.11-1.67, p = 0.22). Landmark analyses between 1 and 5 years also showed no significant differences between groups.

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.

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

Fractura de bioprótesis aórtica quirúrgica: valoración mediante TC seriada / Bioprosthetic aortic valve fracture: evaluation by serial cardiac CT

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Association of fractalkine with functional severity of heart failure and impact on clopidogrel efficacy in patients with ischemic heart disease.

INTRODUCTION: Patients with heart failure (HF) display elevated levels of soluble fractalkine, a chemokine involved in inflammation processes, atherosclerosis and platelet activation. Further, fractalkine has been associated with reduced pharmacodynamic (PD) responsiveness to clopidogrel. The aim of this study was to investigate the association of fractalkine with the severity of HF and its impact on platelet activation and clopidogrel response in patients with coronary artery disease (CAD) with and without HF. MATERIALS AND METHODS: This prospective PD study included 116 stable CAD patients on DAPT with aspirin and clopidogrel. Subjects were classified in two groups: patients with HF and reduced (<40%) left ventricular ejection fraction (HFrEF group, n = 56) and patients without HF (no HF group, n = 60). Clinical severity of HF was graded according to NYHA classification. Platelet function assays included vasodilator-stimulated phosphoprotein assay, multiple electrode aggregometry and light transmittance aggregometry. Fractalkine and P-selectin concentrations were determined by ELISA. RESULTS: Fractalkine levels progressively increased with the severity of the disease in the HFrEF group (NYHA I: 471.2 ± 52.4 pg/ml, NYHA II: 500.5 ± 38.4 pg/ml, NYHA III: 638.9 ± 54.3 pg/ml, p for linear trend 0.023). Numerically higher concentrations of fractalkine were observed in the HFrEF group compared to the no HF group with borderline significance (p = 0.052). No significant differences in clopidogrel-induced platelet inhibition according to fractalkine values were observed in any of the groups. CONCLUSIONS: Fractalkine levels were increased in patients with HFrEF and positively associated with the functional severity of the disease. No evident impact of fractalkine on clopidogrel PD efficacy was found.

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.

Diabetes mellitus is not independently associated with mortality in elderly patients with ST-segment elevation myocardial infarction. Insights from the Codi Infart registry.

BACKGROUND: Diabetes mellitus predicts poorer outcomes in patients with acute coronary syndrome (ACS), but the magnitude of this association in patients at older ages remains controversial. METHODS: Data were extracted from the Codi Infart database. All consecutive patients with diagnosis of ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) between 2010 and 2015 were included. We assessed the impact of diabetes mellitus on 30-day and one-year mortality in patients aged less than and at least 75 years. RESULTS: A total of 12 792 cases were registered, of whom 3023 (23.6%) were aged at least 75 years. About 20% patients had previous diabetes mellitus diagnosis. Patients aged at least 75 years had higher prevalence of comorbidities, higher proportion of heart failure at admission, a more extensive coronary artery disease and significant delay to reperfusion (P < 0.001). Diabetes mellitus was associated with higher 30-day mortality both in young [odds ratio (OR) 1.97, 95% confidence interval (CI): 1.43-2.70] and in elderly patients (OR 1.43, 95% CI: 1.07-1.91). After adjusting for potential confounders, this association remained significant in young patients (OR 1.47, 95% CI: 1.00-2.16, P = 0.047), but not in the elderly (OR 1.14, P = 0.43). Likewise, a crude association between diabetes mellitus and one-year mortality was observed in both groups (young patients: HR = 1.93; 95% CI: 1.51-2.46; older patients: HR = 1.33; 95% CI: 1.08-1.64). However, after adjusting for potential confounders, this association remained significant in younger patients (HR = 1.46; 95% CI: 1.13-1.89; P < 0.001), but not in the elderly (HR = 1.16; P = 0.17). CONCLUSION: A significant proportion of these nonselected patients with STEMI had previous diabetes mellitus. The association between diabetes mellitus and outcomes is different according to age.

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

Persistence with dual antiplatelet therapy after percutaneous coronary intervention for ST-segment elevation acute coronary syndrome: a population-based cohort study in Catalonia (Spain).

