RESUMO
BACKGROUND: In this prespecified AIDA-trial sub-study we investigate the clinical performance of absorb bioresorbable vascular scaffold (BVS) compared to Xience everolimus-eluting stent (EES) in routine percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) at complete 3-year follow-up. METHODS AND RESULTS: All 1,845 randomized patients were subdivided by medical history with DM or without DM. Of the 924 Absorb BVS patients, 171 (18.5%) patients had DM, of which 65 (38.0%) were treated with insulin (iTDM). Of the 921 Xience EES patients, 153 (16.6%) patients had DM, of which 45 (29.4%) were insulin-treated diabetes mellitus (iTDM). Target vessel failure (TVF), composite of cardiac death, target vessel myocardial infarction, and target vessel revascularization, occurred in 18.7% of diabetic patients treated with Absorb patients versus in 18.0% patients treated with Xience EES (p = .840). In nondiabetics the rates of TVF were 12.3% in Absorb BVS versus 11.0% in Xience EES (p = .391). Definite/probable device thrombosis occurred more frequently in Absorb BVS compared to Xience EES in both diabetic and nondiabetic patients (4.8% versus 0.7%; p = .028 and 3.2% vs. 0.5%; p < .001, respectively). CONCLUSIONS: In routine PCI practice, both Absorb BVS and Xience EES have worse clinical outcomes in diabetic patients as compared to nondiabetic patients. Throughout all clinical presentations, Absorb BVS was associated with higher rates of device thrombosis at 3-year follow-up.
Assuntos
Fármacos Cardiovasculares , Doença da Artéria Coronariana , Diabetes Mellitus , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Diabetes Mellitus/diagnóstico , Everolimo/efeitos adversos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Fatores de Risco , Stents , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice. METHODS: We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients). The primary end point was target-vessel failure (a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization). The data and safety monitoring board recommended early reporting of the study results because of safety concerns. This report provides descriptive information on end-point events. RESULTS: The median follow-up was 707 days. Target-vessel failure occurred in 105 patients in the scaffold group and in 94 patients in the stent group (2-year cumulative event rates, 11.7% and 10.7%, respectively; hazard ratio, 1.12; 95% confidence interval [CI], 0.85 to 1.48; P=0.43); event rates were based on Kaplan-Meier estimates in time-to-event analyses. Cardiac death occurred in 18 patients in the scaffold group and in 23 patients in the stent group (2-year cumulative event rates, 2.0% and 2.7%, respectively), target-vessel myocardial infarction occurred in 48 patients in the scaffold group and in 30 patients in the stent group (2-year cumulative event rates, 5.5% and 3.2%), and target-vessel revascularization occurred in 76 patients in the scaffold group and in 65 patients in the stent group (2-year cumulative event rates, 8.7% and 7.5%). Definite or probable device thrombosis occurred in 31 patients in the scaffold group as compared with 8 patients in the stent group (2-year cumulative event rates, 3.5% vs. 0.9%; hazard ratio, 3.87; 95% CI, 1.78 to 8.42; P<0.001). CONCLUSIONS: In this preliminary report of a trial involving patients undergoing PCI, there was no significant difference in the rate of target-vessel failure between the patients who received a bioresorbable scaffold and the patients who received a metallic stent. The bioresorbable scaffold was associated with a higher incidence of device thrombosis than the metallic stent through 2 years of follow-up. (Funded by Abbott Vascular; AIDA ClinicalTrials.gov number, NCT01858077 .).
