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1.
Angiology ; 74(10): 987-996, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36222189

RESUMO

SARS-Cov-2 has been suggested to promote thrombotic complications and higher mortality. The aim of the present study was to evaluate the impact of SARS-CoV-2 positivity on in-hospital outcome and 30-day mortality in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) enrolled in the International Survey on Acute Coronary Syndromes ST-segment elevation Myocardial Infarction (ISACS-STEMI COVID-19 registry. The 109 SARS-CoV-2 positive patients were compared with 2005 SARS-CoV-2 negative patients. Positive patients were older (P = .002), less often active smokers (P = .002), and hypercholesterolemic (P = .006), they presented more often later than 12 h (P = .037), more often to the hub and were more often in cardiogenic shock (P = .02), or requiring rescue percutaneous coronary intervention after failed thrombolysis (P < .0001). Lower postprocedural Thrombolysis in Myocardial Infarction 3 flow (P = .029) and more thrombectomy (P = .046) were observed. SARS-CoV-2 was associated with a significantly higher in-hospital mortality (25.7 vs 7%, adjusted Odds Ratio (OR) [95% Confidence Interval] = 3.2 [1.71-5.99], P < .001) in-hospital definite in-stent thrombosis (6.4 vs 1.1%, adjusted Odds Ratio [95% CI] = 6.26 [2.41-16.25], P < .001) and 30-day mortality (34.4 vs 8.5%, adjusted Hazard Ratio [95% CI] = 2.16 [1.45-3.23], P < .001), confirming that SARS-CoV-2 positivity is associated with impaired reperfusion, with negative prognostic consequences.

2.
Respir Res ; 23(1): 207, 2022 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-35971173

RESUMO

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is projected to become the third cause of mortality worldwide. COPD shares several pathophysiological mechanisms with cardiovascular disease, especially atherosclerosis. However, no definite answers are available on the prognostic role of COPD in the setting of ST elevation myocardial infarction (STEMI), especially during COVID-19 pandemic, among patients undergoing primary angioplasty, that is therefore the aim of the current study. METHODS: In the ISACS-STEMI COVID-19 registry we included retrospectively patients with STEMI treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 from 109 high-volume primary PCI centers in 4 continents. RESULTS: A total of 15,686 patients were included in this analysis. Of them, 810 (5.2%) subjects had a COPD diagnosis. They were more often elderly and with a more pronounced cardiovascular risk profile. No preminent procedural dissimilarities were noticed except for a lower proportion of dual antiplatelet therapy at discharge among COPD patients (98.9% vs. 98.1%, P = 0.038). With regards to short-term fatal outcomes, both in-hospital and 30-days mortality occurred more frequently among COPD patients, similarly in pre-COVID-19 and COVID-19 era. However, after adjustment for main baseline differences, COPD did not result as independent predictor for in-hospital death (adjusted OR [95% CI] = 0.913[0.658-1.266], P = 0.585) nor for 30-days mortality (adjusted OR [95% CI] = 0.850 [0.620-1.164], P = 0.310). No significant differences were detected in terms of SARS-CoV-2 positivity between the two groups. CONCLUSION: This is one of the largest studies investigating characteristics and outcome of COPD patients with STEMI undergoing primary angioplasty, especially during COVID pandemic. COPD was associated with significantly higher rates of in-hospital and 30-days mortality. However, this association disappeared after adjustment for baseline characteristics. Furthermore, COPD did not significantly affect SARS-CoV-2 positivity. TRIAL REGISTRATION NUMBER: NCT04412655 (2nd June 2020).


