RESUMEN
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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Cardiología , Enfermedades Cardiovasculares , Humanos , Angiografía Coronaria , Delgadez/complicaciones , Resultado del Tratamiento , Obesidad/complicaciones , Obesidad/diagnóstico , Obesidad/epidemiología , Índice de Masa Corporal , Factores de RiesgoRESUMEN
BACKGROUND: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke. INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. FUNDING: Biosensors, Aarhus University Hospital, and participating sites.
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Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/terapia , Intervención Coronaria Percutánea/métodos , Anciano , Enfermedad de la Arteria Coronaria/mortalidad , Stents Liberadores de Fármacos/normas , Europa (Continente) , Femenino , Humanos , Masculino , Infarto del Miocardio , Accidente Cerebrovascular , Resultado del TratamientoRESUMEN
OBJECTIVES: We performed a post hoc analysis of outcome in patients with, versus those without, calcified target lesions from the BASE ACS trial. BACKGROUND: The outcome of contemporary stent implantation in patients with calcified lesions presenting with acute coronary syndrome is unknown. METHODS: The BASE ACS trial randomized 827 patients (1:1) presenting with acute coronary syndrome to receive either titanium-nitride-oxide-coated stents or everolimus-eluting stents. Calcified lesions were defined as moderate or severe calcification in the vessel wall by 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. Follow-up was planned at 12 months, and yearly thereafter for up to 7 years. RESULTS: Of 827 patients enrolled in the trial, 352 (42.6%) had calcified target lesions. Median follow-up was 5.0 years. The incidence of MACE was higher in patients with, versus those without, calcified target lesions (19.6% vs. 12.2%, respectively, P = 0.004). This was driven by more frequent cardiac death and non-fatal myocardial infarction events (P < 0.05, both). The rates of ischemia-driven target lesion revascularization were comparable (P > 0.05). MACE and the other endpoints were comparable between the 2 propensity-score matched subgroups (P > 0.05 for all). Hypertension and smaller vessel size independently predicted MACE in patients treated for calcified lesions. CONCLUSIONS: Patients presenting with acute coronary syndrome who were treated for calcified lesions had worse long-term clinical outcome, compared with those treated for non-calcified lesions, mainly due to more frequent safety events. In the propensity score-matched analysis, the outcome was comparable.
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Síndrome Coronario Agudo/cirugía , Intervención Coronaria Percutánea , Stents , Calcificación Vascular/cirugía , Síndrome Coronario Agudo/complicaciones , Síndrome Coronario Agudo/mortalidad , Anciano , Angiografía Coronaria , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Puntaje de Propensión , Stents/efectos adversos , Factores de Tiempo , Titanio , Resultado del Tratamiento , Calcificación Vascular/complicaciones , Calcificación Vascular/diagnóstico por imagenRESUMEN
AIMS: Randomized trials of coronary bifurcation stenting have shown better outcomes from a simple (provisional) strategy rather than a complex (planned two-stent) strategy in terms of short-term efficacy and safety. Here, we report the 5-year all-cause mortality based on pooled patient-level data from two large bifurcation coronary stenting trials with similar methodology: the Nordic Bifurcation Study (NORDIC I) and the British Bifurcation Coronary Study: old, new, and evolving strategies (BBC ONE). METHODS AND RESULTS: Both multicentre randomized trials compared simple (provisional T-stenting) vs. complex (culotte, crush, and T-stenting) techniques, using drug-eluting stents. We analysed all-cause death at 5 years. Data were collected from phone follow-up, hospital records, and national mortality tracking. Follow-up was complete for 890 out of 913 patients (97%). Both Simple and Complex groups were similar in terms of patient and lesion characteristics. Five-year mortality was lower among patients who underwent a simple strategy rather than a complex strategy [17 patients (3.8%) vs. 31 patients (7.0%); P = 0.04]. CONCLUSION: For coronary bifurcation lesions, a provisional single-stent approach appears to be associated with lower long-term mortality than a systematic dual stenting technique.
