RESUMEN
BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).
Asunto(s)
Implantes Absorbibles , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Anciano , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Trombosis Coronaria/epidemiología , Everolimus/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Lesion length has been an important factor in predicting a worse outcome after percutaneous coronary interventions (PCI); however, the safety and efficacy of second-generation drug eluting stents in very long coronary lesions has not been validated in large scale randomized controlled trials. METHODS: We performed a patient level pooled analysis of 13,266 patients undergoing planned overlapping stent treatment of very long coronary lesions with the XIENCE V everolimus eluting coronary stent system from 6 trials evaluating the XIENCE V stent (Spirit II, III, IV, V, Spirit Small Vessel and XIENCE V USA). Patients were divided into two cohorts, a very long lesion (VLL) group (lesions ≥35 mm) and a control group (lesions >24 to <35 mm). The primary outcome measures were Target Lesion Failure (TLF), Major Adverse Cardiac Events (MACE), and Academic Research Consortium (ARC) defined definite and probable stent thrombosis at 1 year. RESULTS: A total of 13,266 patients were included in the pooled analysis of which 2.4% (323 patients with 328 total lesions) had a mean lesion length of 47.1 ± 13.7 mm in the VLL group which were compared to controls comprised of 3.6% of the cohort (482 patients with 500 total lesions) with mean lesion length of 28.1 ± 2.4 mm.There was no significant difference in the rates of TLF between the VVL and control groups (8.9 vs. 10%, P = 0.63), MACE (9.2 vs. 10%, P = 0.74) or stent thrombosis (1.6 vs. 1.5%, P = 0.92) at 1 year. CONCLUSIONS: In the treatment of very long coronary lesions, the XIENCE V stent appears as safe and effective as percutaneous coronary interventions for long lesions. © 2016 Wiley Periodicals, Inc.
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Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/etiología , Trombosis Coronaria/etiología , Everolimus/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The Xience V USA Study demonstrated safety and efficacy of the XIENCE V(®) everolimus-eluting stent (EES) in a large, prospective study of a real-world, unselected patient population. There is limited long-term data regarding EES performance in high risk patients with bifurcation lesions (BIF). The objective of this analysis was to evaluate the long-term safety and effectiveness of EES in patients with BIF from the XIENCE V USA study. METHODS: The Xience V USA Study was a single arm, prospective, multicenter, real-world study (n = 5,054) undergoing PCI with EES. Baseline data and clinical outcomes at 4 years were evaluated in the subgroup of patients with ≥ 1 BIF who did not undergo a staged procedure. Co-primary endpoints were ARC definite/probable stent thrombosis and a composite of cardiac death and ARC-defined myocardial infarction (MI). Endpoints were adjudicated by an independent CEC. RESULTS: Of 4,768 patients who did not undergo a staged procedure, there were 511 (10.7%) patients with BIF and 4,257 (89.3%) patients without BIF. Follow-up data was available in 4,459 patients (466 BIF, 3,993 non-BIF). Through binary outcome analysis, at 1 year the overall definite/probable stent thrombosis rates were higher in the BIF group (1.84% vs. 0.76%, P = 0.03). However, at 4 years, the difference in cumulative rates of ARC definite/probable stent thrombosis (BIF 2.3% vs. non-BIF 1.4%, P = 0.13) remained the same as that at 1 year, with no incremental definite/probable stent thrombosis in BIF patients from 2-4 years. The 4-year rates of composite cardiac death and MI were 13.5% for BIF vs. 14.1% for non-BIF (P = 0.78). At 4 years, target lesion failure (19.1% vs. 18.3%, P = 0.66) and ischemia driven-target lesion revascularization (10.2% vs. 10.1%, P = 0.89) were comparable between the two groups. CONCLUSIONS: This subgroup analysis of BIF lesions in a real world population receiving EES demonstrates continued low rates of clinical outcomes in the BIF subgroup at 4 years with no incremental stent thrombosis increase in BIF patients from 2 to 4 years. © 2015 Wiley Periodicals, Inc.