Assuntos
COVID-19 , Intervenção Coronária Percutânea , Doença Pulmonar Obstrutiva Crônica , Infarto do Miocárdio com Supradesnível do Segmento ST , Idoso , COVID-19/epidemiologia , Mortalidade Hospitalar , Humanos , Pandemias , Intervenção Coronária Percutânea/efeitos adversos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Doença Pulmonar Obstrutiva Crônica/terapia , Sistema de Registros , Estudos Retrospectivos , SARS-CoV-2 , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Resultado do Tratamento
3.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-35437213

RESUMO

INTRODUCTION AND OBJECTIVES: The DECADE cooperation is a pooled analysis of individual patient data from drug-eluting stent (DES) trials with a 10-year follow-up. This analysis reports the risk of definite stent thrombosis (ST) through to 10 years after percutaneous coronary intervention (PCI) in patients treated with early- and new-generation DES. METHODS: Individual patient data from 5 DES trials with a 10-year follow-up were pooled. The primary endpoint was definite ST up to 10 years after PCI. Patients were divided into 2 groups as per the generation of DES implanted (early and new DES). Individual participant data were analyzed using a 1-stage approach. RESULTS: We included 9700 patients, 6866 in the new DES group and 2834 in the early DES group. Through to 10 years, definite ST occurred in 69 of 6866 patients treated with new DES and in 91 of 2834 patients treated with early DES (1.0% vs 3.5%, adjusted hazard ratio, 0.32; 95%CI, 0.23-0.45). The rate of definite ST was lower in the new DES group than in the early DES group from 1 to 5 years (rate ratio, 0.14; 95%CI, 0.08-0.26) and from 5 to 10 years (rate ratio, 0.23; 95%CI, 0.08-0.61) after PCI. CONCLUSIONS: The incidence of definite ST through to 10 years after PCI with new-generation DES was 1%. New-generation DES are associated with a lower 10-year incidence of definite ST than early-generation DES, particularly beyond 1 year after PCI.

4.
Catheter Cardiovasc Interv ; 99(3): 730-735, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34233071

RESUMO

OBJECTIVE: To investigate the impact of invasive functional guidance for coronary artery bypass graft surgery (CABG) on graft failure. BACKGROUND: Data on the impact of fractional flow reserve (FFR) in guiding CABG are still limited. METHODS: Systematic review and individual patient data meta-analysis were performed. Primary objective was the risk of graft failure, stratified by FFR. Risk estimates are reported as odds ratios (ORs) derived from the aggregated data using random-effects models. Individual patient data were analyzed using mixed effect model to assess relationship between FFR and graft failure. This meta-analysis is registered in PROSPERO (CRD42020180444). RESULTS: Four prospective studies comprising 503 patients referred for CABG, with 1471 coronaries, assessed by FFR were included. Graft status was available for 1039 conduits at median of 12.0 [IQR 6.6; 12.0] months. Risk of graft failure was higher in vessels with preserved FFR (OR 5.74, 95% CI 1.71-19.29). Every 0.10 FFR units decrease in the coronaries was associated with 56% risk reduction of graft failure (OR 0.44, 95% CI 0.34 to 0.59). FFR cut-off to predict graft failure was 0.79. CONCLUSION: Surgical grafting of coronaries with functionally nonsignificant stenoses was associated with higher risk of graft failure.


Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Angiografia Coronária , Doença da Artéria Coronariana/cirurgia , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/cirurgia , Humanos , Estudos Prospectivos , Resultado do Tratamento
5.
Biomarkers ; 26(7): 632-638, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34259098

RESUMO

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMICS) with or without out-of-hospital cardiac arrest (OHCA) have some pathophysiological differences and could potentially be considered as two individual clinical entities. Thus, there may also be differences in terms of blood borne biomarkers. PURPOSE: To explore potential differences in concentrations of the biomarkers lactate, mid-regional proadrenomedullin (MRproADM), Copeptin, pro-atrial natriuretic peptide (proANP), Syndecan-1, soluble thrombomodulin (sTM), soluble suppression of tumorigenicity 2 (sST2) and neutrophil gelatinase-associated lipocalin (NGAL), in patients with AMICS with or without OHCA. METHOD: Patients admitted for acute coronary angiography due to suspected ST-elevation myocardial infarction were enrolled during a 1-year period. In the present study 86 patients with confirmed AMICS at admission were included. RESULTS: In the adjusted analysis OHCA patients had higher levels of lactate (p = 0.008), NGAL (p = 0.03) and sTM (p = 0.011) while the level of sST2 was lower (p = 0.029). There was little difference in 30-day mortality between the OHCA and non-OHCA groups (OHCA 37% vs. non-OHCA 38%). CONCLUSION: AMICS patients with or without OHCA had similar 30-day mortality but differed in terms of Lactate, NGAL, sTM and sST2 levels. These findings support that non-OHCA and OHCA patients with CS could be considered as two individual clinical entities.


