Myocardial revascularization failure among patients requiring cardiac catheterization and secondary revascularization in contemporary clinical practice: Results of the REVASEC multicenter registry.

BACKGROUND: Myocardial revascularization failure (MRF) and Secondary revascularization (SR) are contemporary interventional cardiology challenges. AIM: To investigate the characteristics, management, and prognosis of patients with myocardial revascularization failure (MRF) and need for secondary revascularization (SR) in contemporary practice. METHODS: The REVASEC study is a prospective registry (NCT03349385), which recruited patients with prior revascularization referred for coronary angiography at 19 centers. The primary endpoint is a patient-oriented composite (POCE) at 1 year, including death, myocardial infarction, or repeat revascularization. RESULTS: A total of 869 patients previously revascularized by percutaneous intervention (83%) or surgery (17%) were recruited. MRF was found in 83.7% (41.1% stent/graft failure, 32.1% progression of coronary disease, and 10.5% residual disease). SR was performed in 70.1%, preferably by percutaneous intervention (95%). The POCE rate at 1 year was 14% in the overall cohort, with 6.4% all-cause death. In the multivariate analysis, lower POCE rates were found in the groups without MRF (9.4%) and with disease progression (11%) compared with graft/stent failure (17%) and residual disease (18%), hazard ratio 0.67 (95% confidence interval: 0.45-0.99), p = 0.043. At 1 year, the SR group had less chronic persistent angina (19% vs. 34%, p < 0.001), but a higher rate of repeat revascularization (9% vs. 2.9%, p < 0.001). CONCLUSION: MRF was found in 84% of patients with prior revascularization referred for coronary angiography. Stent/graft failure and residual coronary disease were associated with a worse prognosis. SR provided better symptom control at the expense of a higher rate of new revascularization.

Overlapping versus single long stents in long chronic total occlusions: insights of the Iberian CTO Registry.

BACKGROUND: It is unknown whether the availability of long drug-eluting stents modify the PCI strategy of long CTO. To describe the contemporary PCI strategy of long chronic total occlusions (CTO) using overlapping (OS) or single long stents (SS) and to analyze its results. METHODS: 2842 consecutive CTO PCIs were included. Those with an occlusion length ≥20 mm in which ≥1 drug eluting stent (DES) was implanted were analyzed. We compared procedural characteristics and clinical outcomes of CTO treated with OS or SS. RESULTS: 1088 CTO PCIs were analyzed (79.9% males; 64.7±10.6 years). Mean J-score was 2.8±0.9. A SS was used in 38.5% of cases and OS in 61.5%. Total stent length was 64.1±29.9 mm; it was higher in the OS group (OS: 79.9±25.5 mm vs. SS: 38.3±14.7 mm; P<0.0001). Mean number of stents in the OS group was 2.3±1. Very long stents (≥40 mm) were used in 27.4% of cases, more frequently in the OS group (OS:32.4% vs. SS:19.3%; P<0.0001). After a mean follow-up of 19±15.9 months, the rate of adverse events (MACE) was 2% (cardiac death: 1.6%, myocardial infarction: 1.6%, target lesion revascularization: 1.9% and stent thrombosis: 0.18%) with no significant differences between both groups. Overlapping was not an independent predictor of MACE. CONCLUSIONS: In long CTO PCIs, OS is more frequently used than single stenting, especially in more complex procedures. Clinical outcomes at a mid-term follow-up are favorable. Using newer generation DES, overlapping was not an independent predictor of MACE; however, a trend toward a higher event rate was observed in the OS group.

Plaque modification in calcified chronic total occlusions: the PLACCTON study.