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Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Anciano , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Trombosis Coronaria/etiología , Everolimus/efectos adversos , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Vigilancia de Productos Comercializados , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
Diabetes mellitus (DM) and coronary artery disease (CAD) are the leading causes of death in the world. Over the last two decades, clinical trials have indicated that DM patients with CAD have poorer cardiac outcomes than non-diabetic patients with CAD. The pivotal findings of the FREEDOM trial greatly impacted the way clinicians approached revascularisation in diabetic patients with multivessel disease (MVD). However, since the publication of the FREEDOM trial, much has changed both in percutaneous coronary intervention (PCI) technology, as well as in the management of diabetes. This review provides insights into advancements in stent technology, enhanced patient management strategies, improved clinical outcomes with newer hypoglycaemic agents, current approaches to antiplatelet therapy, and advances in lipid management in diabetic patients. The influence of patient-specific factors such as comorbidities and anatomical complexities on treatment decisions in diabetic patients with MVD is also discussed. The ongoing TUXEDO-2 India trial was designed to primarily compare the clinical outcomes of PCI with the new-generation ultrathin-strut Supraflex Cruz stent, compared to the second-generation XIENCE stent in the setting of contemporary optimal medical therapy in Indian diabetic patients with MVD. The secondary objective of this study is to compare clinical outcomes in the combined group from both study arms against a performance goal derived from the coronary artery bypass grafting (CABG) arm of the FREEDOM trial (historical cohort). The tertiary objective is to compare the efficacy and safety of ticagrelor versus prasugrel in diabetic patients with MVD. In view of recent advances in PCI and medical therapy since the FREEDOM trial, now is an appropriate time to revisit the results of CABG versus PCI in diabetic patients with MVD.
RESUMEN
BACKGROUND: The latest generation ultrathin Supraflex Cruz (Sahajanand Medical Technologies Limited, Surat, India) sirolimus-eluting stent (SES) has shown early healing properties and represents an attractive percutaneous coronary intervention (PCI) device in a high bleeding risk (HBR) population. The aim of this Cruz HBR registry was to assess safety and efficacy of the Supraflex Cruz SES in a large cohort of all-comer patients, of whom about one third were patients at HBR. METHODS: Patients undergoing PCI were enrolled in this prospective, multi-centre, open label registry and stratified into non-HBR and HBR groups. The primary endpoint was a device-oriented composite endpoint (DOCE), a composite of cardiovascular death, myocardial infarction not clearly attributable to a non-target vessel and clinically driven target lesion revascularization within 12 months after PCI. The predefined aims were to show non-inferiority of the non-HBR group to the Supraflex arm of the TALENT Trial, and of the HBR group to polymer-free biolimus-coated stent arm of LEADERS FREE Trial. RESULTS: A total of 1203 patients were enrolled across 26 European centers, including a significant proportion (38.7%; N.=466) of HBR patients. A total of 1745 lesions were treated in 1203 patients and 2235 stents were implanted. The DOCE occurred within the total cohort in 5.8% of patients with a significant difference between HBR patients and non-HBR patients (8.1% vs. 4.4%; P<0.001). All-cause mortality at 12 months was significantly (P<0.0001) different among HBR (9.0%) and non-HBR patients (1.7%), respectively. At 12 months, the overall incidence of definite and probable stent thrombosis was 1.0%. Major bleeding occurred in 5.9% patients of the HBR group. These results met the non-inferiority criteria with respect to the TALENT trial for the non-HBR group (P<0.0001), and the LEADERS FREE trial for the HBR group (P<0.0001). CONCLUSIONS: The Cruz HBR registry confirms that PCI with the Supraflex Cruz SES is associated with a favorable clinical outcome in an all-comer population, including complex patients with HBR.
Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Hemorragia , Intervención Coronaria Percutánea , Polímeros , Sistema de Registros , Sirolimus , Humanos , Stents Liberadores de Fármacos/efectos adversos , Sirolimus/administración & dosificación , Sirolimus/uso terapéutico , Masculino , Femenino , Enfermedad de la Arteria Coronaria/cirugía , Estudios Prospectivos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Anciano , Persona de Mediana Edad , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Resultado del Tratamiento , Europa (Continente)/epidemiología , Implantes Absorbibles , Diseño de Prótesis , Factores de RiesgoRESUMEN
BACKGROUND: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points. METHODS: We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization). RESULTS: Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80). CONCLUSIONS: Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.)
