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1.
Artigo em Inglês | MEDLINE | ID: mdl-31769161

RESUMO

BACKGROUND: The Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel biodegradable polymer sirolimus-eluting coronary stent has been evaluated in the randomized TARGET I trial in which low-risk patients were enrolled with strict eligibility criteria. Recently, the TARGET All Comers study has shown similar results of the Firehawk compared to the XIENCE stent (Abbott Vascular, Santa Clara). However, clinical outcomes in high-risk patients are unclear. METHODS: The TARGET All Comer study was a randomized trial that assigned patients to either Firehawk or XIENCE implantation. This TARGET AC subanalysis sought to evaluate the 2 year clinical outcomes of patients according to two risk groups; patients meeting all inclusion criteria and no exclusion criteria of the TARGET I trial were classified as "low-risk," while their counterparts were classified as "high-risk." The primary endpoint was target lesion failure. RESULTS: A total of 1,585 patients were included, of which 1,334 (84%) were classified as high-risk. At 2 years, the high-risk group had a significantly higher rate of TLF than the low-risk group (9.5% vs. 3.6%, p = .003), mainly driven by increased target vessel myocardial infarction (6.3% vs. 2.4%, p = .02). The Firehawk and XIENCE had no significant differences in TLF among both low-risk (3.1% vs. 4.2%, p = .66) and high-risk (9.9% vs. 9.1%, p = .57) patients. CONCLUSIONS: High-risk patients had worse clinical outcomes at 2 years in the TARGET All Comer study. Outcomes with the Firehawk were similar to the XIENCE stent among both low-risk and high-risk patients at 2 years.

4.
EuroIntervention ; 2019 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-31543500

RESUMO

AIMS: To demonstrate the noninferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the Xience stent regarding patients oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA). METHODS AND RESULTS: The POLBOS LM study is a single-arm prospective multi-centre study enrolling 260 patients (SYNTAX score ≤32) with pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrollment will comply with objective inclusion criteria of diameter stenosis ≥50% in LMCA based on off-line quantitative coronary angiography (QCA) analyzed by an independent core laboratory using dedicated-bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the specific technical classification for the BiOSS LIM (modified MADS classification) and the stent implantation is optimized by using pre-specified intravascular ultrasound criteria. Primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularization) at 12 months. CONCLUSION: The POLBOS LM study will indicate the efficacy of BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.

5.
EuroIntervention ; 2019 Sep 03.
Artigo em Inglês | MEDLINE | ID: mdl-31475907

RESUMO

Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularization procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug-release mechanisms and anti-proliferative drugs, have progressively reduced the rate of device-related adverse clinical events, and objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognized as an intra-procedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomized comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents including the mechanistic evaluation of coronary stents which recommend operational definitions of device success. While the majority of clinical trials investigating drug-eluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.

6.
JACC Cardiovasc Interv ; 12(17): 1679-1687, 2019 Sep 09.
Artigo em Inglês | MEDLINE | ID: mdl-31129092

RESUMO

OBJECTIVES: The aim of this study was to assess the 2-year clinical outcomes of the Firehawk stent (Shanghai MicroPort Medical Group, Shanghai, China), a novel abluminal groove-filled biodegradable-polymer sirolimus-eluting coronary stent, compared with XIENCE (Abbott Vascular, Santa Clara, California), a durable-polymer everolimus-eluting coronary stent. BACKGROUND: The long-term outcomes of the Firehawk stent have not been evaluated beyond 1 year in a randomized all-comers clinical trial. METHODS: The TARGET All Comers study is a prospective, multicenter, all-comers, randomized, noninferiority trial conducted in Europe. A total of 1,653 patients were randomly assigned to undergo implantation of either the Firehawk or the XIENCE stent. The primary endpoint was target lesion failure, a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. RESULTS: At 2-year follow-up, the incidence of target lesion failure was 8.7% in the Firehawk group versus 8.6% in the XIENCE group (p = 0.92). The event rates of individual components of the primary endpoint were comparable for the 2 groups. Landmark analyses between 1- and 2-year follow-up revealed no statistically significant difference of TLF for the Firehawk versus the XIENCE stent. Beyond 1 year, very late definite or probable stent thrombosis occurred in 3 patients (0.4%) in the Firehawk group and in 7 patients (0.9%) in the XIENCE group (p = 0.34). CONCLUSIONS: The 2-year follow-up of the TARGET All Comers study confirms comparable safety and efficacy profiles of the Firehawk and XIENCE stents.

