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1.
Am Heart J ; 239: 19-26, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33992606

RESUMO

Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based assessment aiming at less-invasiveness and shorter procedural time as well as cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement of multiple projections and are time consuming. METHODS/DESIGN: The ReVEAL iFR (Radiographic imaging Validation and EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims to validate the diagnostic accuracy of the Angio-iFR medical software device (Philips, San Diego, US) in patients undergoing angiography for Chronic Coronary Syndrome (CCS). The Angio-iFR will enable operators to predict both the iFR and FFR value within a few seconds from a single projection of cine angiography by using a lumped parameter fluid dynamics model. Approximately 440 patients with at least one de-novo 40% to 90% stenosis by visual angiographic assessment will be enrolled in the study. The primary endpoint is the sensitivity and specificity of the iFR and FFR for a given lesion compared to the corresponding invasive measures. The enrollment started in August 2019, and was completed in March 2021. SUMMARY: The Angio-iFR system has the potential of simplifying physiological evaluation of coronary stenosis compared with available systems, providing estimates of both FFR and iFR. The ReVEAL iFR study will investigate the predictive performance of the novel Angio-iFR software in CCS patients. Ultimately, based on its unique characteristics, the Angio-iFR system may contribute to improve adoption of functional coronary assessment and the workflow in the catheter laboratory.


Assuntos
Angiografia Coronária , Estenose Coronária/diagnóstico por imagem , Vasos Coronários , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Software/normas , Angiografia Coronária/métodos , Angiografia Coronária/tendências , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/fisiopatologia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/fisiopatologia , Precisão da Medição Dimensional , Humanos , Avaliação de Resultados em Cuidados de Saúde , Valor Preditivo dos Testes , Sensibilidade e Especificidade , Índice de Gravidade de Doença
2.
Catheter Cardiovasc Interv ; 98(3): E379-E387, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33951265

RESUMO

OBJECTIVES: We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial. BACKGROUND: TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated. METHODS: Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD <3 mm were analyzed in 893 PCI patients and were compared to 865 CABG patients. RESULTS: TSL as a continuous variable was significantly associated with 10-year mortality (adjusted hazard ratio [HR], 1.05 [1.01-1.09] per 10 mm increase). PCI patients with extensive stenting had a higher 10 year mortality than CABG patients (adjusted HR, 1.97 [1.41-2.74]) or not- extensive stenting PCI (adjusted HR, 1.94 [1.36-2.77]). Although ASD did not have a significant association with 10 year mortality (adjusted HR, 0.97 [0.85-1.11] per 0.25 mm increase), PCI with small stents was associated with a higher 10 year mortality, compared to CABG (adjusted HR, 1.66 [1.23-2.26]) and PCI performed with large stents (adjusted HR, 1.74 [1.19-2.53]). Patients treated with not-extensive and large stents had similar mortality rates (24.0 versus 23.8%) as those treated with CABG. CONCLUSIONS: Extensive and small stenting were associated with higher 10 year mortality, compared with CABG. When patients have to be treated with extensive or small stenting, revascularization with CABG should be preferred.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Stents , Resultado do Tratamento
3.
J Electrocardiol ; 66: 114-121, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33906059

RESUMO

BACKGROUND: Atrial fibrillation (AF) induces functional mitral regurgitation (FMR) and tricuspid regurgitation (FTR) during atrial remodeling. FMR and FTR are associated with AF prognosis, but the effects for AF recurrence after ablation have not been determined conclusively. METHODS: Two hundred thirty nine patients who underwent AF ablation were enrolled. Forty five patients were excluded. In total, 194 patients were analyzed. FMR and FTR were assessed by echocardiography. The left atrial volume index (LAVI) was evaluated by contrast-enhanced computed tomography. RESULTS: Significant FMR and moderate FTR were observed in 15 (7.7%) and in 25 (12.9%) patients, respectively. The severity of tricuspid regurgitation (TR) significant correlated with age, NT-proBNP, and LAVI. During a 13.4 month follow-up period of, 39 patients (20.1%) demonstrated AF recurrence. In the Cox proportional-hazards model, E/e', FTR, and LAVI, were termed as predictor factors of AF recurrence (E/e'. hazard ratio [HR] = 1.117; P = 0.019, significant FTR. HR = 4.679; P = 0.041, LAVI. HR = 1.057; P = 0.003). Kaplan-Meier analysis showed that AF recurrence was more frequent in FTR compared with the nonsignificant FTR cases (log-rank, P = 0.001). Although survival analysis showed no difference with or without FMR, the presence of FMR and FTR was strongly associated with high-AF recurrence (log-rank, P = 0.004). CONCLUSIONS: AF recurrence was associated with E/e', LAVI, and extensive FTR. Specifically, the combination of FTR and FMR markedly worsens the AF prognosis.


