RESUMEN
BACKGROUND: The wide variation in bifurcation anatomy has generated an ongoing search for stents explicitly designed for coronary bifurcations, and to date, results have been underachieved. METHODS: The POLBOS I and POLBOS II were international, multicentre, randomized, open-label, controlled trials. Patients were randomly assigned to BiOSS Expert (in POLBOS I, biodegradable polymer eluting paclitaxel)/BiOSS LIM (in POLBOS II, biodegradable polymer eluting sirolimus) stent implantation or regular drug-eluting stent (rDES) deployment. A provisional T-stenting strategy was the default treatment option. The primary endpoint of this pooled data study was the cumulative rate of major adverse cardiovascular events (MACE) consisting of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Telephone follow-up was performed annually up to 72 months. (ClinicalTrials.gov Identifier: POLBOS I-NCT02192840, POLBOS II-NCT02198300). RESULTS: The total study population consisted of 445 patients, 222 patients in the BiOSS group and 223 patients in the rDES group. The follow-up rate was 93.7% in the BiOSS group and 91.9% in the rDES group. At 72 months, there was no significant difference between BiOSS and rDES groups regarding MACE (25.7% vs 25.1%, HR 1.06, 95% CI 0.73-1.52), cardiac death (3.1% vs 4.0%, HR 0.94, 95% CI 0.43-2.34), MI (3.6% vs 4.9%, HR 0.76, 95% CI 0.32-2.89), TLR (18.9% vs 16.1%, HR 1.17, 95% CI 0.75-1.83) and stent thrombosis rates (0.9% vs 0.5%, HR 1.21, 95CI 0.75-2.09). CONCLUSIONS: At the 6-year follow-up, clinically significant clinical events did not differ between BiOSS stents and rDES.
Asunto(s)
Implantes Absorbibles , Vasos Coronarios/patología , Stents Liberadores de Fármacos , Anciano , Stents Liberadores de Fármacos/clasificación , Femenino , Cardiopatías , Insuficiencia Cardíaca/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Sirolimus/uso terapéuticoRESUMEN
Pathological changes after third-generation drug-eluting stent implantation remain unclear. We compared the tissue responses of coronary arteries after the implantation of third-generation abluminal biodegradable-polymer everolimus-eluting stent (3rd EES) and second-generation durable-polymer EES (2nd EES) using autopsy specimens and an atherosclerotic porcine model. We compared the histology of stented coronary arteries obtained by autopsy performed 1-10 months after 3rd EES (n (number of cases) = 4, stent-implanted period of 3-7 months) and 2nd EES (n (number of cases) = 9, stent-implanted period of 1-10 months) implantations. The ratio of covered stent struts was higher with 3rd EESs than with 2nd EESs (3rd; 0.824 ± 0.032 vs. 2nd; 0.736 ± 0.022, p = 0.035). Low-density lipoprotein receptor knockout minipigs were stented with 3rd or 2nd EES in the coronary arteries and the stented regions were investigated. The fibrin deposition around the 2nd EES was more prominent. Additionally, higher density of smooth muscle cells was confirmed after the 3rd EES implantation. Pathological examination after the 3rd EES demonstrated a combination of less fibrin deposition and more rapid acquisition of well-developed neointima as compared to the 2nd EES at autopsy and the atherosclerotic porcine model.
Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Modelos Animales de Enfermedad , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Everolimus/administración & dosificación , Neointima/etiología , Intervención Coronaria Percutánea/efectos adversos , Porcinos Enanos/cirugía , Porcinos/cirugía , Implantes Absorbibles/efectos adversos , Anciano , Anciano de 80 o más Años , Animales , Animales Modificados Genéticamente , Autopsia , Vasos Coronarios/patología , Vasos Coronarios/cirugía , Femenino , Fibrina/metabolismo , Técnicas de Inactivación de Genes , Humanos , Masculino , Persona de Mediana Edad , Neointima/metabolismo , Placa Aterosclerótica/cirugía , Diseño de Prótesis , Receptores de LDL/genética , Resultado del TratamientoRESUMEN
AIMS: Compare the degree of acute vascular injury caused by a polymer-free, thin-strut drug-eluting stent (DES) to that caused by a bioresorbable polymer, thick-strut DES using optical coherence tomography (OCT). METHODS AND RESULTS: Fifty patients requiring nonurgent PCI were randomized to receive either a thin or a thick-strut DES. OCT was performed before and after stent implantation. OCT-based injury score (IS) after implantation was numerically higher within thick-strut stents 0.32 vs. 0.23, but the difference was NS (P = 0.61). Edge dissections were present in 36% of the patients without differences between groups. Tissue prolapse (TP) area was larger with thin-strut stents (2.26 vs. 1.83 mm2, P = 0.04). Stent expansion and symmetry index were similar between the two platforms (85% vs. 94%, P = 0.08; and 0.82 vs. 0.80, P = 0.25). No differences were observed in total malapposition area (1.85 mm2 in thin-strut stents vs. 1.47 mm2, P = 0.48). Regarding the influence of plaque-type, IS tended to be higher (non-significant) with thick strut DES in fibrocalcific plaques. Stent malapposition area was smaller in fibrous plaques, especially with thin strut stents (P = 0.03). CONCLUSION: There was no difference in the extent of OCT-based vessel injury associated with thin and thick-strut DES platforms. TP was larger with the thin strut DES, potentially reflecting a deeper stent embedment in the vessel wall.
Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Complicaciones Intraoperatorias , Intervención Coronaria Percutánea , Tomografía de Coherencia Óptica/métodos , Lesiones del Sistema Vascular , Anciano , Plásticos Biodegradables/farmacología , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/lesiones , Vasos Coronarios/patología , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Femenino , Humanos , Complicaciones Intraoperatorias/diagnóstico por imagen , Complicaciones Intraoperatorias/etiología , Complicaciones Intraoperatorias/prevención & control , Masculino , Evaluación de Resultado en la Atención de Salud , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Placa Aterosclerótica/diagnóstico por imagen , Sirolimus/análogos & derivados , Sirolimus/farmacología , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/etiología , Lesiones del Sistema Vascular/prevención & controlRESUMEN
OBJECTIVES: Recent improvements in coronary stent design have focussed on thinner struts, different alloys and architecture, more biocompatible polymers, and shorter drug absorption times. This study evaluates safety and efficacy of a newer generation thin-strut cobalt chromium sirolimus-eluting coronary stent (SES, Ultimaster) in comparison with a second-generation thicker strut stainless steel biolimus-eluting stent (BES, Nobori) in percutaneous coronary intervention (PCI) practice. METHODS: A propensity score analysis was performed to adjust for differences in baseline characteristics of 8137 SES patients and 2738 BES patients of two PCI registries (e-Ultimaster and NOBORI 2). An independent clinical event committee adjudicated all endpoint-related adverse events. RESULTS: The use of SES, as compared with BES was associated with a significantly lower rate of myocardial infarction (MI) (1.2% vs 2.2%; P = 0.0006) and target vessel-related MI (1.1% vs 1.8%; P = 0.002) at 1 year. One-year composite endpoints of all predefined endpoints were lower in patients undergoing SES implantation (target lesion failure: 3.2% vs 4.1%; P = 0.03, target vessel failure: 3.7% vs 5.0%; P = 0.003, patient-oriented composite endpoint 5.7% vs 6.8%; P = 0.03). No significant differences between SES and BES were observed in all-cause death (2.0% vs 1.6%; P = 0.19), cardiac death (1.2% vs 1.2%; P = 0.76) or stent thrombosis (0.6% vs 0.8%; P = 0.43). CONCLUSIONS: These findings suggest an improved clinical safety and efficacy of a newer generation thin-strut SES as compared with a second-generation thicker strut BES.
