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1.
Can J Cardiol ; 2022 Apr 27.
Artigo em Inglês | MEDLINE | ID: mdl-35489669

RESUMO

Master endurance athletes are individuals > 35 years of age who either train for or participate in competitions. Considering the potential burden of coronary artery disease in this population, clinicians should be aware of the inherent dangers of exercise. A tailored approach with shared decision-making, balancing risks and benefits of exercise, is recommended to ensure safe exercise in these individuals.

2.
CJC Open ; 2022 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-35252829

RESUMO

BACKGROUND: Effective treatments for COVID-19 are urgently needed but conducting randomized trials during the pandemic has been challenging. METHODS: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3,500 outpatients and 2,500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine versus usual care, and aspirin versus usual care. The primary outcome for the colchicine randomization is hospitalization or death, and for the aspirin randomization is major thrombosis, hospitalization, or death. The inpatient trial is evaluating colchicine versus usual care, and the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily versus usual care. The primary outcome for the colchicine randomization is need for high flow oxygen, mechanical ventilation, or death, and for the rivaroxaban plus aspirin randomization is major thrombotic events, need for high flow oxygen, mechanical ventilation, or death. RESULTS: At the completion of enrolment on February 10, 2022, the outpatient trial had enrolled 3,917 patients and the inpatient trial 2,754 patients. Challenges encountered included lack of preliminary data about the interventions under evaluation, uncertainties related to the expected event rates, delays in regulatory and ethics approvals and in obtaining study interventions, as well as the changing pattern of the COVID-19 pandemic. CONCLUSIONS: The ACT trials will determine the efficacy of anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin given alone or in combination with rivaroxaban across the spectrum of mild, moderate, and severe COVID-19. Lessons learned from the conduct of these trials will inform planning of future trials.

3.
Catheter Cardiovasc Interv ; 99(4): 1065-1073, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35077606

RESUMO

BACKGROUND: Chronic total occlusions (CTO) are common and are associated with lower percutaneous coronary intervention (PCI) success rates, often due to failure of antegrade guidewire crossing. Local, intralesional delivery of collagenase (MZ-004) may facilitate guidewire crossing in CTO. AIMS: To evaluate the effect of MZ-004 in facilitating antegrade wire crossing in CTO angioplasty. METHODS: A total of 76 patients undergoing CTO PCI were enrolled at 13 international sites: 38 in the randomized training stage (collagenase [MZ-004] 900 or 1200 µg) and 38 in the placebo-controlled stage (MZ-004 900 or 1200 µg or placebo). Patients received the MZ-004 or identical volume saline (placebo group) in a double-blind design, injected via microcatheter directly into the proximal cap of the CTO. The following day patients underwent CTO PCI using antegrade wire techniques only. RESULTS: Patients were generally similar except for a trend for higher Japanese chronic total occlusion (J-CTO) score in the MZ-004 group (MZ-004 J-CTO score 1.9 vs. 1.4, p = 0.07). There was a numerical increase in the rates of guidewire crossing in the MZ-004 groups compared to placebo (74% vs. 63%, p = 0.52). Guidewire crossing with a soft-tip guidewire (≤1.5 g tip load) was significantly higher in the MZ-004 groups (0% in placebo, 17% in 900 µg, and 29% in 1200 µg MZ-004 group, p = 0.03). Rates of the major adverse cardiovascular event were similar between groups. CONCLUSION: Local delivery of MZ-004 into coronary CTOs appears safe and may facilitate CTO crossing, particularly with softer tipped guidewires. These data support the development of a pivotal trial to further evaluate this agent.


Assuntos
Oclusão Coronária , Intervenção Coronária Percutânea , Doença Crônica , Colagenases , Angiografia Coronária/métodos , Oclusão Coronária/cirurgia , Oclusão Coronária/terapia , Vasos Coronários , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Resultado do Tratamento
4.
Catheter Cardiovasc Interv ; 99(3): 627-638, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-33660326