INTRODUCTION AND OBJECTIVES: Severe calcification is present in> 50% of coronary chronic total occlusions (CTOs) undergoing percutaneous intervention. We aimed to describe the contemporary use and outcomes of plaque modification devices (PMDs) in this context. METHODS: Patients were included in the prospective, consecutive Iberian CTO registry (32 centers in Spain and Portugal), from 2015 to 2020. Comparison was performed according to the use of PMDs. RESULTS: Among 2235 patients, wire crossing was achieved in 1900 patients and PMDs were used in 134 patients (7%), requiring more than 1 PMD in 24 patients (1%). The selected PMDs were rotational atherectomy (35.1%), lithotripsy (5.2%), laser (11.2%), cutting/scoring balloons (27.6%), OPN balloons (2.9%), or a combination of PMDs (18%). PMDs were used in older patients, with greater cardiovascular burden, and higher Syntax and J-CTO scores. This greater complexity was associated with longer procedural time but similar total stent length (52 vs 57mm; P=.105). If the wire crossed, the procedural success rate was 87.2% but increased to 96.3% when PMDs were used (P=.001). Conversely, PMDs were not associated with a higher rate of procedural complications (3.7 vs 3.2%; P=.615). Despite the worse baseline profile, at 2 years of follow-up there were no differences in the survival rate (PMDs: 94.3% vs no-PMDs: 94.3%, respectively; P=.967). CONCLUSIONS: Following successful wire crossing in CTOs, PMDs were used in 7% of the lesions with an increased success rate. Mid-term outcomes were comparable despite their worse baseline profile, suggesting that broader use of PMDs in this setting might have potential technical and prognostic benefits.

Design and Rationale for a Real-World Prospective, Multicenter Registry of Myocardial Revascularization Failure and Secondary Revascularization: The REVASEC Study.

AIM: To investigate key aspects of the problem of myocardial revascularization failure (MRF) and repeat or secondary myocardial revascularization (SR) in contemporary practice. METHODS: The registry of secondary revascularization (REVASEC) is an investigator-initiated, multicenter, prospective registry enhanced with data monitoring and independent event adjudication (ClinicalTrials.govNCT03349385). It includes patients with prior revascularization referred to coronary angiography for suspected MRF with broad inclusion criteria. The main objectives are to describe the characteristics of patients with prior revascularization referred for repeat angiography, to describe and the rate and mechanisms of MRF (stent or graft failure, coronary artery disease progression or residual coronary artery disease); to evaluate the management including medical treatment and SR of these patients; and to assess the prognosis according to the outlined causative mechanisms. The registry has one year follow up for the primary endpoint (Patient-oriented composite endpoint including all-cause death, any myocardial infarction or any new unplanned revascularization according to subsets of MRF), but extended follow-up will be carried out up to 5 years. CONCLUSION: The REVASEC Registry will provide updated data on the characteristics, patterns of treatment, and 1-year outcomes of patients with MRF and SR in contemporary clinical practice.

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

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

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

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

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

Impact of renin-angiotensin system inhibitors on clinical outcomes and ventricular remodelling after transcatheter aortic valve implantation: rationale and design of the RASTAVI randomised multicentre study.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) as a treatment in severe aortic stenosis (AS) is an excellent alternative to conventional surgical replacement. However, long-term outcomes are not benign. Renin-angiotensin system (RAS) blockade has shown benefit in terms of adverse remodelling in severe AS and after surgical replacement. METHODS AND ANALYSIS: The RAS blockade after TAVI (RASTAVI) trial aims to detect if there is a benefit in clinical outcomes and ventricular remodelling with this therapeutic strategy following the TAVI procedure. The study has been designed as a randomised 1:1 open-label study that will be undertaken in 8 centres including 336 TAVI recipients. All patients will receive the standard treatment. The active treatment group will receive ramipril as well. Randomisation will be done before discharge, after signing informed consent. All patients will be followed up for 3 years. A cardiac magnetic resonance will be performed initially and at 1 year to assess ventricular remodelling, defined as ventricular dimensions, ejection fraction, ventricular mass and fibrosis. Recorded events will include cardiac death, admission due to heart failure and stroke. The RASTAVI Study will improve the management of patients after TAVI and may help to increase their quality of life, reduce readmissions and improve long-term survival in this scenario. ETHICS AND DISSEMINATION: All authors and local ethics committees have approved the study design. All patients will provide informed consent. Results will be published irrespective of whether the findings are positive or negative. TRIAL REGISTRATION NUMBER: NCT03201185.

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.

