RESUMEN
Valve-in-valve transcatheter aortic valve implantation (ViV TAVI) is rapidly arising as a safe and effective alternative to redo-surgery in the treatment of bioprostheses deterioration. While scientific community is currently focusing its attention on the most common limitations related to this procedure, such as the risk of coronary obstruction and patient-prosthesis mismatch, data regarding the first step of a ViV TAVI, the crossing of a degenerated bioprosthesis, are still lacking. The aim of this review is to analyze the available information about bioprosthesis crossing, to show the inherent challenges encountered by interventional cardiologists during valve crossing and to describe the current strategies to perform a correct crossing.
Asunto(s)
Válvula Aórtica , Bioprótesis , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Falla de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiopatología , Resultado del Tratamiento , Factores de Riesgo , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/efectos adversosRESUMEN
BACKGROUND: Uncovered struts are a determinant of stent failure. The impact of plaque composition and procedural factors on the occurrence, evolution, and outcomes of uncovered struts in a high-risk setting has not been investigated. OBJECTIVE: To investigate the determinants and long-term clinical impact of largely uncovered struts (LUS) in thin-struts drug-eluting stents (DES) implanted in complex lesions by intracoronary optical coherence tomography (OCT). METHODS: Ninety patients with multivessel disease undergoing staged complete revascularization were randomly assigned to bioabsorbable or durable polymer DES. OCT were serially performed during the index procedure, at 3- and 18-month follow-up, and analyzed by an independent core lab. Struts were defined uncovered by OCT if no tissue was visible above the struts. LUS were defined as ≥30% of uncovered struts at 3-month follow-up. Clinical outcomes were the occurrence of target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up. RESULTS: LUS occurred in 31 patients (34.4%) regardless of stent platform. At 5 years, no differences were observed in the rate of TVF (12.7% vs. 13.4%; p = 0.91) and MACCE (23.9% vs. 24.9%; p = 0.88) between the two groups. At multivariate logistic regression, plaque rupture, mean lumen diameter, proximal reference vessel area, and maximum stent deployment pressure were independent predictors of LUS. CONCLUSIONS: LUS are a frequent finding in complex coronary lesions treated with thin-struts DES, especially in the presence of plaque rupture. However, in this study, no significant safety signal related to LUS emerged in long-term follow-up.
Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Placa Aterosclerótica , Humanos , Tomografía de Coherencia Óptica/métodos , Resultado del Tratamiento , Diseño de Prótesis , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/etiología , Intervención Coronaria Percutánea/efectos adversosRESUMEN
BACKGROUND: Coronavirus Disease-2019 (COVID-19) may impair outcomes of patients with ST-segment elevation myocardial infarction (STEMI). The extent of this phenomenon and its mechanisms are unclear.MethodsâandâResults:This study prospectively included 50 consecutive STEMI patients admitted to our center for primary percutaneous coronary intervention (PCI) at the peak of the Italian COVID-19 outbreak. At admission, a COVID-19 test was positive in 24 patients (48%), negative in 26 (52%). The primary endpoint was in-hospital all-cause mortality. Upon admission, COVID-19 subjects had lower PO2/FiO2 (169 [100-425] vs. 390 [302-477], P<0.01), more need for oxygen support (62.5% vs. 26.9%, P=0.02) and a higher rate of myocardial dysfunction (ejection fraction <30% in 45.8% vs. 19.2%, P=0.04). All patients underwent emergency angiography. In 12.5% of COVID-19 patients, no culprit lesions were detected, thus PCI was performed in 87.5% and 100% of COVID-19 positive and negative patients, respectively (P=0.10). Despite a higher rate of obstinate thrombosis in the COVID-19 group (47.6% vs. 11.5%, P<0.01), the PCI result was similar (TIMI 2-3 in 90.5% vs. 100%, P=0.19). In-hospital mortality was 41.7% and 3.8% in COVID-19 positive and negative patients, respectively (P<0.01). Respiratory failure was the leading cause of death (80%) in the COVID-19 group, frequently associated with severe myocardial dysfunction. CONCLUSIONS: In-hospital mortality of COVID-19 patients with STEMI remains high despite successful PCI, mainly due to coexisting severe respiratory failure. This may be a critical factor in patient management and treatment selection.
