Impacto de un sistema de evaluación de tiempos a la reperfusión en infarto agudo de miocardio con elevación del ST / Impact of an Evaluation System of Times to Reperfusion in ST-segment Elevation Acute Myocardial Infarction

RESUMEN • Introducción: El tratamiento del infarto con supradesnivel del ST (IAMCEST) es tiempo-dependiente, por lo que los centros con angioplastia primaria (ATCp) deben estar organizados para asegurar una rápida reperfusión. Objetivos: Evaluar el impacto de un sistema de evaluación sistemática de los tiempos de reperfusión y feedback de resultados en la reducción de las demoras. Material y métodos: Estudio observacional, prospectivo, realizado en 46 centros con ATCp 24/7 de la Iniciativa Stent-Save a Life! Argentina. Se incluyeron pacientes con IAMCEST sometidos a ATCp antes de las 12 h desde el inicio de los síntomas, asistidos entre marzo de 2016 y febrero de 2019. La población se dividió en tres etapas consecutivas de 1 año cada una desde la inclusión de cada centro. Resultados: Se incluyeron 3492 pacientes consecutivos (primer año: 1482; segundo año: 1166; tercer año: 844). Se observó una reducción significativa del tiempo puerta-balón (TPB) (68, 60 y 50 min; p < 0,0001) a lo largo de los años considerados, independientemente de dónde haya sido el primer contacto médico (PCM) y del tiempo desde el primer contacto médico (PCM) al balón (115, 112 y 98 min; p < 0,0001), sin diferencias en el tiempo desde el inicio de los síntomas al PCM ni en el tiempo total de isquemia (TTI). Asimismo, en aquellos pacientes que tuvieron su PCM en centros sin hemodinamia y fueron derivados para la realización de ATCp, se observó una disminución del TTI (274, 260 y 235 min; p < 0,001). Conclusiones: La implementación de un programa puerta-balón (PPB) en centros con ATCp permitió reducir los tiempos al tratamiento.

ABSTRACT • Background: Treatment of patients with ST-elevation myocardial infarction (STEMI) is time-dependent; therefore centers with primary percutaneous coronary intervention (pPCI) capability should be organized to achieve rapid reperfusion. Objectives: The aim of this study was to assess the impact of a systematic evaluation of reperfusion times with periodic feed-back of results in reducing delays to treatment. Methods: This was an observational, prospective study conducted in 46 centers with 24/7 pPCI capability participating in the Stent-Save a Life! Argentina Initiative. Patients with STEMI who underwent pPCI within 12 hours from the onset of symptoms were included from March 2016 to February 2019. The population was divided into three consecutive stages lasting one year each since the inclusion of each center in the Stent-Save a Life! Initiative. Results: A total of 3,492 patients were included (1st year: 1,482, 2nd year: 1,166, 3rd year: 844). There was a significant reduction in door-to-balloon (DTB) time (68, 60 and 50 min; p <0.0001), regardless of the type of first medical contact (FMC), and of the time from FMC to reperfusion (115, 112 and 98 min; p<0.0001), without differences in time from the onset of symptoms to FMC or total ischemic time (TIT). In addition, patients with FMC in centers without PCI capability who were referred for pPCI also evidenced a significant reduction of TIT (274, 260 and 235 min; p<0.001). Conclusion: The implementation of a DTB program in centers with pPCI capability resulted in a significant reduction of treatment times.

Iniciativa Stent-Save a Life! Argentina / Stent-Save a Life! Argentina Initiative

RESUMEN 31. Introducción: La iniciativa Stent-Save a Life! (SSL) es un programa europeo que busca mejorar el acceso de pacientes con infarto agudo de miocardio con elevación del ST (IAMCEST) a un tratamiento de reperfusión basado en las recomendaciones de las guías clínicas, reduciendo así su morbimortalidad. Objetivo: Describir los resultados de los primeros tres años de la iniciativa SSL Argentina Material y métodos: Se realizó inicialmente un mapeo para analizar la situación local y luego se desarrolló el Programa Puerta-Balón (PPB) como un proceso de mejora continua para centros con capacidad de realizar angioplastia primaria (ATCp). Resultados: Desde marzo de 2016 hasta marzo de 2018 se trataron 3041 pacientes con IAMCEST en 38 centros participantes del citado programa. El 20% (n = 610) de esos pacientes tuvo su primer contacto médico (PCM) con el servicio de emergencias médicas. Excluyendo los 184 pacientes sin lesiones coronarias (6% del total), el 93% fue reperfundido, principalmente con ATCp (95%). El tiempo global de isquemia fue de 117 minutos, variando según el momento del PCM. La mortalidad global intrahospitalaria fue del 7%. Conclusiones: La falta de una "cultura de reperfusión" fue la barrera en común de centros públicos y privados que motivó el desarrollo del PPB. La identificación de los puntos críticos que impiden un tratamiento a tiempo, junto con la organización de los centros puertas adentro, representan el primer paso para mejorar la atención de estos pacientes. Es necesario el trabajo integrado de todos los actores involucrados a partir de la organización de redes de atención, adaptadas a la realidad local de cada centro y región.