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Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Sirolimus/análogos & derivados , Anciano , Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria/mortalidad , Stents Liberadores de Fármacos/efectos adversos , Everolimus , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Retratamiento/estadística & datos numéricos , Método Simple Ciego , Sirolimus/administración & dosificación , Trombosis/epidemiología , Trombosis/prevención & control , Insuficiencia del TratamientoRESUMEN
The aim of this analysis was to analyze outcomes of patients undergoing Xience V EES treatment of bifurcation lesions, a subset in which treatment is particularly challenging. The SPIRIT V Study provided an evaluation of the Xience V everolimus eluting stent (EES) performance in complex patient and lesion population. The SPIRIT V Single Arm Study enrolled 2700 patients with de novo coronary artery lesions suitable to be optimally treated with a maximum of four planned Xience V EES. Lesion evaluation was by visual assessment. The outcomes of the 492 patients undergoing Xience V EES stenting of ≥1 bifurcation lesion were compared to those with no bifurcation lesion treated. Compared to those without bifurcation treatment, patients with bifurcation treatment were more likely to have multi-vessel disease (49% vs 40%), left main treatment (3.1% vs 0.9%), more lesions treated (1.5 vs 1.3), calcification (36.4% vs 27.5%), and ostial (17.1% vs 8.2%) and angulated lesions (29.3% vs 21.1%), all P < 0.001. The 30-day composite rate of death, myocardial infarction (MI), target vessel revascularization (TVR) was 4.3% in patients with bifurcation PCI and 2.2% in those with non-bifurcation PCI (P = 0.017). At 2 years, this composite event rate was 11.3% and 10.0% in these two groups, respectively (P = 0.403). Rates of cardiac death, MI, target lesion revascularization (TLR), TVR, and ARC defined definite or probable stent thrombosis (0.4% vs 0.9%, P = 0.402) were not significantly different between the two groups. Despite greater patient and lesion complexity, treatment of patients with bifurcation lesions using the Xience V EES in the SPIRIT V prospective Single Arm Study was safe and effective, with low overall event rates that were similar to those without bifurcation lesion treatment. © 2013 Wiley Periodicals, Inc.
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Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Sirolimus/análogos & derivados , Asia , Canadá , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Trombosis Coronaria/etiología , Europa (Continente) , Everolimus , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Nueva Zelanda , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Inhibidores de Agregación Plaquetaria/uso terapéutico , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Sirolimus/administración & dosificación , Sudáfrica , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: The objective of this analysis was to evaluate the safety and effectiveness of XIENCE V in acute myocardial infarction (AMI). BACKGROUND: The XIENCE V(®) Everolimus-eluting coronary stent was superior to the TAXUS(®) paclitaxel-eluting stent in angiographic and clinical outcomes in the SPIRIT II, III, and IV randomized controlled trials, but patients with AMI were excluded. METHODS: XIENCE V USA is a large, prospective, multicenter, real-world single-arm postmarket surveillance trial. Consecutive patients undergoing PCI with XIENCE V were enrolled. For this analysis, clinical outcomes in 673 patients presenting with AMI (STEMI, n = 125) were as compared to patients without AMI (n = 3528) at 1 year. RESULTS: At 1 year, ARC-defined stent thrombosis (ST) rates were 1.08% in AMI vs. 0.85% in the non-AMI group (P = 0.4987). The late ST (30 days-1 year) rates were 0.31% vs. 0.47% (AMI vs. non-AMI, P = 0.7551). Rates of target lesion revascularization (TLR) were 4.1% vs. 4.6% (P = 0.6104), and rates of target lesion failure (TLF) were 9.1% vs. 8.5%, (P = 0.5964). With the historical WHO definition of MI, 1 year TLF rates were 7.0% vs. 6.7% (P = 0.8001). Improvements in quality of life, angina frequency, angina stability, and physical limitations occurred at 6 months (each P < 0.0001) and were sustained at 1 year in both groups. There were no significant differences in clinical outcomes between STEMI and non-STEMI patients. CONCLUSIONS: At 1 year, AMI patients treated with XIENCE V had low rates of ST, TLR, and TLF, similar to non-AMI patients. Marked improvements in patients' health status in this subgroup were also demonstrated.
