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1.
Am Heart J ; 249: 45-56, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-35305955

RESUMEN

BACKGROUND: Diabetes mellitus (DM) is an important predictor of neointimal hyperplasia (NIH) and adverse clinical outcomes after percutaneous coronary intervention (PCI). LABR-312, a novel intravenous formulation of liposomal alendronate, has been shown in animal models to decrease NIH at vascular injury sites and around stent struts. The aim of the Biorest Liposomal Alendronate Administration for Diabetic Patients Undergoing Drug-Eluting Stent Percutaneous Coronary Intervention trial was to assess the safety, effectiveness, and dose response of LABR-312 administered intravenously at the time of PCI withDES in reducing NIH as measured by optical coherence tomography postprocedure in patients with DM. METHODS: Patients with DM were randomized to a bolus infusion of LABR-312 vs placebo at the time of PCI. Dose escalation of LABR-312 in the study arm was given: 0.01 mg, 0.03 mg, and 0.08 mg. The primary endpoint was the in-stent %NIH volume at 9 months as measured by optical coherence tomography. RESULTS: From September 2016 to December 2017, 271 patients with DM undergoing PCI were enrolled; 136 patients were randomized to LABR-312 infusion and 135 patients were randomized to placebo. At 9-month follow-up, no difference was seen in the primary endpoint of %NIH between LABR-312 and placebo (13.3% ± 9.2 vs 14.6% ± 8.5, P = .35). No differences were present with the varying LABR-312 doses. Clinical outcomes at 9 months were similar between groups. CONCLUSIONS: Among patients with DM undergoing PCI with drug-eluting stents, a bolus of LABR-312 injected systematically at the time of intervention did not result in a lower rate in-stent %NIH volume at 9-month follow-up.


Asunto(s)
Enfermedad de la Arteria Coronaria , Diabetes Mellitus , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Alendronato , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Enfermedad de la Arteria Coronaria/cirugía , Humanos , Neointima/etiología , Intervención Coronaria Percutánea/métodos , Tomografía de Coherencia Óptica , Resultado del Tratamiento
3.
Heart Surg Forum ; 16(4): E190-2, 2013 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-23958529

RESUMEN

Iatrogenic coronary ostial stenosis after aortic valve replacement (AVR) is a rare but life-threatening complication. This condition has been treated with urgent coronary bypass surgery, but such surgery is associated with high morbidity and mortality. The clinical symptoms are usually severe and may appear from 1 to 6 months postoperatively. Pains in the chest that are typical for coronary artery disease but occur in patients after the AVR operation suggest a significant threat. We report a case of left main coronary artery ostial stenosis in a patient who had normal preoperative coronary angiography results. The patient was successfully treated with implantation of a drug-eluting stent.


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Válvula Aórtica/cirugía , Estenosis Coronaria/etiología , Estenosis Coronaria/cirugía , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Prótesis Valvulares Cardíacas/efectos adversos , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Estenosis Coronaria/diagnóstico por imagen , Femenino , Humanos , Radiografía , Resultado del Tratamiento
4.
Circulation ; 123(16): 1745-56, 2011 Apr 26.
Artículo en Inglés | MEDLINE | ID: mdl-21482968

RESUMEN

BACKGROUND: Concerns persist regarding the risk of stent thrombosis in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction. METHODS AND RESULTS: The Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial included 3602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention who were randomized to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI) (n=1802) versus bivalirudin monotherapy (n=1800). Stents were implanted in 3202 patients, including 2261 who received drug-eluting stents and 861 who received only bare metal stents. Definite or probable stent thrombosis within 2 years occurred in 137 patients (4.4%), including 28 acute events (0.9%), 49 subacute events (1.6%), 32 late events (1.0%), and 33 very late events (1.1%). The 2-year cumulative rates of stent thrombosis were 4.4% with both drug-eluting stents and bare metal stents (P=0.98) and 4.3% versus 4.6% in patients randomized to bivalirudin monotherapy versus heparin plus a GPI, respectively (P=0.73). Acute stent thrombosis occurred more frequently in patients assigned to bivalirudin compared with heparin plus a GPI (1.4% versus 0.3%; P<0.001), whereas stent thrombosis after 24 hours occurred less frequently in patients with bivalirudin compared with heparin plus a GPI (2.8% versus 4.4%; P=0.02). Pre-randomization heparin and a 600-mg clopidogrel loading dose were independent predictors of reduced acute and subacute stent thrombosis, respectively. CONCLUSIONS: Stent thrombosis is not uncommon within the first 2 years after primary percutaneous coronary intervention in ST-segment elevation myocardial infarction, and occurs with similar frequency in patients receiving drug-eluting stents versus bare metal stents and bivalirudin alone versus heparin plus a GPI. Optimizing adjunct pharmacology including early antithrombin therapy preloading with a potent antiplatelet therapy may further reduce stent thrombosis in ST-segment elevation myocardial infarction.