Asunto(s)
Aleaciones de Cromo/farmacología , Enfermedad de la Arteria Coronaria/cirugía , Reestenosis Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Complicaciones Posoperatorias , Sirolimus/análogos & derivados , Sirolimus/farmacología , Anciano , Materiales Biocompatibles/farmacología , Reestenosis Coronaria/diagnóstico , Reestenosis Coronaria/etiología , Reestenosis Coronaria/mortalidad , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Análisis de Falla de Equipo , Femenino , Humanos , Inmunosupresores/farmacología , Masculino , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/mortalidad , Diseño de Prótesis , Sistema de Registros/estadística & datos numéricos , Análisis de SupervivenciaRESUMEN
AIMS: There is limited information on the clinical relevance and procedural impact of coronary artery calcification (CAC) in the contemporary percutaneous coronary intervention (PCI) setting. This study sought to determine the incidence and clinical significance of procedural techniques on the outcomes in 'real-world' patients with CAC undergoing PCI with drug-eluting stents (DESs). METHODS AND RESULTS: Using patient-level data from seven stent-specific, prospective DES registries, we evaluated 17 084 patients who underwent PCI with various DES types between July 2007 and July 2015. The primary outcome was target-vessel failure (TVF), defined as a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization. Outcomes through 3 years (and between 0-1 and 1-3 years) were assessed according to CAC status (none/mild vs. moderate/severe) and stenting technique (predilation or post-dilation). Among 17 084 patients with 22 739 lesions included in the pooled dataset, moderate to severe CAC was observed in 11.3% of patients (10.1% of lesions). Older age, lower BMI, diabetes, hypertension, family history of coronary artery disease, and renal failure were independent predictors of moderate/severe CAC. The presence of moderate/severe CAC was significantly associated with an adjusted risk of TVF at 3 years [hazard ratio, 1.37; 95% confidence interval (CI), 1.19-1.58; P < 0.001]. For severe CAC, optimal lesion preparation with predilation was associated with a lower 3-year rate of TVF (no vs. yes, 22.3 vs. 12.8%), in which the effect of predilation was prominent at the late period of 1-3 years (hazard ratio, 0.28; 95% CI, 0.12-0.69; P = 0.003) than at the early period through 1 year (hazard ratio, 1.16; 95% CI, 0.37-3.71; P = 0.80). However, post-dilation (with a high-pressure noncompliant balloon) had no effect on the outcome. CONCLUSIONS: In this study, moderate/severe CAC was common (~10%) and strongly associated with TVF during 3 years of follow-up. For severe CAC, optimal lesion preparation with pre-balloon dilation has a significant effect on long-term outcomes, especially during the late period beyond 1 year. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186133.
Asunto(s)
Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Stents Liberadores de Fármacos , Efectos Adversos a Largo Plazo , Infarto del Miocardio , Intervención Coronaria Percutánea , Calcificación Vascular , Anciano , Causalidad , Angiografía Coronaria/métodos , Angiografía Coronaria/estadística & datos numéricos , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/mortalidad , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Dilatación/métodos , Dilatación/estadística & datos numéricos , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Femenino , Humanos , Efectos Adversos a Largo Plazo/diagnóstico , Efectos Adversos a Largo Plazo/epidemiología , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Prevalencia , Pronóstico , Diseño de Prótesis , Ajuste de Riesgo/métodos , Índice de Severidad de la Enfermedad , Calcificación Vascular/diagnóstico , Calcificación Vascular/etiologíaRESUMEN
INTRODUCTION: Improvements in coronary drug-eluting stent technology has focused on reducing the long-term complications associated with the effects of the residual footprint on the vessel wall. Although many of the newer stents have exhibited noninferiority to the durable polymer everolimus-eluting stent (DP-EES), they have yet to exhibit clear superiority. We compared the performance of the latest ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) to DP-EES. METHODS: We searched the electronic databases for randomized controlled trials comparing BP-SES to DP-EES. A random effect meta-analysis was performed using the Poisson regression model. The primary end point was target lesion failure (TLF), a composite of target vessel myocardial infarction (TVMI), cardiac death and target lesion revascularization (TLR). RESULTS: There was no difference between the stents in stent thrombosis [incidence rate ratio (IRR) = 0.79, 95% confidence interval (CI) 0.58-1.06), TLR (IRR = 0.88, 95% CI 0.57-1.38), TVMI (IRR = 0.79, 95% CI 0.61-1.01), cardiac death (IRR = 0.99, 95% CI 0.76-1.29) and target vessel failure (IRR = 0.82, 95% CI 0.64-1.06). In addition, there was no difference in TLF (IRR = 0.82, 95% CI 0.64-1.06). There was evidence of reduced TLF in small vessels with BP-SES based on definition used (defined as ≤2.75 mm; IRR 0.64, 95% CI 0.46-0.91 versus ≤3 mm; IRR 1.11, 95% CI 0.90-1.36). CONCLUSION: In our study, the performance of the latest generation BP-SES was comparable to DP-EES but failed to show superiority. The possible benefit in patients with small vessels should be explored future trials.
Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos , Everolimus/farmacología , Intervención Coronaria Percutánea/instrumentación , Sirolimus/farmacología , Implantes Absorbibles , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Humanos , Inmunosupresores/farmacología , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
BACKGROUND: Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce. METHODS: Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm. RESULTS: Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique. CONCLUSIONS: Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.
