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BACKGROUND: Data regarding the mean resident time (RT) after left main (LM) bifurcation stenting are scant. In the present study we performed a patient-specific computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in LM patients treated with single-or double stenting techniques. METHODS: Patients were identified after reviewing the local Optical Coherence Tomography (OCT) scans database. Overall, 27 patients (mean age 65.5 ± 12.4, 21 males) [10 patients treated with provisional cross-over stenting, 7 with the double kissing crush (DK crush) and 10 with the nano-inverted T (NIT) technique, respectively] with isolated and significant LM bifurcation disease were analyzed. RESULTS: After LM bifurcation stenting, the NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and provisional cross-over stenting. Moreover, the mean RT resulted lower after NIT compared to provisional or DK crush. During the diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional. CONCLUSION: The present OCT-derived CFD analysis revealed that, in patients with complex bifurcation LM disease, the provisional approach resulted in lower WSS values, while double stenting techniques, especially the NIT technique, resulted in a marked reduction of average RT compared to the provisional approach. CONDENSED ABSTRACT: In the present study we performed a patient-specific Optical coherence tomography (OCT)-based computational fluid dynamic (CFD) analysis to investigate the different post-stenting mean RT values in 27 patients treated with provisional cross-over stenting, DK crush and Nano-inverted-T (NIT) stenting. The NIT showed a higher averages WSS values at all bifurcation sites compared to DK crush and Provisional. The mean RT resulted lower in NIT compared to Provisional or DK crush. During the entire diastolic phase, the average RT of the entire LM bifurcation was 0.46 s, 0.38 s and 0.33 s after using the provisional stenting, DK crush and NIT, respectively. Moreover, the average RT in the entire LM bifurcation decreased by 17.1 % using the DK crush and by 28.2 % using the NIT compared to the Provisional.
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Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Masculino , Humanos , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/métodos , Resultado do Tratamento , Fatores de Tempo , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/etiologia , Stents , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Angiografia Coronária/métodosRESUMO
AIMS: Data regarding the risk of incident pericarditis in coronavirus disease 2019 (COVID-19) recovered patients are lacking. We determined the risk of incident pericarditis after COVID-19 infection by performing a systematic review and meta-analysis of available data. METHODS: Following the PRISMA guidelines, we searched MEDLINE and Scopus to locate all articles published up to 11 February 2023 reporting the risk of incident pericarditis in patients who had recovered from COVID-19 infection compared to noninfected patients (controls) defined as those who did not experience the disease over the same follow-up period. Pericarditis risk was evaluated using the Mantel-Haenszel random effects models with hazard ratio (HR) as the effect measure with 95% confidence interval (CI) while heterogeneity was assessed using Higgins I2 statistic. RESULTS: Overall, 16 412 495 patients (mean age 55.1âyears, 76.8% males), of whom 1 225 715 had COVID-19 infection, were included. Over a mean follow-up of 9.6âmonths, pericarditis occurred in 3.40 (95% CI: 3.39-3.41) out of 1000 patients who survived COVID-19 infection compared with 0.82 (95% CI: 0.80-0.83) out of 1000 control patients. Recovered COVID-19 patients presented a higher risk of incident pericarditis (HR: 1.95, 95% CI: 1.56-2.43, I2 : 71.1%) compared with controls. Meta-regression analysis showed a significant direct relationship for the risk of incident pericarditis using HT ( P â=â0.02) and male sex ( P â=â0.02) as moderators, while an indirect association was observed when age ( P â=â0.01) and the follow-up length ( P â=â0.02) were adopted as moderating variables. CONCLUSIONS: Recovered COVID-19 patients have a higher risk of pericarditis compared with patients from the general population.