Angioplastia primaria en mayores de 75 años. Perfil de pacientes y procedimientos, resultados y predictores pronósticos en el registro ESTROFA IM + 75 / Primary angioplasty in patients older than 75 years. profile of patients and procedures, outcomes, and predictors of prognosis in the ESTROFA IM + 75 registry

Introducción y objetivos: La proporción de pacientes de edad avanzada que se someten a angioplastia primaria está creciendo. Este estudio describe el perfil clínico, las características de los procedimientos, la evolución y los predictores pronósticos. Métodos: Registro en 31 centros de pacientes consecutivos mayores de 75 años tratados con angioplastia primaria. Se recogieron variables clínicas y del procedimiento y se efectuó seguimiento clínico. Resultados: Se incluyó a 3.576 pacientes (el 39,3% mujeres, el 48,5% con insuficiencia renal, el 11,5% en Killip III o IV y el 29,8% con más de 6 h de dolor). El 55,4% presentaba enfermedad multivaso y al 24,8% se les trató además lesiones no culpables. Se utilizó vía radial en el 56,4%, bivalirudina en el 11,8%, aspiración de trombo en el 55,9% y stents farmacoactivos en el 26,6%. La incidencia de muerte cardiaca al mes era del 10,1% y a los 2 años, del 14,7%. A los 2 años la trombosis definitiva o probable era del 3,1%; la revascularización de lesión tratada, del 2,3% y las hemorragias BARC > 2, del 4,2%. Los predictores pronósticos fueron: diabetes mellitus, insuficiencia renal, fibrilación auricular, retraso > 6 h, fracción de eyección < 45%, clase Killip III-IV, vía radial, bivalirudina, stents farmacoactivos, flujo final TIMI III y revascularización incompleta al alta. Conclusiones: En este registro destaca el frecuente retraso en la presentación y la alta prevalencia de factores adversos como la insuficiencia renal o la enfermedad multivaso. Se identificaron como factores protectores relacionados con el procedimiento el menor retraso, el uso de vía radial, la bivalirudina, los stents farmacoactivos y la revascularización completa antes del alta (AU)

Introduction and objectives: The proportion of elderly patients undergoing primary angioplasty is growing. The present study describes the clinical profile, procedural characteristics, outcomes, and predictors of outcome. Methods: A 31-center registry of consecutive patients older than 75 years treated with primary angioplasty. Clinical and procedural data were collected, and the patients underwent clinical follow-up. Results: The study included 3576 patients (39.3% women, 48.5% with renal failure, 11.5% in Killip III or IV, and 29.8% with > 6 hours of chest pain). Multivessel disease was present in 55.4% and nonculprit lesions were additionally treated in 24.8%. Radial access was used in 56.4%, bivalirudin in 11.8%, thromboaspiration in 55.9%, and drug-eluting stents in 26.6%. The 1-month and 2-year incidences of cardiovascular death were 10.1% and 14.7%, respectively. The 2-year rates of definite or probable thrombosis, repeat revascularization, and BARC bleeding > 2 were 3.1%, 2.3%, and 4.2%, respectively. Predictive factors were diabetes mellitus, renal failure, atrial fibrillation, delay to reperfusion > 6 hours, ejection fraction < 45%, Killip class III-IV, radial access, bivalirudin, drug-eluting stents, final TIMI flow of III, and incomplete revascularization at discharge. Conclusions: Notable registry findings include frequently delayed presentation and a high prevalence of adverse factors such as renal failure and multivessel disease. Positive procedure-related predictors include shorter delay, use of radial access, bivalirudin, drug-eluting stents, and complete revascularization before discharge (AU)

Primary Angioplasty in Patients Older Than 75 Years. Profile of Patients and Procedures, Outcomes, and Predictors of Prognosis in the ESTROFA IM+75 Registry.

INTRODUCTION AND OBJECTIVES: The proportion of elderly patients undergoing primary angioplasty is growing. The present study describes the clinical profile, procedural characteristics, outcomes, and predictors of outcome. METHODS: A 31-center registry of consecutive patients older than 75 years treated with primary angioplasty. Clinical and procedural data were collected, and the patients underwent clinical follow-up. RESULTS: The study included 3576 patients (39.3% women, 48.5% with renal failure, 11.5% in Killip III or IV, and 29.8% with>6hours of chest pain). Multivessel disease was present in 55.4% and nonculprit lesions were additionally treated in 24.8%. Radial access was used in 56.4%, bivalirudin in 11.8%, thromboaspiration in 55.9%, and drug-eluting stents in 26.6%. The 1-month and 2-year incidences of cardiovascular death were 10.1% and 14.7%, respectively. The 2-year rates of definite or probable thrombosis, repeat revascularization, and BARC bleeding>2 were 3.1%, 2.3%, and 4.2%, respectively. Predictive factors were diabetes mellitus, renal failure, atrial fibrillation, delay to reperfusion>6hours, ejection fraction<45%, Killip class III-IV, radial access, bivalirudin, drug-eluting stents, final TIMI flow of III, and incomplete revascularization at discharge. CONCLUSIONS: Notable registry findings include frequently delayed presentation and a high prevalence of adverse factors such as renal failure and multivessel disease. Positive procedure-related predictors include shorter delay, use of radial access, bivalirudin, drug-eluting stents, and complete revascularization before discharge.