Asunto(s)
Angioplastia Coronaria con Balón/efectos adversos , Reestenosis Coronaria/prevención & control , Trombosis Coronaria/prevención & control , Stents Liberadores de Fármacos/efectos adversos , Infarto del Miocardio/terapia , Anciano , Angioplastia Coronaria con Balón/estadística & datos numéricos , Anticoagulantes/uso terapéutico , Antitrombinas/uso terapéutico , Clopidogrel , Reestenosis Coronaria/epidemiología , Trombosis Coronaria/epidemiología , Quimioterapia Combinada , Stents Liberadores de Fármacos/estadística & datos numéricos , Femenino , Heparina/uso terapéutico , Hirudinas , Humanos , Masculino , Metales , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Paclitaxel/uso terapéutico , Fragmentos de Péptidos/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Valor Predictivo de las Pruebas , Proteínas Recombinantes/uso terapéutico , Factores de Riesgo , Ticlopidina/análogos & derivados , Ticlopidina/uso terapéutico , Resultado del Tratamiento , Moduladores de Tubulina/uso terapéutico
5.
Lancet ; 377(9784): 2193-204, 2011 Jun 25.
Artículo en Inglés | MEDLINE | ID: mdl-21665265

RESUMEN

BACKGROUND: Primary results of the HORIZONS-AMI trial have been previously reported. In this final report, we aimed to assess 3-year outcomes. METHODS: HORIZONS-AMI was a prospective, open-label, randomised trial undertaken at 123 institutions in 11 countries. Patients aged 18 years or older were eligible for enrolment if they had ST-segment elevation myocardial infarction (STEMI), presented within 12 h after onset of symptoms, and were undergoing primary percutaneous coronary intervention. By use of a computerised interactive voice response system, we randomly allocated patients 1:1 to receive bivalirudin or heparin plus a glycoprotein IIb/IIIa inhibitor (GPI; pharmacological randomisation; stratified by previous and expected drug use and study site) and, if eligible, randomly allocated 3:1 to receive a paclitaxel-eluting stent or a bare metal stent (stent randomisation; stratified by pharmacological group assignment, diabetes mellitus status, lesion length, and study site). We produced Kaplan-Meier estimates of major adverse cardiovascular events at 3 years by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00433966. FINDINGS: Compared with 1802 patients allocated to receive heparin plus a GPI, 1800 patients allocated to bivalirudin monotherapy had lower rates of all-cause mortality (5·9%vs 7·7%, difference -1·9% [-3·5 to -0·2], HR 0·75 [0·58-0·97]; p=0·03), cardiac mortality (2·9%vs 5·1%, -2·2% [-3·5 to -0·9], 0·56 [0·40-0·80]; p=0·001), reinfarction (6·2%vs 8·2%, -1·9% [-3·7 to -0·2], 0·76 [0·59-0·99]; p=0·04), and major bleeding not related to bypass graft surgery (6·9%vs 10·5%, -3·6% [-5·5 to -1·7], 0·64 [0·51-0·80]; p=0·0001) at 3 years, with no significant differences in ischaemia-driven target vessel revascularisation, stent thrombosis, or composite adverse events. Compared with 749 patients who received a bare-metal stent, 2257 patients who received a paclitaxel-eluting stent had lower rates of ischaemia-driven target lesion revascularisation (9·4%vs 15·1%, -5·7% [-8·6 to -2·7], 0·60 [0·48-0·76]; p<0·0001) after 3 years, with no significant differences in the rates of death, reinfarction, stroke or stent thrombosis. Stent thrombosis was high (≥4·5%) in both groups. INTERPRETATION: The effectiveness and safety of bivalirudin monotherapy and paclitaxel-eluting stenting are sustained at 3 years for patients with STEMI undergoing primary percutaneous coronary intervention. FUNDING: Boston Scientific and The Medicines Company.


Asunto(s)
Angioplastia de Balón/métodos , Heparina/administración & dosificación , Hirudinas/administración & dosificación , Infarto del Miocardio/terapia , Paclitaxel/farmacología , Fragmentos de Péptidos/administración & dosificación , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Angioplastia de Balón/mortalidad , Terapia Combinada , Intervalos de Confianza , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Quimioterapia Combinada , Stents Liberadores de Fármacos , Electrocardiografía , Femenino , Estudios de Seguimiento , Heparina/efectos adversos , Hirudinas/efectos adversos , Humanos , Estimación de Kaplan-Meier , Masculino , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Fragmentos de Péptidos/efectos adversos , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/administración & dosificación , Estudios Prospectivos , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Stents , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento
6.
N Engl J Med ; 360(19): 1946-59, 2009 May 07.
Artículo en Inglés | MEDLINE | ID: mdl-19420364