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COVID-19 , Pericardite , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , COVID-19/complicações , COVID-19/epidemiologia , Pericardite/diagnóstico , Pericardite/epidemiologia , Modelos de Riscos ProporcionaisRESUMO
AIMS: To assess the sex- and age-specific trends in acute myocardial infarction (AMI) mortality in the modern European Union (EU-27) member states between years 2012 and 2020. METHODS AND RESULTS: Data on cause-specific deaths and population numbers by sex for each country of the EU-27 were retrieved through a publicly available European Statistical Office (EUROSTAT) dataset for the years 2012 to 2020. AMI-related deaths were ascertained when codes for AMI (ICD-10 codes I21.0-I22.0) were listed as the underlying cause of death in the medical death certificate. Deaths occurring before the age of 65 years were defined as premature deaths. To calculate annual trends, we assessed the average annual percent change (AAPC) with relative 95% confidence intervals (CIs) using joinpoint regression. During the study period, 1 793 314 deaths (1 048 044 males and 745 270 females) occurred in the EU-27 due to of AMI. The proportion of AMI-related deaths per 1000 total deaths decline from 5.0% to 3.5% both in the entire population (P for trend < 0.001) and in males or females, separately. Joinpoint regression analysis revealed a continuous linear decrease in age-adjusted AMI-related mortality from 2012 to 2020 among EU-27 members [AAPC: -4.6% (95% CI: -5.1 to -4.0), P < 0.001]. The age-adjusted mortality rate showed a plateau in some Eastern European countries and was more pronounced in EU-27 females and in subjects aged ≥65 years. CONCLUSION: Over the last decade, the age-adjusted AMI-related mortality has been continuously declining in most of the in EU-27 member states. However, some disparities still exist between western and eastern European countries.
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Infarto do Miocárdio , Feminino , Humanos , Masculino , União Europeia , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidadeRESUMO
Data on mortality trends in patients with acute myocardial infarction (AMI) with cardiogenic shock (CS) are scant. This study aimed to assess the trends in CS-AMI-related mortality in United States (US) subjects over the latest 21 years. Mortality data of US subjects with AMI listed as the underlying cause of death and CS as contributing cause were obtained from the Centers for Disease Control and Prevention WONDER (Wide-Ranging Online Data for Epidemiologic Research) dataset from January 1999 to December 2019. CS-AMI-related age-adjusted mortality rates (AAMRs) per 100,000 US population were stratified by gender, race and ethnicity, geographic areas, and urbanicity. Nationwide annual trends were assessed as annual percent change (APC) and average APC with relative 95% confidence intervals (CIs). Between 1999 and 2019, CS-AMI was listed as the underlying cause of death in 209,642 patients, (AAMR of 3.01 per 100,000 people [95% CI 2.99 to 3.02]). AAMR from CS-AMI remained stable from 1999 to 2007 (APC -0.2%, [95% CI -2.0 to 0.5], p = 0.22) and then significantly increased (APC 3.1% [95% CI 2.6 to 3.6], p <0.0001), especially in male patients. Starting in 2009, the AAMR increase was more pronounced in those <65 years, Black Americans, and residents of rural areas. The higher AAMRs were clustered in the South (average APC 4.5%, [95% CI 4.4 to 4.6]) of the country. In conclusion, CS-AMI-related mortality in US patients increased from 2009 to 2019. Targeted health policy measures are needed to address the rising burden of CS-AMI in US subjects.
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Infarto do Miocárdio , Choque Cardiogênico , Humanos , Masculino , Estados Unidos/epidemiologia , Choque Cardiogênico/etiologia , Mortalidade Hospitalar , Política de SaúdeAssuntos
Doença da Artéria Coronariana , Litotripsia , Intervenção Coronária Percutânea , Calcificação Vascular , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Angiografia Coronária , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Resultado do Tratamento , Ultrassonografia de Intervenção , Intervenção Coronária Percutânea/efeitos adversosRESUMO
INTRODUCTION: Arterial Hypertension (HT) has been described as a common comorbidity and independent risk factor of short-term outcome in COVID-19 patients. However, data regarding the risk of new-onset HT during the post-acute phase of COVID-19 are scant. AIM: We assess the risk of new-onset HT in COVID-19 survivors within one year from the index infection by a systematic review and meta-analysis of the available data. METHODS: Data were obtained searching MEDLINE and Scopus for all studies published at any time up to February 11, 2023, and reporting the long-term risk of new-onset HT in COVID-19 survivors. Risk data were pooled using the Mantel-Haenszel random effects models with Hazard ratio (HR) as the effect measure with 95% confidence interval (CI). Heterogeneity among studies was assessed using I2 statistic. RESULTS: Overall, 19,293,346 patients (mean age 54.6 years, 54.6% males) were included in this analysis. Of them, 758,698 survived to COVID-19 infection. Over a mean follow-up of 6.8 months, new-onset HT occurred to 12.7 [95% CI 11.4-13.5] out of 1000 patients survived to COVID-19 infection compared to 8.17 [95% CI 7.34-8.53] out of 1000 control subjects. Pooled analysis revealed that recovered COVID-19 patients presented an increased risk of new-onset HT (HR 1.70, 95% CI 1.46-1.97, p < 0.0001, I2 = 78.9%) within seven months. This risk was directly influenced by age (p = 0.001), female sex (p = 0.03) and cancer (p < 0.0001) while an indirect association was observed using the follow-up length as moderator (p < 0.0001). CONCLUSIONS: Our findings suggest that new-onset HT represents an important post-acute COVID-19 sequelae.