Estudio aleatorizado para comparar el stentbioactivo de titanio con el stent de everolimus en pacientes diabéticos (TITANIC XV), resultados a 1 año / A Randomized Study to Compare Bioactive Titanium Stents and Everolimus-eluting Stents in Diabetic Patients (TITANIC XV): 1-year Results

Introducción y objetivos Hasta un 25% de los pacientes sometidos a intervencionismo coronario percutáneo presentan alguna limitación para la utilización de los stents farmacoactivos. Nuestro objetivo es evaluar si el stent bioactivo de titanio y óxido nítrico podía ser una buena alternativa al stent de everolimus para pacientes diabéticos.MétodosSe aleatorizó a 173 pacientes diabéticos con lesiones de riesgo de reestenosis intermedio (criterios de exclusión: diámetro < 2,5 mm o longitud > 28 mm en vasos < 3 mm, oclusión crónica): 83 pacientes en el grupo con titanio y 90 en el grupo con everolimus.ResultadosLas variables basales estaban bien equilibradas, el 28,3% eran insulinodependientes. Al año, las incidencias de eventos adversos cardiacos mayores (muerte, infarto de miocardio no fatal, ictus o nueva revascularización del vaso tratado) eran significativamente más frecuente en el grupo con titanio que en el grupo con everolimus (total, el 14,5 frente al 4,4%; p = 0,02; subgrupo no insulinodependiente, el 9,7 frente al 3,2%; p = 0,14; insulinodependiente, el 28,6 frente al 7,1%; p = 0,04) y de muerte, infarto de miocardio no fatal, ictus o cualquier revascularización, del 16,9% en el grupo con titanio y el 7,8% en el grupo con everolimus (p = 0,06). La revascularización de la lesión diana se produjo en el 8,4 frente al 3,3% (p = 0,15), y la del vaso tratado, el 13,3 frente al 3,3% (p = 0,01). El seguimiento angiográfico a 9 meses mostró una pérdida luminal tardía significativamente menor en el grupo con everolimus (en el segmento, 0,52 ± 0,58 frente a -0,05 ± 0,32 mm; en el stent, 0,76 ± 0,54 frente a 0,13 ± 0,31 mm; p < 0,0001). ConclusionesEl stent de everolimus fue superior al titanio en pacientes diabéticos incluso con lesiones de riesgo de eventos clínicos y angiográficos intermedio (AU)

Introduction and objectives Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients.MethodsA total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3 mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients).ResultsBaseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001).ConclusionsThe everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis (AU)

A randomized study to compare bioactive titanium stents and everolimus-eluting stents in diabetic patients (TITANIC XV): 1-year results.

INTRODUCTION AND OBJECTIVES: Up to 25% of patients who undergo a percutaneous coronary intervention show some limitation in the use of drug-eluting stents. The aim of this study was to evaluate if titanium-nitride-oxide-coated stents could be a good alternative to everolimus-eluting stents in diabetic patients. METHODS: A total of 173 diabetic patients with lesions at moderate risk of restenosis (exclusion criteria: diameter < 2.5 mm or length > 28 mm in vessels < 3mm, chronic occlusion) were randomized to a titanium group (83 patients) or an everolimus group (90 patients). RESULTS: Baseline characteristics were well balanced; 28.3% of patients were insulin dependent. At 1 year, the incidence of major adverse cardiac events (death, nonfatal myocardial infarction, stroke, or repeat target vessel revascularization) was significantly higher in the titanium group than in the everolimus group (total, 14.5% vs 4.4%; P = .02; noninsulin-dependent subgroup, 9.7% vs 3.2%; P = .14; insulin-dependent subgroup, 28.6% vs 7.1%; P = .04). The incidence of death, nonfatal myocardial infarction, stroke, or any revascularization was 16.9% in the titanium group and 7.8% in the everolimus group (P = .06). Target lesion and vessel revascularizations occurred in 8.4% compared with 3.3% (P = .15) and in 13.3% compared with 3.3% (P = .01) in the titanium and everolimus groups, respectively. Angiographic follow-up at 9 months showed significantly less late lumen loss in the everolimus group (in-segment, 0.52 [standard deviation, 0.58) mm vs -0.05 [0.32] mm; in-stent, 0.76 [0.54] mm vs 0.13 [0.31] mm; P < .0001). CONCLUSIONS: The everolimus-eluting stent is superior to the titanium stent for clinical and angiographic end points in diabetic patients with lesions at moderate risk of restenosis.