Asunto(s)
COVID-19/fisiopatología , Pulmón/fisiopatología , Intervención Coronaria Percutánea , Respiración , Insuficiencia Respiratoria/fisiopatología , Infarto del Miocardio con Elevación del ST/terapia , Anciano , Anciano de 80 o más Años , COVID-19/diagnóstico , COVID-19/mortalidad , COVID-19/virología , Causas de Muerte , Femenino , Mortalidad Hospitalaria , Humanos , Pulmón/virología , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Insuficiencia Respiratoria/diagnóstico , Insuficiencia Respiratoria/mortalidad , Insuficiencia Respiratoria/virología , Medición de Riesgo , Factores de Riesgo , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/fisiopatología , Factores de Tiempo , Resultado del TratamientoAsunto(s)
Estenosis de la Válvula Aórtica/epidemiología , Betacoronavirus , Infecciones por Coronavirus/complicaciones , Neumonía Viral/complicaciones , Reemplazo de la Válvula Aórtica Transcatéter/estadística & datos numéricos , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Estenosis de la Válvula Aórtica/cirugía , COVID-19 , Femenino , Humanos , Italia/epidemiología , Masculino , Pandemias , Sistema de Registros , SARS-CoV-2 , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: Trans-catheter closure of coronary artery fistulae (CAF) has become a successful alternative to cardiac surgery with excellent results and acceptable low rate of complications. Different techniques and devices are available to treat the extreme anatomical variability of CAF. AIM: We retrospectively describe our case series of five patients trans-radially treated using an Amplatzer vascular plug IV (AVP-IV) with telescoping catheter technique. RESULTS: Trans-radial closure of CAF using the "Child in Mother" technique with dedicated catheters to deliver the vascular plugs AVP-IV was successfully performed in all patients, in one case for a complex CAF, an hybrid step approach using coils and plugs was needed. CONCLUSIONS: Trans-radial closure of CAF using AVP-IV and a telescoping catheter appeared to be safe and feasible in our case series. A persistent closure of CAF was achieved in all patients at 2 year coronary angiography follow-up.
Asunto(s)
Cateterismo Cardíaco/instrumentación , Cateterismo Periférico , Anomalías de los Vasos Coronarios/terapia , Embolización Terapéutica/instrumentación , Arteria Radial , Fístula Vascular/terapia , Adulto , Anciano , Aleaciones , Cateterismo Cardíaco/efectos adversos , Catéteres Cardíacos , Cateterismo Periférico/efectos adversos , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Anomalías de los Vasos Coronarios/fisiopatología , Embolización Terapéutica/efectos adversos , Diseño de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Punciones , Estudios Retrospectivos , Resultado del Tratamiento , Fístula Vascular/diagnóstico por imagen , Fístula Vascular/fisiopatologíaRESUMEN
BACKGROUND: Iatrogenic hemorrhagic pericardial tamponade (IHPT) represents a life-threating condition requiring emergency pericardiocentesis. In this clinical context, reinfusion of pericardial blood can stabilize the patient and sustain hemodynamic conditions. AIMS AND METHODS: We reviewed all cases of IHPT occurred at our hospital over a 10 years span. In all patient autologous blood reinfusion through a femoral vein was performed. RESULTS: In our clinical experience of 30 consecutive patients with hemorrhagic cardiac tamponade, this technique was successful to limit blood transfusions, to prevent further clinical worsening and bridge patients with intractable bleeding, to cardiac surgery. No major adverse reactions were directly related to blood autotransfusion. CONCLUSION: In the complex clinical scenario of acute tamponade occurring during catheter-based cardiac procedures, autotransfusion of pericardial blood through a femoral vein is safe and effective. It can be a useful trick up the sleeve of the interventional cardiologist.