RESUMEN

BACKGROUND: There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI). METHODS: We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical bare-metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months. RESULTS: Patients who received paclitaxel-eluting stents, as compared with those who received bare-metal stents, had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio, 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P=0.006), with noninferior rates of the composite safety end point (8.1% vs. 8.0%; hazard ratio, 1.02; 95% CI, 0.76 to 1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1 to 2.4; P=0.01 for noninferiority; P=0.92 for superiority). Patients treated with paclitaxel-eluting stents and those treated with bare-metal stents had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; hazard ratio, 0.44; 95% CI, 0.33 to 0.57; P<0.001). CONCLUSIONS: In patients with ST-segment elevation myocardial infarction who were undergoing primary PCI, implantation of paclitaxel-eluting stents, as compared with bare-metal stents, significantly reduced angiographic evidence of restenosis and recurrent ischemia necessitating repeat revascularization procedures. No safety concerns were apparent at 1 year. (ClinicalTrials.gov number, NCT00433966.)


Asunto(s)
Stents Liberadores de Fármacos , Infarto del Miocardio/terapia , Paclitaxel/administración & dosificación , Stents , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón , Terapia Combinada , Angiografía Coronaria , Reestenosis Coronaria/epidemiología , Reestenosis Coronaria/prevención & control , Estenosis Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Femenino , Fibrinolíticos/uso terapéutico , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/tratamiento farmacológico , Infarto del Miocardio/mortalidad , Recurrencia , Retratamiento/estadística & datos numéricos , Riesgo , Stents/efectos adversos , Suecia
7.
Heart Surg Forum ; 15(4): E240-1, 2012 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-22917833

RESUMEN

The left internal mammary artery (LIMA) is a widely used conduit during coronary artery bypass graft (CABG) surgery because of its excellent long-term patency. Although large LIMA side branches are typically ligated during the surgery, the occurrence of a coronary steal phenomenon related to these side branches following surgery remains controversial. Advocates for occlusion of LIMA side branches in the setting of left anterior descending artery (LAD) ischemia indicate that anginal symptoms often improve and that objective measures of LAD ischemia frequently resolve. We present a patient with ischemia in the LAD distribution secondary to coronary steal from a large LIMA side branch that was successfully treated using the Embolization Coil-IMWCE-3-PDA5 (Cook Medical, Bjaeverskov, Denmark).


Asunto(s)
Angina Estable/diagnóstico , Angina Estable/etiología , Angina Estable/cirugía , Puente de Arteria Coronaria/efectos adversos , Arterias Mamarias/cirugía , Arterias Mamarias/trasplante , Humanos , Ligadura , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
8.
N Engl J Med ; 358(21): 2218-30, 2008 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-18499566

RESUMEN

BACKGROUND: Treatment with the direct thrombin inhibitor bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in similar suppression of ischemia while reducing hemorrhagic complications in patients with stable angina and non-ST-segment elevation acute coronary syndromes who are undergoing percutaneous coronary intervention (PCI). The safety and efficacy of bivalirudin in high-risk patients are unknown. METHODS: We randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatment with heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization for ischemia, and stroke (hereinafter referred to as net adverse clinical events) within 30 days. RESULTS: Anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in a reduced 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; 95% confidence interval [CI] 0.63 to 0.92; P=0.005), owing to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; 95% CI, 0.46 to 0.77; P<0.001). There was an increased risk of acute stent thrombosis within 24 hours in the bivalirudin group, but no significant increase was present by 30 days. Treatment with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, resulted in significantly lower 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; 95% CI, 0.40 to 0.95; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; 95% CI, 0.44 to 1.00; P=0.047). CONCLUSIONS: In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, anticoagulation with bivalirudin alone, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in significantly reduced 30-day rates of major bleeding and net adverse clinical events. (ClinicalTrials.gov number, NCT00433966 [ClinicalTrials.gov].).


Asunto(s)
Angioplastia Coronaria con Balón , Antitrombinas/uso terapéutico , Infarto del Miocardio/terapia , Fragmentos de Péptidos/uso terapéutico , Stents , Adulto , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Antitrombinas/efectos adversos , Terapia Combinada , Quimioterapia Combinada , Femenino , Hemorragia/inducido químicamente , Heparina/efectos adversos , Heparina/uso terapéutico , Hirudinas/efectos adversos , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/mortalidad , Fragmentos de Péptidos/efectos adversos , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéutico , Recurrencia , Stents/efectos adversos , Accidente Cerebrovascular/etiología , Trombosis/epidemiología , Trombosis/etiología
9.
N Engl J Med ; 358(21): 2205-17, 2008 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-18499565