Use of the radial approach in primary angioplasty: results in 1029 consecutive patients and analyses in unfavorable subgroups.

INTRODUCTION AND OBJECTIVES: The transradial approach is associated with a reduction in vascular access-related complications after primary percutaneous coronary interventions. The purpose of this study was to examine the feasibility of the routine use of transradial access in primary angioplasty and to evaluate how it affects subgroups with less favorable characteristics. METHODS: We analyzed 1029 consecutive patients with an ST-segment elevation acute coronary syndrome treated with primary angioplasty. RESULTS: Transradial access was the primary approach in 93.1% of the patients. The success rate of primary angioplasty was 95.9%, and 87.6% of the patients were event-free 30 days after the procedure. Crossover was required in 3.0% of the patients with primary transradial access, and this rate remained stable over the years. Predictors of the need for crossover were age older than 75 years (odds ratio=2.50, 95% confidence interval, 1.09-5.71; P=.03) and a history of ischemic heart disease (odds ratio=2.65; 95% confidence interval, 1.12-6.24; P=.02). Primary transfemoral access use was higher in women older than 75 years. Use of the transradial approach in this subgroup did not affect reperfusion time or the success of angioplasty, although there was a greater need for crossover (10.9% vs 2.6%; P=.006). Among patients in cardiogenic shock, the transradial approach was used in 51.5%; reperfusion times and angioplasty success rates were similar to those obtained with transfemoral access, but there was a greater need for crossover. CONCLUSIONS: Transradial access can be used safely and effectively in most primary angioplasty procedures. In older women and in patients in cardiogenic shock, there is a higher crossover requirement, with no detriment to reperfusion time.

Clinical impact of intravascular ultrasound guidance in drug-eluting stent implantation for unprotected left main coronary disease: pooled analysis at the patient-level of 4 registries.

OBJECTIVES: This study sought to investigate the clinical impact of the use of intravascular ultrasound (IVUS) during revascularization of patients with left main coronary artery (LM) disease with drug-eluting stents (DES). BACKGROUND: Whether the use of IVUS during the procedure adds a clinical benefit remains unclear. There is only 1 previous observational study, with relevant limitations, supporting the value of this strategy. METHODS: We performed a patient-level pooled analysis of 4 registries of patients with LM disease treated with DES in Spain. A propensity score-matching method was used to obtain matched pairs of patients with and without IVUS guidance. RESULTS: A total of 1,670 patients were included, and 505 patients (30.2%) underwent DES implantation under IVUS guidance (IVUS group). By means of the matching method, 505 patients without the use of IVUS during revascularization were selected (no-IVUS group). Survival free of cardiac death, myocardial infarction, and target lesion revascularization at 3 years was 88.7% in the IVUS group and 83.6% in the no-IVUS group (p = 0.04) for the overall population, and 90% and 80.7%, respectively (p = 0.03), for the subgroups with distal LM lesions. The incidence of definite and probable thrombosis was significantly lower in the IVUS group (0.6% vs. 2.2%; p = 0.04). Finally, IVUS-guided revascularization was identified as an independent predictor for major adverse events in the overall population (hazard ratio: 0.70, 95% confidence interval: 0.52 to 0.99; p = 0.04) and in the subgroup with distal lesions (hazard ratio: 0.54, 95% confidence interval: 0.34 to 0.90; p = 0.02). CONCLUSIONS: The results of this pooled analysis show an association of IVUS guidance during percutaneous coronary intervention with better outcomes in patients with LM disease undergoing revascularization with DES.