Asunto(s)
Transfusión de Sangre Autóloga , Cateterismo Cardíaco/efectos adversos , Taponamiento Cardíaco/terapia , Vena Femoral , Hemorragia/terapia , Enfermedad Iatrogénica , Pericardiocentesis , Anciano , Anciano de 80 o más Años , Transfusión de Sangre Autóloga/efectos adversos , Taponamiento Cardíaco/diagnóstico por imagen , Taponamiento Cardíaco/etiología , Estudios de Factibilidad , Femenino , Hemorragia/diagnóstico por imagen , Hemorragia/etiología , Humanos , Masculino , Persona de Mediana Edad , Pericardiocentesis/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
Aims: Delayed healing and endothelial dysfunction may occur with drug-eluting stents (DES), promoting accelerated infiltration of lipids in the neointima and development of neoatherosclerosis (NA). Pathology data suggest durable polymer (DP) of DES to play a major role in this process. Whether biodegradable polymer (BP) may address these issues is uncertain. We compared in vivo vessel healing and NA of current generation BP- or DP-DES using serial optical coherence tomography (OCT) assessments. Methods and results: Ninety patients with multivessel coronary artery disease were randomized 1:1 to BP everolimus-eluting stents (EES, Synergy) or DP zotarolimus-eluting stents (ZES, Resolute Integrity). Co-primary endpoints were the maximum length of uncovered struts at 3 months (powered for non-inferiority) and the percentage of patients presenting with frames of NA at 18 months (powered for superiority) as measured by OCT. The maximum length of uncovered struts at 3 months was 10 ± 8 mm in the BP-EES group and 11 ± 7 mm in the DP-ZES group (mean difference -1 mm; upper 97.5% confidence interval +2 mm; P = 0.05 for non-inferiority; P = 0.45 for superiority). The percentage of patients presenting with frames of NA at 18 months was low and similar between BP-EES and DP-ZES groups (11.6% vs. 15.9%; P = 0.56). There was no stent thrombosis in both groups at 24 months. Conclusion: BP-EES and DP-ZES showed a similar healing response at 3 months and a low incidence of NA at 18 months. Biocompatible polymers, regardless of whether they are durable or biodegradable, may favourably impact the long-term vascular response to current-generation DES.
Asunto(s)
Implantes Absorbibles , Aterosclerosis/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Neointima/diagnóstico por imagen , Intervención Coronaria Percutánea , Anciano , Materiales Biocompatibles , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Everolimus/administración & dosificación , Femenino , Humanos , Inmunosupresores/administración & dosificación , Masculino , Persona de Mediana Edad , Sirolimus/administración & dosificación , Sirolimus/análogos & derivados , Factores de Tiempo , Tomografía de Coherencia Óptica , Cicatrización de HeridasRESUMEN
Percutaneous aortic balloon valvuloplasty as a bridge-to-decision strategy was performed in an 89-year-old woman with multiple comorbidities and cachexia. The patient did well; after 2 weeks, she was discharged home and referred for possible TAVR.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Valvuloplastia con Balón/métodos , Cateterismo Cardíaco/métodos , Anciano de 80 o más Años , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Aortografía/métodos , Femenino , Humanos , Arteria Radial/cirugíaRESUMEN
BACKGROUND: Distal transradial access in the anatomical snuffbox has advantages over standard access in terms of patient and operator comfort levels and risk of ischemia. Radial artery preservation could be a relevant issue in patients requiring multiple radial artery procedures and coronary bypass with the use of a radial graft. One relevant drawback is the challenging puncture of a small and weak artery, with a steeper learning curve. AIM: The study was aimed at proving feasibility and safety of right and left transradial access in the anatomical snuffbox. METHODS: All 52 consecutive patients assigned to only one operator program underwent diagnostic or procedural intervention through distal transradial access in the anatomical snuffbox. RESULTS: The overall feasibility was 90%, greater than expected in our early clinical experience, with 47 successful accesses out of 52 patients. Failures were due to proximal radial artery occlusion and hypoplastic/vasospastic distal radial artery. CONCLUSION: Distal transradial access in the anatomical snuffbox is an appealing and feasible option for both patients and operators. Further studies are needed to evaluate the clinical benefits conferred by this approach.
Asunto(s)
Cateterismo Cardíaco/métodos , Enfermedad de la Arteria Coronaria/cirugía , Intervención Coronaria Percutánea/métodos , Arteria Radial/cirugía , Anciano , Cateterismo Cardíaco/efectos adversos , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversosRESUMEN
Trans-ulnar access is a viable alternative approach by experienced operators when the radial and femoral arteries cannot be accessed or used to preserve the contralateral radial artery as possible vascular graft for coronary bypass surgery, hemodynamic monitoring, or shunt creation for hemodialysis. We report a challenging case of ipsilateral trans-ulnar recanalization of a chronic radial artery occlusion, which allowed us to perform a complex trans-ulnar PCI.
