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Importance: Titanium-nitride-oxide (TiNO)-coated stents show faster strut coverage compared with drug-eluting stents without excessive intimal-hyperplasia observed in bare metal stents. It is important to study long-term clinical outcomes after treatment of patients with an acute coronary syndrome (ACS) by TiNO-coated stents, which are neither drug-eluting stents nor bare metal stents. Objective: To compare the rate of main composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 5 years in patients with ACS randomized to receive either a TiNO-coated stent or a third-generation everolimus-eluting stent (EES). Design, Setting, and Participants: This multicenter, randomized, controlled, open-label trial was conducted in 12 clinical sites in 5 European countries and enrolled patients from January 2014 to August 2016. Patients presenting with ACS (ST-segment elevation MI, non-ST-segment elevation MI, and unstable angina) with at least 1 de novo lesion were randomized to receive either a TiNO-coated stent or an EES. The present report analyzes the long-term follow-up for the main composite outcome and its individual components. Analysis took place between November 2022 to March 2023. Main outcome: The primary end point was a composite of cardiac death, MI, or target lesion revascularization at 12-month follow-up. Results: A total of 1491 patients with ACS were randomly assigned to receive either TiNO-coated stents (989 [66.3%]) or EES (502 [33.7%]). The mean (SD) age was 62.7 (10.8) years, and 363 (24.3%) were female. At 5 years, the main composite outcome events occurred in 111 patients (11.2%) in the TiNO group vs 60 patients (12%) in the EES group (hazard ratio [HR], 0.94; 95% CI, 0.69-1.28; P = .69). The rate of cardiac death was 0.9% (9 of 989) vs 3.0% (15 of 502) (HR, 0.30; 95% CI, 0.13-0.69; P = .005), the rate of MI was 4.6% (45 of 989) vs 7.0% (35 of 502) (HR, 0.64; 95% CI, 0.41-0.99; P = .049), the rate of stent thrombosis was 1.2% (12 of 989) vs 2.8% (14 of 502) (HR, 0.43; 95% CI, 0.20-0.93; P = .034), and the rate of target lesion revascularization was 7.4% (73 of 989) vs 6.4% (32 of 502) (HR, 1.16; 95% CI, 0.77-1.76; P = .47) in the TiNO-coated stent arm and in the EES arm, respectively. Conclusion and relevance: In this study, patients with ACS had a main composite outcome that was not different 5 years after TiNO-coated stent or EES. Trial Registration: ClinicalTrials.gov Identifier: NCT02049229.
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Síndrome Coronariana Aguda , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Everolimo/farmacologia , Everolimo/uso terapêutico , Síndrome Coronariana Aguda/cirurgia , Síndrome Coronariana Aguda/tratamento farmacológico , Resultado do Tratamento , Intervenção Coronária Percutânea/efeitos adversos , Stents , Infarto do Miocárdio/epidemiologia , Infarto do Miocárdio/etiologia , MorteRESUMO
Introducción y objetivos Evaluar mediante tomografía de coherencia óptica (OCT) el proceso de cicatrización neointimal tras el implante de stents de cromo cobalto con recubrimiento de titanio-óxido nítrico (TiNO) y de stents de platino-cromo liberadores de everolimus (SLE) con polímero biodegradable en pacientes con síndrome coronario agudo. Métodos Los pacientes fueron aleatorizados (1:1) para recibir el stent TiNO o SLE. Se obtuvieron imágenes de OCT a los 30 días (cohorte A, n=52) y a los 6 meses (cohorte B, n=30) de seguimiento. El objetivo primario del estudio fue el porcentaje de struts no cubiertos por paciente. Resultados En la cohorte A, el porcentaje de struts no cubiertos fue menor con los stents TiNO que con los SLE (3,2% frente a 19,6%, p <0,001). El porcentaje de struts mal apuestos fue del 0,4% en el grupo TiNO y del 2,1% en el grupo SLE (p <0,001). En la cohorte B, el porcentaje de struts no cubiertos también fue menor con los stents TiNO (0,0% frente a 8,7% (p <0,001). El porcentaje de struts mal apuestos fue del 0% en el grupo de stent TiNO y del 0,3% en el grupo de SLE (p=0,008). A ninguno de los pacientes se les tuvo que repetir la revascularización durante los 6 meses de seguimiento. Conclusiones Tras una intervención percutánea por síndrome coronario agudo, el implante de un stent TiNO se asoció a un menor porcentaje de struts no cubiertos y mal apuestos por paciente, en comparación con el SLE, en un seguimiento temprano y a medio plazo (AU)