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Stents , Enfermedad de la Arteria Coronaria , Humanos , Factores de Tiempo , Resultado del TratamientoRESUMEN
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 Coronario Agudo , Stents Liberadores de Fármacos , Infarto del Miocardio , Intervención Coronaria Percutánea , Humanos , Femenino , Persona de Mediana Edad , Masculino , Everolimus/farmacología , Everolimus/uso terapéutico , Síndrome Coronario Agudo/cirugía , Síndrome Coronario Agudo/tratamiento farmacológico , Resultado del Tratamiento , Intervención Coronaria Percutánea/efectos adversos , Stents , Infarto del Miocardio/epidemiología , Infarto del Miocardio/etiología , MuerteRESUMEN
BACKGROUND: It is unknown whether the preferred 1-stent bifurcation stenting approach with stenting of the main vessel (MV) and optional side branch stenting using drug-eluting stents should be finalized by a kissing balloon dilatation (FKBD). Therefore, we compared strategies of MV stenting with and without FKBD. METHODS AND RESULTS: We randomized 477 patients with a bifurcation lesion to FKBD (n=238) or no FKBD (n=239) after MV stenting. The primary end point was major adverse cardiac events: cardiac death, non-procedure-related index lesion myocardial infarction, target lesion revascularization, or stent thrombosis within 6 months. The 6-month major adverse cardiac event rates were 2.1% and 2.5% (P=1.00) in the FKBD and no-FKBD groups, respectively. Procedure and fluoroscopy times were longer and more contrast media was needed in the FKBD group than in the no-FKBD group. Three hundred twenty-six patients had a quantitative coronary assessment. At 8 months, the rate of binary (re)stenosis in the entire bifurcation lesion (MV and side branch) was 11.0% versus 17.3% (P=0.11), in the MV was 3.1% versus 2.5% (P=0.68), and in the side branch was 7.9% versus 15.4% (P=0.039) in the FKBD versus no-FKBD groups, respectively. In patients with true bifurcation lesions, the side branch restenosis rate was 7.6% versus 20.0% (P=0.024) in the FKBD and no-FKBD groups, respectively. CONCLUSIONS: MV stenting strategies with and without FKBD were associated with similar clinical outcomes. FKBD reduced angiographic side branch (re)stenosis, especially in patients with true bifurcation lesions. The simple no-FKBD procedures resulted in reduced use of contrast media and shorter procedure and fluoroscopy times. Long-term data on stent thrombosis are needed. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00914199.
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Angioplastia Coronaria con Balón , Enfermedad de la Arteria Coronaria/patología , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Anciano , Angioplastia Coronaria con Balón/métodos , Enfermedad de la Arteria Coronaria/epidemiología , Dinamarca/epidemiología , Femenino , Finlandia/epidemiología , Estudios de Seguimiento , Humanos , Letonia/epidemiología , Masculino , Persona de Mediana Edad , Noruega/epidemiología , Suecia/epidemiologíaRESUMEN
BACKGROUND: Treatment of acute myocardial infarction with stem cell transplantation has achieved beneficial effects in many clinical trials. The bone marrow microenvironment of ST-elevation myocardial infarction (STEMI) patients has never been studied even though myocardial infarction is known to cause an imbalance in the acid-base status of these patients. The aim of this study was to assess if the blood gas levels in the bone marrow of STEMI patients affect the characteristics of the bone marrow cells (BMCs) and, furthermore, do they influence the change in cardiac function after autologous BMC transplantation. The arterial, venous and bone marrow blood gas concentrations were also compared. METHODS: Blood gas analysis of the bone marrow aspirate and peripheral blood was performed for 27 STEMI patients receiving autologous stem cell therapy after percutaneous coronary intervention. Cells from the bone marrow aspirate were further cultured and the bone marrow mesenchymal stem cell (MSC) proliferation rate was determined by MTT assay and the MSC osteogenic differentiation capacity by alkaline phosphatase (ALP) activity assay. All the patients underwent a 2D-echocardiography at baseline and 4 months after STEMI. RESULTS: As expected, the levels of pO(2), pCO(2), base excess and HCO(3) were similar in venous blood and bone marrow. Surprisingly, bone marrow showed significantly lower pH and Na(+) and elevated K(+) levels compared to arterial and venous blood. There was a positive correlation between the bone marrow pCO(2) and HCO(3) levels and MSC osteogenic differentiation capacity. In contrast, bone marrow pCO(2) and HCO(3) levels displayed a negative correlation with the proliferation rate of MSCs. Patients with the HCO(3) level below the median value exhibited a more marked change in LVEF after BMC treatment than patients with HCO(3) level above the median (11.13 ± 8.07% vs. 2.67 ± 11.89%, P = 0.014). CONCLUSIONS: Low bone marrow pCO(2) and HCO(3) levels may represent the optimal environment for BMCs in terms of their efficacy in autologous stem cell therapy in STEMI patients.