Assuntos
Fibrilação Atrial , Insuficiência da Valva Mitral , Insuficiência da Valva Tricúspide , Fibrilação Atrial/cirurgia , Eletrocardiografia , Átrios do Coração , Humanos , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/cirurgia
5.
Catheter Cardiovasc Interv ; 98(7): 1287-1297, 2021 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33539048

RESUMO

AIMS: We aimed to update the logistic clinical SYNTAX score to predict 2 year all-cause mortality after contemporary percutaneous coronary intervention (PCI). METHODS AND RESULTS: We analyzed 15,883 patients in the GLOBAL LEADERS study who underwent PCI. The logistic clinical SYNTAX model was updated after imputing missing values by refitting the original model (refitted original model) and fitting an extended new model (new model, with, selection based on the Akaike Information Criterion). External validation was performed in 10,100 patients having PCI at Fu Wai hospital. Chronic obstructive pulmonary disease, prior stroke, current smoker, hemoglobin level, and white blood cell count were identified as additional independent predictors of 2 year all-cause mortality and included into the new model. The c-indexes of the original, refitted original and the new model in the derivation cohort were 0.74 (95% CI 0.72-0.76), 0.75 (95% CI 0.73-0.77), and 0.78 (95% CI 0.76-0.80), respectively. The c-index of the new model was lower in the validation cohort than in the derivation cohort, but still showed improved discriminative ability of the newly developed model (0.72; 95% CI 0.67-0.77) compared to the refitted original model (0.69; 95% CI 0.64-0.74). The models overestimated the observed 2 year all-cause mortality of 1.11% in the Chinese external validation cohort by 0.54 percentage points, indicating the need for calibration of the model to the Chinese patient population. CONCLUSIONS: The new model of the logistic clinical SYNTAX score better predicts 2 year all-cause mortality after PCI than the original model. The new model could guide clinical decision making by risk stratifying patients undergoing PCI.

6.
JACC Cardiovasc Interv ; 14(3): 237-246, 2021 02 08.
Artigo em Inglês | MEDLINE | ID: mdl-33541534

RESUMO

Intracoronary physiology is routinely used in setting the indication for percutaneous coronary intervention (PCI) but seldom in assessing procedural results. This attitude is increasingly challenged by accumulated evidence demonstrating the value of post-PCI functional assessment in predicting long-term patient outcomes. Besides fractional flow reserve, a number of new indexes recently incorporated to clinical practice, including nonhyperemic pressure and functional angiographic indexes, provide new opportunities for the physiological assessment of PCI results. Largely, the benefit of these tools is derived from longitudinal analysis of the treated vessel, which allows precise identification of the vessel segment accounting for a suboptimal functional result and enabling operators to perform accurate PCI optimization. In this document the authors review available evidence supporting why physiological assessment should be extended to immediate post-PCI with the aim of improving patient outcomes. A step-by-step guide on how available physiological tools can be used for such purpose is provided.


Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Stents , Angiografia Coronária , Doença da Artéria Coronariana/cirurgia , Reserva Fracionada de Fluxo Miocárdico , Humanos , Medicina de Precisão , Valor Preditivo dos Testes , Resultado do Tratamento
8.
Future Cardiol ; 17(2): 227-237, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32907391

RESUMO

Percutaneous coronary interventions with drug-eluting stents is currently the preferred revascularization treatment strategy for coronary artery disease. Following the first generation, the second-generation drug-eluting stents was designed with a thinner strut, better biocompatible polymer with/without bioresorbable coating or even polymer-free struts. The SUPRAFLEX stent system has ultra-thin struts (60 µm) across all stent diameters and a biodegradable polymer coating, enabling 70% of the sirolimus elution within 7 days. SUPRAFLEX has been assessed in large scale randomized controlled trials. This review summarizes the design of the SUPRAFLEX stent, the results of the pivotal clinical trials and outlines the ongoing research programs.