El uso del acceso radial en la angioplastia primaria: resultados en 1.029 pacientes consecutivos y análisis en subgrupos desfavorables / Use of the radial approach in primary angioplasty: results in 1029 consecutive patients and analyses in unfavorable subgroups

INTRODUCCIÓN Y OBJETIVO:S: El acceso radial reduce las complicaciones vasculares tras la angioplastia primaria. El objetivo es examinar la factibilidad del acceso radial sistemático en la angioplastia primaria y evaluar cómo afecta a los subgrupos menos favorables. MÉTODOS: Se ha analizado a 1.029 pacientes consecutivos con síndrome coronario agudo con elevación del segmento ST tratados con angioplastia primaria. RESULTADOS: En el 93,1% de los pacientes, el acceso radial ha sido el acceso primario. La tasa de éxito de angioplastia primaria fue del 95,9%, y el 87,6% de los pacientes estaban libres de eventos clínicos a los 30 días del procedimiento. La tasa de cruce vascular fue del 3,0%, estable durante el periodo estudiado. La edad mayor de 75 años (odds ratio = 2,50; intervalo de confianza del 95%, 1,09-5,71; p = 0,03) y la historia de cardiopatía isquémica previa (odds ratio = 2,65, intervalo de confianza del 95%, 1,12-6,24; p = 0,02) fueron predictores de necesidad de cruce. En las mujeres y los mayores de 75 años, el uso del acceso femoral primario fue mayor. Sin embargo, en este subgrupo de pacientes el acceso radial no afectó a los tiempos de reperfusión ni al éxito de la angioplastia, aunque sí se observó una mayor tasa de cruce (el 10,9 frente al 2,6%; p = 0,006). En los pacientes en shock cardiogénico, el acceso radial se utilizó en el 51,5% de los casos, con tiempos de reperfusión y tasas de éxito de la angioplastia similares a los del acceso femoral, aunque con mayor necesidad de cruce. CONCLUSIONES: El acceso radial se puede utilizar de manera segura y eficaz en la mayoría de las angioplastias primarias. En mujeres de edad avanzada y en pacientes en shock, aumenta la necesidad de cruce sin penalizar los tiempos de reperfusión

INTRODUCTION AND OBJECTIVES: The transradial approach is associated with a reduction in vascular access-related complications after primary percutaneous coronary interventions. The purpose of this study was to examine the feasibility of the routine use of transradial access in primary angioplasty and to evaluate how it affects subgroups with less favorable characteristics. METHODS: We analyzed 1029 consecutive patients with an ST-segment elevation acute coronary syndrome treated with primary angioplasty. RESULTS: Transradial access was the primary approach in 93.1% of the patients. The success rate of primary angioplasty was 95.9%, and 87.6% of the patients were event-free 30 days after the procedure. Crossover was required in 3.0% of the patients with primary transradial access, and this rate remained stable over the years. Predictors of the need for crossover were age older than 75 years (odds ratio=2.50, 95% confidence interval, 1.09-5.71; P=.03) and a history of ischemic heart disease (odds ratio=2.65; 95% confidence interval, 1.12-6.24; P=.02). Primary transfemoral access use was higher in women older than 75 years. Use of the transradial approach in this subgroup did not affect reperfusion time or the success of angioplasty, although there was a greater need for crossover (10.9% vs 2.6%; P=.006). Among patients in cardiogenic shock, the transradial approach was used in 51.5%; reperfusion times and angioplasty success rates were similar to those obtained with transfemoral access, but there was a greater need for crossover. CONCLUSIONS: Transradial access can be used safely and effectively in most primary angioplasty procedures. In older women and in patients in cardiogenic shock, there is a higher crossover requirement, with no detriment to reperfusion time

Comparison of paclitaxel-eluting stents (Taxus) and everolimus-eluting stents (Xience) in left main coronary artery disease with 3 years follow-up (from the ESTROFA-LM registry).