7.
EuroIntervention ; 15(4): e362-e369, 2019 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-30066672

RESUMO

AIMS: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. METHODS AND RESULTS: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). CONCLUSIONS: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.


Assuntos
Doença da Artéria Coronariana , Stents Farmacológicos , Intervenção Coronária Percutânea , Implantes Absorvíveis , Europa (Continente) , Everolimo , Humanos , Estudos Prospectivos , Método Simples-Cego , Sirolimo , Stents , Resultado do Tratamento
8.
Eur Heart J ; 39(41): 3689-3698, 2018 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-30312411

RESUMO

Aims: Coronary computed tomography angiography (CTA) has emerged as a non-invasive diagnostic method for patients with suspected coronary artery disease, but its usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the agreement between separate heart teams on treatment decision-making based on either coronary CTA or conventional angiography. Methods and results: Separate heart teams composed of an interventional cardiologist, a cardiac surgeon, and a radiologist were randomized to assess the coronary artery disease with either coronary CTA or conventional angiography in patients with de novo left main or three-vessel coronary artery disease. Each heart team, blinded for the other imaging modality, quantified the anatomical complexity using the SYNTAX score and integrated clinical information using the SYNTAX Score II to provide a treatment recommendations based on mortality prediction at 4 years: coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or equipoise between CABG and PCI. The primary endpoint was the agreement between heart teams on the revascularization strategy. The secondary endpoint was the impact of fractional flow reserve derived from coronary CTA (FFRCT) on treatment decision and procedural planning. Overall, 223 patients were included. A treatment recommendation of CABG was made in 28% of the cases with coronary CTA and in 26% with conventional angiography. The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91). The heart teams agreed on the coronary segments to be revascularized in 80% of the cases. FFRCT was available for 869/1108 lesions (196/223 patients). Fractional flow reserve derived from coronary CTA changed the treatment decision in 7% of the patients. Conclusion: In patients with left main or three-vessel coronary artery disease, a heart team treatment decision-making based on coronary CTA showed high agreement with the decision derived from conventional coronary angiography suggesting the potential feasibility of a treatment decision-making and planning based solely on this non-invasive imaging modality and clinical information. Trial registration number: NCT02813473.


Assuntos
Tomada de Decisão Clínica/métodos , Angiografia por Tomografia Computadorizada , Angiografia Coronária , Doença da Artéria Coronariana , Vasos Coronários , Idoso , Ponte de Artéria Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea
9.
Lancet ; 392(10153): 1117-1126, 2018 09 29.
Artigo em Inglês | MEDLINE | ID: mdl-30190206

RESUMO

BACKGROUND: The FIREHAWK is a drug-eluting stent with a fully biodegradable sirolimus-containing polymer coating localised to recessed abluminal grooves on the stent surface. We investigated clinical outcomes with this targeted, low-dose, biodegradable polymer, sirolimus-eluting stent compared with XIENCE durable polymer, everolimus-eluting stents in an all-comers population. METHODS: The TARGET All Comers study was a prospective, multicentre, open-label randomised non-inferiority trial done at 21 centres in ten European countries. Patients with symptomatic or asymptomatic coronary artery disease and objective evidence of myocardial ischaemia who qualified for percutaneous coronary intervention were randomised 1:1 to undergo implantation of a FIREHAWK or XIENCE. Randomisation was web-based, with random block allocation and stratification by centre and ST elevation myocardial infarction. Outcome assessors were masked to treatment allocation, but treating physicians and patients were not. The primary endpoint was target lesion failure at 12 months, a composite of cardiac death, target vessel myocardial infarction, or ischaemia-driven target lesion revascularisation. The control event rate for XIENCE was assumed to be 7%, the non-inferiority margin was 3.5%, and the primary analysis was in the intention-to-treat population, censoring patients who did not have either an event before 365 days or contact beyond 365 days. Late lumen loss was the primary endpoint of an angiographic substudy designed to investigate the non-inferiority of the FIREHAWK compared with the XIENCE stent. This trial is registered with ClinicalTrials.gov, number NCT02520180. FINDINGS: From Dec 17, 2015, to Oct 14, 2016, 1653 patients were randomly assigned to implantation of the FIREHAWK (n=823) or XIENCE (n=830). 65 patients in the FIREHAWK group and 66 in the XIENCE group had insufficient follow-up data and were excluded from the analyses. At 12 months, target lesion failure occurred in 46 (6·1%) of 758 patients in the FIREHAWK group and in 45 (5·9%) of 764 patients in the XIENCE group (difference 0·2%, 90% CI -1·9 to 2·2, pnon-inferiority=0·004, 95% CI -2·2 to 2·6, psuperiority=0·88). There were no differences in ischaemia-driven revascularisation or stent thrombosis rates at 12 months. 176 patients were included in the angiographic substudy, in which in-stent late lumen loss was 0·17 mm (SD 0·48) in the FIREHAWK group and 0·11 mm (0·52) in the XIENCE group (p=0·48), with an absolute difference of 0·05 mm (95% CI -0·09 to 0·18, pnon-inferiority=0·024). INTERPRETATION: In a broad all-comers population of patients requiring stent implantation for myocardial ischaemia, the FIREHAWK was non-inferior to the XIENCE as assessed with the primary endpoint of target lesion failure at 12 months and in-stent late lumen loss at 13 months. The FIREHAWK is a safe and effective alternative stent to treat patients with ischaemic coronary artery disease in clinical practice. FUNDING: Shanghai Microport Medical.