9.
Cardiovasc Revasc Med ; 25: 29-35, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33109476

RESUMO

AIMS: The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD). STUDY DESIGN: The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021. CONCLUSIONS: The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD. Clinical Trial Registration URL: https://clinicaltrials.gov. Unique identifier: NCT03913832.


Assuntos
Angioplastia Coronária com Balão , Fármacos Cardiovasculares , Doença da Artéria Coronariana , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Humanos , Paclitaxel , Estudos Prospectivos , Sirolimo , Resultado do Tratamento
10.
EuroIntervention ; 16(18): e1484-e1495, 2021 Apr 02.
Artigo em Inglês | MEDLINE | ID: mdl-32338610

RESUMO

Composite endpoints are commonly used in clinical trials, and time-to-first-event analysis has been the usual standard. Time-to-first-event analysis treats all components of the composite endpoint as having equal severity and is heavily influenced by short-term components. Over the last decade, novel statistical approaches have been introduced to overcome these limitations. We reviewed win ratio analysis, competing risk regression, negative binomial regression, Andersen-Gill regression, and weighted composite endpoint (WCE) analysis. Each method has both advantages and limitations. The advantage of win ratio and WCE analyses is that they take event severity into account by assigning weights to each component of the composite endpoint. These weights should be pre-specified because they strongly influence treatment effect estimates. Negative binomial regression and Andersen-Gill analyses consider all events for each patient -rather than only the first event - and tend to have more statistical power than time-to-first-event analysis. Pre-specified novel statistical methods may enhance our understanding of novel therapy when components vary substantially in severity and timing. These methods consider the specific types of patients, drugs, devices, events, and follow-up duration.


Assuntos
Projetos de Pesquisa , Determinação de Ponto Final , Humanos , Recidiva
11.
Can J Cardiol ; 37(1): 122-130, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32450057

RESUMO

BACKGROUND: Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding. METHODS: Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days. RESULTS: In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; Pinteraction = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; Pinteraction = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant. CONCLUSIONS: Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.


Assuntos
Artéria Femoral , Hemorragia/epidemiologia , Intervenção Coronária Percutânea/métodos , Artéria Radial , Medição de Risco , Idoso , Doença da Artéria Coronariana/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/epidemiologia , Acidente Vascular Cerebral/epidemiologia
12.
J Atheroscler Thromb ; 28(6): 590-603, 2021 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-32863297

RESUMO

AIM: Arterial stiffness results in elevated left ventricular filling pressure and can promote atrial remodeling due to chronic pressure overload. However, the impact of arterial stiffness on the process of atrial remodeling in association with atrial fibrillation (AF) has not been fully evaluated. METHODS: We enrolled 237 consecutive patients diagnosed with AF who had undergone ablation; data from 213 patients were analyzed. Cardio-ankle vascular index (CAVI) was used as a marker of arterial stiffness. The left atrial (LA) and right atrial (RA) volumes were determined by computed tomography imaging; atrial conduction and voltage amplitude were evaluated using a three-dimensional electromapping system used to guide the ablation procedure. RESULT: In univariate analysis, CAVI significantly correlated with atrial structural and electrical remodeling (LA volume index, r=0.297, P=0.001; RA volume index, r=0.252, P=0.004; LA conduction velocity, r=0.254, P= 0.003; LA mean voltage, r=-0.343, P=0.001, RA mean voltage; r=-0.245, P=0.015). Multivariate regression analysis revealed that CAVI and plasma levels of N-terminal B-type natriuretic peptide were independent determinants of LA and RA remodeling, respectively. On the other hand, age and LA conduction velocity were independent variables with respect to CAVI. Age-adjusted CAVI was highest in long-standing persistent AF when compared with measures of persistent or paroxysmal AF. CONCLUSION: CAVI was closely associated with biatrial remodeling in patients diagnosed with AF. These results suggest that arterial stiffness may play a significant role with respect to disease progression.