Asunto(s)
Enfermedad de la Arteria Coronaria , Vasos Coronarios , Stents Liberadores de Fármacos , Everolimus/uso terapéutico , Efectos Adversos a Largo Plazo , Falla de Prótesis , Sirolimus/análogos & derivados , Plásticos Biodegradables/uso terapéutico , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Análisis de Falla de Equipo , Femenino , Humanos , Inmunosupresores/uso terapéutico , Efectos Adversos a Largo Plazo/epidemiología , Efectos Adversos a Largo Plazo/etiología , Efectos Adversos a Largo Plazo/terapia , Masculino , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Falla de Prótesis/efectos adversos , Falla de Prótesis/etiología , Sirolimus/uso terapéuticoRESUMEN
BACKGROUND: Sirolimus-coated balloons (SCBs) represent a novel therapeutic option for both in-stent restenosis (ISR) and de novo coronary lesions treatment, especially in small vessels. Our registry sought to evaluate the procedural and clinical outcomes of such devices in a complex acute coronary syndrome (ACS) clinical setting. METHODS AND RESULTS: We treated 74 consecutive patients with percutaneous coronary intervention (PCI) with at least 1 SCB used for ISR and/or de novo coronary lesion in small vessels at our institution. Sixty-two patients presented with ACS, and their data were included in our analysis. The mean age was 67 ± 10 years, and patients presenting with ST-elevated myocardial infarction (STEMI) were 14 (23%). De novo lesions were 52%, whereas ISR was 48%. Procedural success occurred in 100% of the cases. At the 11 ± 7 months follow-up, major adverse cardiovascular events (MACEs) were 3 (4.8%). Cardiovascular death (CD) occurred in 1 (1.6%) patient and myocardial infarction (MI) in 2 patients (3.2%) as well as ischemia-driven target lesion revascularization (TLR). One probable subacute thrombosis occurred (1.6%) with no major bleedings. In a subgroup analysis, the incidence of MACE did not show significant differences between patients treated for de novo lesions and ISR (HR: 0.239; CI 95%: 0.003-16.761, p=0.509). CONCLUSIONS: In the SELFIE prospective registry, SCB showed a good safety and efficacy profile for the treatment of coronary lesions, both ISR and/or de novo in small vessels, in a complex ACS population of patients at the 11 ± 7 months follow-up.
Asunto(s)
Síndrome Coronario Agudo , Angioplastia Coronaria con Balón , Reestenosis Coronaria , Stents Liberadores de Fármacos , Infarto del Miocardio con Elevación del ST , Sirolimus/farmacología , Síndrome Coronario Agudo/diagnóstico , Síndrome Coronario Agudo/epidemiología , Síndrome Coronario Agudo/etiología , Síndrome Coronario Agudo/cirugía , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Reestenosis Coronaria/complicaciones , Reestenosis Coronaria/epidemiología , Stents Liberadores de Fármacos/clasificación , Stents Liberadores de Fármacos/estadística & datos numéricos , Femenino , Humanos , Inmunosupresores/farmacología , Italia/epidemiología , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Sistema de Registros/estadística & datos numéricos , Infarto del Miocardio con Elevación del ST/complicaciones , Infarto del Miocardio con Elevación del ST/epidemiologíaRESUMEN
BACKGROUND: Patients aged ≥80â¯years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients. METHODS: We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization. RESULTS: The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80â¯years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, Pâ¯=â¯.04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, Pâ¯<â¯.001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, Pâ¯=â¯.88) and repeat target vessel revascularization (1.9% vs 2.8%, Pâ¯=â¯.16). In multivariate analyses, ageâ¯≥â¯80â¯years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, Pâ¯<â¯.001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (nâ¯=â¯459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, Pâ¯<â¯.001). CONCLUSIONS: Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.