RESUMO

BACKGROUND: More than half of patients undergoing percutaneous coronary intervention (PCI) have multivessel disease (MVD). The prognostic significance of PCI in stable patients has recently been debated, but little data exists about the potential benefit of complete revascularization (CR) in stable MVD. We investigated the prognostic benefit of CR in patients undergoing PCI for stable disease. METHODS: We compared CR versus incomplete revascularization (IR) in 8,436 patients with MVD. The primary outcome was all-cause mortality at 5 years. RESULTS: A total of 1,399 patients (17%) underwent CR during the index PCI procedure for stable disease. CR was associated with lower mortality (6.2 vs. 10.7%, p < .001) and lower repeat revascularization at 5 years (12.7 vs. 18.4%, p < .001). Multivariable-adjusted analyses indicated that CR was associated with lower mortality (HR = 0.73, 95% CI: 0.58-0.91, p = .005) and repeat revascularization at 5 years (HR = 0.78, 95% CI: 0.66-0.93, p = .005). These findings were also confirmed in propensity-matched cohorts. Subgroup analyses indicated that CR conferred survival in older patients, male patients, absence of renal disease, greater angina (CCS Class III-IV) and heart failure (NYHA Class III-IV) symptoms, and greater burden of coronary disease. In sensitivity analyses where patients with subsequent repeat revascularization events were excluded, CR remained a strong predictor for lower mortality (HR = 0.69, 95% CI: 0.54-0.89, p = .004). CONCLUSIONS: In this study of stable patients with MVD, CR was an independent predictor of long-term survival. This benefit was specifically seen in higher risk patient groups and indicates that CR may benefit selected stable patients with MVD.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Idoso , Colúmbia Britânica , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Masculino , Sistema de Registros , Resultado do Tratamento
5.
CJC Open ; 3(10): 1221-1229, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34888505

RESUMO

BACKGROUND: We aimed to determine the association of atrial fibrillation (AF) with 1-year outcome in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). METHODS: Patients (n = 8830) enrolled in the Trial of Routine Aspiration Thrombectomy with PCI vs PCI Alone in Patients With STEMI (TOTAL) were followed for 1 year. The primary outcome was a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening class IV heart failure. The presence or absence of AF was determined from a single pre-PCI electrocardiogram. RESULTS: Patients with AF (n = 437; 4.9%) were older, and more often had a history of stroke, hypertension, or myocardial infarction. The rate of the primary outcome was higher in the AF group than in the sinus rhythm (SR) group (17.4% vs 7.4%, P < 0.001), as was the rate of cardiovascular death (9.8% vs 3.3%, P < 0.001). In multivariable analysis, AF was independently predictive of the primary outcome (adjusted hazard ratio [aHR] 1.68; 95% confidence interval [CI], 1.30-2.16, P < 0.001), cardiovascular death (aHR 1.69; 95% CI, 1.19-2.40, P = 0.003), all-cause mortality (aHR 1.63; 95% CI, 1.18-2.24, P = 0.003), and severe heart failure (aHR 1.96; 95% CI, 1.25-3.07, P = 0.003). Among patients who were in SR, the primary outcome occurred in 307 of 4252 (7.2%) in the thrombectomy group and 310 of 4141 (7.5%) in the PCI alone group, and among those with AF, these rates were respectively 42 of 218 (19.3%) and 34 of 219 (15.5%) (P interaction = 0.26). CONCLUSIONS: In STEMI patients, AF on the pre-PCI electrocardiogram is associated with a higher risk of the primary composite cardiovascular outcome, all-cause and cardiovascular death, and severe heart failure during 1-year follow-up than it is in patients with SR.


CONTEXTE: Notre objectif était de déterminer le lien entre la fibrillation auriculaire (FA) et le résultat à un an de patients ayant subi un infarctus du myocarde avec élévation du segment ST (STEMI) puis une intervention coronarienne percutanée (ICP) primaire. MÉTHODOLOGIE: Les patients (n = 8 830) admis à l'étude TOTAL ( T rial o f Routine Aspiration T hrombectomy with PCI vs PCI Al one in Patients With STEMI) ont été suivis pendant une année. Le principal critère d'évaluation était composé des décès d'origine cardiovasculaire, de l'infarctus du myocarde récurrent, du choc cardiogénique ou de l'apparition/aggravation d'une insuffisance cardiaque de classe IV. La présence ou l'absence de FA était établie à partir d'un seul électrocardiogramme effectué avant l'ICP. RÉSULTATS: Les patients atteints de FA (n = 437; 4,9 %) étaient âgés, et la plupart avaient des antécédents d'AVC, d'hypertension ou d'infarctus du myocarde. La fréquence des manifestations liées au principal critère d'évaluation était plus élevée dans le groupe FA que dans le groupe en rythme sinusal (17,4 % vs 7,4 %, p < 0,001); il en était de même pour le taux de décès d'origine cardiovasculaire (9,8 % vs 3,3 %, p < 0,001). Dans une analyse multivariée, la FA était indépendamment prédictive des manifestations liées au principal critère d'évaluation (rapport des risques instantanés ajusté [RRIa] : 1,68; intervalle de confiance [IC] à 95 % : 1,30-2,16, p < 0,001), décès d'origine cardiovasculaire (RRIa : 1,69; IC à 95 % : 1,19-2,40, p = 0,003), mortalité toutes causes confondues (RRIa : 1,63; IC à 95 % : 1,18-2,24, p = 0,003) et insuffisance cardiaque grave (RRIa : 1,96; IC à 95 % : 1,25-3,07, p = 0,003). Parmi les patients en rythme sinusal, les manifestations du principal critère d'évaluation sont survenues chez 307 patients sur les 4 252 (7,2 %) du groupe ayant subi une thrombectomie, et chez 310 patients sur les 4 141 (7,5 %) du groupe ayant subi une ICP sans thrombectomie; parmi ceux atteints de FA, ces taux étaient respectivement de 42 sur 218 (19,3 %) et de 34 sur 219 (15,5 %) (p interaction = 0,26). CONCLUSIONS: Chez les patients ayant subi un STEMI, la détection d'une FA à l'électrocardiogramme réalisé avant l'ICP est associée à un risque accru de manifestation cardiovasculaire liée au principal critère d'évaluation composé, de décès toutes causes confondues et d'origine cardiovasculaire, et d'insuffisance cardiaque grave, pendant la première année de suivi comparativement aux patients en rythme sinusal.