RESUMEN

BACKGROUND: We hypothesized that percutaneous coronary intervention (PCI) preceded by early treatment with abciximab plus half-dose reteplase (combination-facilitated PCI) or with abciximab alone (abciximab-facilitated PCI) would improve outcomes in patients with acute ST-segment elevation myocardial infarction, as compared with abciximab administered immediately before the procedure (primary PCI). METHODS: In this international, double-blind, placebo-controlled study, we randomly assigned patients with ST-segment elevation myocardial infarction who presented 6 hours or less after the onset of symptoms to receive combination-facilitated PCI, abciximab-facilitated PCI, or primary PCI. All patients received unfractionated heparin or enoxaparin before PCI and a 12-hour infusion of abciximab after PCI. The primary end point was the composite of death from all causes, ventricular fibrillation occurring more than 48 hours after randomization, cardiogenic shock, and congestive heart failure during the first 90 days after randomization. RESULTS: A total of 2452 patients were randomly assigned to a treatment group. Significantly more patients had early ST-segment resolution with combination-facilitated PCI (43.9%) than with abciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01 and P=0.003, respectively). The primary end point occurred in 9.8%, 10.5%, and 10.7% of the patients in the combination-facilitated PCI group, abciximab-facilitated PCI group, and primary-PCI group, respectively (P=0.55); 90-day mortality rates were 5.2%, 5.5%, and 4.5%, respectively (P=0.49). CONCLUSIONS: Neither facilitation of PCI with reteplase plus abciximab nor facilitation with abciximab alone significantly improved the clinical outcomes, as compared with abciximab given at the time of PCI, in patients with ST-segment elevation myocardial infarction. (ClinicalTrials.gov number, NCT00046228 [ClinicalTrials.gov].)


Asunto(s)
Angioplastia Coronaria con Balón , Anticuerpos Monoclonales/uso terapéutico , Fibrinolíticos/administración & dosificación , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Infarto del Miocardio/terapia , Activador de Tejido Plasminógeno/administración & dosificación , Abciximab , Anciano , Anticuerpos Monoclonales/efectos adversos , Infarto Cerebral/inducido químicamente , Terapia Combinada , Método Doble Ciego , Electrocardiografía , Femenino , Fibrinolíticos/efectos adversos , Hemorragia/inducido químicamente , Humanos , Fragmentos Fab de Inmunoglobulinas/efectos adversos , Estimación de Kaplan-Meier , Masculino , Infarto del Miocardio/clasificación , Infarto del Miocardio/complicaciones , Infarto del Miocardio/mortalidad , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Factores de Tiempo , Activador de Tejido Plasminógeno/efectos adversos , Resultado del Tratamiento
10.
Med Sci Monit ; 17(1): CR26-32, 2011 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-21169907

RESUMEN

BACKGROUND: Adipokines such as adiponectin and resistin, as well as angiogenin, may be associated with inflammation and atherosclerosis. The relationship between their levels and prognosis in high risk patients is, however, still unclear. The aim of this study was to evaluate the prognostic value of these adipokines in patients with stable multivessel coronary artery disease (MCAD). MATERIAL/METHODS: The study group comprised 107 MCAD patients (74% males, mean age 63 ± 8 years). Adiponectin, resistin and angiogenin plasma levels were measured at admission and after 1-year follow-up. Primary end point (major adverse cardiac and cerebrovascular events--MACCE) was defined as cardiac death, nonfatal myocardial infarction, stroke, and hospitalization for angina or heart failure over a 1-year period. RESULTS: After 1-year follow-up, 9 (8%) patients died, all from cardiovascular causes. Primary end point was experienced by 32% of patients. Surgical treatment (CABG) was received by 51% of patients, while 49% were treated medically alone. Total cholesterol concentration levels ≥ 173 mg/dl were associated with a 7-fold increase (OR 7.3; 95% CI, 1.6-33.0); LDL ≥ 93.5 mg/dl with a 16-fold increase (OR 16.3; 95% CI, 2.8-93.8), and resistin ≥ 17.265 ng/ml with a 13-fold increase in MACCE risk (OR 13.5; 95% CI, 2.3-80.3). In multivariate analysis, a medical treatment strategy (p = 0.001), a higher CCS class (p = 0.004), resistin levels (p = 0.003) and a higher Gensini score (p = 0.03) were independent predictors of MACCE. CONCLUSIONS: In stable patients with MCAD, elevated plasma resistin (as opposed to adiponectin or angiogenin) is a strong, independent predictive factor for the occurrence of MACCE over 1-year follow-up.