Assuntos
Infarto do Miocárdio/complicações , Parada Cardíaca Extra-Hospitalar/complicações , Admissão do Paciente , Choque Cardiogênico/complicações , Idoso , Biomarcadores/sangue , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Parada Cardíaca Extra-Hospitalar/sangue , Choque Cardiogênico/sangue
6.
Biomed Pharmacother ; 138: 111469, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33740523

RESUMO

BACKGROUND: Concerns have been raised on a potential interaction between renin-angiotensin system inhibitors (RASI) and the susceptibility to coronavirus disease 2019 (COVID-19). No data have been so far reported on the prognostic impact of RASI in patients suffering from ST-elevation myocardial infarction (STEMI) during COVID-19 pandemic, which was the aim of the present study. METHODS: STEMI patients treated with primary percutaneous coronary intervention (PPCI) and enrolled in the ISACS-STEMI COVID-19 registry were included in the present sub-analysis and divided according to RASI therapy at admission. RESULTS: Our population is represented by 6095 patients, of whom 3654 admitted in 2019 and 2441 in 2020. No difference in the prevalence of SARSCoV2 infection was observed according to RASI therapy at admission (2.5% vs 2.1%, p = 0.5), which was associated with a significantly lower mortality (adjusted OR [95% CI]=0.68 [0.51-0.90], P = 0.006), confirmed in the analysis restricted to 2020 (adjusted OR [95% CI]=0.5[0.33-0.74], P = 0.001). Among the 5388 patients in whom data on in-hospital medication were available, in-hospital RASI therapy was associated with a significantly lower mortality (2.1% vs 16.7%, OR [95% CI]=0.11 [0.084-0.14], p < 0.0001), confirmed after adjustment in both periods. Among the 62 SARSCoV-2 positive patients, RASI therapy, both at admission or in-hospital, showed no prognostic effect. CONCLUSIONS: This is the first study to investigate the impact of RASI therapy on the prognosis and SARSCoV2 infection of STEMI patients undergoing PPCI during the COVID-19 pandemic. Both pre-admission and in-hospital RASI were associated with lower mortality. Among SARSCoV2-positive patients, both chronic and in-hospital RASI therapy showed no impact on survival.


Assuntos
Anti-Hipertensivos/uso terapêutico , COVID-19/mortalidade , Reperfusão Miocárdica , SARS-CoV-2 , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Idoso , COVID-19/terapia , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Intervenção Coronária Percutânea , Prognóstico , Sistema de Registros , Sistema Renina-Angiotensina , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Tratamento Farmacológico da COVID-19
7.
Lancet ; 397(10278): 985-995, 2021 03 13.
Artigo em Inglês | MEDLINE | ID: mdl-33714389