Assuntos
Implantes Absorvíveis , Stents Farmacológicos , Imunossupressores/administração & dosagem , Isquemia Miocárdica/cirurgia , Sirolimo/administração & dosagem , Idoso , Estudos de Equivalência como Asunto , Everolimo/administração & dosagem , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese , Resultado do Tratamento
10.
Eur Heart J ; 39(36): 3381-3389, 2018 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-30124834

RESUMO

Aim: In current device trials, the values of angiographic late lumen loss (LLL) have become extremely low and the relationship between LLL and clinical endpoints has not been recently re-evaluated. The impact of LLL on target lesion revascularization (TLR) in a patient- and study-level analysis of contemporary coronary devices was investigated. Methods and results: We performed a patient-level meta-analysis of seven randomized controlled trials including 2426 patients treated with first- and second-generation drug-eluting stents (DES) and a study-level meta-analysis of 40 studies including 19 199 patients treated with CE-marked DES. In the patient-level analysis, the probability regression curve showed an exponential relationship between in-stent LLL and 2-year incidence of TLR. The optimal cut-off value of LLL based on Youden's index for 2-year TLR event was 0.50 mm. In the Cox proportional hazard model, LLL >0.50 mm was independently associated with an increased incidence of TLR up to 4 years after angiographic follow-up {adjusted hazard ratio (HR) 6.62 [95% confidence interval (95% CI) 4.67-9.39], P < 0.001}. In the meta-regression analysis of the DES studies, pooled mean value of LLL was as low as 0.23 mm (95% CI 0.20-0.26), and there was a moderate correlation between the 1- and 5-year incidence of TLR and the percentage of the lesions with LLL >0.50 mm (R2 = 0.44, P < 0.001 at 1 year, R2 = 0.40, P < 0.001 at 5 years). Conclusion: An angiographic LLL ≤0.50 mm was not predictive of the incidence of TLR whereas a LLL >0.50 mm was. Low LLL in contemporary device trials may not be a sufficiently discriminating parameter for the comparative evaluation of devices.


Assuntos
Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Stents Farmacológicos , Revascularização Miocárdica/métodos , Angiografia Coronária , Doença da Artéria Coronariana/patologia , Humanos
11.
Circulation ; 137(24): 2635-2650, 2018 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-29891620

RESUMO

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.


Assuntos
Bioprótese/normas , Implante de Prótese Vascular/normas , Prótese Vascular/normas , Vasos Coronários/cirurgia , Desenho de Prótese/normas , Stents/normas , Estenose da Valva Aórtica , Ensaios Clínicos como Assunto , Consenso , Humanos
12.
Eur Heart J ; 39(23): 2192-2207, 2018 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-29897428

RESUMO

The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.


Assuntos
Ensaios Clínicos como Assunto , Doença da Artéria Coronariana/terapia , Equipamentos e Provisões , Medidas de Resultados Relatados pelo Paciente , Implantes Absorvíveis , Ásia , Europa (Continente) , Humanos , Stents , Tecidos Suporte , Estados Unidos
13.
J Am Coll Cardiol ; 71(24): 2756-2769, 2018 06 19.
Artigo em Inglês | MEDLINE | ID: mdl-29802016