Asunto(s)
Adiponectina/sangre , Enfermedad de la Arteria Coronaria/complicaciones , Paro Cardíaco/diagnóstico , Resistina/sangre , Ribonucleasa Pancreática/sangre , Accidente Cerebrovascular/diagnóstico , Anciano , Angiografía Coronaria , Ecocardiografía , Ensayo de Inmunoadsorción Enzimática , Femenino , Paro Cardíaco/etiología , Humanos , Masculino , Persona de Mediana Edad , Polonia , Pronóstico , Estadísticas no Paramétricas , Accidente Cerebrovascular/etiología
12.
EuroIntervention ; 17(6): 466-473, 2021 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-34031023

RESUMEN

BACKGROUND: Despite primary PCI (PPCI), ST-elevation myocardial infarction (STEMI) can still result in large infarct size (IS). New technology with rapid intravascular cooling showed positive signals for reduction in IS in anterior STEMI. AIMS: We investigated the effectiveness and safety of rapid systemic intravascular hypothermia as an adjunct to PPCI in conscious patients, with anterior STEMI, without cardiac arrest. METHODS: Hypothermia was induced using the ZOLL® Proteus™ intravascular cooling system. After randomisation of 111 patients, 58 to hypothermia and 53 to control groups, the study was prematurely discontinued by the sponsor due to inconsistent patient logistics between the groups resulting in significantly longer total ischaemic delay in the hypothermia group (232 vs 188 minutes; p<0.001). RESULTS: There were no differences in angiographic features and PPCI result between the groups. Intravascular temperature at wire crossing was 33.3+0.9°C. Infarct size/left ventricular (IS/LV) mass by cardiac magnetic resonance (CMR) at day 4-6 was 21.3% in the hypothermia group and 20.0% in the control group (p=0.540). Major adverse cardiac events at 30 days increased non-significantly in the hypothermia group (8.6% vs 1.9%; p=0.117) while cardiogenic shock (10.3% vs 0%; p=0.028) and paroxysmal atrial fibrillation (43.1% vs 3.8%; p<0.001) were significantly more frequent in the hypothermia group. CONCLUSIONS: The ZOLL Proteus intravascular cooling system reduced temperature to 33.3°C before PPCI in patients with anterior STEMI. Due to inconsistent patient logistics between the groups, this hypothermia protocol resulted in a longer ischaemic delay, did not reduce IS/LV mass and was associated with increased adverse events.


Asunto(s)
Infarto del Miocardio , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Imagen por Resonancia Magnética , Infarto del Miocardio/terapia , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Infarto del Miocardio con Elevación del ST/terapia , Factores de Tiempo , Resultado del Tratamiento
13.
Lancet ; 374(9696): 1149-59, 2009 Oct 03.
Artículo en Inglés | MEDLINE | ID: mdl-19717185

RESUMEN

BACKGROUND: In the HORIZONS-AMI trial, patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) who were treated with the thrombin inhibitor bivalirudin had substantially lower 30-day rates of major haemorrhagic complications and net adverse clinical events than did patients assigned to heparin plus a glycoprotein IIb/IIIa inhibitor (GPI). Here, we assess whether these initial benefits were maintained at 1 year of follow-up. METHODS: Patients aged 18 years or older were eligible for enrolment in this multicentre, open-label, randomised controlled trial if they had STEMI, presented within 12 h after the onset of symptoms, and were undergoing primary PCI. 3602 eligible patients were randomly assigned by interactive voice response system in a 1:1 ratio to receive bivalirudin (0.75 mg/kg intravenous bolus followed by 1.75 mg/kg per h infusion; n=1800) or heparin plus a GPI (control; 60 IU/kg intravenous bolus followed by boluses with target activated clotting time 200-250 s; n=1802). The two primary trial endpoints were major bleeding and net adverse clinical events (NACE; consisting of major bleeding or composite major adverse cardiovascular events [MACE; death, reinfarction, target vessel revascularisation for ischaemia, or stroke]). This prespecified analysis reports data for the 1-year follow-up. Analysis was by intention to treat. Patients with missing data were censored at the time of withdrawal from the study or at last follow-up. This trial is registered with ClinicalTrials.gov, number NCT00433966. FINDINGS: 1-year data were available for 1696 patients in the bivalirudin group and 1702 patients in the control group. Reasons for participant dropout were loss to follow-up and withdrawal of consent. The rate of NACE was lower in the bivalirudin group than in the control group (15.6%vs 18.3%, hazard ratio [HR] 0.83, 95% CI 0.71-0.97, p=0.022), as a result of a lower rate of major bleeding in the bivalirudin group (5.8%vs 9.2%, HR 0.61, 0.48-0.78, p<0.0001). The rate of MACE was similar between groups (11.9%vs 11.9%, HR 1.00, 0.82-1.21, p=0.98). The 1-year rates of cardiac mortality (2.1%vs 3.8%, HR 0.57, 0.38-0.84, p=0.005) and all-cause mortality (3.5%vs 4.8%, HR 0.71, 0.51-0.98, p=0.037) were lower in the bivalirudin group than in the control group. INTERPRETATION: In patients with STEMI undergoing primary PCI, anticoagulation with bivalirudin reduced the rates of net adverse clinical events and major bleeding at 1 year compared with treatment with heparin plus a GPI. This finding has important clinical implications for the selection of optimum treatment strategies for patients with STEMI. FUNDING: Cardiovascular Research Foundation, with unrestricted grant support from Boston Scientific Corporation and The Medicines Company.