Introduction and objectives To evaluate by optical coherence tomography neointimal healing response after implantation of cobalt-chromium-based titanium-nitride-oxide-coated (TiNO) stents and platinum-chromium-based biodegradable-polymer-coated everolimus-eluting stents (EES) in patients with acute coronary syndrome. Methods Patients were randomized (1:1) to receive either a TiNO-stent or EES. Optical coherence tomography images were obtained at 30-day (cohort A, n = 52) and 6-month (cohort B, n = 30) follow-up. The primary endpoint was the percentage of uncovered struts per patient. Results In cohort A, the percentage of uncovered struts was lower with TiNO-stents vs EES (3.2% vs 19.6%, P <.001). The percentage of malapposed struts was 0.4% in the TiNO-group and 2.1% in the EES group (P <.001). In cohort B, the percentage of uncovered struts was also lower with TiNO-stents (0.0% vs 8.7% (P <.001). The percentage of malapposed struts was 0% in the TiNO-stent group and 0.3% in the EES group (P=.008). None of the patients had repeat revascularization during the 6 months of follow-up. Conclusions Following percutaneous intervention for acute coronary syndrome, TiNO stent implantation was associated with a lower percentage of uncovered and malapposed struts per patient, compared with EES, at early and mid-term follow-up (AU)
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Humanos , Síndrome Coronariana Aguda/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea , Sirolimo/administração & dosagem , Tomografia de Coerência Óptica , Resultado do Tratamento , Óxido Nítrico/administração & dosagem , TitânioRESUMO
INTRODUCTION AND OBJECTIVES: To evaluate by optical coherence tomography neointimal healing response after implantation of cobalt-chromium-based titanium-nitride-oxide-coated (TiNO) stents and platinum-chromium-based biodegradable-polymer-coated everolimus-eluting stents (EES) in patients with acute coronary syndrome. METHODS: Patients were randomized (1:1) to receive either a TiNO-stent or EES. Optical coherence tomography images were obtained at 30-day (cohort A, n = 52) and 6-month (cohort B, n = 30) follow-up. The primary endpoint was the percentage of uncovered struts per patient. RESULTS: In cohort A, the percentage of uncovered struts was lower with TiNO-stents vs EES (3.2% vs 19.6%, P <.001). The percentage of malapposed struts was 0.4% in the TiNO-group and 2.1% in the EES group (P <.001). In cohort B, the percentage of uncovered struts was also lower with TiNO-stents (0.0% vs 8.7%, (P <.001). The percentage of malapposed struts was 0% in the TiNO-stent group and 0.3% in the EES group, (P=.008). None of the patients had repeat revascularization during the 6 months of follow-up. CONCLUSIONS: Following percutaneous intervention for acute coronary syndrome, TiNO stent implantation was associated with a lower percentage of uncovered and malapposed struts per patient, compared with EES, at early and mid-term follow-up. This study is registered under ClinicalTrials.gov, with number NCT02464397.
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Síndrome Coronariana Aguda , Stents Farmacológicos , Intervenção Coronária Percutânea , Humanos , Everolimo , Sirolimo , Óxido Nítrico , Titânio , Resultado do Tratamento , Vasos Coronários , Cromo , Tomografia de Coerência Óptica/métodosRESUMO
BACKGROUND: In patients with some cardiovascular disease conditions, slightly elevated body mass index (BMI) is associated with a lower mortality risk (termed "obesity paradox"). It is uncertain, however, if this obesity paradox exists in patients who have had invasive cardiology procedures. We evaluated the association between BMI and mortality in patients who underwent coronary angiography. METHODS: We utilised the KARDIO registry, which comprised data on demographics, prevalent diseases, risk factors, coronary angiographies, and interventions on 42,636 patients. BMI was categorised based on WHO cut-offs or transformed using P-splines. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated for all-cause mortality. RESULTS: During a median follow-up of 4.9 years, 4688 all-cause deaths occurred. BMI was nonlinearly associated with mortality risk: compared to normal weight category (18.5-25 kg/m2 ), the age-adjusted HRs (95% CIs) for all-cause mortality were 1.90 (1.49, 2.43), 0.96 (0.92, 1.01), 1.04 (0.99, 1.09), 1.08 (0.96, 1.20), and 1.45 (1.22, 1.72) for underweight (<18.5 kg/m2 ), preobesity (25 to <30 kg/m2 ), obesity class I (30 to <35 kg/m2 ), obesity class II (35 to <40 kg/m2 ), and obesity class III (>40 kg/m2 ), respectively. The corresponding multivariable adjusted HRs (95% CIs) were 2.00 (1.55, 2.58), 0.92 (0.88, 0.97) 1.01 (0.95, 1.06), 1.10 (0.98, 1.23), and 1.49 (1.26, 1,78), respectively. CONCLUSIONS: In patients undergoing coronary angiography, underweight and obesity class III are associated with increased mortality risk, and the lowest mortality was observed in the preobesity class. It appears the obesity paradox may be present in patients who undergo invasive coronary procedures.