Asunto(s)
Stents Liberadores de Fármacos/clasificación , Everolimus/farmacología , Infarto del Miocardio , Complicaciones Posoperatorias , Sirolimus/análogos & derivados , Sirolimus/farmacología , Anciano de 80 o más Años , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Femenino , Humanos , Inmunosupresores/farmacología , Masculino , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/etiología , Infarto del Miocardio/mortalidad , Intervención Coronaria Percutánea , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/mortalidad , Reoperación/métodos , Reoperación/estadística & datos numéricos , Ajuste de Riesgo/métodos , Factores de Riesgo , Resultado del TratamientoRESUMEN
OBJECTIVE: To compare major clinical outcomes after successful percutaneous coronary intervention (PCI) with first-generation (1G) drug-eluting stents (DES) and second-generation (2G) DES in patients with acute myocardial infarction (AMI) and prediabetes. BACKGROUND: Patients with prediabetes are associated with an increased incidence of coronary artery disease. The relative superiority of 1G- and 2G-DES in these patients is not well established. METHODS: A total of 4997 patients with AMI and prediabetes were divided into two groups: the 1D-DES group (n = 726) and the 2G-DES group (n = 4271). The primary outcomes were the patient-oriented composite outcomes (POCOs) defined as all-cause death, recurrent myocardial infarction (Re-MI), and any disease revascularization at 2-year follow-up. The secondary outcome was probable or definite stent thrombosis (ST). RESULTS: After propensity score-matching (PSM) analysis, two PSM groups (698 pairs, n = 1396, C-statistics = 0.725) were generated. The cumulative incidence rates of POCOs (hazard ratio (HR): 1.467; 95% confidence interval (CI): 1.068-2.015; p = 0.018), any disease revascularization (HR: 2.259; 95% CI: 1.397-3.654; p = 0.001), and ST (HR: 4.361; 95% CI: 1.243-15.30; p = 0.021) in the 1G-DES group were significantly higher than those in the 2G-DES group. However, the cumulative incidence rates of all-cause death, cardiac death, and Re-MI were similar between the two groups. CONCLUSIONS: In patients with AMI and prediabetes, 2G-DES implantation was more efficacious than 1G-DES implantation over a 2-year follow-up period. However, further studies are needed to confirm these results.
Asunto(s)
Stents Liberadores de Fármacos , Hemoglobina Glucada/análisis , Infarto del Miocardio/cirugía , Intervención Coronaria Percutánea/instrumentación , Estado Prediabético , Investigación sobre la Eficacia Comparativa , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/epidemiología , Selección de Paciente , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Estado Prediabético/sangre , Estado Prediabético/diagnóstico , Estado Prediabético/epidemiología , Resultado del TratamientoAsunto(s)
Infarto de la Pared Anterior del Miocardio/cirugía , Stents Liberadores de Fármacos/clasificación , Everolimus/uso terapéutico , Trasplante de Hígado/efectos adversos , Antineoplásicos/uso terapéutico , Carcinoma Hepatocelular/complicaciones , Carcinoma Hepatocelular/cirugía , Stents Liberadores de Fármacos/efectos adversos , Electrocardiografía/métodos , Humanos , Neoplasias Hepáticas/tratamiento farmacológico , Neoplasias Hepáticas/fisiopatología , Trasplante de Hígado/métodos , Masculino , Persona de Mediana EdadRESUMEN
OBJECTIVES: Long-term data from randomized studies on polymer-free stents are scarce. Long-term data of Cre8 amphilimus eluting stent are still not available. We sought to investigate contribution of a polymer-free design versus a permanent-polymer one on the long-term. METHODS AND RESULTS: Patients undergoing percutaneous coronary intervention for de novo lesions were randomized 1:1 to Cre8 or Taxus Liberté (323 overall, 126 Cre8). Original primary endpoint (6-month angiographic in-stent late lumen loss) already demonstrated the superiority of Cre8 vs Taxus (0.14â¯+â¯0.36â¯mm vs. 0.34â¯+â¯0.40â¯mm; pâ¯<â¯0.001). Secondary endpoints were the device oriented composite endpoint (DOCE), patient oriented composite endpoint (POCE) up to 5-year. Long-term follow-up data confirmed the superiority shown by Cre8 in the analysis of the angiographic endpoint at 6-month, especially in the diabetic patients, where the device strongly reduced the clinical difference with non-diabetic. Landmark analysis demonstrated that the incidence of DOCE after 1-year and up to 5-year follow up was significantly lower in patients implanted with Cre8 AES (2.1% Cre8 vs. 9.3% Taxus, pâ¯=â¯0.009). While no differences were found in terms of DOCE rate among diabetic and non-diabetic patients treated with the Cre8 AES (HR 1.039; 95%CI 0.320-3.374), this was not true for Taxus (HR 2.64; 95%CI 1.112-6.278). CONCLUSIONS: Cre8 showed favourable safety and efficacy results versus Taxus at 5-years follow-up, with a superior clinical performance for the DOCE endpoint from 1 to 5â¯years. Cre8, differently from Taxus, has been able to strongly reduce the differences in clinical outcome between diabetic and non-diabetic up to 5â¯years, suggesting the higher efficacy of Cre8 in the treatment of diabetic patients.