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Células de la Médula Ósea/fisiología , Trasplante de Médula Ósea/fisiología , Microambiente Celular/fisiología , Infarto del Miocardio/fisiopatología , Adulto , Anciano , Análisis de los Gases de la Sangre , Médula Ósea/irrigación sanguínea , Células de la Médula Ósea/química , Células de la Médula Ósea/metabolismo , Células de la Médula Ósea/patología , Células Cultivadas , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/patología , Infarto del Miocardio/terapia , Proyectos Piloto , Pronóstico , Volumen Sistólico/fisiología , Trasplante Autólogo , Resultado del Tratamiento , Adulto JovenRESUMEN
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 Coronario Agudo/terapia , Fármacos Cardiovasculares/administración & dosificación , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Titanio , Síndrome Coronario Agudo/diagnóstico por imagen , Síndrome Coronario Agudo/mortalidad , Anciano , Fármacos Cardiovasculares/efectos adversos , Europa (Continente) , Everolimus/efectos adversos , Femenino , Hemorragia/etiología , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Diseño de Prótesis , Factores de Tiempo , Resultado del TratamientoRESUMEN
Background: It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation. Methods: The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates. Results: A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment. Conclusion: In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years. Trial registration number: NCT01496638.
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Angioplastia Coronaria con Balón/instrumentación , Enfermedad de la Arteria Coronaria/terapia , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/mortalidad , Femenino , Humanos , Letonia , Lituania , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Estudios Prospectivos , Factores de Riesgo , Países Escandinavos y Nórdicos , Factores de Tiempo , Resultado del TratamientoRESUMEN
AIMS: To assess the efficacy and safety of bone marrow cell (BMC) therapy after thrombolytic therapy of an acute ST-elevation myocardial infarction (STEMI). METHODS AND RESULTS: Patients with STEMI treated with thrombolysis followed by percutaneous coronary intervention (PCI) 2-6 days after STEMI were randomly assigned to receive intracoronary BMCs (n = 40) or placebo medium (n = 40), collected and prepared 3-6 h prior PCI and injected into the infarct artery immediately after stenting. Efficacy was assessed by the measurement of global left ventricular ejection fraction (LVEF) by left ventricular angiography and 2-D echocardiography, and safety by measuring arrhythmia risk variables and restenosis of the stented vessel by intravascular ultrasound. At 6 months, BMC group had a greater absolute increase of global LVEF than placebo group, measured either by angiography (mean +/- SD increase 7.1 +/- 12.3 vs. 1.2 +/- 11.5%, P = 0.05) or by 2-D echocardiography (mean +/- SD increase 4.0 +/- 11.2 vs. -1.4 +/- 10.2%, P = 0.03). No differences were observed between the groups in the adverse clinical events, arrhythmia risk variables, or the minimal lumen diameter of the stented coronary lesion. CONCLUSION: Intracoronary BMC therapy is associated with an improvement of global LVEF and neutral effects on arrhythmia risk profile and restenosis of the stented coronary lesions in patients after thrombolytic therapy of STEMI.
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Arritmias Cardíacas , Trasplante de Médula Ósea/efectos adversos , Infarto del Miocardio/cirugía , Terapia Trombolítica/métodos , Función Ventricular Izquierda/fisiología , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/etiología , Método Doble Ciego , Femenino , Estudios de Seguimiento , Frecuencia Cardíaca , Humanos , Inyecciones Intraarteriales , Leucocitos Mononucleares/trasplante , Masculino , Persona de Mediana Edad , Infarto del Miocardio/tratamiento farmacológico , Medición de Riesgo , Stents , Volumen Sistólico/fisiología , Resultado del Tratamiento , Función Ventricular Izquierda/efectos de los fármacosRESUMEN
Myocardial infarction in a young patient is rare, and its diagnosis and treatment may be delayed. Vasculitis can cause inflammation in the coronary artery and cause a myocardial infarction even in a young person. We describe a sudden myocardial infarction caused by vasculitis in two young adults having chest pain symptoms.