ABSTRACT 39. Introduction: The Stent-Save a Life! (SSL) initiative is a European program that seeks to improve the access of patients with ST-segment elevation acute myocardial infarction (STEMI) to reperfusion therapies based on clinical guideline recommendations, thus reducing morbidity and mortality. Objective: The aim of this study was to describe the results of the first three years of the SSL Argentina initiative. Methods: Initially, a mapping was carried out to analyze the local situation and then the Door-to- Balloon Program (DBP) was developed as a continuous improvement process for centers with primary percutaneous coronary intervention (pPCI) capability. Results: From March 2016 to March 2018, 3,041 patients with STEMI were treated in 38 centers participating in this program. In 20% of cases (n=610) patients had their first medical contact with the emergency medical services. After excluding 184 patients (6%) without coronary lesions, reperfusion therapy was performed in 93% of cases, mainly by pPCI (95%). Total ischemic time was 117 minutes, with differences according to the time of first medical contact. Overall in-hospital mortality was 7%. Conclusions: The lack of a "reperfusion culture" was the common barrier of public and private centers that motivated the development of the DBP. The identification of critical points that prevent treatment on time, together with enhancement of in-hospital organization, represent the first step to improve the care of these patients. The integrated work of all the involved parties is necessary to develop care networks adapted to the local reality of each center and region.

Hipertensión pulmonar postparto / Postpartum pulmonary hypertension

La presencia de hipertensión pulmonar (HP) en el embarazo es poco frecuente y conlleva un alto riesgo para madres e hijos. Existe escasa bibliografía relacionada al diagnóstico de la misma luego del parto. Se describen tres pacientes a quienes se diagnostica HP luego de cursar sus embarazos y partos libres de eventos. A pesar de desconocerse las causas, son varios los mecanismos propuestos, como la hipercoagulabilidad, la hipoxia placentaria o la embolia de líquido amniótico. Resulta difícil definir si la HP diagnosticada en el puerperio, corresponde a una HP en período asintomático que fue desenmascarada por el estrés fisiológico del parto o es una condición de reciente comienzo. A pesar de la falta de datos que avalen la ausencia de HP previa al embarazo en nuestras tres casos, el curso libre de eventos en sus embarazos, sin síntomas y con partos normales, indican que no padecían esta enfermedad hasta el momento del parto, y que la desarrollaron posteriormente. De haberla padecido antes se hubieran presentado síntomas previos al parto o en el puerperio inmediato, ya que las demandas hemodinámicas deterioran gravemente a un ventrículo con poca reserva.

Pulmonary hypertension (PH) in pregnancy is a rare disorder that carries a high risk to mother and child, and as such, it is considered a contraindication to becoming pregnant. However, there are few published reports related to the diagnosis of this condition after delivery. We describe three PH cases diagnosed after their normal pregnancies and deliveries. Although the causes are unknown, several mechanisms such as hypercoagulation, placental hypoxia or amniotic fluid embolism have been considered as possible causes. It is difficult to define whether a PH diagnosed in the postpartum period, relates to an earlier asymptomatic PH period that was triggered by the physiological stress of labor or if it is a recently acquired condition. Despite the lack of data to support the absence of PH previous to pregnancy in our three patients, lack of events during this period, asymptomatic and normal deliveries, lead us to believe that they did not suffer this disease prior to pregnancy; considering that high hemodynamic demands impair a ventricle with little reserve, and its subsequent appearance at time of delivery.

Hipertensión pulmonar postparto

La presencia de hipertensión pulmonar (HP) en el embarazo es poco frecuente y conlleva un alto riesgo para madres e hijos. Existe escasa bibliografía relacionada al diagnóstico de la misma luego del parto. Se describen tres pacientes a quienes se diagnostica HP luego de cursar sus embarazos y partos libres de eventos. A pesar de desconocerse las causas, son varios los mecanismos propuestos, como la hipercoagulabilidad, la hipoxia placentaria o la embolia de líquido amniótico. Resulta difícil definir si la HP diagnosticada en el puerperio, corresponde a una HP en período asintomático que fue desenmascarada por el estrés fisiológico del parto o es una condición de reciente comienzo. A pesar de la falta de datos que avalen la ausencia de HP previa al embarazo en nuestras tres casos, el curso libre de eventos en sus embarazos, sin síntomas y con partos normales, indican que no padecían esta enfermedad hasta el momento del parto, y que la desarrollaron posteriormente. De haberla padecido antes se hubieran presentado síntomas previos al parto o en el puerperio inmediato, ya que las demandas hemodinámicas deterioran gravemente a un ventrículo con poca reserva.(AU)

Pulmonary hypertension (PH) in pregnancy is a rare disorder that carries a high risk to mother and child, and as such, it is considered a contraindication to becoming pregnant. However, there are few published reports related to the diagnosis of this condition after delivery. We describe three PH cases diagnosed after their normal pregnancies and deliveries. Although the causes are unknown, several mechanisms such as hypercoagulation, placental hypoxia or amniotic fluid embolism have been considered as possible causes. It is difficult to define whether a PH diagnosed in the postpartum period, relates to an earlier asymptomatic PH period that was triggered by the physiological stress of labor or if it is a recently acquired condition. Despite the lack of data to support the absence of PH previous to pregnancy in our three patients, lack of events during this period, asymptomatic and normal deliveries, lead us to believe that they did not suffer this disease prior to pregnancy; considering that high hemodynamic demands impair a ventricle with little reserve, and its subsequent appearance at time of delivery.(AU)

Fractura de stent liberador de sirolimus / Sirolimus-Eluting stent Fracture

La fractura del stent es una complicación que se ha comunicado luego del implante de stents liberadores de sirolimus con una frecuencia que oscila entre el 1,9% y el 16% según las series y que se asocia con una tasa mayor de reestenosis y de eventos cardíacos a largo plazo. En esta presentación se describe el caso de un paciente en el que, casi 6 años después del implante de dos stents liberadores de sirolimus telescopados, a través de tomografia computarizada multidetector y angiografía invasiva se evidenció la fractura de los stents telescopados, asociada con oclusión del stent.