Asunto(s)
Enfermedad de la Arteria Coronaria , Vasos Coronarios , Paclitaxel/farmacología , Intervención Coronaria Percutánea/instrumentación , Sirolimus/farmacología , Materiales Biocompatibles Revestidos/farmacología , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Stents Liberadores de Fármacos/clasificación , Ácidos Grasos/farmacología , Femenino , Humanos , Inmunosupresores/farmacología , Efectos Adversos a Largo Plazo , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/estadística & datos numéricos , Polímeros/farmacología , Diseño de Prótesis , Resultado del TratamientoRESUMEN
Coronary artery disease in patients with diabetes mellitus (DM) is characterized by extensive atherosclerosis, longer lesions, and diffuse distal disease. Consequently, these patients have worse outcomes after coronary revascularization, regardless of the modality used. Traditionally, coronary artery bypass grafting (CABG) has been regarded as more effective than percutaneous coronary intervention (PCI) in patients with DM, likely because of more complete revascularization and protection against disease progression in the bypass segment. Revascularization with balloon angioplasty, bare-metal stents, and first-generation drug-eluting stents have all been shown to be inferior to CABG in patients with DM. Current professional society guidelines reflect these findings, strongly recommending CABG over PCI in this setting. Newer stent platforms, however, have challenged this notion. The use of thinner struts, biocompatible polymer coating, and newer antiproliferative agents have improved the rates of cardiovascular events in patients with DM revascularized percutaneously. Since the publication of current guidelines, new studies suggested acceptable outcomes in patients with DM revascularized with second-generation drug-eluting stents, even though these conclusions are drawn from small subgroup analyses or nonrandomized studies. Robust registry data suggest similar mortality with lower rates of stroke after PCI compared with surgery, at the expense of increased rates of repeat revascularization. If complete revascularization can be achieved, similar rates of myocardial infarction are also observed. Therefore, contemporary revascularization in patients with DM with multivessel coronary artery disease should involve a multidisciplinary approach, in which interventional cardiologists and cardiac surgeons involve their patients to individualize treatment choices, and balance the risks and effectiveness of each modality.
Asunto(s)
Materiales Biocompatibles/farmacología , Enfermedad de la Arteria Coronaria , Diabetes Mellitus/epidemiología , Stents Liberadores de Fármacos/clasificación , Revascularización Miocárdica , Complicaciones Posoperatorias , Comorbilidad , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/terapia , Humanos , Revascularización Miocárdica/efectos adversos , Revascularización Miocárdica/instrumentación , Revascularización Miocárdica/métodos , Revascularización Miocárdica/normas , Selección de Paciente , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Guías de Práctica Clínica como Asunto , Ajuste de RiesgoRESUMEN
BACKGROUND: Polymer-free drug eluting stents (PF-DES) were developed, in part, to overcome risk of late ischemic events observed with permanent polymer-coated DES (PP-DES). However, trial results are inconsistent with longer-term safety and efficacy of PF-DES remaining unknown. We performed a meta-analysis of randomized trials assessing outcomes of patients receiving PF-DES versus PP-DES for treatment of coronary artery disease (CAD). METHODS: Electronic searches were performed for randomized trials comparing outcomes between PF-DES and PP-DES. Trials reporting major adverse cardiovascular events (MACE), myocardial infarction (MI), stent thrombosis (ST), all-cause death, target lesion/vessel revascularization (TLR/TVR), and late lumen loss (LLL) were included. Analyses were performed at longest follow-up and landmarked beyond 1-year. RESULTS: Twelve trials (6,943 patients) were included. There was no significant difference in MACE between PF-DES and PP-DES at longest follow-up (Odds Ratio [OR] 0.96, 95%CI 0.85-1.10, P = 0.59) or landmark analysis beyond 1-year (OR 0.96, 95%CI 0.76-1.20, P = 0.70). Although PF-DES were associated with a significant reduction in all-cause death (OR 0.85, 95%CI 0.72-1.00, P < 0.05), this effect was not present on landmark analysis beyond 1-year (OR 0.89, 95%CI 0.73-1.10, P = 0.30). There were no differences observed for MI (OR 1.00, 95%CI 0.77-1.28, P = 0.99) or ST (OR 0.95, 95%CI 0.54-1.68, P = 0.86), with similar efficacy outcomes including TVR (OR 1.07, 95%CI 0.91-1.26, P = 0.42), TLR (OR 1.03, 95%CI 0.88-1.21, P = 0.68) and angiographic LLL (pooled mean difference 0.01 mm, 95%CI -0.08 to 0.11, P = 0.76). CONCLUSIONS: PF-DES are as safe and efficacious as PP-DES for the treatment of patients with CAD, but do not significantly reduce late ischemic complications.
