RESUMO
OBJECTIVES: We aimed to evaluate the use of bare metal stent (BMS) implantation in current percutaneous coronary intervention (PCI) era, focusing on indications for use and clinical outcomes. BACKGROUND: Limited data on BMS usage in current clinical practice are available. METHODS: All patients who underwent PCI with at least one BMS implantation in 18 Italian centers from January 1, 2013 to December 31, 2017, were included in our registry. Rates of BMS use and reasons for BMS implantations were reported for the overall study period and for each year. Primary outcomes were mortality, bleeding (Bleeding Academic Research Consortium-BARC and Thrombolysis in Myocardial Infarction-TIMI non-CABG definitions), and major adverse cardiac events (MACE) defined as the composite of all-cause and cardiac death, any myocardial infarction, target vessel revascularization, or any stent thrombosis. RESULTS: Among 58,879 patients undergoing PCI in the study period, 2,117 (3.6%) patients (mean age 73 years, 69.7% males, 73.3% acute coronary syndrome) were treated with BMS implantation (2,353 treated lesions). The rate of BMS implantation progressively decreased from 10.1% (2013) to 0.3% (2017). Main reasons for BMS implantation were: ST-elevation myocardial infarction (STEMI) (23.1%), advanced age (24.4%), and physician's perception of high-bleeding risk (34.0%). At a mean follow-up of 2.2 ± 1.5 years, all-cause and cardiac mortality were 25.6 and 12.7%, respectively; MACE rate was 35.3%, any bleeding rate was 13.0% (BARC 3-5 bleeding 6.3%, TIMI non-CABG major bleeding 6.1%). CONCLUSION: In a large, contemporary, real-world, multicenter registry, BMS use progressively reduced over the last 5 years. Main reasons for BMS implantation were STEMI, advanced age, and physician's perception of high-bleeding risk. High rates of mortality and MACE were observed in this real-world high-risk population.
Assuntos
Stents Farmacológicos , Intervenção Coronária Percutânea , Feminino , Humanos , Itália , Masculino , Intervenção Coronária Percutânea/efeitos adversos , Sistema de Registros , Stents , Resultado do TratamentoRESUMO
OBJECTIVES: To compare the effectiveness and safety of self-expandable, sirolimus-eluting Stentys stents (SES) and second-generation drug-eluting stents (DES-II) for the treatment of the unprotected left main (ULM). BACKGROUND: SES may provide a valuable option to treat distal ULM, particularly when significant caliber gaps with side branches are observed. METHODS: Patients from the multicenter SPARTA (clinicaltrials.gov: NCT02784405) and FAILS2 registries were included. Propensity-score with matching was performed to account for the lack of randomization. Primary end-point was the rate of major adverse cardiovascular events (MACE, a composite of all cause death, myocardial infarction, target lesion revascularization [TLR], unstable angina and definite stent thrombosis [ST]). Single components of MACE were the secondary end-points. RESULTS: Overall, 151 patients treated with SES and 1270 with DES-II were included; no differences in MACE rate at 250 days were observed (9.8% vs. 11.5%, P = 0.54). After propensity score with matching, 129 patients treated with SES and 258 with DES-II, of which about a third of female gender, were compared. After a follow-up of 250 days, MACE rate did not differ between the two groups (9.9% vs. 8.5%, P = 0.66), as well as the rate of ULM TLR (1.6% vs. 3.1%, P = 0.36) and definite ST (0.8% vs. 1.2%, P = 0.78). These results were consistent also when controlling for the treatment with provisional vs. 2-stents strategies for the ULM bifurcation. CONCLUSION: SES use for ULM treatment was associated with a similar MACE rate compared to DES-II at an intermediate-term follow-up. SES might represent a potential option in this setting.
Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/instrumentação , Stents Metálicos Autoexpansíveis , Sirolimo/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Ligas , Fármacos Cardiovasculares/efeitos adversos , Pesquisa Comparativa da Efetividade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Desenho de Prótese , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Sirolimo/efeitos adversos , Fatores de Tempo , Resultado do TratamentoAssuntos
Síndrome Coronariana Aguda/epidemiologia , Infecções por Coronavirus/epidemiologia , Hospitalização/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Betacoronavirus , COVID-19 , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Pandemias , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Estudos Retrospectivos , SARS-CoV-2 , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologiaRESUMO
OBJECTIVES: To compare clinical outcomes of patients treated with overlapping versus non-overlapping Absorb BVS. BACKGROUND: Limited data are available on the clinical impact of stent overlap with the Absorb BVS bioresorbable stent. METHODS: We compared outcomes of patients receiving overlapping or non-overlapping Absorb BVS in the multicenter prospective RAI Registry. RESULTS: Out of 1,505 consecutive patients treated with Absorb BVS, 1,384 were eligible for this analysis. Of these, 377 (27%) were in the overlap group, and 1,007 (73%) in the non-overlap group. The most frequent overlap configuration was the marker-to-marker type (48%), followed by marker-over-marker (46%) and marker-inside-marker (6%) types. Patients of the overlap group had higher prevalence of multivessel disease and higher SYNTAX score, and required more frequently the use of intravascular imaging. At a median follow-up of 368 days, no difference was observed between overlap and non-overlap groups in terms of a device-related composite endpoint (cardiac death, TV-MI, ID-TLR) (5.8% vs. 4.1%, P = 0.20) or of a patient-related composite endpoint (any death, any MI, any revascularization) (15.4% vs. 12.5%, P = 0.18). Cardiac death (1.0% vs. 1.3%, P = 0.54), MI (4.5% vs. 3.6%, P = 0.51), TVR (4.5% vs. 3.6%, P = 0.51) and stent thrombosis (1.1 vs. 1.5%, P = 1.00) were also comparable between groups. When assessing outcomes of the overlap population according to overlap configurations used, no difference was observed in terms of the device- or patient-related composite endpoints. CONCLUSIONS: Outcomes of patients with or without overlapping BVS were comparable at mid-term follow-up despite higher angiographic complexity of the overlap subset. © 2017 Wiley Periodicals, Inc.
Assuntos
Implantes Absorvíveis , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Everolimo/administração & dosagem , Isquemia Miocárdica/cirurgia , Intervenção Coronária Percutânea/instrumentação , Idoso , Fármacos Cardiovasculares/efeitos adversos , Angiografia Coronária , Everolimo/efeitos adversos , Feminino , Humanos , Itália , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/mortalidade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Estudos Prospectivos , Desenho de Prótese , Recidiva , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Tomografia de Coerência Óptica , Resultado do Tratamento , Ultrassonografia de IntervençãoRESUMO
OBJECTIVES: To evaluate the acute recoil of the ABSORB bioabsorbable vascular scaffold (BVS) and its relationship with procedural characteristics in a real world population. BACKGROUND: In vivo acute recoil of the BVS was evaluated in selected patients. METHODS: Acute recoil was studied with videodensitometry in a consecutive series of patients treated by means of a BVS, and the results were compared with those obtained in subjects receiving an everolimus-eluting stent (EES). Recoil was defined as the difference between the mean diameter of the fully expanded balloon on which the device was mounted (or the mean diameter of the post-dilatation balloon), and the mean luminal diameter of the treated segment immediately after the final inflation. RESULTS: Recoil was assessed in 106 lesions treated with a BVS and 71 treated with an EES. The absolute and percent recoil of the BVS were significantly greater (0.32 ± 0.16 mm and 10% ± 5% vs. 0.17 ± 0.07 and 5% ± 3%; P < 0.001). Multiple regression analysis showed that BVS use was associated with acute recoil (ß = 0.477; P<0.001). Suboptimal lesion preparation (residual stenosis after balloon angioplasty >20%) (ß = 0.217; P = 0.027) and a small vessel reference diameter (ß = 0.335; P = 0.002) were associated with increased BVS but not EES recoil. CONCLUSIONS: In unselected patients, the acute recoil of the BVS was significantly greater than that of the metal EES. In the BVS group, residual stenosis after predilatation correlated with percent recoil, and so optimal lesion preparation seems to be mandatory in order to maximize the mechanical properties of the scaffold.