Assuntos
Implantes Absorvíveis , Estenose Coronária/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea , Stents Metálicos Autoexpansíveis , Implantes Absorvíveis/efeitos adversos , Idoso , Everolimo/administração & dosagem , Feminino , Seguimentos , Cardiopatias/mortalidade , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Stents Metálicos Autoexpansíveis/efeitos adversos , Trombose/epidemiologia , Trombose/etiologia , Resultado do TratamentoRESUMO
BACKGROUND: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS. METHODS AND RESULTS: We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS. The rate of the 2-year primary endpoint of target vessel failure (TVF) was similar after treatment with Absorb BVS or Xience EES in ACS patients (10.2% versus 9.0% respectively; P = 0.49) and in no-ACS patients (11.7% versus 10.7%, respectively; P = 0.67) Definite or probable device thrombosis occurred more frequently with Absorb BVS compared to Xience EES in ACS patients (4.3% versus 1.7%, respectively, P = 0.03) as well as in no-ACS patients (2.4% versus 0.2%, respectively; P = 0.002). There were no statistically significant interactions between clinical presentation and randomized device modality for TVF (P = 0.80) and for the endpoint of definite or probable device thrombosis (P = 0.17). CONCLUSION: In the AIDA trial, the 2-year outcomes of PCI with Absorb BVS versus Xience EES were consistent in ACS and no-ACS patients: similar rates for TVF and consistently higher rates of definite or probable stent thrombosis under Absorb BVS versus Xience EES. There were no statistically significant interactions between clinical presentation and randomized device modality.
Assuntos
Implantes Absorvíveis , Síndrome Coronariana Aguda/terapia , Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Metais , Intervenção Coronária Percutânea/instrumentação , Síndrome Coronariana Aguda/diagnóstico por imagem , Idoso , Fármacos Cardiovasculares/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Trombose Coronária/etiologia , Everolimo/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Fatores de Risco , Método Simples-Cego , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Absorb bioresorbable vascular scaffold (BVS)-related events have been reported between 1 and 3 years - the period of active scaffold bioresorption. Data on the performance of the Absorb BVS in daily clinical practice beyond this time point are scarce. AIMS: This report aimed to provide the final five-year clinical follow-up of the Absorb BVS in comparison with the XIENCE everolimus-eluting stent (EES). In addition, we evaluated the effect of prolonged dual antiplatelet therapy (DAPT) administration on events in the scaffold group. METHODS: AIDA was a multicentre, investigator-initiated, non-inferiority trial, in which 1,845 unselected patients with coronary artery disease were randomly assigned to either the Absorb BVS (n=924) or the XIENCE EES (n=921). Target vessel failure (TVF), a composite of cardiac death, target vessel myocardial infarction or target vessel revascularisation, was the primary endpoint. Scaffold thrombosis cases were matched with controls and tested for the effect of prolonged DAPT. RESULTS: Up to five-year follow-up, there was no difference in TVF between the Absorb BVS (17.7%) and the XIENCE EES (16.1%) (hazard ratio [HR] 1.31, 95% confidence interval [CI]: 0.90-1.41; p=0.302). Definite or probable device thrombosis (DT) occurred in 43 patients (4.8%) in the scaffold group compared to 13 patients (1.5%) in the stent group (HR 3.32, 95% CI: 1.78-6.17; p<0.001). DT between 3 and 4 years occurred six times in the Absorb arm versus three times in the XIENCE arm. Between 4 and 5 years, the incidence was three versus two, respectively. Of those three DT in the scaffold group, two occurred in XIENCE EES-treated lesions. The odds ratio of scaffold thrombosis in patients on DAPT compared to off DAPT throughout five-year follow-up was 0.36 (95% CI: 0.15-0.86). CONCLUSIONS: The excess risk of the Absorb BVS on late adverse events, in particular device thrombosis, in routine PCI continues up to 4 years and seems to plateau afterwards. Clinical Trial Registration ClinicalTrials.gov: NCT01858077.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Doença da Artéria Coronariana/cirurgia , Everolimo , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Desenho de Prótese , Stents , Resultado do TratamentoRESUMO
AIMS: We aimed to evaluate the impact of the complexity of coronary disease as assessed by the SYNTAX score (SXscore) on the clinical outcomes in the AIDA trial. METHODS AND RESULTS: In the AIDA trial, we compared Absorb versus XIENCE in routine clinical practice. Clinical outcomes were stratified by SXscore tertiles: SXlow (SXscore ≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15). The SXscore was available in 1,661 of the 1,845 (90%) patients. The event rate of TVF was numerically lower in Absorb compared to XIENCE (3.7% versus 5.6%; p=0.257) in the SXlow tertile, numerically higher in Absorb in the SXmid tertile (11.4% versus 9.3%, p=0.421) and similar in the SXhigh tertile (15.5% versus 15.6%; p=0.960). The rates of definite/probable device thrombosis in Absorb versus XIENCE were significantly higher in the SXmid tertile (3.3% versus 0.8%, p=0.043) and in the SXhigh tertile (3.7% versus 0.8%, p=0.006). CONCLUSIONS: We found no significantly different rates of TVF between Absorb and XIENCE patients. Absorb-treated patients in the SXmid and SXhigh tertiles had an increased risk of device thrombosis when compared to XIENCE-treated patients. The rates of device thrombosis in the SXlow tertile, while still higher for Absorb, are more acceptable than in the SXmid and SXhigh score tertiles.