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COVID-19 , Hipertensão , Neoplasias , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , COVID-19/diagnóstico , COVID-19/epidemiologia , Hipertensão/diagnóstico , Hipertensão/epidemiologia , Comorbidade , Fatores de RiscoRESUMO
INTRODUCTION: Over the last 5 years, the armamentarium of the interventional cardiologist dealing with percutaneous closure of patent foramen ovale (PFO) has been enriched by some novel devices and further improvements of existing ones that have or promise to increase the safety and effective closure rate of PFO patients. AREAS COVERED: This review presents and discusses recent advancements in device design and composition from both technical and clinical perspectives. EXPERT OPINION: Device technology is continuously evolving. The recent modification of delivery system, device hooking, and composition, as well as the advent of new bioabsorbable materials, is promising to make percutaneous PFO closure devices safer. The search for more effectiveness with possibly less metal behind is still ongoing.
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Forame Oval Patente , Dispositivo para Oclusão Septal , Acidente Vascular Cerebral , Humanos , Forame Oval Patente/cirurgia , Cateterismo Cardíaco , Catéteres , Resultado do TratamentoRESUMO
The prognostic value of exercise stress test after complex left main (LM) coronary artery bifurcation (LM) stenting has been poorly investigated. To partially fill this gap in knowledge, we retrospectively analyzed the procedural and medical data of consecutive patients referred to our center for complex LM bifurcation disease between January 2008 and May 2018 who were treated using either single- or dual-stenting techniques. The prognostic impact of an exercise stress test, performed 6 months after the coronary intervention, was evaluated in 502 patients (316 males, mean age 70.3 ± 12.8 years, mean Syntax score 31.6 ± 6.3). At follow up after a mean of 37.1 ± 10.8 months (range 22.1-47.3 months), the target lesion failure (TLF) rate was 10.1% while stent thrombosis and cardiovascular mortality were 1.2 and 3.6%, respectively. A positive exercise stress test was detected at 6-month follow up in 42 out of 502 patients (8.4%); the incidence of a significant restenosis was 7.6% (n = 38). Patients with a negative exercise stress test at 6-month follow up had higher freedom from TLF and improved survival compared to those with a positive exercise stress test.
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Among the angiographic views used to evaluate left coronary system, the so-called "spider view" represents one of the most iconic, in particular for its ability to evaluate the Left Main stem (LM) and/or to guide percutaneous coronary interventions (PCIs) on LM bifurcation disease. Unfortunately, the use of such view is graved by a high X-ray exposure for both the operator and the patient. To overcome these limitations, we described an alternative coronary angiographic view, called "reverse spider" which is able to give more information about LM body and bifurcation disease with less X-ray exposure for the operator.
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Coronary bifurcation percutaneous interventions (PCI) comprise a challenging subset of patients with coronary artery disease. Beyond the well-known debate about single versus double stent strategies, which have different outcomes on mid- and long-term follow up, both strategies may be subject, although rarely, to several different technical complications, rarely reported in clinical trials, which need to be defined, classified, and understood by cardiovascular professionals involved in the management of patients with coronary bifurcation disease. The present paper aims to broaden the knowledge of the range of intraprocedural complications and relative treatment during PCI of coronary bifurcations.
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BACKGROUND: Cardiac implantable electronic device (CIED) implantation rates as well as the clinical and procedural characteristics and outcomes in patients with known active coronavirus disease 2019 (COVID-19) are unknown. OBJECTIVE: The purpose of this study was to gather information regarding CIED procedures during active COVID-19, performed with personal protective equipment, based on an international survey. METHODS: Fifty-three centers from 13 countries across 4 continents provided information on 166 patients with known active COVID-19 who underwent a CIED procedure. RESULTS: The CIED procedure rate in 133,655 hospitalized COVID-19 patients ranged from 0 to 16.2 per 1000 patients (P <.001). Most devices were implanted due to high-degree/complete atrioventricular block (112 [67.5%]) or sick sinus syndrome (31 [18.7%]). Of the 166 patients in the study survey, the 30-day complication rate was 13.9% and the 180-day mortality rate was 9.6%. One patient had a fatal outcome as a direct result of the procedure. Differences in patient and procedural characteristics and outcomes were found between Europe and North America. An older population (76.6 vs 66 years; P <.001) with a nonsignificant higher complication rate (16.5% vs 7.7%; P = .2) was observed in Europe vs North America, whereas higher rates of critically ill patients (33.3% vs 3.3%; P <.001) and mortality (26.9% vs 5%; P = .002) were observed in North America vs Europe. CONCLUSION: CIED procedure rates during known active COVID-19 disease varied greatly, from 0 to 16.2 per 1000 hospitalized COVID-19 patients worldwide. Patients with active COVID-19 infection who underwent CIED implantation had high complication and mortality rates. Operators should take these risks into consideration before proceeding with CIED implantation in active COVID-19 patients.