Asunto(s)
Angioplastia de Balón , Arteriopatías Oclusivas/terapia , Cateterismo Periférico , Oclusión Coronaria/terapia , Intervención Coronaria Percutánea , Arteria Radial , Arteria Cubital , Angiografía , Angioplastia de Balón/instrumentación , Arteriopatías Oclusivas/complicaciones , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/fisiopatología , Enfermedad Crónica , Constricción Patológica , Oclusión Coronaria/complicaciones , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/fisiopatología , Humanos , Masculino , Persona de Mediana Edad , Punciones , Arteria Radial/diagnóstico por imagen , Arteria Radial/fisiopatología , Resultado del Tratamiento , Arteria Cubital/diagnóstico por imagen , Grado de Desobstrucción VascularRESUMEN
Despite remarkable advances in the interventional landscape, device delivery during percutaneous coronary intervention (PCI) can still present technical challenges especially when performed in complex anatomical settings and through radial approach. To overcome difficult coronary stent delivery, several strategies have been developed. A niche option in such complex cases is the anchoring balloon technique, which involves inflation of a balloon non-coaxially in a side branch or distally to the target lesion in a coaxial fashion, to facilitate stent delivery. However, the main limitation of this technique is the requirement of a large guide catheter (≥7French) which may preclude the use of radial approach. We describe, step-by-step, the distal anchoring ballooning technique performed by a 6Fr radial approach to overcome the stent delivery failure in complex anatomical scenarios and to safely and successfully carry out the PCI procedures.
Asunto(s)
Angioplastia Coronaria con Balón/métodos , Cateterismo Cardíaco/métodos , Cateterismo Periférico/métodos , Enfermedad de la Arteria Coronaria/terapia , Arteria Radial , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/instrumentación , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos , Cateterismo Periférico/instrumentación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Stents Liberadores de Fármacos , Humanos , Masculino , Punciones , Arteria Radial/diagnóstico por imagen , Resultado del TratamientoRESUMEN
We report the case of a 51-year-old woman, treated with radiotherapy at the age of two years, for a pulmonary sarcoma. Subsequently she developed severe aortic stenosis and bilateral ostial coronary artery disease, symptomatic for dyspnea (NYHA III functional class). Due to the prohibitive surgical risk, she underwent successful stenting in the right coronary artery and left main ostia with drug eluting stents and, afterwards, transcatheter aortic valve replacement with transfemoral implantation of a 23 mm Edwards SAPIEN XT valve. The percutaneous treatment was successful without complications and the patient is in NYHA II functional class at 2 years' follow-up, fully carrying out normal daily activities.
Asunto(s)
Enfermedad de la Arteria Coronaria/terapia , Trasplante de Corazón/efectos adversos , Revascularización Miocárdica/métodos , Intervención Coronaria Percutánea/métodos , Trasplante Heterotópico/efectos adversos , Adulto , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/etiología , Stents Liberadores de Fármacos , Insuficiencia Cardíaca/etiología , Humanos , MasculinoRESUMEN
BACKGROUND: The Cappella Sideguard (CS) sidebranch stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the sidebranch ostium designed to treat bifurcation lesions. OBJECTIVE: To evaluate the mechanism of long-term lumen patency of the novel, self-expanding CS sidebranch stent compared with a balloon-expandable stent in the main vessel. METHODS: We performed intravascular ultrasound postintervention and at follow-up in 24 CS stents and in 28 balloon-expandable drug-eluting stents deployed in the corresponding main vessel. Thirteen patients also had optical coherence tomography (OCT) at follow-up to evaluate neointimal hyperplasia and strut coverage. RESULTS: CS stent area at the sidebranch carina increased significantly from 3.8 ± 1.2 mm(2) postintervention to 4.6 ± 1.2 mm(2) at follow-up (P < 0.001), resulting in no change in lumen area (3.8 ± 1.2 mm(2) to 3.7 ± 1.2 mm(2) , P = 0.72) despite a neointimal area at follow-up of 0.9 ± 0.8 mm(2) . Volumetric changes were similar, and the distribution of neointimal hyperplasia peaked 1-2 mm distal to the carina. Change of lumen volume inversely correlated to the neointimal volume (R = -0.48, P < 0.001), but correlated positively to the change in stent volume (R = 0.52, P < 0.0001). By OCT, most CS struts were covered (100% [98.9, 100]) at the bifurcation site, whereas 61% of floating DES struts that crossed the sidebranch were covered by smooth tissue with a similar texture compared with neointima. CONCLUSION: Although neointimal hyperplasia accumulates within the CS stent mainly 1-2 mm distal to the carina, the self-expanding CS stent may be effective in maintaining an adequate patency in the sidebranch by continued stent expansion noted at follow-up.