Evidence regarding therapy with drug-eluting stents in the left main coronary artery (LM) is based mostly on trials performed with first-generation drug-eluting stents. The aim of this study was to evaluate long-term clinical outcomes after treatment for unprotected LM disease with paclitaxel-eluting stents (PES) and everolimus-eluting stents (EES). The ESTROFA-LM is a multicenter retrospective registry including consecutive patients with unprotected LM disease treated with PES or EES. A total of 770 patients have been included at 21 centers, 415 with treated PES and 355 with EES. Treatment with 2 stents was more frequent with PES (17% vs 10.4%, p = 0.007), whereas intravascular ultrasound was more frequently used with EES (35.2% vs 26%, p = 0.006). The 3-year death and infarction survival rates were 86.1% for PES and 87.3% for EES (p = 0.50) and for death, infarction, and target lesion revascularization were 83.6% versus 82% (p = 0.60), respectively. Definite or probable thrombosis was 1.6% for PES and 1.4% for EES (p = 0.80). The use of 2 stents, age, diabetes, and acute coronary syndromes were independent predictors of mortality. In the subgroup of distal lesions, the use of intravascular ultrasound was an independent predictor of better outcome. Comparison of propensity score-matched groups did not yield differences between the 2 stents. In conclusion, the results of this multicenter registry show comparable safety and efficacy at 3 years for PES and EES in the treatment of LM disease. The use of bifurcation stenting techniques in distal lesions was a relevant independent predictor for events. The use of intravascular ultrasound appears to have a positive impact on patients treated for LM distal disease.

Ventricular arrhythmias among implantable cardioverter-defibrillator recipients for primary prevention: impact of chronic total coronary occlusion (VACTO Primary Study).

BACKGROUND: An implantable cardioverter-defibrillator (ICD) is the therapy of choice for primary prevention in patients with ischemia who are at risk for sudden cardiac death (SCD). One third of patients with significant coronary disease have chronic total coronary occlusion (CTO), which is associated with long-term mortality in patients with previous myocardial infarction. However, the impact of CTO on the occurrence of ventricular arrhythmias and long-term mortality in ICD recipients remains unknown. METHODS AND RESULTS: All consecutive patients with coronary artery disease receiving ICD therapy for the prevention of SCD were included in the study. Among other characteristics, the existence of CTO was assessed. During follow-up, the occurrence of appropriate device delivery because of ventricular arrhythmias as well as mortality were noted. A total of 162 patients (mean age, 62±9 years; 93% men) with an ICD were included and followed for a median of 26 months (interquartile range, 12-42). At least 1 CTO was present in 71 (44%) patients. Appropriate device therapy was detected in 18% of the patients during the follow-up. The presence of CTO was associated with higher ventricular arrhythmia and mortality rates (log-rank test, <0.01). Multivariable analysis revealed that CTO was independently associated with appropriate ICD intervention (hazard ratio, 3.5; P=0.003). CONCLUSIONS: In patients with ischemic heart disease receiving ICDs for primary prevention of SCD, CTO is an independent predictor for the occurrence of ventricular arrhythmias and has an adverse impact on long-term mortality.

Angioplastia vía retrógrada: una alternativa en las oclusiones totales coronarias / Retrograde angioplasty: an option for total coronary artery occlusions

La angioplastia en oclusiones totales crónicas coronarias ha demostrado su efectividad y su seguridad en diversos estudios, aunque con una tasa de éxitos menor que en intervenciones convencionales. Constituye un reto por la complejidad de los procedimientos. Para casos seleccionados, se ha desarrollado una técnica de angioplastia por vía retrógrada a la localización de la oclusión. Presentamos la primera serie publicada en nuestro país con 11 procedimientos en 9 pacientes en los que se realizó un intento de desobstrucción de la oclusión total crónica por vía retrógrada y evaluamos las características del procedimiento, los resultados y complicaciones (AU)

The safety and effectiveness of angioplasty for chronic total occlusions of the coronary arteries have been demonstrated in several studies, but the success rate is less than for conventional interventions. The complexity of the procedures presents a major challenge. In selected cases, performing angioplasty of the occlusion via a retrograde approach has been used as an alternative. We present the first published Spanish series, comprising 11 procedures in 9 patients, in which a retrograde approach was used to eliminate obstructions caused by chronic total coronary artery occlusions. The characteristics, outcomes and complications of the procedure were assessed (AU)

[Retrograde angioplasty: an option for total coronary artery occlusions]. / Angioplastia vía retrógrada: una alternativa en las oclusiones totales coronarias.

The safety and effectiveness of angioplasty for chronic total occlusions of the coronary arteries have been demonstrated in several studies, but the success rate is less than for conventional interventions. The complexity of the procedures presents a major challenge. In selected cases, performing angioplasty of the occlusion via a retrograde approach has been used as an alternative. We present the first published Spanish series, comprising 11 procedures in 9 patients, in which a retrograde approach was used to eliminate obstructions caused by chronic total coronary artery occlusions. The characteristics, outcomes and complications of the procedure were assessed.