Asunto(s)
Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Polímeros/farmacología , Materiales Biocompatibles Revestidos/farmacología , Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Humanos , Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
Drug-eluting stents (DES) are increasingly being used as a less invasive alternative to coronary artery bypass grafting. Early generation DES had durable polymers that provided acceptable efficacy outcomes but had high rates of stent thrombosis leading to myocardial infarction and death. Second-generation DES have improved outcomes by reducing stent thrombosis and recurrent stenosis. Newer DES with biodegradable polymers have similar efficacy as second-generation DES, but have higher rates of stent thrombosis. This review compares outcomes of bioresorbable scaffolds and looks at stent technology developments that may improve outcomes.
Asunto(s)
Implantes Absorbibles , Enfermedad de la Arteria Coronaria/cirugía , Reestenosis Coronaria/prevención & control , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Andamios del Tejido , Reestenosis Coronaria/etiología , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Humanos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/métodos , Resultado del TratamientoRESUMEN
BACKGROUND: Previously, we examined the difference in stent designs across different sizes for six widely used Drug Eluting Stents (DESs). Although stent post-dilatation to larger diameter is commonly done, typically in the setting of long tapering segment or left-main PCI, there is an increasing recognition that information with regard to the different stent model designs has a critical impact on overexpansion results. This study aims to provide an update on stent model designs for contemporary DES platforms as well as test overexpansion results under with oversized post-dilatation. METHODS AND RESULTS: We studied 6 different contemporary commercially available DES platforms: Synergy, Xience Xpedition, Ultimaster, Orsiro, Resolute Onyx and Biomatrix Alpha. We investigated for each platform the difference in stent designs across different sizes and results obtained after post-expansion with larger balloon sizes. The stents were deployed at nominal diameter and subsequently over expanded using increasingly large post dilatation balloon sizes (4.0, 5.0 and 6.0mm at 14ATM). Light microscopy was used to measure the changes in stent geometry and lumen diameter after over-expansion. For each respective DES platform, the MLD observed after overexpansion of the largest stent size available with a 6.0mm balloon was 5.7mm for Synergy, 5.6mm for Xience, 5.2mm for Orsiro, 5.8mm for Ultimaster, 5.5mm for 4mm Onyx (5.9mm for the 5mm XL size) and 5.8mm for BioMatrix Chroma. CONCLUSION: This update presents valuable novel insights that may be helpful for careful selection of stent size for contemporary DES based on model designs. Such information is especially critical in left main bifurcation stenosis treatment where overexpansion to larger oversized diameter may be required to ensure full stent apposition.
Asunto(s)
Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/instrumentación , Estenosis Coronaria/cirugía , Stents Liberadores de Fármacos , Complicaciones Posoperatorias , Diseño de Prótesis , Angioplastia Coronaria con Balón/métodos , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Falla de Equipo , Humanos , Ensayo de Materiales/métodos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Diseño de Prótesis/efectos adversos , Diseño de Prótesis/métodosRESUMEN
BACKGROUND: The Absorb bioresorbable vascular scaffold (BVS) was developed to address long-term safety issues of metallic drug-eluting stents. However, it may be associated with an increased event risk during the first year. METHODS: A systematic literature search was performed (in MEDLINE/PubMed, Cochrane CENTRAL, EMBASE, and scientific meeting abstracts) to identify studies that compared BVS and cobalt-chromium durable polymer everolimus-eluting stents (EES). For randomized clinical trials and non-randomized propensity score matched studies that reported 1-year outcome data, fixed/random-effects models were used to generate pooled estimates of outcomes, presented as odds ratios (OR) with 95%-confidence intervals (CI). RESULTS: The 1-year follow-up data of 6 trials with 5588 patients were analyzed. A device-oriented composite endpoint (DOCE - cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization (TLR)) was reached by 308 BVS or EES patients (195/3253 vs. 113/2315). Meta-analysis showed that patients who received BVS had an increased risk of MI (4.3% vs. 2.3%; OR:1.63, 95%-CI: 1.18-2.25, p<0.01) and definite-or-probable scaffold thrombosis (1.3% vs. 0.6%; OR:2.10, 95%-CI: 1.13-3.87, p=0.02). However, there was no significant between-group difference in risk of DOCE (6.0% vs. 4.9%; OR:1.19, 95%-CI: 0.94-1.52, p=0.16), cardiac death (0.8% vs. 0.7%; OR:1.14, 95%-CI: 0.54-2.39, p=0.73), or TLR (2.5% vs. 2.5%; OR: 0.98, 95%-CI:0.69-1.40, p=0.92). CONCLUSIONS: During the first year of follow-up, patients treated with BVS had a higher incidence of MI and scaffold thrombosis. The risk of DOCE was not significantly different. As BVS may pay off later, future robust data on long-term clinical outcome will be of paramount importance.
Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Stents Liberadores de Fármacos/clasificación , Everolimus/farmacología , Intervención Coronaria Percutánea/instrumentación , Implantes Absorbibles/efectos adversos , Prótesis Vascular/efectos adversos , Reestenosis Coronaria/etiología , Humanos , Evaluación de Procesos y Resultados en Atención de Salud , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/métodos , Diseño de Prótesis , Ensayos Clínicos Controlados Aleatorios como Asunto , Andamios del Tejido/efectos adversosRESUMEN
BACKGROUND: Coatings consisting of a polymer and drug are widely used in drug-eluting stents (DES) and are essential in providing programmable drug release kinetics. Among other factors, stent coating technologies can influence blood compatibility, affect acute and sub-acute healing, and potentially trigger a chronic inflammatory response. OBJECTIVE: The aim of this study was to investigate the short-term (7 and 28 days) and long-term (90 and 180 days) coating integrity of the Xience Prime Everolimus-Eluting Stent (EES), Resolute Zotarolimus-Eluting Stent (ZES), Taxus Paclitaxel-Eluting Stent (PES), and Nobori Biolimus A9-Eluting Stent (BES) in a rabbit ilio-femoral stent model. METHODS AND RESULTS: Stented arteries (n = 48) were harvested and the tissue surrounding the implanted stents digested away with an enzymatic solution. Results demonstrated that the majority of struts of EES were without any coating defects with a few struts showing minor defects. Similarly, for the ZES, most of the struts were without coating defects at all time points except at 180 days. The majority of PES demonstrated mostly webbing and uneven coating. In the BES group, the majority of strut coating showed polymer cracking. CONCLUSION: Overall, the EES and ZES had fewer coating defects than the PES and BES. Coating defects, however increase over time for the ZES, whereas the percent of coating irregularities remained constant for the EES. These results provide, for the first time, a comparison of the long-term durability of these drug-eluting stent coatings in vivo.
Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Antineoplásicos Fitogénicos/uso terapéutico , Plásticos Biodegradables/uso terapéutico , Enfermedad Coronaria/terapia , Stents Liberadores de Fármacos , Inmunosupresores/uso terapéutico , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/métodos , Animales , Materiales Biocompatibles Revestidos/uso terapéutico , Modelos Animales de Enfermedad , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/clasificación , Análisis de Falla de Equipo/métodos , Ensayo de Materiales/métodos , Modelos Anatómicos , Conejos , Factores de TiempoAsunto(s)
Angioplastia Coronaria con Balón , Cateterismo Periférico , Enfermedad Coronaria , Vasos Coronarios , Stents Liberadores de Fármacos , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/métodos , Cateterismo Periférico/instrumentación , Cateterismo Periférico/métodos , Toma de Decisiones Clínicas , Angiografía Coronaria/métodos , Enfermedad Coronaria/diagnóstico , Enfermedad Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/patología , Stents Liberadores de Fármacos/clasificación , Stents Liberadores de Fármacos/normas , Humanos , Diseño de Prótesis , Arteria Radial/cirugíaRESUMEN
The early phase arterial reaction after implantation of second-generation drug-eluting stents (2nd DES) and baremetal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remains unclear.The MECHANISM pilot study is a multi-center prospective registry that enrolled 24 STEMI patients (from 11 centers) who had undergone implantation of everolimus-eluting (n = 6), biolimus A9-eluting (n = 6) or zotarolimus-eluting stents (n = 6), or BMS (n = 6). Scheduled optical coherence tomography (OCT) was performed 2 weeks after implantation, and images were independently analyzed at a core laboratory in a blinded fashion. Intra-stent thrombus was quantitatively analyzed in terms of the maximal area and the percentage of cross-sections with thrombus (the numbers of cross-section with thrombus × 100 divided by total number of cross-sections within the stented segment). More than 90% of struts were already covered 2 weeks after the index procedure, regardless of the stent type. There were no differences in stent diameter, minimal lumen diameter, minimal lumen area, neointimal thickness, or the frequencies of malapposed and uncovered struts among the 4 groups. The quantity of intra-stent thrombus also did not differ among the 4 groups.The results of this pilot study suggest that the 2-week vascular responses seem to be similar among 2nd DES and BMS in STEMI patients. Considering the possible advantage of 2nd DES in the prevention of restenosis, 2nd DES are a feasible option for the treatment of patients with STEMI.