Asunto(s)
Angioplastia Coronaria con Balón , Anticoagulantes/uso terapéutico , Infarto del Miocardio/tratamiento farmacológico , Fragmentos de Péptidos/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón/efectos adversos , Anticoagulantes/efectos adversos , Femenino , Estudios de Seguimiento , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Heparina/efectos adversos , Heparina/uso terapéutico , Hirudinas/efectos adversos , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Fragmentos de Péptidos/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Modelos de Riesgos Proporcionales , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéutico , Stents/efectos adversos , Tasa de Supervivencia , Trombosis/etiología , Trombosis/prevención & control , Resultado del Tratamiento
14.
Eur Heart J ; 30(14): 1736-43, 2009 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-19376786

RESUMEN

AIMS: The aim of this analysis was to examine the influence of different in-cath-lab antiplatelet regimens for the primary percutaneous coronary intervention (PCI) on all-cause mortality. METHODS AND RESULTS: The study group consisted of 7193 patients (pts) undergoing primary PCI in 38 centres in 2003 in Poland. All patients received pretreatment with 300 mg of aspirin, 992 pts (14%) received glycoprotein (GP) IIb/IIIa inhibitors, 2690 pts (37%) were treated with 300 mg loading dose of clopidogrel, and 1566 (22%) received combined antiplatelet treatment with both GP IIb/IIIa inhibitors and clopidogrel. Remaining 1945 patients (27%) did not receive GP IIb/IIIa inhibitors or clopidogrel. Primary endpoint of the study was all-cause mortality up to 1 year from ST-segment elevation myocardial infarction (STEMI). One year mortality rates in the four groups were: 10.4%, 9.0%, 9.7%, and 15.3%, respectively. Propensity-adjusted survival analysis showed significant reduction of mortality for combination therapy with GP IIb/IIIa inhibitors and clopidogrel, clopidogrel alone, and GP IIb/IIIa inhibitors alone over aspirin alone. No additive effect on survival was seen for a combination therapy with GP IIb/IIIa inhibitors and clopidogrel in comparison to treatment with clopidogrel alone. CONCLUSION: In this large cohort, multicentre STEMI registry in-cath-lab use of GP IIb/IIIa inhibitors and clopidogrel alone or in combination was associated with the reduction of 1 year all-cause mortality in the setting of primary PCI in comparison with aspirin only. However, the use of GP IIb/IIIa inhibitors on top of 300 mg loading dose of clopidogrel did not further reduce mortality.


Asunto(s)
Angioplastia Coronaria con Balón/mortalidad , Infarto del Miocardio/mortalidad , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios de Cohortes , Quimioterapia Combinada , Determinación de Punto Final , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infarto del Miocardio/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/efectos adversos , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Polonia/epidemiología , Análisis de Supervivencia
15.
Kardiol Pol ; 68(1): 22-30, 2010 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-20131185

RESUMEN

BACKGROUND: Treatment of chronic diseases, such as atherosclerosis, usually leads to significant short-term improvement. Mid- and long-term results are not always as satisfactory. That is why improvement of quality of life should be the leading qualification criterion for invasive procedures, which sometimes carry a risk of complications. AIM: To determine the quality of life in patients with stable, multivessel coronary artery disease (MCAD), treated surgically or medically. METHODS: The study group comprised 107 patients (pts; 80 males) suffering from MCAD, assigned to coronary artery bypass grafting (CABG) (55 pts) or to medical treatment alone (52 pts). The mean Gensini score in the whole group was 90 (66-132). To evaluate quality of life we used a Short Form-36 (SF-36) health status survey by the International Quality of Life Assessment Project. RESULTS: During a 12-month follow-up 9 pts died (6 pts in the medically treated group and 3 in the CABG group), all for cardiovascular reasons. Patients treated conservatively were more often hospitalised due to angina symptoms (20 vs. 5, p = 0.003). Analysis of SF-36 showed that pts treated surgically had better improvement of quality of life in comparison with medically treated patients. Significant differences were found for physical functioning, bodily pain, vitality, mental health and mental component summary. CONCLUSIONS: This study has shown that there is a significant difference in health-related quality of life 12 months after CABG surgery and medical treatment alone in high-risk patients with MCAD. Surgical treatment decreases the number of adverse events, better attenuates of anginal and heart failure symptoms, and improves the quality of life, especially the mental component. Our results should encouraged selecting patients with advanced atherosclerosis for revascularisation procedures, even if there is a very high peri-procedural risk.