6.
JAMA Netw Open ; 4(12): e2141328, 2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34964849

RESUMO

Importance: Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality. Objective: To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia. Design, Setting, and Participants: The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription-polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021. Interventions: Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first. Main Outcomes and Measures: The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days. Results: A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%). Conclusions and Relevance: This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia. Trial Registration: ClinicalTrials.gov Identifier: NCT04328480.


Assuntos
Anti-Inflamatórios/uso terapêutico , COVID-19/terapia , Colchicina/uso terapêutico , Hospitalização , Intubação Intratraqueal , Respiração Artificial , Corticosteroides/uso terapêutico , Adulto , Idoso , Anti-Inflamatórios/efeitos adversos , COVID-19/mortalidade , COVID-19/patologia , Colchicina/efeitos adversos , Feminino , Humanos , Inflamação/tratamento farmacológico , Inflamação/etiologia , Masculino , Pessoa de Meia-Idade , SARS-CoV-2 , Padrão de Cuidado
7.
J Electrocardiol ; 68: 65-71, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34365136

RESUMO

BACKGROUND: The importance of the grade of ischemia (GI) ECG classification in the risk assessment of patients with STEMI has been shown previously. Grade 3 ischemia (G3I) is defined as ST-elevation with distortion of the terminal portion of the QRS complex in two or more adjacent leads, while Grade 2 ischemia (G2I) is defined as ST-elevation without QRS distortion. Our aim was to evaluate the prognostic impact of the GI classification on the outcome in patients with STEMI. METHODS: 7,211 patients from the TOTAL trial were included in our study. The primary outcome was a composite of cardiovascular death, recurrent myocardial infarction (MI), cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year. RESULTS: The primary outcome occurred in 153 of 1,563 patients (9.8%) in the G3I group vs. 364 of 5,648 patients (6.4%) in the G2I group (adjusted HR 1.27; 95% CI, 1.04 - 1.55; p=0.022). The rate of cardiovascular death (4.8% vs. 2.5%; adjusted HR 1.48; 95% CI 1.09 - 2.00; p=0.013) was also higher in patients with G3I. CONCLUSIONS: G3I in the presenting ECG was associated with an increased rate of the composite of cardiovascular death, recurrent MI, cardiogenic shock, or NYHA class IV heart failure within one year compared to patients with G2I. Patients with G3I also had a higher cardiovascular death compared to patients with G2I.


Assuntos
Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Eletrocardiografia , Humanos , Infarto do Miocárdio/diagnóstico , Prognóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Trombectomia
8.
EuroIntervention ; 17(12): e971-e980, 2021 Dec 17.
Artigo em Inglês | MEDLINE | ID: mdl-34374343

RESUMO

BACKGROUND: The radial artery is recommended by international guidelines as the default vascular access in patients with acute coronary syndromes (ACS) managed invasively. However, crossover from radial to femoral access is required in 4-10% of cases and has been associated with worse outcomes. No standardised algorithm exists to predict the risk of radial crossover. AIMS: We sought to derive and externally validate a risk score to predict radial crossover in patients with ACS managed invasively. METHODS: The derivation cohort consisted of 4,197 patients with ACS undergoing invasive management via the randomly allocated radial access from the MATRIX trial. Using logistic regression, we selected predictors of radial crossover and developed a numerical risk score. External validation was accomplished among 3,451 and 491 ACS patients managed invasively and randomised to radial access from the RIVAL and RIFLE-STEACS trials, respectively. RESULTS: The MATRIX score (age, height, smoking, renal failure, prior coronary artery bypass grafting, ST-segment elevation myocardial infarction, Killip class, radial expertise) showed a c-index for radial crossover of 0.71 (95% CI: 0.67-0.75) in the derivation cohort. Discrimination ability was modest in the RIVAL (c-index: 0.64; 95% CI: 0.59-0.67) and RIFLE-STEACS (c-index: 0.66; 95% CI: 0.57-0.75) cohorts. A cut-off of ≥41 points was selected to identify patients at high risk of radial crossover. CONCLUSIONS: The MATRIX score is a simple eight-item risk score which provides a standardised tool for the prediction of radial crossover among patients with ACS managed invasively. This tool can assist operators in anticipating and better addressing difficulties related to transradial procedures, potentially improving outcomes.