Asunto(s)
Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Tomografía de Coherencia Óptica , Ultrasonografía Intervencional , Grado de Desobstrucción Vascular/fisiología , Anciano , Aleaciones , Análisis de Varianza , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/métodos , Distribución de Chi-Cuadrado , Angiografía Coronaria/métodos , Estenosis Coronaria/diagnóstico por imagen , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Fisiológico/métodos , Neointima/patología , Neointima/fisiopatología , Docilidad , Estudios Prospectivos , Diseño de Prótesis , Estadísticas no ParamétricasAsunto(s)
Cardiomiopatías/cirugía , Trasplante de Corazón/métodos , Hemodinámica/fisiología , Hipertensión Pulmonar/cirugía , Resistencia Vascular/fisiología , Adolescente , Adulto , Anciano , Anastomosis Quirúrgica/métodos , Cardiomiopatías/epidemiología , Cardiomiopatías/fisiopatología , Niño , Comorbilidad , Femenino , Estudios de Seguimiento , Atrios Cardíacos/cirugía , Humanos , Hipertensión Pulmonar/epidemiología , Hipertensión Pulmonar/fisiopatología , Masculino , Persona de Mediana Edad , Arteria Pulmonar/cirugía , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVES: We compared the mechanisms of lumen gain after Cappella Sideguard (CS) side branch (SB) bifurcation stent deployment versus a balloon-expandable stent in the corresponding main vessel (MV). BACKGROUND: The novel CS SB bifurcation stent is a self-expanding, thin-strut, nitinol device with anatomic flaring at the SB ostium. METHODS: In 28 bifurcation lesions, intravascular ultrasound imaging of both the SB and the MV was performed both pre- and postintervention; vessel and lumen areas were measured every 1 mm over a 5 mm segment beginning at the carina. RESULTS: Although minimum lumen area (MLA) within the distal 5 mm segment beginning at the carina increased from 2.8 ± 1.3 mm(2) to 3.8 ± 1.1 mm(2), P < 0.001, in the SB and from 3.4 ± 1.4 mm(2) to 6.0 ± 1.1 mm(2), P < 0.001, in the MV, stent expansion (minimum stent area/distal reference lumen area) was significantly less in the SB compared with the MV (77.8 ± 21.3% vs. 91.6 ± 18.4%, P = 0.02). Post stenting, the MLA site was located at the carina more frequently in the SB (85.7%) than in the MV (60.7%), P = 0.04. Plaque volume in the 5 mm proximal to carina in the MV tended to decrease, whereas plaque volume in the SB increased slightly with no change in overall plaque volume in the 5-mm-long segment distal to the carina in the MV, suggesting plaque shift from the proximal MV to the SB. CONCLUSIONS: Acute CS lumen gain is less than the lumen gain of a balloon-expandable stent in the MV because of less aggressive acute expansion and/or the plaque shift from the proximal MV to the SB.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Enfermedad de la Arteria Coronaria/terapia , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Ultrasonografía Intervencional , Anciano , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Resultado del TratamientoRESUMEN
BACKGROUND: New generation drug-eluting stents (DES) incorporate thinner struts and novel alloys to improve clinical performance. Nevertheless, the impact of novel stent materials and designs on human vascular response to DES remains elusive. We sought to evaluate the in-vivo coronary artery response to platinum-chromium (PtCr) versus cobalt-chromium (CoCr) stents featuring the same durable polymer and antiproliferative drug by optical coherence tomography (OCT). METHODS AND RESULTS: A total of 42 patients with de novo lesions in native coronary vessels was treated with PtCr-everolimus eluting stent (EES; n = 21) or