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.

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.

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.

Late vascular response at the edges of sirolimus analogous-eluting stents in diabetic patients

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 deffects. 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 6 22 mm3 to 72.2 6 25 mm3: P = 0.02) and distal (from 54.4 6 22 mm3 to 59.8 6 22 mm3: 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.