RESUMO

BACKGROUND: Near-infrared spectroscopy (NIRS) and intravascular ultrasound are promising imaging modalities to identify non-obstructive plaques likely to cause coronary-related events. We aimed to assess whether combined NIRS and intravascular ultrasound can identify high-risk plaques and patients that are at risk for future major adverse cardiac events (MACEs). METHODS: PROSPECT II is an investigator-sponsored, multicentre, prospective natural history study done at 14 university hospitals and two community hospitals in Denmark, Norway, and Sweden. We recruited patients of any age with recent (within past 4 weeks) myocardial infarction. After treatment of all flow-limiting coronary lesions, three-vessel imaging was done with a combined NIRS and intravascular ultrasound catheter. Untreated lesions (also known as non-culprit lesions) were identified by intravascular ultrasound and their lipid content was assessed by NIRS. The primary outcome was the covariate-adjusted rate of MACEs (the composite of cardiac death, myocardial infarction, unstable angina, or progressive angina) arising from untreated non-culprit lesions during follow-up. The relations between plaques with high lipid content, large plaque burden, and small lumen areas and patient-level and lesion-level events were determined. This trial is registered with ClinicalTrials.gov, NCT02171065. FINDINGS: Between June 10, 2014, and Dec 20, 2017, 3629 non-culprit lesions were characterised in 898 patients (153 [17%] women, 745 [83%] men; median age 63 [IQR 55-70] years). Median follow-up was 3·7 (IQR 3·0-4·4) years. Adverse events within 4 years occurred in 112 (13·2%, 95% CI 11·0-15·6) of 898 patients, with 66 (8·0%, 95% CI 6·2-10·0) arising from 78 untreated non-culprit lesions (mean baseline angiographic diameter stenosis 46·9% [SD 15·9]). Highly lipidic lesions (851 [24%] of 3500 lesions, present in 520 [59%] of 884 patients) were an independent predictor of patient-level non-culprit lesion-related MACEs (adjusted odds ratio 2·27, 95% CI 1·25-4·13) and non-culprit lesion-specific MACEs (7·83, 4·12-14·89). Large plaque burden (787 [22%] of 3629 lesions, present in 530 [59%] of 898 patients) was also an independent predictor of non-culprit lesion-related MACEs. Lesions with both large plaque burden by intravascular ultrasound and large lipid-rich cores by NIRS had a 4-year non-culprit lesion-related MACE rate of 7·0% (95% CI 4·0-10·0). Patients in whom one or more such lesions were identified had a 4-year non-culprit lesion-related MACE rate of 13·2% (95% CI 9·4-17·6). INTERPRETATION: Combined NIRS and intravascular ultrasound detects angiographically non-obstructive lesions with a high lipid content and large plaque burden that are at increased risk for future adverse cardiac outcomes. FUNDING: Abbott Vascular, Infraredx, and The Medicines Company.


Assuntos
Infarto do Miocárdio/diagnóstico por imagem , Placa Aterosclerótica/diagnóstico por imagem , Espectroscopia de Luz Próxima ao Infravermelho/métodos , Ultrassonografia/métodos , Idoso , Angina Instável/epidemiologia , Morte , Feminino , Humanos , Lipídeos/análise , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Placa Aterosclerótica/química , Estudos Prospectivos , Países Escandinavos e Nórdicos
8.
Cardiology ; 146(2): 161-171, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33524985

RESUMO

BACKGROUND: Bioresorbable scaffolds (BRSs) is a relatively new approach in treating coronary artery stenosis. The initial results of the first commercially available scaffolds consisting of a backbone of poly-L-lactide raised safety concerns related to delayed resorption and healing. The magnesium alloy-based scaffold degrades via bio-corrosion within months, whereas it often takes several years for polymer scaffolds to degrade. The aim of the study was to assess the healing stage by optical coherence tomography (OCT) after 6 months in patients with non-ST-segment elevation myocardial infarct (NSTEMI) randomized to OCT or angiography-guided percutaneous coronary intervention with implantation of a magnesium sirolimus-eluting Magmaris scaffold (Magmaris; Biotronik, Bülach, Switzerland). METHODS: We analyzed the healing process by comparing OCT at baseline and after 6 months. Five stages of healing were defined with stage 1 being the least healed and stage 5 demonstrating complete resorption and healing with no visible scaffold/remnant. The primary end point is a calculated healing score that is based on 5 subtypes of healing stage: (1) malapposed, (2) uncovered with no detection of smooth surface tissue on top of struts or remnants, (3) covered protruding, (4) covered embedded, and (5) complete healing with a smooth neointimal surface and no sign of struts or visible remnants assessed by OCT 6 months after the index procedure. RESULTS: The impact of OCT-guided compared to angiography-guided scaffold implantation will be illuminated. CONCLUSION: The present study will provide new information on midterm healing properties of the magnesium BRS in patients with NSTEMI.