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Fármacos Cardiovasculares/administración & dosificación , Stents Liberadores de Fármacos , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/instrumentación , Sirolimus/análogos & derivados , Anciano , Trombosis Coronaria/etiología , Everolimus , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Vigilancia de Productos Comercializados , Estudios Prospectivos , Factores de Riesgo , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
BACKGROUND: Currently, no data are available on the direct comparison between the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) and conventional metallic drug-eluting stents. METHODS: The ABSORB II study is a randomized, active-controlled, single-blinded, multicenter clinical trial aiming to compare the second-generation Absorb BVS with the XIENCE everolimus-eluting metallic stent. Approximately 501 subjects will be enrolled on a 2:1 randomization basis (Absorb BVS/XIENCE stent) in approximately 40 investigational sites across Europe and New Zealand. Treated lesions will be up to 2 de novo native coronary artery lesions, each located in different major epicardial vessels, all with an angiographic maximal luminal diameter between 2.25 and 3.8 mm as estimated by online quantitative coronary angiography (QCA) and a lesion length of ≤48 mm. Clinical follow-up is planned at 30 and 180 days and at 1, 2, and 3 years. All subjects will undergo coronary angiography, intravascular ultrasound (IVUS) and IVUS-virtual histology at baseline (pre-device and post-device implantation) and at 2-year angiographic follow-up. The primary end point is superiority of the Absorb BVS vs XIENCE stent in terms of vasomotor reactivity of the treated segment at 2 years, defined as the QCA quantified change in the mean lumen diameter prenitrate and postnitrate administration. The coprimary end point is the noninferiority (reflex to superiority) of the QCA-derived minimum lumen diameter at 2 years postnitrate minus minimum lumen diameter postprocedure postnitrate by QCA. In addition, all subjects allocated to the Absorb BVS group will undergo multislice computed tomography imaging at 3 years. CONCLUSIONS: The ABSORB II randomized controlled trial (ClinicalTrials.gov NCT01425281) is designed to compare the safety, efficacy, and performance of Absorb BVS against the XIENCE everolimus-eluting stent in the treatment of de novo native coronary artery lesions.
Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria/complicaciones , Stents Liberadores de Fármacos , Inmunosupresores/uso terapéutico , Isquemia Miocárdica/terapia , Proyectos de Investigación , Sirolimus/análogos & derivados , Andamios del Tejido , Implantes Absorbibles/efectos adversos , Adulto , Anciano , Aspirina/administración & dosificación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Trombosis Coronaria/etiología , Trombosis Coronaria/prevención & control , Stents Liberadores de Fármacos/efectos adversos , Europa (Continente) , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/tratamiento farmacológico , Isquemia Miocárdica/etiología , Isquemia Miocárdica/cirugía , Nueva Zelanda , Piperazinas/administración & dosificación , Inhibidores de Agregación Plaquetaria/uso terapéutico , Clorhidrato de Prasugrel , Tamaño de la Muestra , Método Simple Ciego , Sirolimus/uso terapéutico , Espectroscopía Infrarroja Corta , Tiofenos/administración & dosificación , Andamios del Tejido/efectos adversos , Tomografía Computarizada por Rayos X , Ultrasonografía IntervencionalRESUMEN
OBJECTIVES: This 2-year follow-up of the XIENCE V USA study examines both the long-term safety and effectiveness of the everolimus-eluting coronary stent system (EECSS) in real-world patients. BACKGROUND: The safety and effectiveness of EECSS at 1 year in real-world clinical settings have been demonstrated in XIENCE V USA trial with low rates of target lesion revascularization (TLR), cardiac death, myocardial infarction (MI), and stent thrombosis (ST). Data on whether efficacy is maintained after 1 year and the event rate of very late stent thrombosis (VLST) between 1 and 2 years have not yet been reported. METHODS: XIENCE V USA is a prospective, multicenter, single-arm, FDA required condition of approval study designed to examine the safety and effectiveness of EECSS in an all-inclusive, consecutively enrolled population from real-world clinical settings. Clinical end-point events, including ST, cardiac death, MI, and revascularization were adjudicated by an independent Clinical Events Committee. RESULTS: Four thousand eight hundred and seventy-three (96.4%) out of 5,054 participants (1,875 standard-risk; 3,059 extended-risk) reached 2-year follow-up. The 2-year rate of Academic Research Consortium (ARC)-defined definite and probable ST was 0.96% (95% CI 0.70-1.28) in the overall population and 0.34% (95% CI 0.12-0.74) and 1.33% (95% CI 0.95-1.81) in the standard-risk and extended-risk cohorts, respectively. The rate of VLST was 0.06% in the overall population, 0.0% in the standard-risk, and 0.10% in the extended-risk cohorts. The 2-year composite rate of cardiac death and ARC-defined MI was 8.9% (95% CI 8.08-9.70) in the overall population and 5.6% (95% CI 4.61-6.78) and 10.8% (95% CI 9.71-11.94) in the standard-risk and extended-risk cohorts, respectively. CONCLUSION: Low event rates observed at 1 year were maintained through 2 years. Despite the increased number of patients who discontinued dual antiplatelet therapy by 2 years, the ST rate remained consistently low, and <1% at 2 years due to low VLST occurrence. These results demonstrate continued safety and effectiveness of the XIENCE V everolimus-eluting stent in a highly complex, real-world patient population through 2 years.