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Cardiologia , Doenças Cardiovasculares , Humanos , Angiografia Coronária , Magreza/complicações , Resultado do Tratamento , Obesidade/complicações , Obesidade/diagnóstico , Obesidade/epidemiologia , Índice de Massa Corporal , Fatores de RiscoRESUMO
OBJECTIVES: This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS). BACKGROUND: Previous generation TiNO-coated stents showed acceptable performance in patients with ACS. METHODS: In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months. RESULTS: A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27). CONCLUSIONS: In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229).
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Síndrome Coronariana Aguda/terapia , Fármacos Cardiovasculares/administração & dosagem , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Titânio , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Idoso , Fármacos Cardiovasculares/efeitos adversos , Europa (Continente) , Everolimo/efeitos adversos , Feminino , Hemorragia/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: We explored the predictors and outcome of poor, versus good, initial TIMI flow in patients with acute coronary syndrome (ACS). DESIGN: We performed post-hoc analysis of a randomized trial of patients presenting with ACS who received 2 comparative stents. Poor initial TIMI flow was defined as baseline TIMI flow grade 0/1 at the initial coronary angiography. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction or ischemia-driven target lesion revascularization. Stent thrombosis (ST) was adjudicated according to the criteria of definite ST described by the Academic Research Consortium. Propensity score-matched analysis was performed. We report data after 5-year follow-up. RESULTS: Of 827 patients enrolled, 279 (33.7%) had initial TIMI 0/1 flow. Median follow-up duration was 5.0 years. Presentation by ST-elevation myocardial infarction and target vessel other than left anterior descending artery predicted initial TIMI 0/1 flow. MACE rate was comparable between the 2 subgroups (14% versus 15.9%, in patients with poor versus good initial TIMI flow, respectively, p = .46). Individual endpoints were comparable (p > .05 for all). Definite ST was more frequent in patients with initial TIMI 0/1 flow (3.6% versus 1.5%, respectively, p = .048). This was driven by more frequent early events (30 days) (p = .036); late/very late events were comparable (p = 1.0). CONCLUSIONS: Predictors of poor initial TIMI flow included presentation by ST-elevation myocardial infarction, and target vessel other than left anterior descending artery. Definite ST occurred more in patients with poor, versus good, initial TIMI flow, mainly driven by difference in early events.
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Síndrome Coronariana Aguda/terapia , Circulação Coronária , Vasos Coronários/fisiopatologia , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/mortalidade , Síndrome Coronariana Aguda/fisiopatologia , Idoso , Distribuição de Qui-Quadrado , Angiografia Coronária , Trombose Coronária/etiologia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Pontuação de Propensão , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Estudos Retrospectivos , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. METHODS: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. CONCLUSIONS: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.
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Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Neointima/diagnóstico por imagem , Intervenção Coronária Percutânea/instrumentação , Implantes Absorvíveis , Idoso , Angiografia Coronária , Reestenose Coronária/etiologia , Reestenose Coronária/prevenção & controle , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/patologia , Estudos Prospectivos , Desenho de Prótese , Sirolimo/administração & dosagem , Alicerces Teciduais , Tomografia de Coerência ÓpticaRESUMO
Background Inadequate neointimal coverage of stent struts is associated with late stent thrombosis. Purpose To demonstrate the extent of neointimal coverage and strut malapposition in titanium-nitride-oxide-coated bioactive stents (BAS) versus everolimus-eluting stents (EES) by optical coherence tomography (OCT) performed at 18-month follow-up. Material and Methods In the BASE-ACS trial, 827 patients presenting with acute coronary syndrome were randomized to receive either BAS or EES. Forty patients (20 BAS, 20 EES) underwent OCT at 18-month follow-up for evaluation of stent strut coverage, malapposition, and neointimal hyperplasia (NIH). Primary endpoint was binary stent strut coverage (ratio of covered struts to all analyzed struts multiplied by 100). Co-primary endpoint was the percentage of malapposed struts. Results We analyzed 3465 struts in 330 cross-sections of BAS and 3327 struts in 316 cross-sections of EES. Binary stent strut coverage, based on strut-level analysis, was higher with BAS versus EES (99.5% versus 94.2%, respectively; P < 0.001), the strut-level percentage of malapposed struts was lower with BAS (0.6% versus 2.5%, respectively; P < 0.001). Yet, the mean NIH thickness was greater with BAS (237 ± 125 versus 108 ± 62 µm, respectively; P < 0.001). Conclusion In the current post-hoc analysis with OCT performed at 18 months, binary strut coverage, based on strut-level analysis, was higher with BAS versus EES; strut-level malapposed struts were fewer with BAS; yet, BAS induced thicker NIH.