RESUMO

BACKGROUND: The functional SYNTAX score (FSS) has been shown to improve the discrimination for major adverse cardiac events compared with the anatomic SYNTAX score (SS) while reducing interobserver variability. However, evidence supporting the noninvasive FSS in patients with multivessel coronary artery disease (CAD) is scarce. OBJECTIVES: The purpose of this study was to assess the feasibility of and validate the noninvasive FSS derived from coronary computed tomography angiography (CTA) with fractional flow reserve (FFRCT) in patients with 3-vessel CAD. METHODS: The CTA-SS was calculated in patients with 3-vessel CAD included in the SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study. The noninvasive FSS was determined by including only ischemia-producing lesions (FFRCT ≤0.80). SS derived from different imaging modalities were compared using the Bland-Altman and Passing-Bablok method, and the agreement on the SS tertiles was investigated with Cohen's Kappa. The risk reclassification was compared between the noninvasive and invasive physiological assessment, and the diagnostic accuracy of FFRCT was assessed by the area under the receiver-operating characteristic curve using instantaneous wave-free ratio as a reference. RESULTS: The CTA-SS was feasible in 86% of patients (66 of 77), whereas the noninvasive FSS was feasible in 80% (53 of 66). The anatomic SS was overestimated by CTA compared with conventional angiography (27.6 ± 6.4 vs. 25.3 ± 6.9; p < 0.0001) whereas the calculation of the FSS yielded similar results between the noninvasive and invasive imaging modalities (21.6 ± 7.8 vs. 21.2 ± 8.8; p = 0.589). The noninvasive FSS reclassified 30% of patients from the high- and intermediate-SS tertiles to the low-risk tertile, whereas invasive FSS reclassified 23% of patients from the high- and intermediate-SS tertiles to the low-risk tertile. The agreement on the classic SS tertiles based on Kappa statistics was slight for the anatomic SS (Kappa = 0.19) and fair for the FSS (Kappa = 0.32). The diagnostic accuracy of FFRCT to detect functional significant stenosis based on an instantaneous wave-free ratio ≤0.89 revealed an area under the receiver-operating characteristics curve of 0.85 (95% CI: 0.79 to 0.90) with a sensitivity of 95% (95% CI: 89% to 98%), specificity of 61% (95% CI: 48% to 73%), positive predictive value of 81% (95% CI: 76% to 86%), and negative predictive value of 87% (95% CI: 74% to 94%). CONCLUSIONS: Calculation of the noninvasive FSS is feasible and yielded similar results to those obtained with invasive pressure-wire assessment. The agreement on the SYNTAX score tertile classification improved with the inclusion of the functional component from slight to fair agreement. FFRCT has good accuracy in detecting functionally significant lesions in patients with 3-vessel CAD. (A Trial to Evaluate a New Strategy in the Functional Assessment of 3-Vessel Disease Using SYNTAX II Score in Patients Treated With PCI; NCT02015832).


Assuntos
Angiografia por Tomografia Computadorizada , Doença da Artéria Coronariana/diagnóstico por imagem , Reserva Fracionada de Fluxo Miocárdico , Idoso , Doença da Artéria Coronariana/fisiopatologia , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade
14.
JACC Cardiovasc Interv ; 11(3): 287-297, 2018 02 12.
Artigo em Inglês | MEDLINE | ID: mdl-29361447

RESUMO

OBJECTIVES: This study sought to compare a new quantitative angiographic technique to cardiac magnetic resonance-derived regurgitation fraction (CMR-RF) for the quantification of prosthetic valve regurgitation (PVR) after transcatheter aortic valve replacement (TAVR). BACKGROUND: PVR after TAVR is challenging to quantify, especially during the procedure. METHODS: Post-replacement aortograms in 135 TAVR recipients were analyzed offline by videodensitometry to measure the ratio of the time-resolved contrast density in the left ventricular outflow tract to that in the aortic root (videodensitometric aortic regurgitation [VD-AR]). CMR was performed within an interval of ≤30 days (11 ± 6 days) after the procedure. RESULTS: The average CMR-RF was 6.7 ± 7.0% whereas the average VD-AR was 7.0 ± 7.0%. The correlation between VD-AR and CMR-RF was substantial (r = 0.78, p < 0.001). On receiver-operating characteristic curves, a VD-AR ≥10% corresponded to >mild PVR as defined by CMR-RF (area under the curve: 0.94; p < 0.001; sensitivity 100%, specificity 83%), whereas a VD-AR ≥25% corresponded to moderate-to-severe PVR (area under the curve: 0.99; p = 0.004; sensitivity 100%, specificity 98%). Intraobserver reproducibility was excellent for both techniques (for CMR-RF, intraclass correlation coefficient: 0.91, p < 0.001; for VD-AR intraclass correlation coefficient: 0.93, p < 0.001). The difference on rerating was -0.04 ± 7.9% for CMR-RF and -0.40 ± 6.8% for VD-AR. CONCLUSIONS: The angiographic VD-AR provides a surrogate assessment of PVR severity after TAVR that correlates well with the CMR-RF.