Assuntos
Síndrome Coronariana Aguda , Artéria Radial , Síndrome Coronariana Aguda/cirurgia , Humanos , Artéria Radial/cirurgia
9.
J Am Heart Assoc ; 10(16): e021198, 2021 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-34369166

RESUMO

Background Inflammation plays a pivotal role in coronary artery disease (CAD). The anti-inflammatory drug colchicine seems to reduce ischemic events in patients with CAD. So far there is equipoise about its safety and impact on mortality. Methods and Results To evaluate the utility of colchicine in patients with acute and chronic CAD, we performed a systematic review and meta-analysis. MEDLINE, EMBASE, Cochrane CENTRAL and conference abstracts were searched from January 1975 to October 2020. Randomized trials assessing colchicine compared with placebo/standard therapy in patients with CAD were included. Data were combined using random-effects models. The reliability of the available data was tested using trial sequential analyses . Of 3108 citations, 13 randomized trials (n=13 125) were included. Colchicine versus placebo/standard therapy in patients with CAD reduced risk of myocardial infarction (odds ratio [OR] 0.64; 95% CI, 0.46-0.90; P=0.01; I2 41%) and stroke/transient ischemic attack (OR 0.50; 95% CI, 0.31-0.81; P=0.005; I2 0%). But treatment with colchicine compared with placebo/standard therapy had no influence on all-cause and cardiovascular mortality (OR 0.96; 95% CI, 0.65-1.41; P=0.83; I2 24%; and OR 0.82; 95% CI, 0.55-1.22; P=0.45; I2 0%, respectively). Colchicine increased the risk for gastrointestinal side effects (P<0.001). According to trial sequential analyses, there is only sufficient evidence for a myocardial infarction risk reduction with colchicine. Conclusions Among patients with CAD, colchicine reduces the risk of myocardial infarction and stroke, but has a higher rate of gastrointestinal upset with no influence on all-cause mortality.


Assuntos
Anti-Inflamatórios/uso terapêutico , Colchicina/uso terapêutico , Doença da Artéria Coronariana/tratamento farmacológico , Idoso , Anti-Inflamatórios/efeitos adversos , Colchicina/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Fatores de Risco , Resultado do Tratamento
11.
JAMA Netw Open ; 4(3): e213505, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33769510

RESUMO

Importance: Patients with shorter ischemic times have a greater viable myocardium and may derive greater benefit from thrombus aspiration. Objective: To study the association of thrombus aspiration with outcomes among patients presenting with ST-segment elevation myocardial infarction (STEMI) based on time. Design, Setting, and Participants: The TOTAL (Thrombectomy With PCI vs PCI Alone in Patients with STEMI) trial was an international randomized clinical trial of 10 732 patients with STEMI undergoing primary percutaneous coronary intervention (PCI) within 12 hours of symptom onset. Patients were recruited between August 5, 2010, and July 25, 2014, and were followed up for 1 year. Data analysis was performed from February 22, 2019, to January 5, 2021. Interventions: Thrombus aspiration vs PCI alone. Main Outcomes and Measures: Post hoc subgroup analyses were performed for total ischemic time and first medical contact (FMC)-to-device time for the primary outcomes (cardiovascular [CV] mortality, myocardial Infarction [MI], cardiogenic shock, and New York Heart Association class IV heart failure) and angiographically determined distal embolization. In addition, a multivariable analysis was performed to assess the association of total ischemic time and FMC-to-device time with CV mortality at 1 year. Results: The study randomized 10 732 patients, and 9986 underwent primary PCI and had time data available (7737 men [77.5%]; mean [SD] age, 61.0 [12.0] years). For the randomized comparison of thrombus aspiration, there was a reduction in angiographic distal embolization with thrombus aspiration that was more pronounced in patients with short ischemic times (<2 hours: odds ratio [OR], 0.23 [95% CI, 0.09-0.62]; 2-6 hours: OR, 0.54 [95% CI, 0.39-0.73]; >6 hours: OR, 0.70 [95% CI, 0.33-1.50]; P = .12 for interaction). However, for the primary composite outcome, there was no benefit based on (1) total ischemic time (<2 hours: hazard ratio [HR], 0.77 [95% CI, 0.46-1.28]; 2-6 hours: HR, 1.03 [95% CI, 0.85-1.25]; >6 hours: HR, 0.87 [95% CI, 0.60-1.27]; P = .46 for interaction) or (2) FMC-to-device time (<60 minutes: HR, 1.14 [95% CI, 0.66-1.95]; 60-90 minutes: HR, 0.94 [95% CI, 0.67-1.32]; >90-120 minutes: HR, 1.19 [95% CI, 0.85-1.67]; >120 minutes: HR, 0.89 [95% CI, 0.70-1.14]; P = .54 for interaction). In a multivariable analysis, both total ischemic time (>2 hours: HR, 1.26 [95% CI, 1.00-1.58) and FMC-to-device time (>120 minutes: HR, 1.45 [95% CI, 1.18-1.79]) were independently associated with CV mortality. Conclusions and Relevance: This analysis suggests that thrombus aspiration does not appear to be associated with an improvement in clinical outcomes regardless of ischemic time. In the current STEMI era, both total ischemic time and FMC-to-device times continue to be important factors associated with mortality. Trial Registration: ClinicalTrials.gov Identifier: NCT01149044.