13.
EuroIntervention ; 16(16): 1333-1341, 2021 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-31289018

RESUMO

AIMS: The feasibility of offline optical coherence tomography (OCT) guidance in bifurcation (with either two-dimensional or three-dimensional images) and its potential benefits have been demonstrated in retrospective studies; however, these have not yet been investigated prospectively. The aim of this trial is to determine the superiority of online three-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition (ISA) at the bifurcation segment. METHODS AND RESULTS: The OPTIMUM trial is a randomised, superiority, multicentre clinical trial. The primary endpoint of this trial is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing balloon dilatation (FKBD). A total of 106 patients will be randomly allocated to either 3D-OFDI guidance or angiography guidance PCI. Bifurcation lesions will be treated with a provisional single-stent strategy using the Ultimaster sirolimus-eluting stent. Patients randomised to the 3D-OFDI guidance arm will undergo OFDI assessment in the main branch (MV) after rewiring into the jailed side branch following stent implantation, while in the angiography guidance arm re-crossing of a wire into the side branch will be performed using conventional fluoroscopic/angiographic guidance. In patients in the 3D-OFDI guidance arm, if the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm the re-crossing position. The proximal optimisation technique and FKBD are mandatory in this trial. The study will provide a 90% power to show superiority of 3D-OFDI guidance PCI compared with angiography-guided PCI. CONCLUSIONS: The OPTIMUM trial will be the first prospective, randomised trial to evaluate the efficacy and safety of online 3D-OFDI-guided PCI in bifurcation lesions. ClinicalTrials.gov Identifier: NCT02972489.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Humanos , Estudos Prospectivos , Estudos Retrospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento
14.
Circ Cardiovasc Interv ; 13(12): e009183, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33272034

RESUMO

BACKGROUND: Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment. METHODS: The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches. RESULTS: Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P=0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36-0.81]; P=0.003). CONCLUSIONS: Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02972489.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Angiografia Coronária , Humanos , Estudos Prospectivos , Tomografia de Coerência Óptica , Resultado do Tratamento
15.
JACC Cardiovasc Interv ; 13(19): 2251-2262, 2020 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-32950419

RESUMO

OBJECTIVES: The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD). BACKGROUND: Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far. METHODS: The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months. RESULTS: From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred. CONCLUSIONS: Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856).


Assuntos
Doença da Artéria Coronariana , Aspirina , Stents Farmacológicos , Humanos , Intervenção Coronária Percutânea , Projetos Piloto , Inibidores da Agregação Plaquetária , Cloridrato de Prasugrel , Resultado do Tratamento
16.
EuroIntervention ; 16(12): e997-e1004, 2020 12 18.
Artigo em Inglês | MEDLINE | ID: mdl-32928717

RESUMO

AIMS: The purpose of the Multivessel TALENT trial is to compare clinical outcomes of the novel Supraflex Cruz stent with those of the SYNERGY stent in patients with three-vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this prospective, randomised, 1:1 balanced, multicentre, open-label trial, 1,550 patients with de novo 3VD without left main disease will be assigned to the Supraflex Cruz or SYNERGY arm. The following treatment principles of "best practice" PCI will be applied: Heart Team consensus based on SYNTAX score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimisation by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularisation, at 12 months post procedure. The powered secondary endpoint is a superiority comparison of the vessel-oriented composite endpoint (VOCE), defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically indicated target vessel revascularisation, at 24 months. CONCLUSIONS: The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin Supraflex Cruz stents, compared with SYNERGY stents. Clinical Trial Registration URL: https://www.clinicaltrials.gov/ct2/show/NCT04390672. Unique Identifier: NCT04390672


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/tratamento farmacológico , Doença da Artéria Coronariana/cirurgia , Everolimo/uso terapêutico , Humanos , Polímeros , Estudos Prospectivos , Sirolimo/uso terapêutico , Stents , Resultado do Tratamento
17.
Circ Cardiovasc Qual Outcomes ; 13(8): e006660, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32762446