Assuntos
Fármacos Cardiovasculares , Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Everolimo , Humanos , Desenho de Prótese , Resultado do TratamentoRESUMO
It has been hypothesized that dedicated optimized Absorb BVS implantation techniques might mitigate the risk of adverse events such as target vessel failure and device thrombosis. In this explorative AIDA trial QCA substudy, we sought to investigate the influence of implantation techniques on lesion-oriented outcomes in both the Absorb BVS and Xience EES arm at complete 3-year follow-up. The current analysis includes 2152 study lesions treated with at least one study device, of which the baseline angiogram was suited for offline QCA analysis, including Dmax analysis. The lesion-oriented composite outcome (LOCE) of this analysis was a composite of definite device thrombosis, target lesion revascularization and target-vessel myocardial infarction. In Absorb BVS, the Lesion-oriented composite endpoint (LOCE) occurred numerically less in correctly QCA sized vessels when compared to incorrectly sized vessels 8.5% (58/696) versus 11.1% (39/358), p = 0.151. In Xience EES, LOCE had occurred more frequently in incorrectly sized devices according to device diameter/RVD matching; 2.2% (4/187) in correctly sized devices versus 7.1% (63/911) in incorrectly sized devices (p = 0.014). In this AIDA trial QCA substudy, rates of LOCE were significantly lower in Xience EES treated lesions in which devices were correctly sized according to the definitions of device diameter/RVD matching.
Assuntos
Implantes Absorvíveis , Angioplastia Coronária com Balão/instrumentação , Angiografia Coronária , Doença da Artéria Coronariana/terapia , Vasos Coronários/diagnóstico por imagem , Stents Farmacológicos , Angioplastia Coronária com Balão/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Humanos , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/etiologia , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Trombose/diagnóstico por imagem , Trombose/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden. This subgroup-analysis sought to assess sex-specific outcomes after Absorb bioresorbable vascular scaffold (BVS) or XIENCE everolimus-eluting stent (EES) implantation. METHODS: The AIDA trial was an investigator-initiated, non-inferiority, all-comers trial, in which 1845 patients were randomly assigned to either Absorb BVS or XIENCE EES. Baseline clinical, angiography and procedural variables, as well as 2-year clinical outcomes were analyzed by sex and device modality. RESULTS: Of the 1845 randomized patients, 475 (25.7%) were females. The 2-year rates of target vessel failure (TVF) with Absorb BVS versus XIENCE EES in females were 6.4% versus 10.6% (HR 0.59; 95% CI: 0.31-1.11; pâ¯=â¯0.10) and in males 12.7% versus 9.7% (HR 1.34; 95% CI: 0.98-1.85; pâ¯=â¯0.07). Males treated with Absorb BVS were at higher risk for TVF compared to females treated with Absorb BVS (HR 2.06; 95% CI 1.21-3.53; pâ¯=â¯0.007). Definite/probable device thrombosis occurred in females with Absorb BVS versus XIENCE EES in 1.6% versus 1.4% (HR 1.15; 95% CI: 0.26-5.12; pâ¯=â¯0.86) and in males 3.9% versus 0.7% (HR 5.55; 95% CI: 2.11-14.35; pâ¯<â¯0.001). A statistical significant interaction between sex and device was present for TVF (pâ¯=â¯0.02), but was not seen for definite/probable device thrombosis (pâ¯=â¯0.08). CONCLUSIONS: In this subgroup analysis, Absorb BVS used in routine practice tends to result in better clinical outcomes in females compared to males.