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Síndrome Coronariana Aguda/tratamento farmacológico , Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Tomografia de Coerência Óptica , Materiais Revestidos Biocompatíveis , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neointima , Titânio , Resultado do TratamentoRESUMO
The Comparison of Bioactive-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS) trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial in patients with, versus those without, preexisting vascular disease. We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary end point was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). A total of 169 (20.4%) patients had preexisting vascular disease. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, preexisting vascular disease (22.5% vs 13.5%, respectively, P = .004). This was driven by more frequent cardiac death and non-fatal MI (5.9% vs 2.4% and 11.8% vs 5.5%, P = .02 and P = .003, respectively). The rates of ischemia-driven TLR were comparable ( P > .05). All events were comparable between the 2 matched-pair subgroups ( P > .05 for all). In patients treated with early percutaneous coronary intervention for ACS, the long-term outcome was worse in patients with, versus those without, preexisting vascular disease.
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Síndrome Coronariana Aguda/tratamento farmacológico , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea , Doenças Vasculares/complicações , Idoso , Materiais Revestidos Biocompatíveis , Angiografia Coronária , Determinação de Ponto Final , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Prospectivos , Método Simples-Cego , Resultado do TratamentoRESUMO
BACKGROUND: The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of elderly versus non-elderly patients from the BASE ACS trial. METHODS: We randomized 827 patients (1:1) presenting with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR). Follow-up was planned at 12months and yearly thereafter for up to 7years. Elderly age was defined as ≥65years. RESULTS: Of the 827 patients enrolled in the BASE ACS trial, 360 (43.5%) were elderly. Mean follow-up duration was 4.2±1.9years. MACE was more frequent in elderly versus younger patients (19.7% versus 12.0%, respectively, p=0.002), probably driven by more frequent cardiac death and non-fatal MI events (5.3% versus 1.5%, and 9.7% versus 4.5%, p=0.002 and p=0.003, respectively). The rates of ischemia-driven TLR were comparable (p>0.05). In propensity score-matched analysis (215 pairs), only cardiac death was more frequent in elderly patients (6% versus 1.4%, respectively, p=0.01). Diabetes independently predicted both MACE and cardiac death in elderly patients. CONCLUSIONS: Elderly patients treated with stent implantation for ACS had worse long-term clinical outcome, compared with younger ones, mainly due to a higher death rate.
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Síndrome Coronariana Aguda/cirurgia , Antineoplásicos/administração & dosagem , Stents Farmacológicos , Everolimo/administração & dosagem , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/métodos , Titânio , Síndrome Coronariana Aguda/epidemiologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Materiais Biocompatíveis , Doenças Cardiovasculares/mortalidade , Diabetes Mellitus/epidemiologia , Intervenção Médica Precoce , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Revascularização Miocárdica/estatística & dados numéricos , Recidiva , Método Simples-Cego , Stents , Resultado do TratamentoRESUMO
BACKGROUND/OBJECTIVES: Optical coherence tomography (OCT) is widely used for evaluation of healing response to stent implantation. We sought to test the agreement between the 1-mm and 0.6-mm sampling intervals for assessment of the percentage of uncovered and malapposed struts by OCT. METHODS: Thirty-eight patients presenting with acute coronary syndrome were randomized to receive either a titanium-nitride-oxide-coated stent (n=19) or an everolimus-eluting stent (n=19). Neointimal strut coverage and strut apposition were evaluated by OCT at 2-month follow-up. Two independent investigators performed offline OCT image analysis at 1-mm intervals. One investigator repeated the measurements at 0.6-mm intervals and measurements were compared between the two sampling intervals. RESULTS: At a median follow-up of 60 [8] days, 694 cross-sections (7603 struts) and 1138 cross-sections (12,331 struts) were analysed at 1-mm and at 0.6-mm intervals, respectively. The median [IQR] percentage of uncovered struts was 3.27% [11.1] versus 3.38% [9.76] (p=0.001), and the mean (±SD) percentage was 7.69±9.99% versus 6.27±8.14% (p=0.004), for the 1-mm sampling interval versus the 0.6-mm sampling interval analysis, respectively; the median percentage of malapposed struts was 0.42% [2.04] versus 0.12% [1.63], respectively, (p=0.003). The intraclass correlation coefficient between the two observers for the percentage of uncovered struts was 0.95. CONCLUSIONS: The OCT-evaluated strut-level measurements of neointimal healing after stent implantation differ significantly between the 1-mm and the 0.6-mm sampling intervals.