CoCr-EES (n = 21). Angiography, intravascular ultrasound, and OCT were performed at the index procedure and 6-month follow-up. PtCr-EES and CoCr-EES had similar concentric expansion (stent eccentricity index; median 0.91 vs. 0.90, respectively, P = 0.47) and very low rate of strut malapposition (median 1.15 vs. 1.80%, P = 0.92) at post implantation. Proportion of struts embedded in tissue was lower in PtCr-EES compared to CoCr-EES (median 2.67 vs. 15.23%, P < 0.001). The primary prespecified end point, the percentage of uncovered struts per patient at 6 months follow-up, was 8.46% [interquartile range (IQR) = 3.05-17.26] in PtCr-EES and 5.88% (IQR = 1.35-13.27) in CoCr-EES (P = 0.36), whereas malapposed struts were observed in 0.00% (IQR = 0.00-0.25) versus 0.48% (IQR = 0.00-1.44), respectively, (P = 0.10). Strut-level neointimal thickness did not differ between the two platforms (median 0.09 vs. 0.08 mm, P = 0.49). CONCLUSIONS: Acute and mid-term responses to EES using PtCr or CoCr platforms were similar, with concentric stent expansion, low malapposition, similar strut coverage and limited amount of neointima. Conversely, at postprocedure, PtCr-EES had fewer embedded struts compared with CoCr-EES.
Asunto(s)
Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/patología , Stents Liberadores de Fármacos , Revascularización Miocárdica/instrumentación , Sirolimus/análogos & derivados , Tomografía de Coherencia Óptica/métodos , Anciano , Antineoplásicos , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sirolimus/farmacología , Ultrasonografía IntervencionalRESUMEN
Randomized controlled trials assessing new drugs and devices tend to exclude subjects who are at greatest risk. The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial incorporated broader inclusion criteria in an attempt to include a more representative spectrum of patients presenting with ST-segment elevation myocardial infarction (STEMI). To identify the differences between this modern trial and the real world, we analyzed the characteristics and outcomes of patients with STEMI who were screened but not enrolled at a high-volume recruiting center. Of 318 consecutive patients with STEMI who were screened, 200 (62.9%) were randomized, and 118 (37.1%) were excluded. The baseline characteristics and 30-day and 1-year clinical outcomes were compared in the 2 groups. The excluded patients had numerous high-risk features compared to those randomized, including being older (67.0 ± 12.8 vs 63.0 ± 11.4 years, p = 0.004), more often had had a previous MI (34.7% vs 8.0%, p <0.001), Killip class III-IV (27.4% vs 4.0%, p <0.001), and lower hemoglobin (13.4 ± 2.3 vs 14.8 ± 1.5 g/dl, p <0.001). The excluded patients had markedly greater 30-day and 1-year rates of all-cause mortality (17.4% vs 2.0%, p <0.001, and 27.6% vs 2.5%, p <0.001, respectively), major adverse cardiovascular events (death, MI, ischemia-driven target vessel revascularization, and stroke), major bleeding, and net adverse clinical events (major adverse cardiovascular events or major bleeding). On multivariate analysis, Killip class III-IV at presentation, age, left ventricular ejection fraction, and final Thrombolysis In Myocardial Infarction flow grade 3 were independent predictors of outcome. In conclusion, despite the broadened entry criteria of the HORIZONS-AMI trial, 37.1% of all patients presenting with STEMI at a center with a high rate of enrollment were judged to be ineligible and were excluded. The excluded patients had a significantly greater risk profile and markedly increased mortality and adverse events compared to the trial-eligible group.