Assuntos
Eletrocardiografia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Trombectomia/métodos , Canadá/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Taxa de Sobrevida/tendências , Resultado do Tratamento
12.
Eur Heart J ; 42(28): 2765-2775, 2021 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-33769515

RESUMO

AIMS: Recent randomized trials demonstrated a benefit of low-dose colchicine added to guideline-based treatment in patients with recent myocardial infarction or chronic coronary disease. We performed a systematic review and meta-analysis to obtain best estimates of the effects of colchicine on major adverse cardiovascular events (MACE). METHODS AND RESULTS: We searched the literature for randomized clinical trials of long-term colchicine in patients with atherosclerosis published up to 1 September 2020. The primary efficacy endpoint was MACE, the composite of myocardial infarction, stroke, or cardiovascular death. We combined the results of five trials that included 11 816 patients. The primary endpoint occurred in 578 patients. Colchicine reduced the risk for the primary endpoint by 25% [relative risk (RR) 0.75, 95% confidence interval (CI) 0.61-0.92; P = 0.005], myocardial infarction by 22% (RR 0.78, 95% CI 0.64-0.94; P = 0.010), stroke by 46% (RR 0.54, 95% CI 0.34-0.86; P = 0.009), and coronary revascularization by 23% (RR 0.77, 95% CI 0.66-0.90; P < 0.001). We observed no difference in all-cause death (RR 1.08, 95% CI 0.71-1.62; P = 0.73), with a lower incidence of cardiovascular death (RR 0.82, 95% CI 0.55-1.23; P = 0.34) counterbalanced by a higher incidence of non-cardiovascular death (RR 1.38, 95% CI 0.99-1.92; P = 0.060). CONCLUSION: Our meta-analysis indicates that low-dose colchicine reduced the risk of MACE as well as that of myocardial infarction, stroke, and the need for coronary revascularization in a broad spectrum of patients with coronary disease. There was no difference in all-cause mortality and fewer cardiovascular deaths were counterbalanced by more non-cardiovascular deaths.


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Acidente Vascular Cerebral , Colchicina/efeitos adversos , Doença da Artéria Coronariana/tratamento farmacológico , Humanos , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
13.
Int J Cardiol ; 319: 40-45, 2020 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-32470531

RESUMO

BACKGROUND: Useful tools for risk assessment in patients with STEMI are needed. We evaluated the prognostic impact of the evolving myocardial infarction (EMI) and the preinfarction syndrome (PIS) ECG patterns and determined their correlation with angiographic findings and treatment strategy. METHODS: This substudy of the randomized Trial of Routine Aspiration Thrombectomy with PCI versus PCI Alone in Patients with STEMI (TOTAL) included 7860 patients with STEMI and either the EMI or the PIS ECG pattern. The primary outcome was a composite of death from cardiovascular causes, recurrent MI, cardiogenic shock, or New York Heart Association (NYHA) class IV heart failure within one year. RESULTS: The primary outcome occurred in 271 of 2618 patients (10.4%) in the EMI group vs. 322 of 5242 patients (6.1%) in the PIS group [AdjustedHR, 1.54; 95% CI, 1.30 to 1.82; p < .001]. The primary outcome occurred in the thrombectomy and PCI alone groups in 131 of 1306 (10.0%) and 140 of 1312 (10.7%) patients with EMI [HR 0.94; 95% CI, 0.74-1.19] and 162 of 2633 (6.2%) and 160 of 2609 (6.1%) patients with PIS [HR 1.00; 95% CI, 0.81-1.25], respectively (pinteraction = 0.679). CONCLUSIONS: Patients with the EMI ECG pattern proved to have an increased rate of the primary outcome within one year compared to the PIS pattern. Routine manual thrombectomy did not reduce the risk of primary outcome within the different dynamic ECG patterns. The PIS/EMI dynamic ECG classification could help to triage patients in case of simultaneous STEMI patients with immediate need for pPCI.