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Síndrome Coronariana Aguda/terapia , Stents Farmacológicos , Everolimo/farmacologia , Intervenção Coronária Percutânea/instrumentação , Titânio/farmacologia , Tomografia de Coerência Óptica/métodos , Síndrome Coronariana Aguda/diagnóstico por imagem , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neointima/patologia , Variações Dependentes do Observador , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Método Simples-Cego , Estatísticas não Paramétricas , Fatores de Tempo , Cicatrização/fisiologiaRESUMO
BACKGROUND: The BASE ACS trial demonstrated an outcome of titanium-nitride-oxide-coated bioactive stents (BAS) that was non-inferior to everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS). We performed a post-hoc analysis of diabetic versus non-diabetic patients from the trial. METHODS: We randomised 827 patients (1:1) with ACS to receive either BAS or EES. The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, non-fatal myocardial infarction (MI) or ischaemia-driven target lesion revascularisation (TLR). Follow-up was planned yearly through 7 years. RESULTS: Of 827 patients, 140 (16.9%) were diabetic; of these, 36 (25.7%) were insulin-treated. Mean follow-up duration was 4.2 ± 1.9 years. MACE was more frequent in diabetics versus non-diabetics (23.6% versus 13.7%, respectively, p = 0.003), mainly driven by more frequent cardiac death (7.9% versus 2.2%, respectively, p = 0.002). The rates of non-fatal MI, ischaemia-driven TLR were comparable (p > 0.05 for all). In diabetic patients, MACE was comparable between the two stent arms (18.5% versus 28.0%, for BAS versus EES, respectively, p = 0.18). CONCLUSIONS: Diabetic patients treated with early percutaneous coronary intervention for ACS had worse long-term outcome, compared with non-diabetics, mainly driven by more frequent cardiac death. The long-term outcome of BAS was comparable to EES in diabetics. Key Messages Diabetic patients presenting with acute coronary syndrome who were treated with early percutaneous coronary intervention had worse long-term clinical outcome, compared with non-diabetics, mainly driven by a high incidence of cardiac death. Age independently predicted both major adverse cardiac events and cardiac death in diabetic patients. The long-term clinical outcome of titanium-nitride-oxide-coated bioactive stents was comparable to that of everolimus-eluting stents in the diabetic, as well as in the non-diabetic subgroup.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Complicações do Diabetes/cirurgia , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Titânio/administração & dosagem , Idoso , Stents Farmacológicos/efeitos adversos , Stents Farmacológicos/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Análise de Sobrevida , Resultado do TratamentoRESUMO
Data on early vascular healing response of novel stent designs are scarce. In this randomized prospective trial, we sought to compare early neointimal coverage of cobalt-chromium-based titanium-nitride-oxide-coated bioactive stents (CoCr-BAS) versus platinum-chromium everolimus-eluting stents (PtCr-EES) at 2-month follow-up in patients with acute coronary syndrome (ACS). Forty patients with ACS were randomized to receive either CoCr-BAS (n = 19) or PtCr-EES (n = 21). Neointimal strut coverage and strut apposition were examined by optical coherence tomography; and coronary flow reserve (CFR), fractional flow reserve (FFR) and index of microcirculatory resistance (IMR) were assessed using a coronary pressure wire at 2 months. Two patients in the PtCr-EES underwent OCT out of the time frame of the study, and were excluded from analysis. At 63 ± 8 days, 302 cross-sections (3412 struts) were analysed in the CoCr-BAS group, and 324 cross-sections (3460 struts) in the PtCr-EES group. Median [IQR] neointimal thickness was 203 [108] µm and 42.2 [41] µm for CoCr-BAS and PtCr-EES, respectively (p < 0.001). Median [IQR] percentage of uncovered struts was 1.2 [2.8] % versus 11.3 [17.7] %, respectively (p < 0.001). Flow measurements were comparable between the two groups (p > 0.05 for all). CoCr-BAS showed earlier and more adequate neointimal coverage of struts at 2 months, compared with PtCr-EES, but with more neointimal hyperplasia. Functional healing as assessed by CFR, FFR, and IMR was similar between the two stent arms.