The reported incidence of stent fracture after sirolimuseluting stent implantation ranges from 1.9 to 16% according to different series. It has been associated with increased rate of restenosis and long-term cardiac events. We describe the case of a patient with a telescoped stent fracture associated with stent occlusion, after 6 years of telescoped sirolimus-eluting stent implantation. It was detected using multislice computed tomography and invasive angiography.

Fractura de stent liberador de sirolimus / Sirolimus-Eluting stent Fracture

La fractura del stent es una complicación que se ha comunicado luego del implante de stents liberadores de sirolimus con una frecuencia que oscila entre el 1,9% y el 16% según las series y que se asocia con una tasa mayor de reestenosis y de eventos cardíacos a largo plazo. En esta presentación se describe el caso de un paciente en el que, casi 6 años después del implante de dos stents liberadores de sirolimus telescopados, a través de tomografia computarizada multidetector y angiografía invasiva se evidenció la fractura de los stents telescopados, asociada con oclusión del stent.(AU)

The reported incidence of stent fracture after sirolimuseluting stent implantation ranges from 1.9 to 16% according to different series. It has been associated with increased rate of restenosis and long-term cardiac events. We describe the case of a patient with a telescoped stent fracture associated with stent occlusion, after 6 years of telescoped sirolimus-eluting stent implantation. It was detected using multislice computed tomography and invasive angiography.(AU)

Avaliação da resolução do supradesnivelamento do segmento ST após angioplastia primária, registro multicêntirco de infarto agudo do miocárdio com supradesnivelamento do segmento ST na Argentina / Evaluation of st segment elevation resolution after primary angioplasty: results of a multicenter registry of acute myocardial infarction with ST segment elevation in Argentina

A magnitude da resolução do supradesnivelamento do segmento ST é um marcador de reperfusão miocárdica em pacientes com infarto agudo do miocárdio. A resolução incompleta do supradesnivelamento do segmento ST foi identificada como preditor de resultados desfavoráveis em pacientes com infarto agudo do miocárdio após terapia de reperfusão. Este estudo teve como objetivos descrever a frequência de resolução incompleta do supradesnivelamento do segmento ST em um registro contemporâneo de pacientes submetidos a angioplastia primária e fazer uma comparação de seus resultados hospitalares com pacientes que apresentaram resolução completa do supradesnivelamento do segmento ST. Método: Entre julho de 2008 e fevereiro de 2009, foram incluídos 183 pacientes consecutivos com infarto agudo do miocárdio (< 24 horas) de oito centros na Argentina em um registro prospectivo de infarto agudo do miocárdio com supradesnivelamento do segmento ST foi definida como redução < ou igual 70 por cento do supradesnivelamento do segmento ST no eletrocardiograma...

Angiographic and intravascular ultrasound findings following implantation of the Endeavor zotarolimus-eluting stents in patients from the real-world clinical practice.

AIMS: The aim of this study was to investigate the angiographic and intravascular ultrasound (IVUS) findings of the Endeavor zotarolimus-eluting stent (ZES) in patients from a "real-world" clinical practice. METHODS AND RESULTS: From January to March 2006, 100 patients undergoing routine or emergency percutaneous intervention were prospectively enrolled at one institution. Overall, 39% of the patients were diabetics and 80.8% of lesions were type B2/C. A total of 140 lesions were successfully treated with 174 ZES, and procedural success was 98%. Mean vessel diameter was 2.69 mm and mean lesion length was 16.0 mm; at 6-month angiographic follow-up (completed in 96%), in-stent late lumen loss was 0.66 mm, and in-segment restenosis was 8.2%. Angiographic restenosis was increased among diabetics (15.5 vs. 2.6%, p=0.009), and diabetes was the only significant predictor of angiographic restenosis (OR=15.27 [95%CI 2.45-95.04], p=0.003). By IVUS (performed in 88% at 6-month), % volume obstruction was 14.4+/-13.4%, and there was no late acquired incomplete stent apposition (ISA). At 1-year, overall MACE rate was 6%, including 5 TLRs (4% of patients), with no occurrence of stent thrombosis. CONCLUSIONS: In this prospective "real-world" experience, the ZES demonstrated favourable angiographic and IVUS results in complex patients, with overall in-stent late lumen loss of 0.66 mm, and absence of late acquired ISA. At 1-year, there were no safety concerns including absence of death and stent thrombosis.

Culprit-only or multivessel percutaneous coronary stenting in patients with non-ST-segment elevation acute coronary syndromes: one-year follow-up.

OBJECTIVE: To investigate the major cardiac events at 1-year follow-up of multivessel versus culprit-vessel stenting in patients presenting with non-ST elevation acute coronary syndrome (NSTE-ACS) and multivessel disease (MVD). INTRODUCTION: Percutaneous coronary intervention is a standard revascularization strategy for patients with NSTE-ACS. However, when these patients have MVD it is not clear whether multivessel (MVR) is superior to culprit-vessel revascularization (CVR). METHODS: We screened 1,100 consecutive patients with NSTE-ACS from an institutional database. Comparisons of 1-year outcomes between multivessel and culprit-vessel revascularized patients were made. The primary outcome was the composite (MACE) of death, myocardial infarction (MI), or any revascularization. Secondary end-points were the components of the composite end-point. Regression analysis was performed to detect predictors of MACE. RESULTS: A total of 609 patients were considered for this analysis: 204 (33.5%) and 405 (66.5%) had MVR and CVR treatment, respectively. The strategy adopted was based on a clinical decision. The incidence of MACE was lower in MVR (9.45% vs. 16.34%, P = 0.02) with lower revascularization rate (7.46% vs. 13.86%, P = 0.04) than in CVR. There was no difference in death (1.99% vs. 1.98%, P = 0.8) nor death/MI (2.49% vs. 3.22%, P = 0.8) between MVR and CVR, respectively. Multivariate analysis showed CVR as the only independent predictor of improved MACE (OR 0.66, CI95% 1.12-3.47, P = 0.01). CONCLUSION: Multivessel stenting in patients with NSTE-ACS and multivessel disease using a clinical decision of treatment is associated with lower rate of MACE driven by lower repeat revascularization, compared with culprit-vessel stenting, without difference in rates of death or MI.

Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents.

Despite the undeniable contribution of intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) to assess drug-eluting stent (DES) effectiveness, the way these image modalities correlate to each other and to target-lesion revascularization (TLR) after PCI, is yet to be established. Thus we sought to evaluate whether there is an acceptable correlation between QCA and IVUS after DES implantation. We analyzed 204 pts treated with DES: Zotarolimus- (126), Sirolimus- (57), and Biolimus (31) with baseline and follow-up QCA and IVUS. The correlation between QCA lumen loss (LL) and intimal hyperplasia (IH) volume obstruction by IVUS was assessed by multiple regression analysis. Two QCA parameters (in-segment diameter stenosis and in-segment LL) and one IVUS variable (in-stent volume of IH) were evaluated as quantitative surrogates of 6 month TLR. The receiver operating characteristic method with c-statistics was used to assess the ability of each surrogate endpoint to predict TLR. QCA LL correlated positively with IVUS IH volume of obstruction (r = 0.69; CI95% 0.61-0.75: P < 0.0001), independent of DES type. The 2 QCA parameters were superior to the IVUS parameter as surrogates for TLR. Of note, QCA LL (c = 0.99) correlated best with TLR, even better than percent DS. In the DES era there is a good correlation between QCA measured LL and IVUS IH volume and therefore can be used as a surrogate of DES efficacy.

Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents / Correlation between quantitative angiographic and intravascular ultrasound parameters in patients treated with sirolimus analogous-eluting stents

Abstract Despite the undeniable contribution of intravascular ultrasound (IVUS) and quantitative coronary

angiography (QCA) to assess drug-eluting stent (DES) effectiveness, the way these image modalities correlate to each other and to target-lesion revascularization

(TLR) after PCI, is yet to be established. Thus we sought to evaluate whether there is an acceptable correlation between QCA and IVUS after DES implantation. We analyzed 204 pts treated with

DES: Zotarolimus- (126), Sirolimus- (57), and Biolimus (31) with baseline and follow-upQCA and IVUS. The correlation between QCA lumen loss (LL) and intimal hyperplasia (IH) volume obstruction by IVUS

was assessed by multiple regression analysis. Two QCA parameters (in-segment diameter stenosis and insegment

LL) and one IVUS variable (in-stent volume of IH) were evaluated as quantitative surrogates of 6 month TLR. The receiver operating characteristic method with c-statistics was used to assess the

ability of each surrogate endpoint to predict TLR. QCA LL correlated positively with IVUS IH volume of obstruction (r = 0.69; CI95% 0.61–0.75: P/0.0001), independent of DES type. The 2 QCA

parameters were superior to the IVUS parameter as surrogates for TLR. Of note, QCA LL (c = 0.99) correlated best with TLR, even better than percent DS. In the DES era there is a good correlation between

QCA measured LL and IVUS IH volume and therefore can be used as a surrogate of DES efficacy.

Stents farmacológios versus não-farmacológicos para o tratamento de pacientes uniarteriais portadores de lesão em artéria descendente anterior: seguimento clínico de dois anos / Drug-Eluting Stents Versus Bare-Metal Stents for the Treatment of Single Left Anterior Descending Artery: Two Year Clinical Follow-Up

Introdução: Pacientes submetidos a intervenção percutânea em hospitais públicos brasileiros não têm acesso aos stents farmacológicos. No início de 2006, participamos de um registro multicêntrico internacional que disponibilizava o uso rotineiro dessas próteses, no cenário do mundo real. Neste artigo, procuramos identificar os perfis clínico, angiográfico e do procedimento de pacientes consecutivamente tratados em períodos subseqüentes de dois meses, de acordo com a disponibilidade desses modelos, visando à identificação de eventuais alterações nesses perfis. Método: Estudo observacional de uma série de 471 pacientes, divididos em dois grupos: A, 229 casos dilatados na vigência da disponibilidade de stents farmacológicos; e B, 242 pacientes subseqüentes tratados da forma usual. Não houve critérios de inclusão/exclusão. Resultados: Stents farmacológicos foram mais implantados no grupo A (44% vs. 2%; p < 0,0001). No que se refere às características de base, observou-se predomínio significante de diabéticos dependentes de insulina em A (8% vs. 3%; p = 0,02), o mesmo ocorrendo com lesões-alvo tipos B2 ou C (73% vs. 57%; p < 0,0001), lesões situadas em bifurcações (15% vs. 9%; p = 0,02) e intervenções multiarteriais (15% vs. 6%; p = 0,003). A angiografia quantitativa identificou os casos de A como portadores de estenoses situadas em vasos de menor calibre (2,4 mm vs. 2,6 mm; p = 0,0004), também exibindo lesões mais longas (14,9 mm vs. 12,7 mm; p = 0,0008). Conclusões: A disponibilidade dos stents farmacológicos gerou alterações no perfil dos casos tratados, que passou a abordar situações mais predispostas à reestenose, como os diabéticos dependentes de insulina, os multiarteriais com lesões de alta complexidade e os portadores de lesões mais longas em vasos de fino calibre.