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Bloqueio Atrioventricular , COVID-19 , Controle de Infecções , Complicações Pós-Operatórias , Implantação de Prótese , SARS-CoV-2/isolamento & purificação , Síndrome do Nó Sinusal , Idoso , Bloqueio Atrioventricular/epidemiologia , Bloqueio Atrioventricular/terapia , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/terapia , Comorbidade , Desfibriladores Implantáveis/estatística & dados numéricos , Feminino , Saúde Global/estatística & dados numéricos , Humanos , Controle de Infecções/instrumentação , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Masculino , Pessoa de Meia-Idade , Mortalidade , Avaliação de Resultados em Cuidados de Saúde , Marca-Passo Artificial/estatística & dados numéricos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/mortalidade , Implantação de Prótese/efeitos adversos , Implantação de Prótese/instrumentação , Implantação de Prótese/mortalidade , Fatores de Risco , Síndrome do Nó Sinusal/epidemiologia , Síndrome do Nó Sinusal/terapia , Inquéritos e QuestionáriosRESUMO
AIMS: Drug-eluting stent (DES) implantation is an effective treatment of in-stent restenosis (ISR). However, literature data indicate that drug-coated balloons (DCBs) may be a valid alternative, particularly for recurrent ISR. We sought to evaluate clinical results on the long-term efficacy of a new DCB for ISR treatment. METHODS: One hundred and ninety-nine patients were treated with paclitaxel drug-coated balloons (Pantera Lux, Biotronik, Switzerland) in the Italian REGistry of Paclitaxel Eluting Balloon in ISR (REGPEB study). Clinical follow-up was scheduled at 1 and 12 months. A subgroup of patients received adjunctive 5-year follow-up. Primary end point was Major Adverse Cardiac Events (MACE) at 1 year. RESULTS: A total of 214 ISR coronary lesions were treated (75.4% DES-ISR). Mean time between stent implantation and DCB treatment is 41 months. DCBs were successfully delivered in 99% of the cases; crossover to a DES occurred in 3% of cases. Procedural success rate was 98.5%. Clinical success rate was 98.5%. First-month follow-up compliance was 98% and freedom from MACE was 96.9%. Twelve-month follow-up compliance was 89.3% with a freedom from MACE rate of 87.3% (CI: 81.3-91.5%). Five-year long-term follow-up showed 65.2% of freedom from MACE. CONCLUSION: Our study confirms that Pantera Lux treatment is effective and well tolerated in ISR, showing good acute and long/very long-term results in the treatment of complex lesions (DES and late ISR).
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Angioplastia Coronária com Balão , Reestenose Coronária , Stents Farmacológicos , Paclitaxel/farmacologia , Intervenção Coronária Percutânea/efeitos adversos , Reoperação , Assistência ao Convalescente/métodos , Assistência ao Convalescente/estatística & dados numéricos , Angioplastia Coronária com Balão/efeitos adversos , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/métodos , Antineoplásicos Fitogênicos/farmacologia , Angiografia Coronária/métodos , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/diagnóstico , Reestenose Coronária/epidemiologia , Reestenose Coronária/cirurgia , Feminino , Humanos , Itália/epidemiologia , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/estatística & dados numéricos , Sistema de Registros , Reoperação/instrumentação , Reoperação/métodos , TempoRESUMO
COVID-19 patients may have cardiovascular complications requiring invasive treatment. Pacemaker implantation procedure may be challenging because of the necessity of personal protective equipment use. We report pacemaker implantation in a 78-year-old man with severe bilateral COVID-19 interstitial pneumonia, a second degree 2:1 atrioventricular block, and concomitant aortic stenosis.