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Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Sirolimus/análogos & derivados , Angioplastia Coronaria con Balón , Everolimus , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Estudios Prospectivos , Sirolimus/administración & dosificación , Trombosis/epidemiología , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Higher rates of adverse cardiac events have been observed in patients with small vessel disease. Therefore, we compared an everolimus-eluting stent (EES) to a paclitaxel-eluting stent (PES) for treatment of small (reference vessel diameter: RVD <2.5 mm) and larger vessels (≥2.5 mm) in a pooled analysis from the SPIRIT III (n = 1,002) and SPIRIT IV (n = 3,687) trials (randomized 2:1, EES vs. PES). METHODS: Data of 4,689 total patients were pooled for a patient level analysis. Lesion length, RVD, and percent diabetics were matched between stent types. EES versus PES performance was evaluated at 1 year in patients with small (n = 1,019) and larger vessels (n = 2,586) who had a single lesion treated. RESULTS: Mean RVD assessed by quantitative coronary angiography in patients with small vessels was 2.24 ± 0.19 and 2.25 ± 0.20 mm in the EES and PES groups, respectively. At 1 year, EES compared to PES in small vessel patients significantly reduced major adverse cardiac events (4.5% vs. 7.9%, P = 0.04), target lesion failure (4.4% vs. 7.9%, P = 0.03), target lesion revascularization (2.4% vs. 5.5%, P = 0.02), and stent thrombosis (0.2% vs. 1.2%, P = 0.04). Relative benefits of EES versus PES were comparable in small and larger vessels (P interaction > 0.05), although the absolute benefits were greater in patients with small vessel disease. CONCLUSION: In high-risk patients requiring percutaneous coronary intervention in small coronary arteries, EES results in significantly improved 1-year rates of event-free survival compared to PES, with evidence present for both enhanced safety and efficacy.
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Angioplastia Coronaria con Balón , Antineoplásicos Fitogénicos/uso terapéutico , Reestenosis Coronaria/prevención & control , Stents Liberadores de Fármacos , Inmunosupresores/uso terapéutico , Paclitaxel/uso terapéutico , Sirolimus/análogos & derivados , Antineoplásicos Fitogénicos/administración & dosificación , Angiografía Coronaria , Reestenosis Coronaria/terapia , Everolimus , Femenino , Humanos , Inmunosupresores/administración & dosificación , Masculino , Persona de Mediana Edad , Paclitaxel/administración & dosificación , Factores de Riesgo , Sirolimus/administración & dosificación , Sirolimus/uso terapéutico , Estadística como AsuntoRESUMEN
1. It is widely believed that pet ownership is beneficial to humans and that some of this benefit is through favourable effects on cardiovascular risk. In the present review, we critically examine the evidence in support of this hypothesis and present the available data with respect to major cardiovascular risk factors. 2. There is evidence that dog owners are less sedentary and have lower blood pressure, plasma cholesterol and triglycerides, attenuated responses to laboratory-induced mental stress and improved survival following myocardial infarction compared with non-pet owners. However, conflicting data exist with regard to the association between pet ownership and each of these risk factors. 3. Numerous non-cardiovascular effects of pet ownership have been reported, largely in the psychosocial domain, but the relationship is complex and can vary with demographic and social factors. 4. A unifying hypothesis is presented, linking improved mood and emotional state to decreased central and regional autonomic activity, improved endothelial function and, thus, lower blood pressure and reduced cardiac arrhythmias. 5. Overall, ownership of domestic pets, particularly dogs, is associated with positive health benefits.
Asunto(s)
Enfermedades Cardiovasculares/prevención & control , Enfermedades Cardiovasculares/psicología , Vínculo Humano-Animal , Mascotas/psicología , Animales , Perros , Humanos , Conducta de Reducción del RiesgoRESUMEN
BACKGROUND: The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials. METHODS: A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1-5.0] years. RESULTS: During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis. CONCLUSIONS: Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).