Asunto(s)
Enfermedad de la Arteria Coronaria/terapia , Calidad de Vida , Angioplastia Coronaria con Balón , Causas de Muerte , Comorbilidad , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/mortalidad , Stents Liberadores de Fármacos , Femenino , Estudios de Seguimiento , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Cuidados Paliativos , Accidente Cerebrovascular/epidemiología , Tasa de Supervivencia , Resultado del Tratamiento
16.
Kardiol Pol ; 78(7-8): 715-724, 2020 08 25.
Artículo en Inglés | MEDLINE | ID: mdl-32432434

RESUMEN

BACKGROUND: Predicting the severity of coronary artery disease (CAD) may be possible during dobutamine stress echocardiography (DSE) with various indices of left ventricular function. AIMS: We assessed the relative value of ejection fraction (EF), force, global longitudinal strain (GLS), and wall motion score index (WMSI) in predicting SYNTAX and Gensini scores in patients with known or suspected CAD. METHODS: We prospectively enrolled 223 patients (120 men; mean [SD] age, 62 [9] years) and assessed the following indices: 1) EF (with triplane imaging); 2) force, calculated as the ratio of systolic blood pressure to left ventricular end­systolic volume; 3) GLS; 4) WMSI. All patients underwent coronary angiography within 12 weeks with SYNTAX and Gensini scores evaluation. RESULTS: The correlation of SYNTAX and Gensini scores was highest with peak WMSI (SYNTAX, rho = 0.591; Gensini, rho = 0.612; P <0.001), intermediate with peak force (SYNTAX, rho = -0.346; Gensini, rho = -0.377; P <0.001) and GLS (SYNTAX, rho = -0.205; P = 0.002 and Gensini rho = -0.216; P = 0.001), and the weakest for EF (SYNTAX, rho = -0.149; P = 0.03 and Gensini, rho = -0.191; P = 0.006). The similar hierarchy of variables was detected for changes during DSE. In the subgroup after myocardial infarction (n = 66 [27%]), GLS outperformed the force. CONCLUSIONS: In patients with CAD at DSE peak, theWMSI and force were better predictors of the coronary SYNTAX and Gensini scores and CAD severity than GLS or EF. However, in patients after myocardial infarction, the GLS correlation with coronary scores improved and got closer to the visual assessment.


Asunto(s)
Enfermedad de la Arteria Coronaria , Infarto del Miocardio , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Dobutamina , Ecocardiografía de Estrés , Humanos , Masculino , Persona de Mediana Edad , Volumen Sistólico
17.
Kardiol Pol ; 67(3): 287-90, 2009 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-19378235

RESUMEN

We report a case of 53-year-old male admitted to the hospital with severe chest pain and elevation of troponin I levels, who was transferred to our department for a coronary angiography. Contrast injection into the right coronary artery (RCA) demonstrated no evidence of coronary artery disease. However, a double outlet coronary artery fistula which drained into the right ventricle was visualised. With standard 2-dimensional echocardiographic imaging abnormal flow was detected in the inflow part of the right ventricular free wall. Three-dimensional colour Doppler imaging clearly demonstrated the presence of double outlet RCA - right ventricle coronary fistula with sufficient quality.


Asunto(s)
Fístula Arterio-Arterial/diagnóstico por imagen , Anomalías de los Vasos Coronarios/diagnóstico por imagen , Ventrículos Cardíacos/anomalías , Angina Inestable/etiología , Fístula Arterio-Arterial/complicaciones , Dolor en el Pecho/etiología , Angiografía Coronaria/métodos , Ecocardiografía Doppler , Humanos , Masculino , Persona de Mediana Edad
18.
Kardiol Pol ; 67(6): 601-10, 2009 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-19618316

RESUMEN

BACKGROUND: Pro-inflammatory cytokine interleukin-1b (IL-1b) plays a role in atherosclerosis. The results of several studies on the association between polymorphism of the IL-1b gene cluster and the course of coronary atherosclerosis have been inconclusive. AIM: To investigate retrospectively whether the patients with the most common variants of polymorphism of the IL-1b gene cluster differ with respect to localisation and extent of coronary atherosclerosis to a degree which may influence the treatment strategy. METHODS: Ninety-two consecutive out-patients (age 39-83, male sex 74%) with coronary artery disease confirmed by angiography were included. In this group, 23 patients underwent coronary artery bypass grafting (CABG) and 69 percutaneous coronary interventions (PCI) of whom in 16 repeated treatment was performed. The polymorphisms of the IL-1b gene - transition C/T at -511 and -31 position - as well as of the IL-1 receptor antagonist gene (IL-1RN) - an 86-base pair variable-number tandem repeat in intron 2 - were determined by PCR. Out of the 54 theoretically possible combinations of polymorphisms, 17 were found in the studied group. The three most common combinations of polymorphisms were selected. The fraction of patients treated by means of primary or elective percutaneous coronary intervention (pPCI, ePCI) and by means of CABG were compared between the subgroups with one of the 3 most common combinations of polymorphisms. RESULTS: The most frequent combinations of polymorphisms were - Variant A: -31 C/T, -511C/T, RN 1/1 - 32.6%; Variant B: -31T/T, -511C/C, RN 1/1 - 27.1%; Variant C: -31C/T, -11C/T, RN 1/2 - 10.8%. The remaining patients (29.5%) represented 14 variants present in very small subgroups consisting only of 1, 2 or 3 persons. Statistical analysis showed that patients with the second most common variant of studied polymorphisms (variant B) were significantly more frequently treated with CABG in comparison to the two other variants. Also, repeated PCI was most frequent in this subgroup. CONCLUSION: The data presented here suggest that carriers of the two relatively frequent variants of the IL-1b gene at -31 and -511 position, i.e. -31TT and -511CC, are at a higher risk of developing coronary artery disease requiring surgical treatment or two-stage percutaneous angioplasty.