Introduction: Patients submitted to percutaneous intervention in public hospitals in Brazil have no access to DES. At the beginning of 2006, we participated in an international multicenter registry which made available the routine use of these prosthesis, in a "real world" scenario. In this article, we intend to identify the clinical, angiographical and procedural profiles of the patients, consecutively treated in twomonth subsequent periods, according to the availability of these models, with the aim of identifying eventual changes in their profiles. Method: Observational series of 471 patients, divided into two groups: A) 229 cases, treated during a period of availability of DES for routine use; and B) 242 patients subsequently treated as usual (no routine avalilability of DES). There were no inclusion/exclusion criteria. Results: More DES were implanted in group A (44% vs. 2%; p<0.0001). Regarding baseline clinical and angiographic characteristics, a significant predominance of insulin-dependent diabetics was observed in group A (8% vs. 3%; p=0.02), as well as B2 or C lesions (73% vs. 57%; p<0.0001); lesions in bifurcations (15% vs. 9%; p=0.02), and multiarterial interventions (15% vs. 6%; p=0.003). Quantitative angiography identified the A group cases as bearers of stenosis placed in smaller vessels (2.4 mm vs. 2.6 mm; p=0.0004), also exhibiting longer lesions (14.9 mm vs. 12.7 mm; p=0.0008). Conclusions: The availability of DES changed the profile of the patients treated, being more likely situations prone to restenosis, such as insulin dependent diabetics, multiarterial disease, patients presenting complex lesions, longer lesions and smaller target vessels.

Incidência de aposição incompleta persistente e tardia após implante de stents com sirolimus e zotarolimus / Incidence of persistent and late-acquired incomplete stent apposition after sirolimus and zotarolimus-eluting stents

Introdução: Aposição incompleta (AI) é descrita após implante de stents farmacológicos (SF) e pode associar-se à trombose de stents. Em razão de diferentes plataformas, polímeros e fármacos utilizados, diferenças na eficácia e na segurança entre SF também são esperadas. Objetivo: Avaliar a incidência de AI persistente e tardia após implante de stents com sirolimus (SES) e com zotarolimus (ZES) e a evolução dos pacientes que apresentem essa alteração. Método: Análise de 242 pacientes tratados com SF (175 pacientes com SES – Cypher® – e 67 pacientes com ZES – Endeavor™) e submetidos a ultra-sonografia intracoronária após o implante e aos seis meses. Resultados: No grupo tratado com SES, 7 (4%) pacientes apresentaram AI tardia e 12 (6,8%), AI persistente. No grupo tratado com ZES, nenhum caso de AI tardia foi identificado e, em 4 pacientes, observou-se AI após o implante e que desapareceu aos seis meses. Nos pacientes com AI tardia, observou-se aumento evolutivo dos volumes do vaso (de 377,2 ± 148,9 mm3 para 431,9 ± 155,1 mm3; p = 0,51)e da placa (de 206,1 ± 51,5 mm3 para 236,9 ± 68,4 mm3; p = 0,36). O volume de hiperplasia intimal foi maior após ZES (16,6 ± 5,8 mm3 vs. 5,1 ± 5,5 mm3; p < 0,0001). Após nove meses, não ocorreram eventos cardíacos adversos nos pacientes com AI. Conclusão: A incidência de AI tardia foi de 2,9% e observada após SES. A presença de AI não esteve relacionada a eventos adversos a médio prazo.

Background: Incomplete stent apposition (ISA) has been documented after drug-eluting stents (DES) and could be related to stent thrombosis. Because DES differ in metal platform, polymer and pharmacological agent, differences in performance and safety are expected. Objective: We sought to investigate the frequency and clinical consequences of ISA after implantation of sirolimus- (SES) and zotarolimuseluting stents (ZES). Methods: 242 patients (pts) who underwent DES placement (175 pts with Cypher® and 67 pts with EndeavorTM stents) had serial intravascular ultrasound (IVUS) performed (at index procedure and after 6-months). Results: 7 pts (4%) had late-acquired ISA after SES. Another 12 (6.8%) pts treated with SES had persistent ISA. Among pts treated with ZES, none had late ISA and 4 had ISA observed after stent implantation that completely resolved at 6-months. There was an increase in vessel (377.2 ± 148.9 to 431.9 ± 155.1 mm3, p = 0.51) and in plaque volume (206.1 ± 51.53 to 236.91 ± 68.4 mm3, p=0.36) in pts with late ISA. Amount of neointimal hyperplasia was significantly higher in ZES than SES (16.6 ± 5.8 mm3 vs 5.1 ± 5.5 mm3, p < 0.0001). After 9 months, no adverse clinical event was observed in pts with ISA. Conclusion: Overall incidence of IVUS-detected late incomplete DES apposition was 2.9%, all after SES. The presence of ISA was not related to clinical adverse events during mid term follow-up.

[Relationship between plasma C-reactive protein level and neointimal hyperplasia volume in patients with zotarolimus-eluting stents. Volumetric analysis by three-dimensional intracoronary ultrasound]. / Asociación entre la concentración plasmática de proteína C reactiva y el volumen de hiperplasia neointimal en pacientes tratados con implante de stent liberador de zotarolimus. Análisis volumétrico con ecografía intracoronaria tridimensional.