Assuntos
Síndrome Coronariana Aguda/terapia , Cromo , Materiais Revestidos Biocompatíveis , Vasos Coronários/efeitos dos fármacos , Stents Farmacológicos , Everolimo/administração & dosagem , Óxido Nítrico/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Platina , Titânio , Vasodilatadores/administração & dosagem , Cicatrização , Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/patologia , Síndrome Coronariana Aguda/fisiopatologia , Idoso , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/patologia , Vasos Coronários/fisiopatologia , Feminino , Finlândia , Reserva Fracionada de Fluxo Miocárdico , Humanos , Hiperplasia , Masculino , Microcirculação , Pessoa de Meia-Idade , Neointima , Intervenção Coronária Percutânea/efeitos adversos , Estudos Prospectivos , Método Simples-Cego , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Resistência VascularRESUMO
OBJECTIVES: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. DESIGN: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. RESULTS: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; p = 0.24 for superiority; p = 0.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; p = 0.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; p = 0.62 and p = 0.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, p = 0.021), the number of vessels treated (HR 1.53, p = 0.025), and reference vessel diameter (HR 0.54, p = 0.006). CONCLUSIONS: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.
Assuntos
Síndrome Coronariana Aguda , Reestenose Coronária , Everolimo/uso terapêutico , Intervenção Coronária Percutânea , Titânio/uso terapêutico , Síndrome Coronariana Aguda/diagnóstico , Síndrome Coronariana Aguda/terapia , Idoso , Antineoplásicos/uso terapêutico , Angiografia Coronária/métodos , Reestenose Coronária/diagnóstico , Reestenose Coronária/etiologia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Desenho de Prótese , Resultado do TratamentoRESUMO
AIMS: The randomized comparison of titanium-nitride-oxide-coated bioactive stent with everolimus-eluting stent in acute coronary syndrome (BASE-ACS) trial demonstrated an outcome of the titanium-nitride-oxide coated bioactive stents (BASs) that was statistically noninferior to that of the everolimus-eluting stents (EESs) at 12-month follow-up, in patients presenting with acute coronary syndrome (ACS) who underwent early percutaneous coronary intervention. We performed a post-hoc gender-based analysis of the BASE-ACS trial at 24-month follow-up. METHODS: A total of 827 patients (198 women) with ACS were randomly assigned to receive either BAS or EES. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction (MI), or ischemia-driven target lesion revascularization. RESULTS: Women were older, and more likely to have diabetes and hypertension compared with men (Pâ<â0.05 for all). Moreover, women had significantly smaller reference vessel diameter and stent diameter (Pâ<â0.05 for all). At 24-month follow-up, the cumulative incidence of the primary endpoint was similar between the two sex subgroups (15.2 versus 11.0%, for women versus men, respectively, Pâ=â0.13). However, the rate of nonfatal MI was significantly higher in women compared with men (8.6 versus 3.8%, respectively, Pâ=â0.007). After propensity score-adjusted analysis, there was a trend toward more nonfatal MI among women (8.6 versus 4.0%, respectively, Pâ=â0.08). Moreover, among male patients, those assigned to BAS had significantly lower nonfatal MI compared with those assigned to EES (Pâ=â0.027). However, among patients assigned to EES, female patients had a significantly higher rate of nonfatal MI compared with men (Pâ=â0.02). CONCLUSION: In the current post-hoc gender-based analysis of the BASE-ACS trial, the 24-month outcome of patients undergoing percutaneous coronary intervention for ACS was slightly worse in women, compared with men, as reflected by a trend toward more nonfatal MI events after propensity score-adjusted analysis.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Intervenção Coronária Percutânea/instrumentação , Caracteres Sexuais , Stents/estatística & dados numéricos , Síndrome Coronariana Aguda/diagnóstico por imagem , Idoso , Antineoplásicos/administração & dosagem , Angiografia Coronária , Everolimo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/estatística & dados numéricos , Pontuação de Propensão , Fatores Sexuais , Titânio , Resultado do TratamentoRESUMO