Assuntos
Implantes Absorvíveis , Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Everolimo/administração & dosagem , Adulto , Idoso , Angioplastia Coronária com Balão/mortalidade , Estudos de Coortes , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Feminino , Seguimentos , Humanos , Itália , Masculino , Metais , Pessoa de Meia-Idade , Análise Multivariada , Desenho de Prótese , Falha de Prótese , Análise de Regressão , Estudos Retrospectivos , Medição de Risco , Índice de Gravidade de Doença , Taxa de Sobrevida , Resultado do TratamentoRESUMO
AIMS: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting. BACKGROUND: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available. METHODS: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. RESULTS: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). CONCLUSION: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Idoso , Antibióticos Antineoplásicos/administração & dosagem , Doenças Cardiovasculares/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Revascularização Miocárdica/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Sistema de Registros , Estudos Retrospectivos , Sirolimo/administração & dosagem , Trombose/epidemiologia , Resultado do TratamentoRESUMO
OBJECTIVES: The objective of this study was to investigate mid-term clinical outcomes of patients treated with 'full-plastic jacket' (FPJ) everolimus-eluting Absorb bioresorbable vascular scaffold (BRS) implantation. BACKGROUND: FPJ with BRS may represent an interesting option for patient with diffuse coronary artery disease (CAD), but data on the clinical impact of FPJ using the Absorb BRS are scant. METHODS: FPJ was defined as the implantation of >56â¯mm of overlapping BRS in at least one vessel. We compared outcomes of patients receiving Absorb FPJ vs. non-FPJ within the multicenter prospective RAI Registry. RESULTS: Out of 1505 consecutive patients enrolled in the RAI registry, 1384 were eligible for this analysis. Of these, 143 (10.3%) were treated with BRS FPJ. At a median follow-up of 649â¯days, no differences were observed between FPJ and non-FPJ groups in terms of the device-oriented composite endpoint (DoCE) (5.6% vs. 4.4%, pâ¯=â¯0.675) or the patient-related composite endpoint (PoCE) (20.9% vs. 15.9%, pâ¯=â¯0.149). Patients receiving FPJ had higher rates of target vessel repeat revascularization (TVR) (11.2% vs. 6.3%, pâ¯=â¯0.042). In the FPJ group, there was no cardiac death and only one (very late) stent thrombosis (ST) (0.7%). CONCLUSIONS: Mid-term outcomes of a FPJ PCI strategy in the setting of diffuse CAD did not show a significant increase in composite device- and patient-related events, with rates of cardiac death and ST comparable to non-FPJ Absorb BRS implantation. However, these findings are hypothesis generating and requiring further validation.