Assuntos
Implantes Absorvíveis/tendências , Bioprótese/tendências , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Caracteres Sexuais , Alicerces Teciduais/tendências , Idoso , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Fatores de Tempo , Resultado do TratamentoRESUMO
Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58-1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52-1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19-0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.
Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Stents Farmacológicos , Everolimo/administração & dosagem , Intervenção Coronária Percutânea/instrumentação , Trombose Coronária/diagnóstico por imagem , Trombose Coronária/etiologia , Humanos , Países Baixos , Intervenção Coronária Percutânea/efeitos adversos , Valor Preditivo dos Testes , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
AIMS: Specific implantation strategies have been proposed for the Absorb bioresorbable vascular scaffold (Absorb BVS) to optimise outcomes. We aimed to analyse whether the occurrence of definite scaffold thrombosis (ScT) and target lesion revascularisation (TLR) in Absorb-treated AIDA patients was influenced by scaffold implantation techniques. METHODS AND RESULTS: Absorb BVS implantation in 1,074 lesions was graded according to definitions of optimal implantation based on predilatation, sizing, and post-dilatation (PSP). Lesion-oriented outcomes (definite ScT and TLR) that occurred during a median follow-up of 707 days were related to the presence or absence of PSP. Of 1,074 lesions, 158 (14.7%) lesions met PSP criteria. The most prevalent reason for not meeting PSP criteria was inadequate sizing: 863 (94.2%). Definite ScT occurred in four of 158 PSP-treated lesions compared with 27 of 916 non PSP-treated lesions, with two-year KM estimates of 3.0% vs. 4.1% and an HR of 1.14 (p=0.811). TLR occurred in eight of 158 PSP-treated lesions compared with 61 of 916 non PSP-treated lesions, with KM estimates of 5.6% vs. 7.1% and an HR of 1.29 (p=0.492). CONCLUSIONS: In AIDA, lesions that underwent scaffold implantation according to an optimised Absorb BVS implantation technique did not have lower rates of ScT and TLR compared to scaffold-treated lesions that did not meet PSP criteria.
Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Trombose , Implantes Absorvíveis , Dilatação , Everolimo , Humanos , Incidência , Resultado do TratamentoRESUMO
AIMS: The aim of this report of the AIDA trial is to provide full two-year outcomes for the primary endpoint of target vessel failure (TVF) and an update on device thrombosis. METHODS AND RESULTS: AIDA was a single-blind, multicentre, investigator-initiated, non-inferiority, randomised (1:1) clinical trial. At complete two-year follow-up, the primary endpoint of TVF had occurred in 100 patients in the Absorb BVS arm versus 90 patients in the XIENCE EES arm (HR 1.12, 95% CI: 0.94-1.49; psuperiority=0.436). Estimated two-year Kaplan-Meier event rates of TVF were 11.0% and 9.9%, respectively (95% CI: -0.9%-3.0%; pnon-inferiority=0.003). Definite or probable device thrombosis at two years occurred in 30 patients in the Absorb BVS arm and in eight patients in the XIENCE EES arm. Kaplan-Meier estimates of device thrombosis were 3.3% in the Absorb BVS arm and 0.9% in the XIENCE EES arm (HR 5.22, 95% CI: 2.00-13.59; p<0.001). CONCLUSIONS: AIDA formally met its criterion for non-inferiority of Absorb BVS versus XIENCE EES in terms of the combined endpoint of TVF. The Absorb BVS, however, was associated with higher rates of scaffold thrombosis and target vessel myocardial infarction at complete two-year follow-up.
Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Everolimo , Seguimentos , Humanos , Método Simples-Cego , Resultado do TratamentoRESUMO
INTRODUCTION: Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal stents. Patients treated with first generation DES more likely suffer from (very) late events which can be cause by the permanent presence of a polymer. Therefore second generation DES with more biocompatible coatings, and third generation DES, with very thin struts coated with biodegradable polymers, were developed. Areas covered: The MiStent SES is one of these third generation DES and is designed to limit the duration of polymer exposure, optimize coronary vessel healing and more precisely and consistently control drug elution to improve safety and clinical outcomes. This review provides a detailed description of the technique behind the MiStent SES, and describes the pre-clinical and clinical trials conducted with this device to date. Expert commentary: Recent clinical trials have shown non-inferiority of very thin strut biodegradable polymer coated DES compared to durable polymer coated DES, whilst maintaining an excellent safety profile. Longer follow-up, to see the real potential benefits of these devices, is mandatory however.
Assuntos
Implantes Absorvíveis , Doença da Artéria Coronariana/terapia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Sirolimo/uso terapêutico , Animais , Ensaios Clínicos como Assunto , Implantes de Medicamento , Liberação Controlada de Fármacos , Humanos , Intervenção Coronária Percutânea/instrumentação , Polímeros/efeitos adversos , Pontuação de Propensão , Desenho de Prótese , Suínos , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Findings from recent studies show that microvascular injury consists of microvascular destruction and intramyocardial hemorrhage (IMH). Patients with ST-segment elevation myocardial infarction (STEMI) with IMH show poorer prognoses than patients without IMH. Knowledge on predictors for the occurrence of IMH after STEMI is lacking. The current study aimed to investigate the prevalence and extent of IMH in patients with STEMI and its relation with periprocedural and clinical variables. METHODS AND RESULTS: A multicenter observational cohort study was performed in patients with successfully reperfused STEMI with cardiovascular magnetic resonance examination 5.5±1.8 days after percutaneous coronary intervention. Microvascular injury was visualized using late gadolinium enhancement and T2-weighted cardiovascular magnetic resonance imaging for microvascular obstruction and IMH, respectively. The median was used as the cutoff value to divide the study population with presence of IMH into mild or extensive IMH. Clinical and periprocedural parameters were studied in relation to occurrence of IMH and extensive IMH, respectively. Of the 410 patients, 54% had IMH. The presence of IMH was independently associated with anterior infarction (odds ratio, 2.96; 95% CI, 1.73-5.06 [P<0.001]) and periprocedural glycoprotein IIb/IIIa inhibitor treatment (odds ratio, 2.67; 95% CI, 1.49-4.80 [P<0.001]). Extensive IMH was independently associated with anterior infarction (odds ratio, 3.76; 95% CI, 1.91-7.43 [P<0.001]). Presence and extent of IMH was associated with larger infarct size, greater extent of microvascular obstruction, larger left ventricular dimensions, and lower left ventricular ejection fraction (all P<0.001). CONCLUSIONS: Occurrence of IMH was associated with anterior infarction and glycoprotein IIb/IIIa inhibitor treatment. Extensive IMH was associated with anterior infarction. IMH was associated with more severe infarction and worse short-term left ventricular function in patients with STEMI.