Assuntos
Stents Farmacológicos , Infarto do Miocárdio sem Supradesnível do Segmento ST , Intervenção Coronária Percutânea , Implantes Absorvíveis , Angiografia Coronária , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Humanos , Infarto do Miocárdio sem Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio sem Supradesnível do Segmento ST/cirurgia , Desenho de Prótese , Tomografia de Coerência Óptica , Resultado do Tratamento
9.
EuroIntervention ; 17(3): 233-239, 2021 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-33433389

RESUMO

BACKGROUND: The BioFreedom drug-coated stent with a stainless steel platform (BF-SS) has been demonstrated to be efficacious in patients at high bleeding risk and receiv-ing only one-month dual antiplatelet therapy. AIMS: The aim of this study was to evaluate the efficacy of the new BioFreedom Ultra drug-coated stent with a thin-strut cobalt-chromium platform (BF-CoCr) compared to the BF-SS in an all-comers population undergoing percutaneous coronary intervention (PCI). METHODS: This was a prospective, multicentre, non-inferiority trial. The primary endpoint was in-stent late lumen loss (LLL) as determined by quantitative coronary angiography at nine-month follow-up. Clinical evaluation was performed at one year. RESULTS: A total of 200 patients were randomised (1:1) to either the BF-CoCr or the BF-SS stent at eight centres in Spain and Denmark. Baseline clinical and lesion characteristics were similar between the groups. Mean age was 66 years and 23% were female. The mean number of stents implanted per patient was 1.5. At nine-month follow-up, mean in-stent LLL was 0.34±0.49 mm in the BF-CoCr group versus 0.29±0.37 mm in the BF-SS group, p=0.005 for non-inferiority. At one year, target lesion failure was similar between the groups (7.3% in BF-CoCr vs 9.3% in the BF-SS group; p=0.60). CONCLUSIONS: The BF-CoCr was non-inferior to the BF-SS in terms of in-stent LLL at nine months. Larger studies powered for clinical endpoints are warranted to compare the efficacy of this new platform with currently available DES.


Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Idoso , Feminino , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Polímeros , Estudos Prospectivos , Desenho de Prótese , Sirolimo/uso terapêutico , Espanha , Stents , Resultado do Tratamento
10.
Biomarkers ; 25(6): 506-512, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32649233

RESUMO

PURPOSE: To validate the IABP-SHOCK II risk score in a Danish cohort and assess the association between the IABP-SHOCK II risk score and admission concentration of biomarkers reflecting neurohormonal - (Copeptin, Pro-atrial natriuretic peptide (proANP), Mid-regional pro-adrenomedullin (MRproADM)) and inflammatory (ST2) activation in patients with CS complicating ST segment elevation myocardial infarction (STEMI). METHODS: A total of 137 consecutive patients admitted with STEMI and CS at two tertiary heart centres were stratified according to the IABP-SHOCK II risk score (0-2; 3/4; 5-9), and had blood sampled upon admission. RESULTS: Plasma concentrations of Copeptin (median (pmol/L) score 0-2: 313; score 3/4: 682; score 5-9: 632 p < 0.0001), proANP (pmol/L) (1459; 2225; 2876 p = 0.0009) and MRproADM (nmol/L) (0.86; 1.2; 1.4 p = 0.04) were significantly associated with the risk score, whereas ST2 (ng/mL) was not (44; 60; 45 p = 0.23). The IABP-SHOCK II risk score predicted 30-day mortality (score 0-2: 22%; score 4/3: 51%; score 5-9: 72%, area under the curve (AUC): 0.73, plogrank < 0.0001), while the tested biomarkers did not (AUC: 0.51