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Infarto del Miocardio/etiología , Vasculitis/complicaciones , Adulto , Angiografía Coronaria , Humanos , Vasculitis/diagnóstico por imagen , Adulto JovenRESUMEN
Although the rate of coronary artery disease mortality has decreased over the last decades, it is still the leading cause of death in Finland. Coronary artery disease appears in women with a delay of ten years as compared with men. For women, diabetes and smoking increase the risk of developing the disease more than for men. Women's coronary arteries are smaller in size, which previously impaired the results of invasive treatment. Treatment outcome with current techniques is equal independently of gender. In spite of this, women in an acute attack of coronary artery disease are less frequently directed to coronary angiography.
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Enfermedad Coronaria/mortalidad , Causas de Muerte , Angiografía Coronaria , Enfermedad Coronaria/diagnóstico por imagen , Complicaciones de la Diabetes/diagnóstico por imagen , Complicaciones de la Diabetes/mortalidad , Femenino , Finlandia/epidemiología , Humanos , Factores de Riesgo , Factores Sexuales , Fumar/efectos adversosRESUMEN
BACKGROUND: The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. METHODS AND RESULTS: A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS). CONCLUSIONS: Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.
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Estenosis Coronaria/cirugía , Stents , Angiografía Coronaria , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Sirolimus/administración & dosificación , Sirolimus/uso terapéutico , Resultado del TratamientoRESUMEN
Objective: We compared percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for the treatment of left main coronary artery (LMCA) disease by conducting a systematic review and meta-analysis of randomised controlled trials (RCTs). Methods: RCTs of PCI versus CABG in patients with LMCA stenosis were identified from MEDLINE, the Cochrane Library and search of bibliographies to November 2016. Study-specific HRs with 95% CIs were aggregated for all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and other cardiovascular events at time points of 30 days, 1 year and 3 years and beyond. Results: Six RCTs comprising 4700 patients were included. There were no significant differences in risk of all-cause mortality in pooled analysis of relevant trials at 30 days (0.61, 95% CI 0.27 to 1.36), 1 year (0.66, 95% CI 0.42 to 1.04), and 3 years and beyond (1.04, 95% CI 0.81 to 1.33), comparing PCI with CABG. There was no significant difference in the risk of MACCE at 30 days (0.72, 95% CI 0.51 to 1.03) and 1 year (1.16, 95% CI 0.94 to 1.44); however, PCI was associated with a higher risk of MACCE compared with CABG during longer-term follow-up (1.27, 95% CI 1.12 to 1.44). Composite outcome of death, stroke or myocardial infarction was lower with PCI at 30 days (0.67, 95% CI 0.49 to 0.92). Repeat revascularisation was increased at 1 year and at 3 years and beyond for PCI. Conclusions: All-cause mortality rates are not significantly different between PCI and CABG at short-term and long-term follow-up. However, PCI is associated with a reduction in the risk of major cardiovascular outcomes at short-term follow-up in patients with LMCA stenosis; but at long term, MACCE rate is increased for PCI.
RESUMEN
INTRODUCTION: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients presenting with a DES or bare-metal stent (BMS) in-stent restenosis. METHODS: The "Nordic Intravascular Ultrasound Study (NIVUS)" study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n=121 and BMS n=88) with in-stent restenosis were enrolled. RESULTS: At the minimum lumen area site in the stented segment, the stent area (5.8±2.2mm2 vs. 7.6±2.4mm2, p<0.001) and intimal hyperplasia area (2.6±2.0mm2 vs. 5.0±2.2mm2, p<0.001) were significantly lower in patients treated with DES compared to BMS. The percentage of stents that did not have a minimum stent area of at least 5.0mm2 (under expansion) was higher in DES (58.7% vs. 37.7%, p=0.008) compared to BMS. Intimal hyperplasia covered 55.4±33.3% of the stent length in the DES compared to 90.7±17.4% in the BMS group, p<0.001. Focal in-stent restenosis was more often seen in DES treated patients compared to BMS treated patients (DES n=84 (59.9%) vs. BMS n=15 (17.0%), p<0.001). CONCLUSION: Stent underexpansion was more often seen in DES than BMS in-stent restenosis. DES more often had focal in-stent restenosis with less intimal hyperplasia.
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Reestenosis Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Metales , Neointima , Intervención Coronaria Percutánea/instrumentación , Stents , Anciano , Proliferación Celular , Reestenosis Coronaria/etiología , Reestenosis Coronaria/patología , Vasos Coronarios/patología , Femenino , Humanos , Hiperplasia , Letonia , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Valor Predictivo de las Pruebas , Estudios Prospectivos , Sistema de Registros , Factores de Riesgo , Países Escandinavos y Nórdicos , Factores de Tiempo , Resultado del Tratamiento , Ultrasonografía IntervencionalRESUMEN
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.