Assuntos
Implantes Absorvíveis , Prótese Vascular/tendências , Doença da Artéria Coronariana/terapia , Stents Farmacológicos/tendências , Everolimo/administração & dosagem , Sistema de Registros , Implantes Absorvíveis/tendências , Idoso , Doença da Artéria Coronariana/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Alicerces Teciduais/tendências , Resultado do TratamentoRESUMO
BACKGROUND: The bioresorbable vascular scaffold (BVS) technology may be an appealing option in ST-segment elevation myocardial infarction (STEMI) patients. However, the available evidence on its use in this challenging subset is limited. METHODS: Registro Absorb Italiano (RAI) is a multicenter, prospective registry that aims to assess BVS performance through a 5-year follow-up of all consecutive patients who undergone at least 1 successful BVS implantation. As a part of it, a subgroup analysis in STEMI patients was performed and the outcomes of this cohort compared to the remaining population (defined as "non-STEMI") are reported here. RESULTS: Among the 1505 patients enrolled, 317 (21.1%) had STEMI on admission. Among those, 232 (73.2%) underwent primary percutaneous coronary intervention (PCI) within 12â¯h from symptom onset; 64 (20.2%) were late-comers (>12â¯h); 16 (5%) underwent PCI after successful thrombolysis while 5 (1.6%) underwent rescue-PCI. At a median follow-up time of 12â¯months (IQR 6-20â¯months) no differences were noticed between STEMI and "non-STEMI" groups in terms of device-oriented composite endpoint (4.1% vs. 5.6%; pâ¯=â¯0.3) and its singular components: ischemia-driven target lesion revascularization (3.2% vs. 3.6%; pâ¯=â¯0.7), target-vessel myocardial infarction (3.2% vs. 2.8%; pâ¯=â¯0.7) and cardiac death (0.6% vs. 0.6%; pâ¯=â¯0.9). The rate of definite/probable scaffold thrombosis (ScT) was numerically higher but not significant in the STEMI group (2.5% vs. 1.3%; pâ¯=â¯0.1). CONCLUSIONS: BVS implantation in an unrestricted cohort of STEMI patients is associated with a numerically higher rate of ScT compared to the non-STEMI group. Further studies exploring the potential clinical impact of a pre-specified BVS implantation strategy in this high-risk clinical setting are needed.
Assuntos
Implantes Absorvíveis/tendências , Prótese Vascular/tendências , Sistema de Registros , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Enxerto Vascular/tendências , Idoso , Estudos de Coortes , Feminino , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/tendências , Estudos Prospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/epidemiologia , Alicerces Teciduais/tendências , Enxerto Vascular/métodosRESUMO
A 43-year-old man with systemic sclerosis and chest pain had negative T waves in precordial electrocardiographic leads. The echocardiogram showed a large left ventricular apical accessory chamber. The coronary arteries were normal. Cardiac magnetic resonance imaging (MRI) showed a large fibrotic aneurysm and a small patch of midwall late enhancement in the septum. The aneurysm was surgically removed. At the 8-month follow-up, cardiac MRI showed the appearance of a new nodular lesion in the anterior wall, causing a localized wall motion abnormality. Myocardial involvement in patients with systemic sclerosis can be severe, and cardiac MRI evaluation is fundamental.
Assuntos
Aneurisma Cardíaco/diagnóstico , Ventrículos do Coração/diagnóstico por imagem , Miocárdio/patologia , Escleroderma Sistêmico/complicações , Adulto , Procedimentos Cirúrgicos Cardíacos/métodos , Angiografia Coronária , Ecocardiografia , Eletrocardiografia , Seguimentos , Aneurisma Cardíaco/etiologia , Aneurisma Cardíaco/cirurgia , Humanos , Imagem Cinética por Ressonância Magnética , Masculino , Escleroderma Sistêmico/diagnósticoRESUMO
BACKGROUND: To assess clinical outcomes of patients needing short dual antiplatelet therapy (S-DAPT) after PCI with Cre8 polymer-free amphilimus eluting-stent (AES). The Cre8-AES with pure i-Carbofilm coating was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: We performed a sub-analysis of unrestricted consecutive patients treated with Cre8-AES between August 2011 and January 2015. Two groups were formed: 1) patients discharged with S-DAPT (≤3-month), because of high bleeding risk or attending urgent non-cardiac surgery; and 2) patients discharged with Recommended DAPT duration (R-DAPT; ≥6-month). The primary ischemic- and bleeding-safety endpoints were Target Vessel Failure (TVF, composite endpoint of cardiac-death, target vessel-myocardial infarction and target vessel-revascularization), and major-bleeding (BARC ≥type-3a) at 6-month and 1-year. RESULTS: 106 patients (8.7%) were discharged with ≤3-month DAPT (83±19days; S-DAPT group) and 1102 patients (90.6%) with ≥6-month DAPT (342±62days; R-DAPT group). Between S-DAPT and R-DAPT groups no significant differences were observed in TVF at 1-year (5.7% vs 5.1%); 1-year BARC major bleeding rate was higher in S-DAPT group (3.4% vs 0.2%, p=0.007) with all bleeding events occurred within 3months. The landmark analysis (started at 90days, ended at 1year) showed no differences in BARC major bleedings between groups (0% vs. 0.3%). CONCLUSIONS: The results of this multicenter registry show that the use of Cre8 AES in patients needing short DAPT (≤3-month) was safe regarding ischemic events and could favor a reduction of bleeding events related to the recommended DAPT. A large randomized trial is necessary to support these preliminary findings.