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OBJECTIVE: To estimate the prevalence of unknown atrial fibrillation (AF) in the elderly population of the Veneto Region, Italy. METHODS: 1820 patients aged ≥ 65 years with no history of AF and not anticoagulated were enrolled in primary-care settings. They underwent an opportunistic electrocardiogram screening with a handheld device (MyDiagnostick) designed to specifically detect AF. The electrocardiogram recordings were reviewed by the researchers, who confirmed the presence of AF. RESULTS: The device detected an arrhythmia in 143 patients, which was confirmed as AF in 101/143 (70.6%), with an overall prevalence of AF of 5.5% (101/1820). Prevalence of unknown AF resulted in 3.6% in patients aged 65-74 years, and 7.5% in patients age 75 or older, and increased according to CHA2DS2-VASc score: 3.5% in patients with a score of 1 or 2, 5.6% in patients with a score of 3, 7.0% in patients with a score of 4, and 7.2% in patients with a score ≥ 5. The detection rate was significantly higher in patients with mild symptoms compared to asymptomatic counterparts (24.1% vs. 4.0%, P < 0.0001). At multivariate analysis, congestive heart failure and age ≥ 75 years-old were independent predictors for screen-detected AF. CONCLUSIONS: An opportunistic screening with handheld device revealed an unexpectedly high prevalence of unknown AF in elderly patients with mild symptoms. Prevalence increased with age and CHA2DS2-VASc score.
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A 52-year-old male with no history of familiar sudden death arrived at our Emergency Department after syncope with loss of consciousness occurred during high fever. The thoracic high-resolution computed tomography demonstrated bilateral multiple ground-glass opacities. The nose-pharyngeal swab resulted positive for SARS-CoV-2. The 12-lead ECG presented a "coved-type" aspect in leads V1 and V2 at the fourth intercostal space and a first degree atrio-ventricular block. As soon as the temperature went down, the 12-lead ECG resumed a normal aspect, maintaining a long PR interval.
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BACKGROUND: Coronavirus Disease 2019 (COVID-19) is responsible for a worldwide pandemic, with a high rate of morbidity and mortality. The increasing evidence of an associated relevant prothrombotic coagulopathy has resulted in an increasing use of antithrombotic doses higher than usual in COVID-19 patients. Information on the benefit/risk ratio of this approach is still lacking. OBJECTIVE: To assess the incidence of relevant bleeding complications in association with the antithrombotic strategy and its relationship with the amount of drug. METHODS: Consecutive COVID-19 patients admitted between February and April 2020 were included in a retrospective analysis. Major bleedings (MB) and clinically relevant non-major bleeding (CRNMB) were obtained from patient medical records and were adjudicated by an independent committee. RESULTS: Of the 324 patients who were recruited, 240 had been treated with prophylactic doses and 84 with higher doses of anticoagulants. The rate of the composite endpoint of MB or CRNMB was 6.9 per 100-person/months in patients who had been given prophylactic doses, and 26.4 per 100-person/months in those who had been prescribed higher doses (hazard ratio, 3.89; 95% confidence interval, 1.90-7.97). The corresponding rates for overall mortality were 12.2 and 20.1 per 100-person/months, respectively. CONCLUSIONS: The rate of relevant bleeding events was high in patients treated with (sub)therapeutic doses of anticoagulants. In the latter group, overall mortality did not differ from that of patients treated with standard prophylactic doses and was even higher. Our result does not support a strategy of giving (sub)therapeutic doses of anticoagulants in non-critically ill patients with COVID-19.