Assuntos
Trombose Coronária , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Eletrocardiografia , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Trombectomia , Resultado do Tratamento
14.
Catheter Cardiovasc Interv ; 96(3): 519-525, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-31613046

RESUMO

OBJECTIVES: To assess the relationship between preprocedural anticoagulation use and clinical and angiographic outcomes. BACKGROUND: For patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the optimal timing of anticoagulant administration remains uncertain. METHODS: Patients enrolled in the TOTAL trial were stratified based on whether or not they had received any parenteral anticoagulant prior to randomization and PCI. Baseline and procedural characteristics were compared. For one-year clinical outcomes, Cox proportional modeling adjusted on a propensity score was used to analyze differences between groups. Angiographic endpoints were analyzed by logistic regression models adjusted for propensity scores. RESULTS: In the trial, 10,064 patients were enrolled and underwent PCI. Preprocedural anticoagulation was used in 6,381 patients (63%).The most common anticoagulant was intravenous unfractionated heparin (5,188, 81%). Patients who received preprocedural anticoagulation had higher rates of TIMI-2-3 or TIMI-3 flow and lower grades of thrombus prior to PCI. Pretreatment with anticoagulation was associated with lower use of bailout thrombectomy, GP IIb/IIIa inhibitors, and intra-aortic balloon pump. After adjustment, preprocedural anticoagulation was associated with lower rates of CABG and minor bleeding at 1 year but there were no significant differences in death, stroke, recurrent MI, cardiogenic shock, or congestive heart failure. CONCLUSIONS: Preprocedural anticoagulation is associated with improved flow and reduced thrombus in the IRA prior to PCI, less bailout thrombectomy during PCI but no difference in death, recurrent infarction, or heart failure at 1 year.


Assuntos
Anticoagulantes/administração & dosagem , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Administração Intravenosa , Idoso , Anticoagulantes/efeitos adversos , Angiografia Coronária , Bases de Dados Factuais , Esquema de Medicação , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Ensaios Clínicos Controlados Aleatórios como Assunto , Recidiva , Medição de Risco , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Choque Cardiogênico/mortalidade , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo , Resultado do Tratamento
15.
Interv Cardiol Clin ; 9(1): 33-40, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31733739

RESUMO

Considerable evidence supports transradial angiography and intervention in patients with acute coronary syndrome, with an emphasis on decreasing major bleeding and access site vascular complications. Patients undergoing invasive treatment are at greatest risk of bleeding and have the most to gain. The radial advantage has consistently been shown to translate into reduced mortality in pooled data analyses. The benefits of transradial access have been demonstrated across the acute coronary syndrome spectrum and in both sexes. A radial-first strategy should be the default approach and continuous efforts should be made to increase operator expertise of transradial access in these patients.


Assuntos
Síndrome Coronariana Aguda/diagnóstico por imagem , Angiografia Coronária/métodos , Intervenção Coronária Percutânea/métodos , Artéria Radial , Feminino , Humanos , Masculino
16.
Am Heart J ; 218: 84-91, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31715434

RESUMO

Advanced age is directly related to worse outcomes following ST-elevation myocardial infarction (STEMI) and higher complication rates from antithrombotic therapies and primary percutaneous coronary intervention (PCI). Often excluded from clinical trials, seniors presenting with STEMI remain an understudied population despite contributing to 140,000 hospital admissions annually. The SAFE-STEMI for Seniors study is a prospective, multicenter, unblinded, randomized clinical trial designed to examine the efficacy and safety of instantaneous wave-free ratio-guided complete revascularization in multivessel disease, while also investigating other components of STEMI care for patients ≥60 years including the efficacy and safety of zotarolimus-eluting stents for primary PCI and transradial PCI with the Glidesheath Slender and TR band. The SAFE-STEMI trial represents North America's first and only prospective randomized investigational device exemption study to use a Coordinated Registry Network infrastructure with collaborative partnering across industry manufacturers, promoting both efficiency and reduced cost of evidence development for regulatory decisions related to both diagnostic and therapeutic technologies in a single study design. The study has been powered to evaluate 2 independent co-primary end points in a population of older patients with STEMI: (1) third-generation drug-eluting stents for primary PCI and (2) instantaneous wave-free ratio-guided complete revascularization versus infarct-related artery-only revascularization.