Asunto(s)
Enfermedad de la Arteria Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Implantes Absorbibles , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Japón , Diseño de Prótesis , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
BACKGROUND: In the prospective randomized Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with de novo Native Coronary Artery Lesions (SPIRIT) III trial, an everolimus-eluting stent (EES) compared with a widely used paclitaxel-eluting stent (PES) resulted in a statistically significant reduction in angiographic in-segment late loss at 8 months and noninferior rates of target vessel failure (cardiac death, myocardial infarction, or target vessel revascularization) at 1 year. The safety and efficacy of EES after 1 year have not been reported. METHODS AND RESULTS: A total of 1002 patients with up to 2 de novo native coronary artery lesions (reference vessel diameter, 2.5 to 3.75 mm; lesion length < or =28 mm) were randomized 2:1 to EES versus PES. Antiplatelet therapy consisted of aspirin indefinitely and a thienopyridine for > or =6 months. Between 1 and 2 years, patients treated with EES compared with PES tended to have fewer episodes of protocol-defined stent thrombosis (0.2% versus 1.0%; P=0.10) and myocardial infarctions (0.5% versus 1.7%; P=0.12), with similar rates of cardiac death (0.3% versus 0.3%; P=1.0) and target vessel revascularization (2.9% versus 3.0%; P=1.0). As a result, at the completion of the 2-year follow-up, treatment with EES compared with PES resulted in a significant 32% reduction in target vessel failure (10.7% versus 15.4%; hazard ratio, 0.68; 95% confidence interval, 0.48 to 0.98; P=0.04) and a 45% reduction in major adverse cardiac events (cardiac death, myocardial infarction, or target lesion revascularization; 7.3% versus 12.8%; hazard ratio, 0.55; 95% confidence interval, 0.36 to 0.83; P=0.004). Among the 360 patients who discontinued clopidogrel or ticlopidine after 6 months, stent thrombosis subsequently developed in 0.4% of EES patients versus 2.6% of PES patients (P=0.10). CONCLUSIONS: Patients treated with EES rather than PES experienced significantly improved event-free survival at a 2-year follow-up in the SPIRIT III trial, with continued divergence of the hazard curves for target vessel failure and major adverse cardiac events between 1 and 2 years evident. The encouraging trends toward fewer stent thrombosis episodes after 6 months in EES-treated patients who discontinued a thienopyridine and after 1 year in all patients treated with EES rather than PES deserve further study.
Asunto(s)
Angioplastia , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Sirolimus/análogos & derivados , Anciano , Antineoplásicos Fitogénicos/administración & dosificación , Antineoplásicos Fitogénicos/efectos adversos , Enfermedad de la Arteria Coronaria/epidemiología , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/prevención & control , Trombosis Coronaria/epidemiología , Trombosis Coronaria/prevención & control , Supervivencia sin Enfermedad , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/estadística & datos numéricos , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Incidencia , Masculino , Persona de Mediana Edad , Paclitaxel/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Prospectivos , Sirolimus/administración & dosificación , Sirolimus/efectos adversos , Resultado del TratamientoRESUMEN
OBJECTIVE: To evaluate whether an everolimus-eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes. BACKGROUND: Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS(2) paclitaxel-eluting stent (PES) compared to the bare metal EXPRESS(2)® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES. METHODS: In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS(2) PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two-year clinical outcomes were evaluated. RESULTS: A periprocedural increase in Creatine Kinase-MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00). CONCLUSIONS: In this post-hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 2010 Wiley-Liss, Inc.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Infarto del Miocardio/prevención & control , Paclitaxel/administración & dosificación , Sirolimus/análogos & derivados , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Biomarcadores/sangre , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Forma MB de la Creatina-Quinasa/sangre , Everolimus , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/sangre , Infarto del Miocardio/etiología , Infarto del Miocardio/patología , Miocardio/enzimología , Miocardio/patología , Necrosis , Estudios Prospectivos , Diseño de Prótesis , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Método Simple Ciego , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento , Estados UnidosRESUMEN