INTRODUCTION AND OBJECTIVES: C-reactive protein (CRP) is an inflammatory marker that predicts cardiac events in patients with coronary syndromes. However, data on the relationship between the CRP level and in-stent restenosis are contradictory. The objective of this study was to investigate the relationship between the basal CRP level and the neointimal hyperplasia volume measured by intracoronary ultrasound 4 months after implantation of a zotarolimus-eluting stent. METHODS: The study included 40 consecutive patients who underwent zotarolimus-eluting stent implantation. Patients were divided into quartiles according to their preprocedural CRP level. Intracoronary ultrasound was performed after stent implantation and at 4 months, and the neointimal hyperplasia volume was determined using Simpson's rule. Correlation and linear regression analyses were used to evaluate the relationships between variables. Multivariate analysis was used to identify variables that were independently related to neointimal hyperplasia volume. RESULTS: The patients' mean age was 58 (8) years, 55% were male, and 40% had diabetes mellitus. There was no difference in baseline characteristics between the quartiles. The hyperplasia volumes were 4.8 (4.2) microl and 15.8 (10.0) microl in the first and fourth quartiles, respectively (P< .001). There was a significant positive correlation between the CRP level and neointimal hyperplasia volume (r = 0.64, P=.0001). The CRP level, the postimplantation lumen volume, and the final deployment pressure were all independent predictors of neointimal hyperplasia. CONCLUSIONS: In this study, an independent correlation was observed between the CRP level before zotarolimus-eluting stent implantation and the neointimal hyperplasia volume at 4-month follow-up.

asociación entre la concentración de plasmática de proteina C reactiva y el volumen de hiperplasia neointimal en pacientes tratados con implante de stent liberador de zotarolimus. Análisis volumétrico con ecografía intracoronariana tridimensional / Relationship between plasma C-reactive protein level and neointimal hyperplasia volume in patients with zotarolimus-eluting stents. Volumetric analysis by three-dimensional intracoronary ultrasound

INTRODUCTION AND OBJECTIVES: C-reactive protein (CRP) is an inflammatory marker that predicts cardiac events in patients with coronary syndromes. However, data on the relationship between the CRP level and in-stent restenosis are contradictory. The objective of this study was to investigate the relationship between the basal CRP level and the neointimal hyperplasia volume measured by intracoronary ultrasound 4 months after implantation of a zotarolimus-eluting stent. METHODS: The study included 40 consecutive patients who underwent zotarolimus-eluting stent implantation. Patients were divided into quartiles according to their preprocedural CRP level. Intracoronary ultrasound was performed after stent implantation and at 4 months, and the neointimal hyperplasia volume was determined using Simpson's rule. Correlation and linear regression analyses were used to evaluate the relationships between variables. Multivariate analysis was used to identify variables that were independently related to neointimal hyperplasia volume. RESULTS: The patients' mean age was 58 (8) years, 55% were male, and 40% had diabetes mellitus. There was no difference in baseline characteristics between the quartiles. The hyperplasia volumes were 4.8 (4.2) microl and 15.8 (10.0) microl in the first and fourth quartiles, respectively (P< .001). There was a significant positive correlation between the CRP level and neointimal hyperplasia volume (r = 0.64, P=.0001). The CRP level, the postimplantation lumen volume, and the final deployment pressure were all independent predictors of neointimal hyperplasia. CONCLUSIONS: In this study, an independent correlation was observed between the CRP level before zotarolimus-eluting stent implantation and the neointimal hyperplasia volume at 4-month follow-up.

Asociación entre la concentración plasmática de proteína C reactiva y el volumen de hiperplasia neointimal en pacientes tratados con implante de stent liberador de zotarolimus. Análisis volumétrico con ecografía intracoronaria tridimensional / Relationship between plasma C-reactive protein level and neointimal hyperplasia volume in patients with zotarolimus-eluting stents. Volumetric analysis by three-dimensional intracoronary ultrasound

Introducción y objetivos. La proteína C reactiva (PCR) es un marcador inflamatorio predictor de eventos cardiacos en los síndromes coronarios; sin embargo, existe evidencia contradictoria sobre su relación con la reestenosis intra-stent. El objetivo es evaluar la asociación entre la concentración sérica de PCR basal y el volumen de hiperplasia neointimal por ecografía intracoronaria a los 4 meses tras el implante de stents con zotarolimus. Métodos. Se incluyó a 40 pacientes tratados consecutivamente con stent liberador de zotarolimus. Se determinó el valor de PCR antes del procedimiento y de acuerdo con éste se agrupó a la población en cuartiles. Se realizó ecografía intracoronaria tras el implante y a los 4 meses, evaluando el volumen de hiperplasia neointimal por la fórmula de Simpson. Para relacionar las variables se utilizaron análisis de correlación y regresión lineal. Se realizó un análisis de regresión múltiple de las variables relacionadas de forma independiente con el volumen neointimal. Resultados. La edad media fue 58 ± 8 años, el 55% eran varones y el 40% tenía diabetes, sin diferencias en las características basales entre los grupos. El volumen de hiperplasia fue 4,8 ± 4,2 µl y 15,8 ± 10 µl para el primer y el cuarto cuartil respectivamente (p < 0,001). Existió correlación positiva entre la PCR y el volumen neointimal (r = 0,64; p = 0,0001). La PCR, el volumen luminal postimplante y la presión de liberación fueron predictores independientes de hiperplasia neointimal. Conclusiones. En este estudio observamos que el valor de la PCR antes del implante de stent con zotarolimus se correlacionó de forma independiente con el volumen de hiperplasia neointimal a los 4 meses de seguimiento (AU)