Assuntos
Adrenomedulina/sangue , Fator Natriurético Atrial/sangue , Glicopeptídeos/sangue , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Choque Cardiogênico/mortalidade , Idoso , Biomarcadores/sangue , Feminino , Humanos , Inflamação/sangue , Inflamação/mortalidade , Inflamação/patologia , Proteína 1 Semelhante a Receptor de Interleucina-1/sangue , Masculino , Pessoa de Meia-Idade , Neurotransmissores/sangue , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/sangue , Infarto do Miocárdio com Supradesnível do Segmento ST/patologia , Choque Cardiogênico/sangue , Choque Cardiogênico/patologia
12.
EuroIntervention ; 14(15): e1585-e1592, 2019 Feb 08.
Artigo em Inglês | MEDLINE | ID: mdl-30418160

RESUMO

AIMS: The aim of this study was to evaluate the Impella CP over veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and their impact on left ventricular unloading and end-organ perfusion. METHODS AND RESULTS: Cardiogenic shock (CS) was induced by injecting microspheres into the left coronary artery in fourteen adult female swine. Impella CP or VA-ECMO was initiated in the presence of CS and evaluated after 60 minutes. Left ventricular pressure-volume area (PVA, total mechanical work) was obtained from a conductance catheter. Results are presented as mean (95% confidence interval) and the rank-sum test was used to assess differences between devices. Compared to the CS state, PVA was unaffected by Impella CP and increased on VA-ECMO (from 2,548 [2,193; 2,904] mmHg x mL during CS to 5,775 [4,451; 7,099], between device p-value=0.02). Arterial lactate increased during CS and decreased on support with no difference between devices. Renal venous oxygen saturation decreased during CS and increased on support with no difference between devices. Cerebral venous oxygen saturation increased to 33% [25, 40] on Impella CP and to 69% [49, 89] on VA-ECMO, p=0.04. CONCLUSIONS: In this porcine model of profound CS, Impella CP unloaded the left ventricle compared to VA-ECMO. Both devices improved end-organ perfusion, with a tendency towards higher venous oxygen saturations on VA-ECMO.


Assuntos
Oxigenação por Membrana Extracorpórea , Coração Auxiliar , Choque Cardiogênico , Animais , Modelos Animais de Doenças , Feminino , Ventrículos do Coração , Suínos
13.
EuroIntervention ; 12(4): 482-9, 2016 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-26342471

RESUMO

AIMS: The Absorb bioresorbable vascular scaffold (Absorb BVS) provides similar clinical outcomes compared with a durable polymer-based everolimus-eluting metallic stent (EES) in stable coronary artery disease patients. ST-elevation myocardial infarction (STEMI) lesions have been associated with delayed arterial healing and impaired stent-related outcomes. The purpose of the present study is to compare directly the arterial healing response, angiographic efficacy and clinical outcomes between the Absorb BVS and metallic EES. METHODS AND RESULTS: A total of 191 patients with acute STEMI were randomly allocated to treatment with the Absorb BVS or a metallic EES 1:1. The primary endpoint is the neointimal healing (NIH) score, which is calculated based on a score taking into consideration the presence of uncovered and malapposed stent struts, intraluminal filling defects and excessive neointimal proliferation, as detected by optical frequency domain imaging (OFDI) six months after the index procedure. The study will provide 90% power to show non-inferiority of the Absorb BVS compared with the EES. CONCLUSIONS: This will be the first randomised study investigating the arterial healing response following implantation of the Absorb BVS compared with the EES. The healing response assessed by a novel NIH score in conjunction with results on angiographic efficacy parameters and device-oriented events will elucidate disease-specific applications of bioresorbable scaffolds.


Assuntos
Fármacos Cardiovasculares/uso terapêutico , Stents Farmacológicos , Everolimo/uso terapêutico , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Implantes Absorvíveis/efeitos adversos , Adolescente , Adulto , Doença da Artéria Coronariana/terapia , Everolimo/administração & dosagem , Feminino , Humanos , Imunossupressores/uso terapêutico , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Polímeros , Sirolimo/administração & dosagem , Sirolimo/uso terapêutico , Resultado do Tratamento , Adulto Jovem
14.
Eur Heart J ; 37(3): 229-40, 2016 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-26405232

RESUMO

AIMS: Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI. METHODS AND RESULTS: ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) -1.06 (-1.96, -0.16); Pnon-inferiority < 0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns). CONCLUSION: Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.