OBJECTIVE: This study evaluates the safety and efficacy of the XIENCE V 4.0 mm stent for the treatment of de novo native coronary artery lesions. BACKGROUND: In the SPIRIT III trial, the XIENCE V everolimus-eluting stent (EES), compared with the TAXUS EXPRESS(2) paclitaxel-eluting stent (PES) in 2.5-3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). METHODS: The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions Asunto(s)
Angioplastia Coronaria con Balón/instrumentación
, Fármacos Cardiovasculares/administración & dosificación
, Angiografía Coronaria
, Estenosis Coronaria/diagnóstico por imagen
, Estenosis Coronaria/terapia
, Stents Liberadores de Fármacos
, Sirolimus/análogos & derivados
, Anciano
, Angioplastia Coronaria con Balón/efectos adversos
, Angioplastia Coronaria con Balón/mortalidad
, Estenosis Coronaria/mortalidad
, Everolimus
, Femenino
, Humanos
, Estimación de Kaplan-Meier
, Masculino
, Persona de Mediana Edad
, Infarto del Miocardio/etiología
, Paclitaxel/administración & dosificación
, Valor Predictivo de las Pruebas
, Estudios Prospectivos
, Sistema de Registros
, Medición de Riesgo
, Método Simple Ciego
, Sirolimus/administración & dosificación
, Trombosis/etiología
, Factores de Tiempo
, Resultado del Tratamiento
, Estados Unidos/epidemiología
RESUMEN
BACKGROUND: Drug-eluting stents (DES) are widely used for treatment of coronary artery disease with benefit of reduced restenosis compared to bare metal stents. The XIENCE VEverolimus Eluting Coronary Stent System is a second-generation DES system for better deliverability while maintaining safety and efficacy profiles. The present pharmacokinetic sub-study from the SPIRIT III Randomized and Controlled Trial (RCT) was to evaluate systemic exposure of patients to everolimus and to further demonstrate safety following implantation of XIENCE Vstents with everolimus doses ranging from 53 to 181 microg. METHODS AND RESULTS: Drug concentrations in whole blood were determined at multiple time points using a validated analytical method with a limit of quantification of 0.1 ng/mL. Individual C(max) ranged from 0.17 to 2.40 ng/mL and occurred between 0.07 and 1.88 hours across all dose levels. Both mean and individual C(max) values were below the trough blood concentrations of everolimus (Certican) for inhibition of organ transplant rejection. The last time point at which drug concentrations could be quantified ranged from 12 to 168 hours postimplantation in individual patients. In most cases, the blood levels dropped below the limit of quantification after 72 hours. CONCLUSIONS: This study confirms that the XIENCE Vstent causes a limited and systemic exposure to everolimus. The presumed localized and efficient delivery of everolimus to target vessels coupled with limited and transient systemic drug exposure contributes to the safety and effectiveness of the XIENCE VEECSS in patients of SPIRIT III RCT for longer than 2 years.
Asunto(s)
Reestenosis Coronaria/tratamiento farmacológico , Stents Liberadores de Fármacos/efectos adversos , Inmunosupresores/farmacocinética , Sirolimus/análogos & derivados , Anciano , Análisis de Varianza , Área Bajo la Curva , Intervalos de Confianza , Stents Liberadores de Fármacos/estadística & datos numéricos , Everolimus , Femenino , Humanos , Inmunosupresores/uso terapéutico , Modelos Lineales , Masculino , Persona de Mediana Edad , Sirolimus/farmacocinética , Sirolimus/uso terapéuticoRESUMEN
BACKGROUND: The ZoMaxx I and II trials were randomized controlled studies of the zotarolimus-eluting, phosphorylcholine-coated, TriMaxx stent for the treatment of de novo coronary lesions. The aim of this study was to compare the vessel response between zotarolimus- (ZES) and paclitaxel-eluting stents (PES) using intravascular ultrasound (IVUS). METHODS AND RESULTS: Data were obtained from the ZoMaxx I and II trials, in which a standard IVUS parameter was available in 263 cases (baseline and 9-months follow up). Neointima-free frame ratio was calculated as the number of frames without IVUS-detectable neointima divided by the total number of frames within the stent. While an increase in vessel and plaque was observed in PES from baseline to follow up, there was no significant change in ZES. At follow up, % neointimal obstruction was significantly higher (15.4 ± 8.8% vs 11.3 ± 9.7%), and minimum lumen area at follow up was significantly smaller in ZES compared to PES. However, the incidence of IVUS-defined restenosis (maximum cross-sectional narrowing >60%) was similar in the 2 groups (3.2% vs 6.7%). Neointima-free frame ratio was significantly lower in ZES. There were 5 cases of late incomplete stent apposition in PES and none in ZES. CONCLUSIONS: These IVUS results demonstrate a similar incidence of severe narrowing between these 2 DES. There was a moderate increase in neointimal hyperplasia that was associated with a greater extent of neointimal coverage in ZES compared with PES.