BACKGROUND: Patients at high bleeding risk would benefit from a shorter dual antiplatelet therapy after PCI. Compared to first-generation devices, the design of newer generation drug-eluting stents may facilitate more rapid anatomical and functional healing of stented vessel based on thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution. METHODS AND RESULTS: Forty-four non-diabetic patients with acute coronary syndrome (ACS) and culprit lesion in the LAD were randomized to receive either biodegradable polymer sirolimus-eluting stent (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES). Neointimal strut coverage was examined using optical coherence tomography, and vasodilator response on invasive thermodilution-derived coronary flow reserve (CFR) at 3-month follow-up. The primary endpoints were percent uncovered struts and CFR. A total of 425 cross-sections (4,897 struts) were analyzed in the BP-SES group, and 425 cross-sections (5,467 struts) in the DP-ZES group. The percent uncovered struts was lower in the BP-SES group compared with the DP-ZES group, both at strut level (3.9% vs. 8.9%, respectively, P<0.001), and stent level (3.9 ± 3.2% vs. 8.9 ± 6.9%, respectively, P=0.019). No significant difference was found between the 2 groups regarding CFR (3.0 ± 1.3 vs. 3.2 ± 1.0, respectively, P>0.05). CONCLUSIONS: In non-diabetic patients with ACS, BP-SES provided slightly better stent strut coverage at 3 months compared with DP-ZES, but neither stent was fully covered. No difference in vasodilator response was seen.
Assuntos
Implantes Absorvíveis , Síndrome Coronariana Aguda , Plásticos Biodegradáveis , Stents Farmacológicos , Neointima , Sirolimo/análogos & derivados , Vasodilatação/efeitos dos fármacos , Síndrome Coronariana Aguda/fisiopatologia , Síndrome Coronariana Aguda/cirurgia , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos ProspectivosRESUMO
Introducción y objetivos Análisis combinado basado en los datos de pacientes de los ensayos TITAX-AMI y BASE-ACS para evaluar los resultados clínicos obtenidos con stents bioactivos con recubrimiento de titanio-óxido nítrico comparados con los stents liberadores de fármacos en pacientes con infarto agudo de miocardio con elevación del segmento ST tras un seguimiento de 2 años. Métodos El ensayo TITAX-AMI comparó los stents bioactivos con los liberadores de paclitaxel en 425 pacientes con infarto agudo de miocardio. El ensayo BASE-ACS comparó stents bioactivos con stents liberadores de everolimus en 827 pacientes con síndrome coronario agudo. El objetivo principal para el análisis combinado fueron los eventos adversos cardiacos mayores: muerte cardiaca, infarto de miocardio recurrente o revascularización de la lesión diana por causa isquémica tras un seguimiento de 2 años. Resultados El análisis combinado incluyó a 501 pacientes; se trató a 245 con stents bioactivos y se implantó stent liberador de fármacos a 256. En el análisis conjunto, el grupo de stentsbioactivos presentó un cociente de riesgos de eventos adversos cardiacos mayores de 0,85 (intervalo de confianza del 95%, 0,53-1,35; p = 0,49) comparado con el grupo de stentsliberadores de fármacos. De igual modo, el grupo conjunto de stents bioactivos mostró un cociente de riesgos de muerte cardiaca de 0,71 (intervalo de confianza del 95%, 0,26-1,95; p = 0,51); de infarto de miocardio recurrente, 0,44 (intervalo de confianza del 95%, 0,20-0,97; p = 0,04), y de revascularización de la lesión diana por causa isquémica, 1,39 (intervalo de confianza del 95%, 0,74-2,59; p = 0,30), en comparación con el grupo conjunto tratado con stents liberadores de fármacos. Estos resultados se confirmaron por un análisis de puntuación de propensión ajustado respecto a la serie de datos conjunta. Conclusiones: En pacientes con infarto agudo de miocardio con elevación del segmento ST, los stents bioactivos, comparados con los stents liberadores de fármacos, se asociaron a menores tasas de infarto de miocardio recurrente tras un seguimiento de 2 años; no obstante, las tasas de muerte cardiaca y de revascularización de la lesión diana por causa isquémica fueron similares
Introduction and objectives We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. Methods The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. Results The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P = .49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P = .51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P = .04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P = .30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. Conclusions In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar
Assuntos
Humanos , Stents Farmacológicos , Titânio/uso terapêutico , Óxido Nítrico/uso terapêutico , Doença das Coronárias/diagnóstico , Intervenção Coronária Percutânea , Infarto do Miocárdio/tratamento farmacológico , Distribuição Aleatória , Imunossupressores/uso terapêutico , Paclitaxel/uso terapêutico , Resultado do Tratamento , Estudos de Casos e ControlesRESUMO
INTRODUCTION AND OBJECTIVES: We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. METHODS: The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. RESULTS: The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. CONCLUSIONS: In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar.