OBJECTIVES: Guidelines recommending 12-month dual antiplatelet therapy (DAPT) in patients with ST-elevation acute coronary syndrome (STEACS) undergoing percutaneous coronary intervention (PCI) were published in year 2012. We aimed to describe the influence of guideline implementation on the trend in 12-month persistence with DAPT between 2010 and 2015 and to evaluate its relationship with DAPT duration regimens recommended at discharge from PCI hospitals. DESIGN: Observational study based on region-wide registry data linked to pharmacy billing data for DAPT follow-up. SETTING: All PCI hospitals (10) belonging to the acute myocardial infarction (AMI) code network in Catalonia (Spain). PARTICIPANTS: 10 711 STEACS patients undergoing PCI between 2010 and 2015 were followed up. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was 12-month persistence with DAPT. Calendar year quarter, publication of guidelines, DAPT duration regimen recommended in the hospital discharge report, baseline patient characteristics and significant interactions were included in mixed-effects logistic regression based interrupted time-series models. RESULTS: The proportion of patients on-DAPT at 12 months increased from 58% (56-60) in 2010 to 73% (71-75) in 2015. The rate of 12-month persistence with DAPT significantly increased after the publication of clinical guidelines with a time lag of 1 year (OR=1.20; 95% CI 1.11 to 1.30). A higher risk profile, more extensive and complex coronary disease, use of drug-eluting stents (OR=1.90; 95% CI 1.50 to 2.40) and a 12-month DAPT regimen recommendation at discharge from the PCI hospital (OR=5.76; 95% CI 3.26 to 10.2) were associated with 12-month persistence. CONCLUSION: Persistence with 12-month DAPT has increased since publication of clinical guidelines. Even though most patients were discharged on DAPT, only 73% with potential indication were on-DAPT 12 months after PCI. A guideline-based recommendation at PCI hospital discharge was highly associated with full persistence with DAPT. Establishing evidence-based, common prescribing criteria across hospitals in the AMI-network would favour adherence and reduce variability.

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.

Evaluación del efecto sinérgico de la metformina y los inhibidores mTOR sobre la endotelización de los stents farmacoactivos en pacientes diabéticos / In vivo evaluation of the synergic effect of metformin and mTOR inhibitors on the endothelial healing of drug-eluting stents in diabetic patients

Introducción y objetivos: Estudios recientes en animales han demostrado que la metformina (MF) perjudica la endotelización de los stents farmacoactivos (SFA). Se evaluó el efecto de la MF en el recubrimiento neointimal de los SFA en pacientes diabéticos por tomografía de coherencia óptica (OCT). Métodos: El ensayo RESERVOIR aleatorizó 116 lesiones en 112 pacientes con diabetes mellitus a stents liberadores de amphilimus o everolimus, a los que se realizó una OCT a los 9 meses. Los pacientes se dividieron en 3 grupos según el tratamiento hipoglucemiante recibido: a) no MF; b) MF sin insulina, y c) MF con insulina. El objetivo primario fue el porcentaje de struts no recubiertos. Resultados: Diecisiete pacientes (19 lesiones) al grupo sin MF; 53 pacientes (54 lesiones) al grupo MF sin insulina y 28 pacientes (28 lesiones) al grupo MF con insulina. Las características basales fueron comparables, aunque los pacientes del grupo MF sin insulina tuvieron un mejor control glucémico (p < 0,01). Por OCT la frecuencia relativa de struts no recubiertos fue comparable entre grupos (3,07 ± 4,80% frente a 2,23 ± 4,73% frente a 3,43 ± 6,69% respectivamente, p = 0,48). El análisis multivariante confirmó que la MF no altera el recubrimiento de los SFA (OR = 1,49; IC95%, 0,71-3,08, p = 0,29). La angiografía cuantitativa tampoco mostró efecto de la MF sobre la pérdida luminal tardía, mientras que el tratamiento con insulina si se asoció a una mayor pérdida luminal tardía (p = 0,02). Conclusiones: El uso de MF no perjudica el recubrimiento neointimal de los SFA en diabéticos independientemente de que reciban o no tratamiento con insulina. De acuerdo a nuestros resultados, el uso de MF parece no estar desaconsejado en estos pacientes

Introduction and objectives: Recent animal studies have shown metformin (MF) to impair endothelialization of drug-eluting stents (DES). The aim of this study was to evaluate the effect of MF on the healing of DES in human coronary arteries of patients with diabetes mellitus by optical coherence tomography (OCT). Methods: The RESERVOIR trial randomized 116 lesions in 112 patients with diabetes mellitus to amphilimus- or everolimus-eluting stents and included mandatory OCT at 9 months of follow-up. Patients were divided in 3 groups according to the glucose-lowering agents received: a) no MF; b) MF in noninsulin treated patients, and c) MF in insulin-treated patients. The primary safety endpoint was the rate of uncovered stents. Results: Seventeen patients with 19 lesions did not receive MF, whereas MF was administered to 53 noninsulin treated patients (54 lesions) and 28 insulin-treated patients (28 lesions). Baseline characteristics were comparable, although noninsulin treated patients who received MF had better glycemic control (P < .01). By OCT, rates of uncovered struts were comparable between groups (3.07 ± 4.80% vs 2.23 ± 4.73% vs 3.43 ± 6.69%, respectively; P = .48). Multivariate models confirmed that MF had no effect on the healing of DES (OR, 1.49, 95%CI, 0.71-3.08; P = .29). Similarly, quantitative angiography showed no effect of MF on late lumen loss, whereas patients treated with exogenous insulin had greater late lumen loss (P = .02). Conclusions: Metformin use does not impair endothelial healing of DES in patients with both insulin- and noninsulin-treated diabetes mellitus. According to these results, MF should not be discouraged in these patients

Long-term prognostic impact of non-invasive follow-up with computed tomography angiography in patients with left main coronary artery stenting.