RESUMO

BACKGROUND: Time-to-first-event analysis considers only the first event irrespective of its severity. There are several methods to assess trial outcomes beyond time-to-first-event analysis, such as analyzing total events and ranking outcomes. In the GLOBAL LEADERS study, time-to-first-event analysis did not show superiority of ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention to conventional 12-month DAPT followed by aspirin monotherapy in the reduction of the primary composite end point of all-cause mortality or new Q-wave myocardial infarction. This study sought to explore various analytical approaches in assessing total ischemic and bleeding events after percutaneous coronary intervention in the GLOBAL LEADERS study. METHODS AND RESULTS: Total ischemic and bleeding events were defined as all-cause mortality, any stroke, any myocardial infarction, any revascularization, or Bleeding Academic Research Consortium grade 2 or 3 bleeding. We used various analytical approaches to analyze the benefit of ticagrelor monotherapy over conventional DAPT. For ischemic and bleeding events at 2 years after percutaneous coronary intervention, ticagrelor monotherapy demonstrated a 6% risk reduction, compared with conventional 12-month DAPT in time-to-first-event analysis (hazard ratio, 0.94 [95% CI, 0.88-1.01]; log-rank P=0.10). In win ratio analysis, win ratio was 1.05 (95% CI, 0.97-1.13; P=0.20). Negative binomial regression and Andersen-Gill analyses which include repeated events showed statistically significant advantage for ticagrelor monotherapy (rate ratio, 0.92 [95% CI, 0.85-0.99; P=0.020] and hazard ratio, 0.92 [95% CI, 0.85-0.99; P=0.028], respectively), although in weighted composite end point analysis, the hazard ratio was 0.93 (95% CI, 0.84-1.04; log-rank P=0.22). CONCLUSIONS: Statistical analyses considering repeated events or event severity showed that ticagrelor monotherapy consistently reduced ischemic and bleeding events by 5% to 8%, compared with conventional 1-year DAPT. Applying multiple statistical methods could emphasize the multiple facets of a trial and result in accurate and more appropriate analyses. Considering the recurrence of ischemic and bleeding events, ticagrelor monotherapy appeared to be beneficial after percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.


Assuntos
Aspirina/uso terapêutico , Terapia Antiplaquetária Dupla , Determinação de Ponto Final , Estudos de Equivalência como Asunto , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária/uso terapêutico , Projetos de Pesquisa , Ticagrelor/uso terapêutico , Aspirina/efeitos adversos , Interpretação Estatística de Dados , Terapia Antiplaquetária Dupla/efeitos adversos , Hemorragia/induzido quimicamente , Humanos , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Infarto do Miocárdio/prevenção & controle , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/prevenção & controle , Ticagrelor/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
18.
Circ Cardiovasc Interv ; 13(9): e009177, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32838554

RESUMO

BACKGROUND: Bleeding and myocardial infarction (MI) after percutaneous coronary intervention are independent risk factors for mortality. This study aimed to investigate the association of all-cause mortality after percutaneous coronary intervention with site-reported bleeding and MI, when considered as individual, repeated, or combined events. METHODS: We used the data from the GLOBAL LEADERS trial (GLOBAL LEADERS: A Clinical Study Comparing Two Forms of Anti-Platelet Therapy After Stent Implantation), an all-comers trial of 15 968 patients undergoing percutaneous coronary intervention. Bleeding was defined as Bleeding Academic Research Consortium (BARC) 2, 3, or 5, whereas MI included periprocedural and spontaneous MIs according to the Third Universal Definition. RESULTS: At 2-year follow-up, 1061 and 498 patients (6.64% and 3.12%) experienced bleeding and MI, respectively. Patients with a bleeding event had a 10.8% mortality (hazard ratio [HR], 5.97 [95% CI, 4.76-7.49]; P<0.001), and the mortality of patients with an MI was 10.4% (HR, 5.06 [95% CI, 3.72-6.90]; P<0.001), whereas the overall mortality was 2.99%. Albeit reduced over time, MI and even minor BARC 2 bleeding significantly influenced mortality beyond 1 year after adverse events (HR of MI, 2.32 [95% CI, 1.18-4.55]; P=0.014, and HR of BARC 2 bleeding, 1.79 [95% CI, 1.02-3.15]; P=0.044). The mortality rates in patients with repetitive bleeding, repetitive MI, and both bleeding and MI were 16.1%, 19.2%, and 19.0%, and their HRs for 2-year mortality were 8.58 (95% CI, 5.63-13.09; P<0.001), 5.57 (95% CI, 2.53-12.25; P<0.001), and 6.60 (95% CI, 3.44-12.65; P<0.001), respectively. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding was associated with a lower subsequent bleeding or MI rate, compared with continuation of antiplatelet therapy (HR, 0.32 [95% CI, 0.11-0.92]; P=0.034). CONCLUSIONS: The fatal impact of bleeding and MI persisted beyond one year. Additional bleeding or MIs resulted in a poorer prognosis. De-escalation of antiplatelet therapy at the time of BARC 3 bleeding could have a major safety merit. These results emphasize the importance of considering the net clinical benefit including ischemic and bleeding events. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01813435.