Assuntos
Síndrome Coronariana Aguda/cirurgia , Reestenose Coronária/prevenção & controle , Stents Farmacológicos , Oclusão de Enxerto Vascular/prevenção & controle , Revascularização Miocárdica/métodos , Inibidores da Agregação Plaquetária/uso terapêutico , Polímeros , Síndrome Coronariana Aguda/tratamento farmacológico , Idoso , Reestenose Coronária/epidemiologia , Feminino , Seguimentos , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Incidência , Itália/epidemiologia , Masculino , Sistema de Registros , Estudos Retrospectivos , Espanha/epidemiologia , Fatores de TempoRESUMO
PURPOSE: To evaluate the outcome of patients with an established indication for oral anticoagulation (OAC) undergoing coronary stent implantation (PCI-S) and stratified by the baseline risk of bleeding. MATERIAL AND METHODS: The database of the prospective, multicentre, observational WAR-STENT registry (ClinicalTrials.gov identifier NCT00722319) was analyzed and patients with atrial fibrillation and CHA2DS2-VASc score ≥2, mechanical heart valve, prior cardiac embolism, intra-cardiac thrombus and recent venous thromboembolism who were treated with either triple (warfarin, aspirin and clopidogrel) or dual (warfarin and clopidogrel) or dual antiplatelet (aspirin and clopidogrel) therapy, identified. Patients were then sorted into two groups at non-low and low risk of bleeding, as defined by an ATRIA score >3 and ≤3 respectively, and compared regarding major adverse cardiac and vascular events (MACVE) and bleeding. RESULTS: At 12-month follow up, MACVE were comparable in the two groups, whereas total, major and minor bleeding, as well as combined MACVE and total bleeding, were significantly more frequent in the non-low bleeding risk group. Upon Cox univariate and multivariable analysis, non-low bleeding risk category confirmed as an independent predictor of major bleeding. The choice of antithrombotic therapy however, appeared not to be influenced by the bleeding risk category at baseline. CONCLUSIONS: In patients with an established indication for OAC undergoing PCI-S, non-low bleeding risk category is the most potent independent predictor of major bleeding. Stratification of the bleeding risk at baseline should therefore be regarded as an indispensable process to be carried out before selection of the antithrombotic therapy.