Asunto(s)
Angioplastia Coronaria con Balón , Electrocardiografía , Infarto del Miocardio/terapia , Inhibidores de Agregación Plaquetaria/uso terapéutico , Medición de Riesgo/métodos , Stents , Anciano , Femenino , Estudios de Seguimiento , Humanos , Italia/epidemiología , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Infarto del Miocardio/fisiopatología , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Resultado del TratamientoRESUMEN
BACKGROUND: The paucity of longitudinal, serial high-resolution imaging studies has limited our understanding of in vivo arterial response to drug-eluting stents. We sought to investigate the human coronary response to paclitaxel-eluting stent implantation, using serial optical coherence tomography assessments. METHODS AND RESULTS: Thirty patients with at least 2 significant coronary lesions in different vessels were treated with a paclitaxel-eluting stent. The most severe stenosis (lesion A) was treated at the initial procedure, and the second target vessel (lesion B) was stented 3 months later. Optical coherence tomography was performed at baseline, 3-, and 9-month follow-up for lesions A and baseline and 6 months for lesions B. Prespecified end points were percent of uncovered and malapposed struts over time. In lesions A, uncovered struts were 3.77±4.94% and 3.02±4.35% at 3 versus 9 months (P=NS). Malapposed struts were 3.55±5.16% at post-procedure, 1.51±3.52% at 3 months, and 0.60±1.82% at 9 months (P<0.05, at 3 versus 9 months). Strut-level neointimal thickness was 0.19±0.09 mm and 0.20±0.11 mm (P=NS) over time. Newly acquired malapposition was detected in 10.4% and 3.3% of 2.5-mm segments at 3- and 9-month follow-up. In lesions B, uncovered struts were 2.91±5.47% at 6-months. Malapposed struts were 4.94±6.70% post-procedure and 1.01±3.11% at 6 months (P<0.01), with 0.19±0.09-mm neointimal thickness at follow-up. CONCLUSIONS: Optical coherence tomography imaging suggested the first 3 months to be the period with most biological activity after paclitaxel-eluting stent implantation, when the proliferative reaction mainly occurs and malapposition resolves. A less active, yet continuous, dynamic arterial response, with resolution and development of malapposition, occurs through 9 months post-treatment.
Asunto(s)
Implantación de Prótesis Vascular , Estenosis Coronaria/tratamiento farmacológico , Estenosis Coronaria/patología , Vasos Coronarios/patología , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Anciano , Angiografía Coronaria , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Factores de Tiempo , Tomografía de Coherencia Óptica , Resultado del TratamientoRESUMEN
OBJECTIVES: We assessed the in vivo vascular response to a new generation of zotarolimus-eluting stents (ZES) with prolonged drug release (Resolute ZES-SR, Medtronic Vascular, Santa Rosa, California) compared with ZES with faster kinetics (Endeavor ZES-FR, Medtronic Vascular) by optical coherence tomography. BACKGROUND: Local drug release kinetics has been implicated with antirestenosis efficacy of drug-eluting stents. However, the impact of different release kinetics on vascular response of diseased human coronary arteries remains to be investigated. METHODS: The study population consisted of 43 patients with long lesions in native coronary vessels treated with multiple overlapping ZES. Twenty-one patients treated with ZES-SR were compared with 22 patients treated with ZES-FR from the ODESSA (Optical coherence tomography for DES SAfety) study. The primary endpoint was in-stent neointimal hyperplasia as assessed by optical coherence tomography at 6-month follow-up. Coprimary endpoints were the percentage of uncovered and malapposed struts. RESULTS: Strut-level median neointimal thickness was 0.11 mm (interquartile range [IQR]: 0.07 to 0.15 mm) in ZES-SR and 0.31 mm (IQR: 0.27 to 0.42 mm) in ZES-FR, respectively (p < 0.001). The 6-month rate of uncovered struts per patient was 7.38% (IQR: 3.06% to 12.72%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001); rate of malapposed and uncovered struts was 1.47% (IQR: 0.32% to 4.23%) in ZES-SR and 0.00% (IQR: 0.00% to 0.00%) in ZES-FR (p < 0.001). CONCLUSIONS: This study demonstrated the impact of different release kinetics on human in vivo vascular response to ZES implantation. The new generation of ZES-SR compared with ZES-FR had better suppression of the neointimal response but higher proportion of uncovered and malapposed struts at 6-month optical coherence tomography follow-up. (Optical Coherence Tomography in Long Lesions [LongOCT]; NCT01133925).