Introduction and objectives. C-reactive protein (CRP) is an inflammatory marker that predicts cardiac events in patients with coronary syndromes. However, data on the relationship between the CRP level and in-stent restenosis are contradictory. The objective of this study was to investigate the relationship between the basal CRP level and the neointimal hyperplasia volume measured by intracoronary ultrasound 4 months after implantation of a zotarolimus-eluting stent. Methods. The study included 40 consecutive patients who underwent zotarolimus-eluting stent implantation. Patients were divided into quartiles according to their preprocedural CRP level. Intracoronary ultrasound was performed after stent implantation and at 4 months, and the neointimal hyperplasia volume was determined using Simpson's rule. Correlation and linear regression analyses were used to evaluate the relationships between variables. Multivariate analysis was used to identify variables that were independently related to neointimal hyperplasia volume. Results. The patients' mean age was 58 (8) years, 55% were male, and 40% had diabetes mellitus. There was no difference in baseline characteristics between the quartiles. The hyperplasia volumes were 4.8 (4.2) µl and 15.8 (10.0) µl in the first and fourth quartiles, respectively (P<.001). There was a significant positive correlation between the CRP level and neointimal hyperplasia volume (r = 0.64, P=.0001). The CRP level, the postimplantation lumen volume, and the final deployment pressure were all independent predictors of neointimal hyperplasia. Conclusions. In this study, an independent correlation was observed between the CRP level before zotarolimus-eluting stent implantation and the neointimal hyperplasia volume at 4-month follow-up (AU)

A three-dimensional intravascular ultrasound comparison between the new zotarolimus-eluting stent (ZoMaxx) and the non-drug-eluting TriMaxx stent.

BACKGROUND: Despite the effectiveness of sirolimus- and paclitaxel-eluting stents in reducing intimal hyperplasia (IH) and the need for repeat revascularization, concerns about their long-term safety have motivated the search for new drug-eluting stents (DES). Recently developed, the ZoMaxx stent combines a sirolimus-analogous agent (zotarolimus), featuring a phosphorycoline polymer and stainless steel and tantalum platform. We sought to assess the efficacy of this new DES in reducing IH. METHODS: A total of 40 patients were treated with the ZoMaxx stent and compared to 50 patients treated with its non-drug-eluting equivalent, the TriMaxx stent. Only single de novo lesions in native coronary vessels greater than or equal to 3.0 mm were enrolled. Serial quantitative coronary angiography and intravascular ultrasound (IVUS) images were obtained at baseline and 6- month follow up. All patients were clinically followed for 1 year. This analysis aimed to compare the percent of IH between the 2 stents. Secondarily, we assessed in-segment late loss, binary restenosis and major adverse cardiac events. RESULTS: Baseline patient and lesion characteristics were comparable between the 2 groups. At follow up, zotarolimus efficiently suppressed neointimal hyperplasia formation with a marked reduction in the percentage of stent obstruction by IVUS (4.6 +/- 3.6% vs. 31.2 +/- 16%; p < 0.0001). Almost 90% of the segments stented with ZoMaxx did not exhibit more than 10% of obstruction. After 1 year, 12 patients treated with the TriMaxx and 2 patients treated with the ZoMaxx presented in-segment binary restenosis (p = 0.03). CONCLUSIONS: In this initial experience, ZoMaxx proved to be clinically safe and superior to its non-drug-coated equivalent in reducing in-stent IH formation and restenosis.

Análise comparativa do segmento de "ovelapping" dos stents liberadores de sirolimus e paclitaxel / Comparative analysis of the overlapping segment of sirolimus-versus paclitaxel-eluting stents

Introdução: No tratamento de obstruções coronárias longas e complexas recomenda-se cobertura total da lesão. Quando mais de um stent é implantado, torna-se mandatário um "overlapping" ou sobreposição dos stents para evitar espaços não cobertos entre eles. Há pouca evidência na literatura sobre a eficácia e segurança de se realizar sobreposição de stents liberadores de sirolimus (Cypher, SES) e paclitaxel (Taxus, SEP). Objetivo: Avaliar, por meio de estudo seriado com ultra-sonografia intravascular (USIC), a eficácia na redução da proliferação neointimal e as mudanças na parede vascular no segmento com sobreposição de stents farmacológicos SES e SEP. Método: Um total de 52 pacientes (72 lesões) foram prospectivamente incluídos nesta análise e randomizados para tratamento percutâneo com implante de SES ou SEP. Cartoze pacientes do grupo SES e 12 do grupo SEP apresentaram segmentos de sobreposição. Angiografia Coronária quantitativa e USIC foram realizados imediatamente após o implante dos stents e repetidos após oito meses. Resultados: Ambos os grupos apresentavam características clínicas e angiográficas basais...

Introduction: To treat long complex coronary obstructions, total lesion coverage is recommended. When more than one stent is deployed an overlap segment is mandatory to avoid uncovered gaps between stents. There is no data comparing Sirolimus- (SES) versus Paclitaxel-eluting stents (PES) at overlapping segments in regards to neointimal inhibition or toxic effects on the vessel wall. Objective: To evaluate, by means of serial intravascular ultrasound (IVUS), the efficacy in reducing neointimal proliferation and the vessel changes in the overlapping segment comparing these two drug-eluting stents. Method: Fifty-two patients with 72 de novo coronary lesions were randomized for SES or PES. Fourteen patients in the SES Group and twelve in the PES Group had overlapping segments. Quantitative coronary angiography and IVUS were performed at the time of the procedure and at 8 months follow-up. Results: No significant baseline differences were identified between the 2 groups. The mean stent/lesion ratios were similar (1.74 ± 0.89 for SES vs. 2.01 ± 0.92 for PES; p= 0.47). SES and PES were comparable in reducing neointima hyperplasia in the overlapping zone (neointima volume 2.24 ± 0.9 mm3 after SES vs. 2.53 ± 1.5 mm3 after PES; p=0.1 and % neointima obstruction of 18.15 ± 8.5% after SES vs. 26.7 ± 16.8% after PES; p=0.1). There was no positive remodeling in the overlapping segment for both groups (expansion ratio 0.74 ± 0.18 vs. 0.76 ± 0.14, respectively; p=0.74). Other IVUS volumetric measurements were also equivalent between the two cohorts. Conclusion: In our preliminary experience, overlapping of DESs proved...