Assuntos
Stents Farmacológicos , Everolimo/administração & dosagem , Imunossupressores/administração & dosagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Implantes Absorvíveis , Angiografia Coronária/métodos , Feminino , Humanos , Masculino , Metais , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Polímeros , Desenho de Prótese , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Método Simples-Cego , Alicerces Teciduais , Resultado do Tratamento , Cicatrização/fisiologia
16.
Catheter Cardiovasc Interv ; 83(7): 1035-42, 2014 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-24311384

RESUMO

OBJECTIVES: We used the Western Denmark Heart Registry to assess one-year and long-term all-cause mortality and stent failure following Percutaneous Coronary Intervention (PCI) with drug-eluting stents (DES) or bare-metal stents (BMS). BACKGROUND: The use of DES compared with BMS during PCI has reduced the risk of restenosis in native coronary artery lesions. In saphenous vein grafts (SVG) the outcome after DES compared with BMS is insufficiently described. METHODS: From January 1, 2002 to December 31, 2010 all patients with PCI of SVG lesions were identified among 3.0 million inhabitants. Stent failure was defined as clinically driven target lesion revascularization, graft occlusion without intervention, or stent thrombosis. RESULTS: The study cohort consisted of 529 patients with 755 SVG lesions (348 DES patients with 510 lesions and 181 BMS patients with 245 lesions). Mean age did not differ between patients with DES-treated lesions compared to patients with BMS-treated lesions (67.5 ± 9.1 years vs. 67.6 ± 9.3 years; P = 0.85). The median follow-up time was 3.0 years (25th-75th percentile: 1.4-5.1 years). One-year (n = 27 (8.2%) vs. n = 12 (6.7%), log rank P = 0.60) and 3-year cumulative mortality (n = 31 (18.8%) vs. n = 59 (21.8%), log rank P = 0.64) did not differ significantly between DES- and BMS-treated patients. One-year cumulative stent failure was seen in 39 (6.6%) DES-treated lesions vs. 24 (10.8%) BMS-treated lesions (P = 0.088), and 3-year cumulative stent failure in 48 (15.4%) vs. 34 (18.8%) lesions (P = 0.25), respectively. CONCLUSION: In SVG lesions, DES showed no long-term benefit compared to BMS in rates of all-cause mortality or stent failure.


Assuntos
Ponte de Artéria Coronária/métodos , Stents Farmacológicos , Oclusão de Enxerto Vascular/cirurgia , Infarto do Miocárdio/cirurgia , Intervenção Coronária Percutânea/métodos , Veia Safena/transplante , Idoso , Angiografia Coronária , Dinamarca/epidemiologia , Feminino , Seguimentos , Oclusão de Enxerto Vascular/diagnóstico por imagem , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Incidência , Masculino , Infarto do Miocárdio/diagnóstico por imagem , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
17.
Ugeskr Laeger ; 175(4): 181-5, 2013 Jan 21.
Artigo em Dinamarquês | MEDLINE | ID: mdl-23347734

RESUMO

The use of primary percutaneous coronary intervention (PCI) as the preferred reperfusion strategy in ST-elevation myocardial infarction (STEMI) requires optimal systems-of-care and logistics in order to enable rapid treatment of all patients. In Denmark, this has been achieved through prehospital electrocardiogram diagnosis, field triage and dedicated PCI centres 24/7. Today, primary PCI is an option for all Danish patients with STEMI, regardless of the distance to a PCI centre. This has led to a decline in both mortality and morbidity.