Assuntos
Anticoagulantes/uso terapêutico , Doença da Artéria Coronariana/cirurgia , Hemorragia/prevenção & controle , Inibidores da Agregação Plaquetária/uso terapêutico , Stents , Ticlopidina/análogos & derivados , Varfarina/uso terapêutico , Administração Oral , Adulto , Idoso , Anticoagulantes/administração & dosagem , Clopidogrel , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Stents/efeitos adversos , Terapia Trombolítica , Ticlopidina/administração & dosagem , Ticlopidina/uso terapêutico , Resultado do Tratamento , Varfarina/administração & dosagem , Adulto JovemRESUMO
OBJECTIVES: This study sought to compare clinical outcome of polymer-free amphilimus-eluting stent (PF-AES) versus biodegradable-polymer biolimus-eluting stent (BD-BES) in "all-comer" diabetes mellitus (DM) and non-DM patients who underwent percutaneous coronary intervention. BACKGROUND: The PF-AES has shown promising preliminary results in patients with DM. METHODS: Data from 2 multicentre-national registries (the ASTUTE and the INSPIRE-1) were used to analyse 1776 patients stratified in non-DM and DM. A double 1:1 propensity-score matched analysis (PF-AES vs. BD-BES) was performed in each group to adjust for clinical and procedural characteristics. Primary stent-efficacy and stent-safety endpoints were 1-year target-lesion revascularization (TLR) and target-lesion failure (TLF, composed of cardiac-death, target-vessel myocardial infarction and any TLR). RESULTS: After propensity-score matching, 850 patients were stratified as non-DM (425 PF-AES/425 BD-BES) and 480 as DM patients (240 PF-AES/240 BD-BES). Both TLF (20 of 425 [5%] vs. 24 of 425 [6%]; Plog-rank=0.527) and TLR (9 of 425 [2%] vs. 18 of 425 [4%]; Plog-rank=0.079) were similar between PF-AES and BD-BES in non-DM patients. In DM, TLF (12 of 240 [5%] vs. 31 of 240 [13%]; Plog-rank=0.002) and TLR (9 of 240 [4%] vs. 21 of 240 [9%]; Plog-rank=0.019) were significantly lower in PF-AES compared to BD-BES. Upon multivariate analysis, the most powerful predictors of TLF were chronic kidney disease in non-DM (OR 4.24, 95% CI: 2.07-8.70, p<0.001) and stent type in DM patients (OR 2.76, 1.36-5.56, p=0.005). CONCLUSIONS: This matched-cohort study suggests that PF-AES has better safety and efficacy profile than BD-BES in patients with DM.
Assuntos
Implantes Absorvíveis/normas , Doença da Artéria Coronariana/cirurgia , Diabetes Mellitus/cirurgia , Stents Farmacológicos/normas , Polímeros , Sirolimo/análogos & derivados , Idoso , Anti-Inflamatórios/administração & dosagem , Estudos de Coortes , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/fisiopatologia , Diabetes Mellitus/epidemiologia , Diabetes Mellitus/fisiopatologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Intervenção Coronária Percutânea/normas , Sistema de Registros , Sirolimo/administração & dosagemRESUMO
BACKGROUND: In-water exercise, hydrotherapy, may offer an attractive alternative to conventional training in markedly compromised patients with advanced HF. This Pilot Study evaluates the safety and efficacy of Cardio-Hydrokinesitherapy (Cardio-HKT) in patients with advanced HF on optimal medical therapy. Cardio-HKT is a novel rehabilitation program that includes training sessions in warm water (31 degrees C), integrated by educational and psycho-behavioural sessions to promote healthy life style modifications. METHODS: We studied 18 adult patients with advanced HF, LVEF < 35%, NYHA functional class > II and peak oxygen uptake (peak VO2) < 18 ml/kg/min. Cardio-HKT consisted of a 3 weeks daily in-water training, combined to educational and psycho-behavioural sessions. Patients underwent a six-minute-walking-test (6mWT), a cardiopulmonary exercise test at baseline and after 3 weeks of Cardio-HKT. Quality of life was assessed with the Minnesota Living with Heart Failure Questionnaire (MLHF). RESULTS: All patients completed the Cardio-HKT rehabilitation program without complications. The 6mWT improved from 453 +/- 172 m to 571 +/- 120 m (p < 0.01), peak VO2 from 13.0 +/- 3.1 to 14.5 +/- 2.9 ml/kg/min (p = 0.03), whereas VE/ CO2 slope declined from 37 +/- 10 to 33 +/- 9 (p = 0.01). MLHF markedly improved from 56 (68-27) to 18 (40-7) (p < 0.01). CONCLUSIONS: Our results support the safety and efficacy of the innovative Cardio-HKT rehabilitation program in patients with advanced HF.