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Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Tratamento Farmacológico da COVID-19 , Hemorragia/induzido quimicamente , Trombose/prevenção & controle , Tromboembolia Venosa/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/administração & dosagem , COVID-19/sangue , COVID-19/epidemiologia , Tomada de Decisão Clínica , Feminino , Hemorragia/epidemiologia , Humanos , Incidência , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Trombose/sangue , Trombose/epidemiologia , Resultado do Tratamento , Tromboembolia Venosa/sangue , Tromboembolia Venosa/epidemiologiaAssuntos
Betacoronavirus , Unidades de Cuidados Coronarianos/estatística & dados numéricos , Infecções por Coronavirus/epidemiologia , Hospitalização/estatística & dados numéricos , Infarto do Miocárdio sem Supradesnível do Segmento ST/epidemiologia , Pneumonia Viral/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Síndrome Coronariana Aguda/epidemiologia , Poluentes Atmosféricos/análise , Teorema de Bayes , COVID-19 , Humanos , Itália/epidemiologia , Cadeias de Markov , Dióxido de Nitrogênio/análise , Pandemias , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , SARS-CoV-2Assuntos
Assistência Ambulatorial/métodos , Betacoronavirus , Bradicardia/terapia , Infecções por Coronavirus/complicações , Marca-Passo Artificial/estatística & dados numéricos , Pneumonia Viral/complicações , Idoso , Idoso de 80 Anos ou mais , Bradicardia/epidemiologia , Bradicardia/etiologia , COVID-19 , Infecções por Coronavirus/epidemiologia , Feminino , Humanos , Incidência , Itália/epidemiologia , Masculino , Pandemias , Pneumonia Viral/epidemiologia , SARS-CoV-2RESUMO
AIMS: Our aim was to assess whether bivalirudin compared with unfractionated heparin (UFH) is associated with consistent outcomes in males and females with acute coronary syndrome (ACS) undergoing invasive management. METHODS AND RESULTS: In the MATRIX programme, 7,213 patients were randomised to bivalirudin or UFH. Patients in the bivalirudin group were subsequently randomly assigned to receive or not a post-PCI bivalirudin infusion. The 30-day co-primary outcomes were major adverse cardiovascular events (MACE), defined as death, myocardial infarction, or stroke, and net adverse clinical events (NACE), defined as MACE or major bleeding. The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target vessel revascularisation (TVR), definite stent thrombosis (ST), or NACE. The rate of MACE was not significantly lower with bivalirudin than with heparin in male (rate ratio [RR] 0.90, 95% confidence interval [CI]: 0.75-1.07; p=0.22) and female patients (RR 1.06, 95% CI: 0.80-1.40; p=0.67) without significant interaction (pint=0.31), nor was the rate of NACE (males: RR 0.85, 95% CI: 0.72-1.01; p=0.07; females: RR 0.98, 95% CI: 0.76-1.28; p=0.91; pint=0.38). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent TVR, definite ST, or NACE (males: RR 0.84, 95% CI: 0.66-1.07; p=0.15; females: RR 1.06, 95% CI: 0.74-1.53; p=0.74; pint=0.28). CONCLUSIONS: In ACS patients, the rates of MACE and NACE were not significantly lower with bivalirudin than with UFH in both sexes. The rate of the composite of urgent TVR, definite ST, or NACE was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion in both sexes.
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Síndrome Coronariana Aguda , Heparina/uso terapêutico , Fragmentos de Peptídeos/uso terapêutico , Intervenção Coronária Percutânea , Síndrome Coronariana Aguda/terapia , Anticoagulantes , Antitrombinas , Feminino , Hirudinas , Humanos , Masculino , Proteínas Recombinantes/uso terapêutico , Resultado do TratamentoRESUMO
OBJECTIVES: To report 1-year clinical outcomes of bioresorbable vascular scaffold (BVS) in acute coronary syndromes (ACS) population. BACKGROUND: BVS use has rapidly extended to high-risk patients as those presenting with ACS. To date limited data have been reported on BVS performance in ACS patients. METHODS: RAI is a multicenter, prospective registry that included 1,505 patients treated with at least 1 successful BVS implantation. A subgroup analysis on ACS patients was performed and the 1-year outcomes of this cohort compared to the remaining stable coronary artery disease (SCAD) population are reported here. Coprimary endpoints were target-lesion revascularization (TLR) and scaffold thrombosis (ScT) at 1-year follow-up. RESULTS: Fifty-nine percent of the patients presented with ACS, of whom 36.5% with ST-elevation myocardial infarctions. ACS patients were significantly younger, with a better cardiovascular risk profile, a lower rate of multivessel disease, chronic total occlusion or in-stent restenosis and a lower Syntax score. Predilation and postdilation were performed in 97.4% and in 96.5% of cases, respectively. No differences were noted in terms of TIMI 3 final flow, but acute gain was greater in ACS compared to SCAD group (P < 0.001). At one-year follow-up no differences were found in terms of TLR (3.3% vs. 3.3%, P = 0.98), and device-oriented composite end-point (4.3% vs. 3.4%, P = 0.4) between ACS and SCAD groups. The rate of definite/probable ScT was numerically higher in ACS vs. stable CAD patients (1.3% vs. 0.8%, P = 0.2). CONCLUSIONS: Our data suggest that the use of BVS in ACS patients is associated with a numerically higher rate of ScT compared to SCAD population numerically higher, but without statistical significance.