Late vascular response at the edges of sirolimus analogous-eluting stents in diabetic patients: An intravascular ultrasound study.

INTRODUCTION: Vascular response at edges of drug-eluting stents is still not well established, particularly in diabetic patients who are prone to aggressive atherosclerosis progression. Recently, Biolimus and Zotarolimus have demonstrated potent antiproliferative effects. OBJECTIVE: To compare the vascular responses at edges of sirolimus analogous-eluting stents in patients with and without diabetes, using intravascular ultrasound (IVUS). METHODS: 306 edges were analyzed in 153 patients treated with drug-eluting stents and divided in: diabetics (122 edges) and nondiabetics (166 edges). IVUS was performed postintervention and at 6-month follow-up and included 5 mm distal and proximal to the stented segment. Vessel, lumen, and plaque volumes were calculated. Volume variation (follow-up minus basal) was also calculated. Edge restenosis was defined as obstruction >50%. RESULTS: Baseline characteristics were similar between groups. In both groups the entire lesion length was covered (stent length/lesion length ratio was 1.5 for both groups). There were no differences in edge volumes and restenosis rate between the groups. Among diabetics, there was no significant volume variation. However, in nondiabetic patients there was significant increase in vessel volume in proximal (from 67.1 +/- 22 mm(3) to 72.2 +/- 25 mm(3): P = 0.02) and distal (from 54.4 +/- 22 mm(3) to 59.8 +/- 22 mm(3): P = 0.001) edges. CONCLUSION: Nondiabetic patients showed a significant positive vascular remodeling in proximal and distal edges of sirolimus analogous-eluting stent. This vascular mechanism was not observed in diabetic patients. Although different vascular responses were observed, restenosis rates were equivalent between the 2 groups at 6-month follow-up.

Evolução clínica tardia de pacientes multiarteriais tratados por revascularização percutânea e cirúrgica / Late clinical outcome after coronary stenting versus bypass surgery in patients with multivessel disease

cirurgia em relação à ocorrência de eventos cardíacos maiores, embora novos procedimentos de revascularização sejam mais freqüentes nos primeiros. Objetivo: Avaliar os resultados a longo prazo da revascularização percutânea com o implante de stents coronários versus a cirurgia no tratamento da doença multiarterial, verificando a incidência de morte, infarto do miocárdio (IAM), acidente vascular encefálico (AVE) e a realização de novas intervenções.Método: Estudo randomizado realizado no período de abril/ 1997 a junho/1998, no qual foram incluídos 66 pacientes multivasculares submetidos ao implante de stents não farmacológicos (33 P) e à cirurgia (33 P). Resultados: Ao final de um período médio de acompanhamento clínico de 8 anos, constatamos que não ocorreram diferenças significativas na sobrevivência livre de eventos cardiovasculares maiores (morte, IAM e AVE), nos 2 grupos: stent ­ 74% x cirurgia ­ 85,1%; p=NS. Procedimentos adicionais de revascularização foram mais freqüentes no pacientes tratados com stents, comparativamente àqueles tratados pela cirurgia (respectivamente, 15 P - 45% x 5 P - 15%; p=0,01). Como conseqüência destes resultados, a sobrevivência livre de todos os eventos, inclusive nova revascularização, foi significativamente menor no grupo percutâneo versus o cirúrgico (49% x 80,5%; p=0,0082). Conclusão: A revascularização com o implante de stents não farmacológicos, no tratamento da doença multiarterial, oferece o mesmo grau de proteção contra eventos cardiovasculares maiores, quando comparada à cirurgia. Contudo, a sobrevivência livre de todos os eventos a longo prazo foi significativamente menor nos pacientes tratados percutaneamente, devido à necessidade mais freqüente de novos procedimentos de revascularização.

Background: Patients with multivessel disease treated percutaneously have similar outcomes when compared to those submitted to surgical procedures in terms of major cardiac events, although the former require new revascularization procedures more frequently. Objective: To assess longterm clinical outcomes after coronary artery bypass graft (CABG) for the treatment of multivessel disease versus surgical procedures to treat multivessel disease determining death, AMI, and stroke incidence rates, as well as new interventions. Methods: A randomized study carried out between April, 1997 and June, 1998 included 66 patients submitted to nondrug eluting stenting (33P) and surgery (33P). Results: Clinical follow-up results after 8 years have shown no significant difference between the two groups in terms of survival free of MACE events (death, stroke or AMI): STENTING: 74% X CABG: 85.1%; p= not significant). Additional revascularizations were more frequent in the stenting group as compared to the surgery group (15 P - 45% x 5 P - 15%, respectively, p=0.01). Consequently, survival rates without MACE and repeated revascularization was significantly lower in patients assigned to stenting when compared to those assigned to CABG (49% x 80.5%, respectively, p=0.0082). Conclusion: Percutaneous revascularization with non-drug eluting stenting for the treatment of multivessel disease offers the same degree of protection against MACE (death, stroke and AMI) as compared to CABG. However, stenting is associated with a greater need of repeated revascularization and lower total event-free survival rates.