Assuntos
Terapia por Exercício , Insuficiência Cardíaca/reabilitação , Hidroterapia/métodos , Adulto , Idoso , Feminino , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Minnesota , Projetos Piloto , Qualidade de Vida , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Despite several improvements in drug-eluting stent (DES) technology, patients with diabetes mellitus (DM) are affected by higher rate of adverse events after PCI with DES, mainly in terms of target lesion revascularization (TLR). The Cre8 stent, a polymer-free amphilimus-eluting stent (AES), has shown promising preliminary results in DM patients. The ASTUTE registry was conceived to assess clinical performance of this polymer-free AES in DM in a "real-world" multicenter-independent cohort of patients. METHODS: 1216 consecutive patients (1637 lesions) treated with Cre8 between August 2011 and January 2015 were retrospectively enrolled and divided in two groups: DM and non-DM patients. The primary and secondary endpoints were target lesion failure (TLF) and TLR at 1-year, respectively. RESULTS: 1-Year clinical outcome was available for 407 (80%) DM and 566 (84%) non-DM patients. Diabetic patients were more frequently affected by hypertension (p<0.001) and dyslipidemia (p<0.001) and more frequently dialyzed (p=0.010). At 1-year, TLF occurred in 50 (5.1%) overall patients, and was similar in DM and non-DM patients (4.9 vs 5.3%, respectively, p=0.788). The secondary endpoint (TLR) occurred in 3% of overall patients and similarly in DM and non-DM patients (3.7 vs 2.5%, respectively, p=0.273). Primary and secondary endpoints were similar also between insulin and non-insulin dependent DM patients. CONCLUSIONS: The results of this large, real-world, multicenter-independent registry show that Cre8 AES has similar safety and efficacy profile in DM as well as non-DM patients, reducing the adverse outcomes related to DM in patients undergoing PCI. A large randomized trial will be necessary to definitely prove these preliminary findings.
Assuntos
Fármacos Cardiovasculares/administração & dosagem , Doença da Artéria Coronariana/terapia , Diabetes Mellitus/terapia , Stents Farmacológicos , Intervenção Coronária Percutânea/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/tratamento farmacológico , Diabetes Mellitus/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. METHODS/DESIGN: The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche "Mario Negri" Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. CONCLUSIONS: The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres.
Assuntos
Implantes Absorvíveis/estatística & dados numéricos , Estenose Coronária/terapia , Stents Farmacológicos/estatística & dados numéricos , Everolimo/uso terapêutico , Sistema de Registros/estatística & dados numéricos , Idoso , Seguimentos , Humanos , Imunossupressores/uso terapêutico , Itália , Estudos Prospectivos , Desenho de Prótese , Resultado do TratamentoRESUMO
Despite first-generation drug-eluting stents (DES) dramatically reduced the need for repeat revascularization in patients undergoing percutaneous coronary intervention, their use was associated with an increased risk of thrombotic events at long-term follow-up. The Nobori biolimus-eluting stent (BES) is a second-generation DES with a biodegradable poly-lactic acid polymer. During the last few years, several randomized trials have compared the Nobori BES with other DES, making this device the most investigated biodegradable DES. In this article, we reviewed current available data about Nobori BES from pharmacokinetic and observational studies to randomized clinical trials.
Assuntos
Stents Farmacológicos , Sirolimo/análogos & derivados , Animais , Proliferação de Células/efeitos dos fármacos , Portadores de Fármacos , Avaliação Pré-Clínica de Medicamentos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Sirolimo/administração & dosagem , Sirolimo/farmacologiaRESUMO
Stress cardiomyopathy is a newly described reversible cardiomyopathy, characterized by transient cardiac dysfunction usually precipitated by intense emotional or physical stress. Apart from the classical apical ballooning syndrome (Takotsubo), it is now increasingly recognized that the spectrum of stress cardiomyopathies is quite wide, with significant individual variations in clinical and morphological pattern. Very recently, it has been suggested that, in young boys in stressful situations, atypical forms of stress cardiomyopathy could be associated with malignant arrhythmias. We describe the case of a 14-year-old boy, in whom stress cardiomyopathy with mid-ventricular ballooning started with an arrhythmic storm.