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Síndrome Coronario Agudo/cirugía , Complicaciones de la Diabetes/cirugía , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Titanio/administración & dosificación , Anciano , Stents Liberadores de Fármacos/efectos adversos , Stents Liberadores de Fármacos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND: The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial. METHODS: We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12months, and yearly thereafter through 7years. RESULTS: Mean follow-up duration was 4.2±1.9years (median 5.0years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58-1.16; p=0.26 for superiority; p<0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p=0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p=0.76 and p=0.58, respectively). CONCLUSIONS: In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES.
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Síndrome Coronario Agudo/mortalidad , Síndrome Coronario Agudo/cirugía , Stents Liberadores de Fármacos/tendencias , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/tendencias , Titanio/administración & dosificación , Anciano , Muerte , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Método Simple Ciego , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVE: Smoking is a risk factor for increased carotid artery intima-media thickness (IMT). The apolipoprotein E (apoE) 4 allele has been associated with cardiovascular diseases, but the role of apoE in regard to intima-media thickness (IMT) has remained controversial. The objective was to investigate whether there is some gene-environment interaction between smoking and apoE polymorphism. DESIGN Cross-sectional case-control study. METHODS: IMTs of 511 hypertensive and control men were measured ultrasonographically and the apoE genotypes were determined. Genotypes with the 4 allele were pooled into one group and the genotypes without it into another. RESULTS: A significant interaction between the 4 allele and smoking affecting IMT was observed among the hypertensive smokers, as assessed by analysis of covariance. The mean carotid IMT was significantly greater (1.01 versus 0.90 mm, P = 0.003) in the 4 carriers than in the subjects without 4 among the hypertensive smokers. The number of plaques was also significantly higher. No differences were found in the other subjects (hypertensive non-smokers or controls). Linear regression analysis indicated that the 4 allele was an independent determinant of IMT in the hypertensive smokers but not in the other subjects. The estimated average effect of the 4 allele on the mean IMT in the hypertensive smokers was 0.088 mm (P < 0.001). In the oldest age group, the interaction of smoking and 4 was also seen in the control subjects. CONCLUSION: The findings suggest that the 4 carriers are particularly susceptible to the atherogenic effects of smoking. This interaction is particularly clear in hypertensive subjects.
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Apolipoproteínas E/genética , Enfermedades de las Arterias Carótidas/etiología , Hipertensión/genética , Arteriosclerosis Intracraneal/etiología , Polimorfismo Genético , Fumar/efectos adversos , Adulto , Apolipoproteína E4 , Estudios de Casos y Controles , Estudios Transversales , Predisposición Genética a la Enfermedad , Heterocigoto , Humanos , Hipertensión/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Túnica Íntima/diagnóstico por imagen , Túnica Media/diagnóstico por imagen , UltrasonografíaRESUMEN
BACKGROUND: The BASE-ACS trial demonstrated an outcome of the titanium-nitride-oxide-coated bioactive stents (BAS) statistically non-inferior to that of the everolimus-eluting stents (EES) at 12-month follow-up in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial with particular focus on stent-oriented versus patient-oriented outcome at 24-month follow-up. METHODS: A total of 827 patients with ACS were randomly assigned to receive either BAS (417) or EES (410). Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal myocardial infarction, or ischemia-driven target lesion revascularization. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal myocardial infarction, or any revascularization. RESULTS: Clinical follow-up for 24 months was completed in 406 (97.4%) patients in the BAS group and in 398 (97.1%) in the EES group. Stent-oriented outcome at 24-month follow-up occurred at similar frequencies in the two stent groups (10.1% for BAS versus 11.2% for EES, P=0.53). Likewise, patient-oriented outcome at 24-month follow-up was similar in the two groups (16.3% versus 19.8%, respectively, P=0.2). CONCLUSIONS: In patients presenting with ACS, the rates of both stent-oriented and patient-oriented outcomes at 24-month follow-up in the BAS group were similar to those in the EES group.
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Síndrome Coronario Agudo/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Stents , Anciano , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Isquemia Miocárdica/epidemiología , Evaluación del Resultado de la Atención al Paciente , Estudios Prospectivos , Método Simple Ciego , Sirolimus/administración & dosificación , Sirolimus/análogos & derivados , Titanio/química , Resultado del TratamientoRESUMEN
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.