Assuntos
Stents Farmacológicos , Imunossupressores/uso terapêutico , Intervenção Coronária Percutânea/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Sirolimo/análogos & derivados , Idoso , Humanos , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Sirolimo/uso terapêutico , Resultado do Tratamento
17.
J Invasive Cardiol ; 31(11): E308-E315, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31671060

RESUMO

BACKGROUND: The presence of intermediate "non-obstructive" saphenous vein graft (SVG) lesions is a strong predictor of cardiac events. We wanted to assess the efficacy of sealing these SVG lesions with drug-eluting stent (DES) implantation for reducing major adverse cardiac event (MACE) rate. METHODS: The present analysis is based on the pooled data from the VELETI and VELETI II randomized trials. Patients with at least 1 intermediate SVG lesion (30%-60% diameter stenosis) were randomized to DES implantation (SVG-DES) or medical treatment (SVG-MT). The primary outcome was the first occurrence of MACE, defined as the composite of cardiac death, myocardial infarction, or coronary revascularization related to the target SVG. RESULTS: A total of 182 patients were included (mean age, 70 ± 9 years), with 90 and 92 patients allocated to the SVG-DES and SVG-MT groups, respectively. After a mean follow-up of 4 ± 1 years, patients in the SVG-MT group exhibited a higher rate of MACE related to the target SVG (23.9% vs 17.8% in the SVG-DES group; P=.04) and MACE related to the target SVG lesion (21.7% vs 12.2% in the SVG-DES group; P<.01). In the multivariable analysis, a higher total cholesterol value at baseline (P=.04) was the only independent predictor of SVG disease progression leading to clinical events. CONCLUSIONS: In patients with prior coronary artery bypass grafting and intermediate non-obstructive SVG lesions, plaque sealing with DES reduced the incidence of MACE related to SVG disease progression. A higher cholesterol level was the main predictor of SVG disease progression leading to clinical events in these patients.


Assuntos
Ponte de Artéria Coronária/efeitos adversos , Stents Farmacológicos , Fibrinolíticos/uso terapêutico , Oclusão de Enxerto Vascular/terapia , Intervenção Coronária Percutânea/métodos , Veia Safena/transplante , Terapia Trombolítica/métodos , Idoso , Angiografia Coronária , Feminino , Seguimentos , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/etiologia , Humanos , Masculino , Projetos Piloto , Estudos Prospectivos , Desenho de Prótese , Reoperação , Veia Safena/diagnóstico por imagem , Fatores de Tempo , Resultado do Tratamento
18.
J Am Coll Cardiol ; 74(22): 2713-2723, 2019 12 03.
Artigo em Inglês | MEDLINE | ID: mdl-31779786

RESUMO

BACKGROUND: The COMPLETE (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Early PCI for STEMI) trial demonstrated that staged nonculprit lesion percutaneous coronary intervention (PCI) reduced major cardiovascular (CV) events in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (CAD). OBJECTIVES: The purpose of this study was to determine the effect of nonculprit-lesion PCI timing on major CV outcomes and also the time course of the benefit of complete revascularization. METHODS: Following culprit-lesion PCI, 4,041 patients with STEMI and multivessel CAD were randomized to staged nonculprit-lesion PCI or culprit-lesion only PCI. Randomization was stratified according to investigator-planned timing of nonculprit-lesion PCI: during or after the index hospitalization. The first coprimary outcome was the composite of CV death or myocardial infarction (MI). In pre-specified analyses, hazard ratios (HRs) were calculated for each time stratum. Landmark analyses of the entire population were performed within 45 days and after 45 days. RESULTS: For nonculprit-lesion PCI planned during the index hospitalization (actual time: median 1 day), CV death or MI was reduced with complete revascularization compared with culprit-lesion only PCI (HR: 0.77; 95% confidence interval [CI]: 0.59 to 1.00). For nonculprit lesion PCI planned to occur after hospital discharge (actual time: median 23 days), CV death or MI was also reduced with complete revascularization (HR: 0.69; 95% CI: 0.49 to 0.97; interaction p = 0.62). Landmark analyses demonstrated an HR of 0.86 (95% CI: 0.59 to 1.24) during the first 45 days and 0.69 (95% CI: 0.54 to 0.89) from 45 days to the end of follow-up for intended nonculprit lesion PCI versus culprit lesion only PCI. CONCLUSIONS: Among STEMI patients with multivessel disease, the benefit of complete revascularization over culprit-lesion only PCI was consistent irrespective of the investigator-determined timing of nonculprit-lesion intervention. The benefit of complete revascularization on hard clinical outcomes emerged mainly over the long term.