Asunto(s)
Enfermedad de la Arteria Coronaria/genética , Enfermedad de la Arteria Coronaria/terapia , Proteína Antagonista del Receptor de Interleucina 1/genética , Interleucina-1beta/genética , Polimorfismo Genético , Adulto , Anciano , Anciano de 80 o más Años , Angioplastia Coronaria con Balón , Angiografía Coronaria , Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
19.
Kardiol Pol ; 67(7): 713-21, 2009 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-19649993

RESUMEN

BACKGROUND: The results of stem cell therapy after myocardial infarction (MI) have been conflicting. The effects of this therapy on ventricular arrhythmias and autonomic control of heart rate have not yet been established. AIM: To assess the effects of bone marrow cell (BMC) transplantation on the occurrence of arrhythmias and heart rate variability (HRV) parameters in short-term observation after ST-elevation myocardial infarction (STEMI). METHODS: Sixty patients with STEMI who underwent primary PCI, were randomly assigned to two groups: Group 1 - 36 patients selected for active treatment (autologous BMC, intracoronary injection mean 7 days after STEMI), and Group 2 - 24 control patients not treated with BMC transplantation. In all patients the infarct-related artery was the left anterior descending, and the left ventricular ejection fraction was < 40%. Two Holter sessions were performed: at baseline (HM1), on average 6 days after MI, and another one (HM2), 1 month after BMC implantation. From these recordings the frequency of non-sustained ventricular tachycardia (nsVT) episodes and the parameters of HRV were calculated. RESULTS: Both groups were comparable with regard to demographic data, the presence of risk factors and electrocardiographic parameters. In HM2 examination the frequency of nsVT tended to be higher in Group 1 (25 vs. 12.5%, NS). The HRV analysis showed lower HF and significant SDNN increase in the BMC group. In controls all the HRV parameters increased. The increase in HF was significantly lower in the BMC group than in controls (22.4 vs. 89.2 ms(2), p $lt 0.011). CONCLUSIONS: 1. During the first month after the intracoronary injection of BMC, non-significant increase of nsVT was observed. 2. The lack of significant increase in HF power after BMC infusion may be a sign of depressed parasympathetic tone.


Asunto(s)
Arritmias Cardíacas/etiología , Trasplante de Médula Ósea/efectos adversos , Frecuencia Cardíaca , Infarto del Miocardio/terapia , Función Ventricular Izquierda , Anciano , Trasplante de Médula Ósea/métodos , Electrocardiografía , Femenino , Humanos , Inyecciones Intraarteriales , Masculino , Persona de Mediana Edad , Polonia , Trasplante Autólogo , Resultado del Tratamiento
20.
Clin Exp Hepatol ; 5(2): 118-122, 2019 May.
Artículo en Inglés | MEDLINE | ID: mdl-31501787

RESUMEN

AIM OF THE STUDY: Ongoing national screening programmes suggest that the prevalence of chronic hepatitis C (CHC) in Poland ranges between 0.5% and 1%. It has been recently noted that patients with confirmed coronary artery disease may be at higher risk for hepatitis C virus (HCV) infection. MATERIAL AND METHODS: Testing for the presence of anti-HCV antibodies was performed in a group of patients admitted to the Cardiology Department with symptomatic ischemic heart disease (IHD) and in patients hospitalised in the Dermatology Department. RESULTS: A total of 1171 patients underwent anti-HCV testing: 672 patients in the Cardiology Department (K group) and 499 patients in the Dermatology Department (D group). Twenty-eight (2.4%) positive anti-HCV results were detected. The prevalence of positive anti-HCV antibodies in groups K and D was 2.23% and 2.61%, respectively (p > 0.05). Presence of HCV RNA was confirmed in 15 cases (1.28%) - 7 patients in group K and 8 patients in group D (1.04% and 1.6%, respectively; p > 0.05). CONCLUSIONS: Our findings suggest that this patient cohort has increased risk of HCV infection, which may influence screening strategies.

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