Assuntos
Stents Farmacológicos , Infarto do Miocárdio/cirurgia , Titânio/uso terapêutico , Stents Farmacológicos/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/mortalidade , Pontuação de Propensão , Recidiva , Titânio/administração & dosagem , Resultado do TratamentoRESUMO
AIMS: Coronary vasodilator dysfunction has been reported after drug-eluting stent (DES) implantation. Recent ESC guidelines suggest that transthoracic echocardiography (TTE) may be considered for assessment of coronary flow reserve (CFR) and microvascular disease in patients with stable angina, but its reliability has not been tested in patients with DES. We sought to assess the agreement between TTE (CFRTTE) and invasive thermodilution-derived CFR (CFRThermodilution) as well as their association with index of microcirculatory resistance (IMR) in mid-term follow-up after percutaneous coronary intervention for acute coronary syndrome. METHODS AND RESULTS: CFRTTE and CFRThermodilution were assessed 3 months after DES implantation in the left anterior descending artery in 24 patients. Patients with haemodynamically significant epicardial stenosis (fractional flow reserve <0.75) were excluded. Correlation between the two methods was good (r = 0.71, P < 0.001), but CFRThermodilution (mean ± SD) tended to be higher (3.17 ± 1.00 vs. 2.87 ± 0.72; mean difference 0.29, 95% confidence interval -0.06 to 0.59). In Bland-Altman analysis, there was a trend towards a greater difference in the range of higher invasive values. Nevertheless, TTE was successful in discriminating moderately impaired CFR (≤2.5) (P = 0.001) and severely impaired CFR (≤2.0) (P < 0.001) when compared with an invasive method. No association between either CFR measurements vs. IMR measurement was detected, suggesting that in addition to microcirculatory function, CFR also accounts for epicardial vasodilator function in the absence of haemodynamically significant stenosis. CONCLUSION: TTE is a feasible and reliable method for the assessment of CFR and vasodilator dysfunction after DES implantation. Values obtained with this method successfully find abnormal CFR confirmed with the invasive thermodilution method.
Assuntos
Síndrome Coronariana Aguda/diagnóstico por imagem , Síndrome Coronariana Aguda/terapia , Stents Farmacológicos , Ecocardiografia/métodos , Circulação Coronária , Feminino , Hemodinâmica/efeitos dos fármacos , Humanos , Imunossupressores/administração & dosagem , Masculino , Microcirculação , Pessoa de Meia-Idade , Intervenção Coronária Percutânea , Estudos Prospectivos , Fatores de Risco , Sirolimo/administração & dosagem , Termodiluição , Resultado do Tratamento , VasodilataçãoRESUMO
BACKGROUND: The TITAX-AMI randomized controlled trial demonstrated a better clinical outcome with titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) at 2-year follow-up, in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We sought to present the 5-year clinical outcome of the TITAX-AMI trial. METHODS: A total of 425 patients with acute MI were randomly assigned to receive either BAS (214), or PES (211). The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, recurrent MI or ischemia-driven target lesion revascularization (TLR). Clinical follow-up was performed to 5 years. RESULTS: The 5-year cumulative incidence of MACE was significantly lower in patients assigned to BAS as compared with those assigned to PES (16.4% versus 25.1%, respectively, p=0.03). Similarly, the 5-year rates of cardiac death and recurrent MI were significantly lower in patients assigned to BAS (1.9% versus 5.7%, and 8.4% versus 18.0%, p=0.04 and p=0.004, respectively). Yet, the rates of ischemia-driven TLR were similar between the two study groups (11.2% versus 10.9%, respectively, p=0.92). The rate of definite stent thrombosis (ST) was again significantly lower in patients assigned to BAS (0.9% versus 7.1%, respectively, p=0.001). CONCLUSIONS: In the current prospective randomized TITAX-AMI trial, among patients presenting with acute MI who underwent early PCI, BAS achieved a better clinical outcome as compared with PES at 5-year follow-up, as reflected by lower cumulative rates of overall MACE, cardiac death, recurrent MI, and definite ST; yet, with statistically similar rates of ischemia-driven TLR.