Assuntos
Vasos Coronários/cirurgia , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Eletrocardiografia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Fatores de Tempo , Resultado do Tratamento
19.
Can J Cardiol ; 35(10): 1377-1385, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31492492

RESUMO

BACKGROUND: Robust comparisons between oral P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) in ST-elevation myocardial infarction (STEMI) patients who undergo primary percutaneous coronary intervention are lacking. We sought to evaluate outcomes on the basis of P2Y12 inhibitor therapy in patients from the Thrombectomy With PCI Versus PCI Alone in Patients With STEMI Undergoing Primary PCI (TOTAL) trial. METHODS: We grouped 9932 patients according to P2Y12 inhibitor at hospital discharge: clopidogrel (n = 6500; 65.5%), prasugrel (n = 1244; 12.5%), or ticagrelor (n = 2188; 22.0%). The primary composite end point of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or New York Heart Association class IV heart failure was examined at 1 year. Secondary efficacy and safety end points were also assessed. Cox proportional hazard ratios were determined and adjusted for confounders via propensity scoring. RESULTS: Baseline characteristics differing between the 3 groups were mainly age 75 years or older, diabetes, and previous stroke. After adjustment, ticagrelor use was associated with a lower rate of the primary composite outcome compared with clopidogrel (adjusted hazard ratio [aHR], 0.72; 95% confidence interval [CI], 0.57-0.91; P < 0.02) and prasugrel (aHR, 0.65; 95% CI, 0.48-0.89; P = 0.02). Prasugrel use was not associated with a lower rate of the primary outcome compared with clopidogrel (aHR, 1.09; 95% CI, 0.86-1.39; P > 0.99). Neither prasugrel nor ticagrelor were associated with increased risk of stroke compared with clopidogrel. Compared with clopidogrel, ticagrelor was associated with significantly lower rates of major bleeding. CONCLUSIONS: In this observational analysis of STEMI patients who underwent primary percutaneous coronary intervention, ticagrelor was associated with improved outcomes compared with clopidogrel and prasugrel. An appropriately powered randomized trial is needed to confirm these findings.


Assuntos
Clopidogrel/uso terapêutico , Intervenção Coronária Percutânea , Cloridrato de Prasugrel/uso terapêutico , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Infarto do Miocárdio com Supradesnível do Segmento ST/tratamento farmacológico , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Ticagrelor/uso terapêutico , Idoso , Terapia Combinada , Feminino , Humanos , Masculino , Estudos Prospectivos , Resultado do Tratamento
20.
J Invasive Cardiol ; 31(7): E192-E198, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31257213

RESUMO

BACKGROUND: During percutaneous cardiac procedures, the use of radial access is growing, but femoral access remains needed for large-bore, high-risk procedures. Methods are needed to make femoral access safer. In this systematic review and meta-analysis of randomized-controlled trials (RCTs), we assess whether ultrasound guidance is associated with a decreased risk of vascular complications during femoral artery catheterization. METHODS: Medline, Embase, and Cochrane Central were searched from inception to April 2018. RCTs assessing the use of ultrasound among adult patients undergoing a femoral artery catheterization were included. The primary outcome was vascular-access related complications. Secondary outcomes included major and minor vascular access bleeding, success rate, venipuncture, number of attempts, and successful placement into the common femoral artery. RESULTS: Five RCTs (n = 1553) met the inclusion criteria, with two trials using blinded outcome assessment. Ultrasound use was associated with a reduction in the rate of vascular-access related complications (1.9% vs 4.3%; odds ratio [OR], 0.44; 95% confidence interval [CI], 0.24-0.81; P<.01). This was primarily driven by a reduction in local hematomas; once hematomas were excluded, the association was no longer significant (0.6% vs 1.7%; OR, 0.39; 95% CI, 0.15-1.07; P=.07). There was no significant reduction in major bleeding (0.3% vs 1.3%; OR, 0.28; 95% CI, 0.07-0.1.16; P=.08) or minor bleeding (1.4% vs 2.8%; OR, 0.50; 95% CI, 0.24-1.05; P=.07). CONCLUSIONS: Ultrasound guidance during femoral artery catheterization is associated with a decreased risk of vascular complications, primarily driven by a reduction in local hematomas. Larger trials are needed to determine the effect of ultrasound on major bleeding and vascular complications (excluding hematomas).


Assuntos
Cateterismo Cardíaco/métodos , Cateterismo Periférico/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ultrassonografia de Intervenção/métodos , Artéria Femoral , Humanos
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