Assuntos
Angioplastia Coronária com Balão/normas , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea/normas , Tempo para o Tratamento/normas , Angioplastia Coronária com Balão/estatística & dados numéricos , Diagnóstico Tardio , Dinamarca , Eletrocardiografia , Serviços Médicos de Emergência/normas , Serviços Médicos de Emergência/estatística & dados numéricos , Humanos , Estimativa de Kaplan-Meier , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/mortalidade , Reperfusão Miocárdica/normas , Reperfusão Miocárdica/estatística & dados numéricos , Intervenção Coronária Percutânea/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Fatores de Tempo , Tempo para o Tratamento/estatística & dados numéricos , Transporte de Pacientes/normas , Transporte de Pacientes/estatística & dados numéricos
18.
Ugeskr Laeger ; 175(4): 194-7, 2013 Jan 21.
Artigo em Dinamarquês | MEDLINE | ID: mdl-23347737

RESUMO

Overall, the future emergency departments in Denmark serve as a single portal of entry for all acute patients. At the same time an expansion of prehospital diagnosing and triage will take place. In patients suspected of life-threatening cardiac conditions with specialized treatment requirements where the time factor is important, the prehospital triage will be important to identify patients who should be transferred directly to a cardiac care unit to reduce prehospital and in-hospital delays of treatment.


Assuntos
Cardiopatias , Triagem , Doença Aguda , Unidades de Cuidados Coronarianos , Dinamarca , Serviço Hospitalar de Emergência/organização & administração , Cardiopatias/diagnóstico , Cardiopatias/terapia , Humanos , Fatores de Tempo
19.
Ugeskr Laeger ; 175(4): 198-201, 2013 Jan 21.
Artigo em Dinamarquês | MEDLINE | ID: mdl-23347738

RESUMO

Today there is solid evidence that high-risk patients with acute myocardial infarction without ST-elevation should undergo routine invasive treatment, preferably with a very short delay. Evidence suggests that acute coronary occlusions are present in many of these patients. Nevertheless, so far no studies have been powered to evaluate the impact of primary percutaneous coronary intervention on outcome in this patient population. With the advanced, prehospital, diagnostic possibilities available today it would be possible to investigate this issue further.


Assuntos
Diagnóstico Precoce , Infarto do Miocárdio/diagnóstico , Angiografia Coronária , Ecocardiografia , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/terapia , Intervenção Coronária Percutânea , Risco , Fatores de Tempo , Troponina T/sangue
20.
Heart ; 93(6): 694-7, 2007 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-17194711

RESUMO

OBJECTIVE: To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario. DESIGN: From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus stent were consecutively registered and followed for 9 months. Re-intervention was driven by clinical symptoms. SETTING: Western Denmark Heart Registry. PATIENTS: 4432 patients with 6102 lesions treated with a Cypher (n = 3791 lesions) or Taxus (n = 2311 lesions) stent. INTERVENTIONS: Percutaneous coronary intervention. MAIN OUTCOME MEASURES: TLR, defined as either new percutaneous coronary intervention or coronary artery bypass graft operation of the target lesion, within 9 months from the index procedure. RESULTS: TLR within 9 months was performed in 2.5% of lesions treated with the Cypher stent and in 3.3% of lesions treated with the Taxus stent (OR 1.36, 95% CI 1.00 to 1.84). After adjustment by multivariate logistic regression, Taxus stent implantation was an independent predictor of TLR (OR 1.43, 95% CI 1.05 to 1.95). Implantation of >1 stent per lesion (OR 1.62, 95% CI 1.13 to 2.33) and reference diameter <2.8 mm (OR 1.42, 95% CI 1.00 to 2.02) were also identified as independent predictors of TLR. CONCLUSIONS: These data from the registry reflect a real-world clinical scenario with operator-driven use of drug-eluting stents and symptom-driven re-intervention. In this setting, use of the Taxus stent, implantation of multiple stents per lesion and stent implantation in small vessels were independent predictors of TLR.


Assuntos
Reestenose Coronária/terapia , Estenose Coronária/terapia , Paclitaxel/administração & dosagem , Sirolimo/administração & dosagem , Stents , Análise de Variância , Angioplastia Coronária com Balão , Reestenose Coronária/epidemiologia , Dinamarca , Sistemas de Liberação de Medicamentos , Desenho de Equipamento , Humanos , Modelos Logísticos , Sistema de Registros , Fatores de Risco , Resultado do Tratamento
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