BACKGROUND: Left main coronary artery (LMCA) stenting is an evolving technique. Whether follow-up computed tomography angiography (CTA) might have clinical impact in these patients is controversial. The aim of present study is to compare clinical outcomes of patients with LMCA stenting followed with CTA versus patients with conventional clinical follow-up. METHODS: From 2003 to 2014 all consecutive patients with unprotected LMCA stenosis treated with single DES implantation were prospectively included. Since 2009 all patients underwent CTA at 6-month after LMCA stenting. Therefore, the non-CTA group included all patients treated from 2003 to 2009 and the CTA group included patients treated from 2009 to 2014. Patients with 6-month cardiac events, renal dysfunction or atrial fibrillation were excluded. All patients underwent at least 2-year clinical follow-up. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction, and LMCA revascularization. RESULTS: A total of 236 patients were included (119 in the non-CTA and 117 in the CTA group). Nine event-free patients presented with in-stent restenosis as assessed by CTA at 6 months; 5 had angiographic confirmation and were revascularized. At 2 years, the primary end-point was observed in 15.1% and 7.3% of patients of the non-CTA and CTA groups, respectively (P=0.07). All-cause mortality was higher in the non-CTA group (8.4% vs. 2.6%; P=0.05). Euroscore and CTA were found independent predictors of the primary end-point in the multivariate analysis. CONCLUSIONS: Elective 6-month CTA after LMCA stenting is associated with better outcomes compared to conventional clinical follow-up.

Temporal trends in frequency, management and outcomes of coronary perforations.

BACKGROUND: Coronary perforations (CP) have been described as a rare but potentially fatal complication in percutaneous coronary interventions (PCI). Our aim is to compare temporal trends in frequency, management and outcomes of coronary perforations (CP). METHODS: All cases of CP recorded in our prospective institutional percutaneous coronary intervention (PCI) registry from 2003 to 2015 were included. Patients were divided in 2 groups according to the time frame in which the CP occurred: the early period (before 2009, when the chronic total occlusions and primary PCI programs started) and the current period. The primary endpoint was the composite of in-hospital serious adverse events, including final TIMI flow 0-1, cardiac tamponade, emergent cardiac surgery or death. RESULTS: Overall, 88 CP occurred in 17,566 procedures (0.50%). Of these, 17 (0.26%) occurred during the early period and 71 (0.64%) during the current period (P<0.001). CP management differed between groups, with less CP sealed by intracoronary devices in the early period than in the current one (23.5% vs. 47.9%, P=0.068). Moreover, patients with CP during the early period experienced more in-hospital serious adverse events (69% vs. 31% respectively, OR 3.18, 95% CI: 1.07-9.45, P=0.037). CONCLUSIONS: Expansion of indications and complexity of PCI in the current era may be associated with an increased frequency of CP. However, progress in technical and device management of CP have led to an improvement in the prognosis of this feared complication.

In Vivo Evaluation of the Synergic Effect of Metformin and mTOR Inhibitors on the Endothelial Healing of Drug-eluting Stents in Diabetic Patients.

INTRODUCTION AND OBJECTIVES: Recent animal studies have shown metformin (MF) to impair endothelialization of drug-eluting stents (DES). The aim of this study was to evaluate the effect of MF on the healing of DES in human coronary arteries of patients with diabetes mellitus by optical coherence tomography (OCT). METHODS: The RESERVOIR trial randomized 116 lesions in 112 patients with diabetes mellitus to amphilimus- or everolimus-eluting stents and included mandatory OCT at 9 months of follow-up. Patients were divided in 3 groups according to the glucose-lowering agents received: a) no MF; b) MF in noninsulin treated patients, and c) MF in insulin-treated patients. The primary safety endpoint was the rate of uncovered stents. RESULTS: Seventeen patients with 19 lesions did not receive MF, whereas MF was administered to 53 noninsulin treated patients (54 lesions) and 28 insulin-treated patients (28 lesions). Baseline characteristics were comparable, although noninsulin treated patients who received MF had better glycemic control (P < .01). By OCT, rates of uncovered struts were comparable between groups (3.07±4.80% vs 2.23±4.73% vs 3.43±6.69%, respectively; P = .48). Multivariate models confirmed that MF had no effect on the healing of DES (OR, 1.49, 95%CI, 0.71-3.08; P = .29). Similarly, quantitative angiography showed no effect of MF on late lumen loss, whereas patients treated with exogenous insulin had greater late lumen loss (P = .02). CONCLUSIONS: Metformin use does not impair endothelial healing of DES in patients with both insulin- and noninsulin-treated diabetes mellitus. According to these results, MF should not be discouraged in these patients.

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.