Assuntos
Hemorragia/mortalidade , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea/mortalidade , Inibidores da Agregação Plaquetária/efeitos adversos , Idoso , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Stents , Fatores de Tempo , Resultado do Tratamento
19.
Front Cardiovasc Med ; 7: 119, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32850981

RESUMO

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been developed and improved as both diagnostic and guidance tools for interventional procedures over the past three decades. IVUS has a resolution of 100 µm with a high tissue penetration and capability of assessing the entire structure of a coronary artery including the external elastic membrane, whereas OCT has a higher resolution of 10-20 µm to assess endoluminal structures with a limited tissue penetration compared to IVUS. Recently, two companies, CONAVI and TERUMO, integrated IVUS and OCT into a single catheter system. With their inherent strength and limitations, the combined IVUS and OCT probes are complementary and work synergistically to enable a comprehensive depiction of coronary artery. In this review, we summarize the performance of the two intracoronary imaging modalities-IVUS and OCT-and discuss the expected potential of the novel hybrid IVUS-OCT catheter system in the clinical field.

20.
JACC Cardiovasc Interv ; 13(14): 1617-1638, 2020 07 27.
Artigo em Inglês | MEDLINE | ID: mdl-32703589

RESUMO

Physiological assessment of coronary artery disease (CAD) has become one of the cornerstones of decision making for myocardial revascularization, with a large body of evidence supporting the benefits of using fractional flow reserve and other pressure-based indexes for functional assessment of coronary stenoses. Furthermore, physiology allows the identification of specific vascular dysfunction mechanisms in patients without obstructive CAD. Currently, more than 10 modalities of functional coronary assessment are available, although the overall adoption of these physiological tools, of either intracoronary or image-based nature, is still low. In this paper the authors review these modalities of functional coronary assessment according to their timing of use: outside the catheterization laboratory, in the catheterization laboratory prior to the percutaneous coronary intervention (PCI), and in the catheterization laboratory during or after PCI. The authors discuss how the information obtained can be used in setting the indication for PCI, in planning and guiding the procedure, and in documenting the final functional result of the intervention. The advantages and limitations of each modality in each setting are discussed. Furthermore, the key value of intracoronary physiology in diagnosing mechanisms of microcirculatory dysfunction, which account for the presence of ischemia in many patients without obstructive CAD, is revisited. On the basis of the opportunities generated by the multiplicity of diagnostic tools described, the authors propose an algorithmic approach to physiological coronary investigations in clinical practice, with the key aims of: 1) avoiding unneeded revascularization procedures; 2) improving procedural PCI and long-term outcomes in patients with obstructive CAD; and 3) diagnosing vascular dysfunction mechanisms that can be effectively treated in patients with NOCAD. The authors believe that such structured approach may also contribute to the wider adoption of available technologies for functional assessment of patients with CAD.


Assuntos
Cateterismo Cardíaco , Angiografia por Tomografia Computadorizada , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Vasos Coronários/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico , Tomada de Decisão Clínica , Doença da Artéria Coronariana/fisiopatologia , Doença da Artéria Coronariana/terapia , Vasos Coronários/fisiopatologia , Humanos , Hiperemia/fisiopatologia , Microcirculação , Intervenção Coronária Percutânea , Valor Preditivo dos Testes , Prognóstico
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