Assuntos
Infarto Miocárdico de Parede Anterior/terapia , Hemorragia/epidemiologia , Intervenção Coronária Percutânea/efeitos adversos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Idoso , Infarto Miocárdico de Parede Anterior/diagnóstico por imagem , Infarto Miocárdico de Parede Anterior/fisiopatologia , Meios de Contraste/administração & dosagem , Bases de Dados Factuais , Feminino , Gadolínio DTPA/administração & dosagem , Hemorragia/diagnóstico por imagem , Humanos , Modelos Logísticos , Imagem Cinética por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Inibidores da Agregação Plaquetária/efeitos adversos , Complexo Glicoproteico GPIIb-IIIa de Plaquetas/antagonistas & inibidores , Prevalência , Estudos Prospectivos , Fatores de Risco , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Volume Sistólico , Fatores de Tempo , Resultado do Tratamento , Função Ventricular EsquerdaRESUMO
INTRODUCTION: ST-elevated myocardial infarction (STEMI) is most frequently caused by coronary occlusion due to formation of an intracoronary thrombus in reaction to rupture of atherosclerotic plaques. Little is known about kinetics of coagulation markers after STEMI in patients treated according to current guidelines. We aimed to investigate kinetics of important coagulation markers in percutaneous coronary intervention (PCI)-treated STEMI patients. MATERIALS AND METHODS: 60 consecutive PCI-treated STEMI patients were prospectively included. Blood samples were collected immediately after as well as 1, 4 and 7 days following PCI. Samples collected 90 days after PCI served as baseline values. ADAMTS13 activity, VWF (von Willebrand factor) activity, VWF antigen, VWF propeptide, fibrinogen antigen, D-dimer, alpha2-antiplasmin (α2AP), plasmin-alpha2-antiplasmin complex (PAP), prothrombin fragment F1+2 (F1+2), prothrombin time (PT), activated partial thromboplastin time (aPTT), and anti-factor Xa (anti-Xa) were measured. Cardiac magnetic resonance (CMR) was performed at 4-6 and 90 days after PCI in 49 patients and left ventricular ejection fraction (LVEF), infarct size and microvascular injury (MVI) were determined. RESULTS: Immediately after PCI, ADAMTS13 activity, fibrinogen antigen and α2AP levels were significantly decreased and VWF activity, VWF antigen and VWF propeptide levels were significantly elevated, compared to baseline. Individual coagulation markers and different combinations thereof were not related to LVEF or infarct size at 90 days, or the occurrence of MVI at 4-6 days after PCI. CONCLUSION: Coagulation parameters show a very dynamic profile in the early days after STEMI. However, individual coagulation parameters or combinations thereof do not predict CMR-defined LVEF, infarct size or MVI.
Assuntos
Fatores de Coagulação Sanguínea/análise , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/cirurgia , Doença da Artéria Coronariana/sangue , Feminino , Humanos , Cinética , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Intervenção Coronária Percutânea , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Resultado do TratamentoRESUMO
AIMS: ADAMTS13, a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13, is a metalloprotease that cleaves von Willebrand factor (VWF). There is considerable evidence that VWF levels increase and ADAMTS13 levels decrease in ST-elevation myocardial infarction (STEMI) patients. It is unclear whether this contributes to no reflow, infarct size, and intramyocardial haemorrhage (IMH). We aimed to determine the role of ADAMTS13 in STEMI patients and to investigate the benefits of recombinant ADAMTS13 (rADAMTS13) in a porcine model of myocardial ischaemia-reperfusion. METHODS AND RESULTS: In 49 consecutive percutaneous coronary intervention (PCI)-treated STEMI patients, blood samples were collected directly after through 7 days following PCI. Cardiac magnetic resonance was performed 4-6 days after PCI to determine infarct size and IMH. In 23 Yorkshire swine, the circumflex coronary artery was occluded for 75 min. rADAMTS13 or vehicle was administered intracoronary following reperfusion. Myocardial injury and infarct characteristics were assessed using cardiac enzymes, ECG, and histopathology. In patients with IMH, VWF activity and VWF antigen were significantly elevated directly after PCI and for all subsequent measurements, and ADAMTS13 activity significantly decreased at 4 and 7 days following PCI, in comparison with patients without IMH. VWF activity and ADAMTS13 activity were not related to infarct size. In rADAMTS13-treated animals, no differences in infarct size, IMH, or formation of microthrombi were witnessed compared with controls. CONCLUSIONS: No correlation was found between VWF/ADAMTS13 and infarct size in patients. However, patients suffering from IMH had significantly higher VWF activity and lower ADAMTS13 activity. Intracoronary administration of rADAMTS13 did not decrease infarct size or IMH in a porcine model of myocardial ischaemia-reperfusion. These data dispute the imbalance in ADAMTS13 and VWF as the cause of no reflow.