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Reestenosis Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Sirolimus/análogos & derivados , Ultrasonografía Intervencional , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Distribución de Chi-Cuadrado , Angiografía Coronaria , Reestenosis Coronaria/etiología , Femenino , Humanos , Hiperplasia , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Medición de Riesgo , Factores de Riesgo , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento , Túnica Íntima/diagnóstico por imagenRESUMEN
BACKGROUND: Device underexpansion is associated with late adverse outcomes after bioresorbable vascular scaffold (BVS) implantation. This study, representing official IVUS results of the ABSORB Japan trial, aimed to characterize IVUS findings, focusing specifically on acute device expansion, and to investigate its impact on late lumen loss (LLL) with Absorb-BVS compared with cobalt-chromium everolimus-eluting stents (CoCr-EES). METHODS: ABSORB Japan enrolled 148 patients (2:1 randomization) in the IVUS cohort. Serial IVUS was prescheduled at post-procedure and 3 years. Acute device expansion was evaluated with respect to the degree and uniformity of the implanted device. RESULTS: Overall, Absorb-BVS showed smaller and more nonuniform device expansion at post-procedure, compared with CoCr-EES, which was particularly prominent in small-vessel lesions. In serial analysis, Absorb-BVS showed unique associations of smaller device expansion (r = 0.40, p = 0.001) and more nonuniformity (r = 0.29, p = 0.007) at post-procedure with greater LLL at 3 years, primarily attributable to greater negative remodeling (r = 0.39, p = 0.006). In contrast, acute device expansion showed no relation with subsequent lumen change in CoCr-EES. In Absorb-BVS, ischemic-driven target lesion or vessel revascularization (ID-TLR or ID-TVR) at 3 years occurred more frequently in small- versus large-vessel lesions (12.5% vs. 0%, p = 0.04 for ID-TLR and 15.6% vs. 2.3%, p = 0.08 for ID-TVR). Conversely, Absorb BVS had no target lesion nor vessel failure, even in small-vessel lesions, when adequate device expansion was achieved at post-procedure. CONCLUSIONS: Unlike CoCr-EES, underexpansion was associated with greater negative remodeling and LLL in Absorb-BVS. This may in part account for the poorer outcomes of Absorb-BVS than CoCr-EES when under-expanded.
RESUMEN
BACKGROUND: Drug-eluting stents with low late loss may be particularly beneficial in small coronary arteries. We therefore examined whether the everolimus-eluting stent is superior to the paclitaxel-eluting stent in patients treated with 2.5-mm stents in the SPIRIT III trial. METHODS: The SPIRIT III trial was a prospective, multicenter, randomized (2:1; XIENCE V: TAXUS Express) trial in which 1002 patients were enrolled. One or more 2.5-mm stents were implanted in 160 patients in the XIENCE V arm, and 59 patients, in the TAXUS arm. Mean vessel diameter was 2.36 +/- 0.30 and 2.34 +/- 0.33 mm in the XIENCE V and TAXUS groups, respectively (P = .69). RESULTS: At 9 months, XIENCE V compared to TAXUS reduced the rates of major adverse cardiac events (cardiac death, myocardial infarction, or ischemic target lesion revascularization) from 12.5% to 3.2% (P = .02) and target vessel failure (cardiac death, reinfarction, or ischemic target vessel revascularization) from 16.1% to 5.2% (P = .02), the differences being driven primarily by reductions in target lesion revascularization (12.5% vs 1.3%; P = .002). In-stent late loss was significantly reduced by XIENCE V when compared to TAXUS (0.54 +/- 0.74 vs 0.11 +/- 0.43 mm, P = .01), as was In-segment binary angiographic restenosis (20.8% vs 4.1%, P = .02). CONCLUSIONS: In this post hoc analysis from the SPIRIT III trial, the XIENCE V 2.5-mm stent significantly reduced clinical and angiographic restenosis compared to the TAXUS 2.5-mm stent, further supporting the hypothesis that lower late loss is beneficial in small vessel disease.