Assuntos
Valva Aórtica/cirurgia , Aortografia/métodos , Imagem por Ressonância Magnética , Insuficiência da Valva Mitral/diagnóstico por imagem , Valva Mitral/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Densitometria , Feminino , Próteses Valvulares Cardíacas , Humanos , Masculino , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/etiologia , Insuficiência da Valva Mitral/fisiopatologia , Variações Dependentes do Observador , Valor Preditivo dos Testes , Interpretação de Imagem Radiográfica Assistida por Computador , Reprodutibilidade dos Testes , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do Tratamento
15.
Catheter Cardiovasc Interv ; 91(7): 1263-1270, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-28836339

RESUMO

OBJECTIVES: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions. BACKGROUND: QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions. Therefore, bifurcation QCA was developed. However, the impact of these different modalities on bifurcation lesion severity classification is yet unknown METHODS: From a randomized controlled trial investigating a novel bifurcation stent (Clinicaltrials.gov NCT01258972), patients with baseline assessment of lesion severity by means of visual estimation, single-vessel QCA, 2D bifurcation QCA and 3D bifurcation QCA were included. We included 113 bifurcations lesions in which all 5 modalities were assessed. The primary end-point was to evaluate how the different modalities affected the classification of bifurcation lesion severity and extent of disease. RESULTS: On visual estimation, 100% of lesions had side-branch diameter stenosis (%DS) >50%, whereas in 83% with single-vessel QCA, 27% with 2D bifurcation QCA and 26% with 3D bifurcation QCA a side-branch %DS >50% was found (P < 0.0001). With regard to the percentage of "true" bifurcation lesions, there was a significant difference between visual estimate (100%), single-vessel QCA (75%) and bifurcation QCA (17% with 2D bifurcation software and 13% with 3D bifurcation software, P < 0.0001). CONCLUSIONS: Our study showed that bifurcation lesion complexity was significantly affected when more advanced bifurcation QCA software were used. "True" bifurcation lesion rate was 100% on visual estimation, but as low as 13% when analyzed with dedicated bifurcation QCA software.


Assuntos
Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico por imagem , Estenose Coronária/diagnóstico por imagem , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Percepção Visual , Humanos , Julgamento , Valor Preditivo dos Testes , Prognóstico , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Software
16.
Eur Heart J ; 38(42): 3124-3134, 2017 11 07.
Artigo em Inglês | MEDLINE | ID: mdl-29020367

RESUMO

Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.


Assuntos
Doença da Artéria Coronariana/cirurgia , Oclusão Coronária/cirurgia , Intervenção Coronária Percutânea/métodos , Implantes Absorvíveis , Idoso , Angioplastia Coronária com Balão/métodos , Atorvastatina/uso terapêutico , Ponte de Artéria Coronária/métodos , Quimioterapia Combinada , Stents Farmacológicos , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Masculino , Infarto do Miocárdio/cirurgia , Inibidores da Agregação de Plaquetas/uso terapêutico , Rosuvastatina Cálcica/uso terapêutico , Cirurgia Assistida por Computador/métodos , Resultado do Tratamento , Ultrassonografia de Intervenção/métodos
17.
Cardiovasc Diagn Ther ; 7(2): 151-158, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28540210

RESUMO

Since the early days of coronary angiography, the extension and severity of coronary artery disease (CAD) have been used for risk stratification. The SYNTAX score objectively characterizes CAD in patients with multivessel disease. Furthermore, recalculating the SYNTAX score by the incorporation of the functional component coronary stenosis (i.e., FFR) increases the discrimination for the risk of adverse events. The calculation of the SYNTAX score derived from non-invasive modalities such as coronary computed tomography angiography (CTA) has emerged as a mean to obtain the SYNTAX score before invasive cardiac catheterization. Likewise, the computation of the non-invasive fractional flow reserve CT (FFRCT) allows for the calculation of the non-invasive functional SYNTAX score. Ultimately, the combination of anatomical and functional evaluations with clinical factors further refines the identification of patients at risk and provides a recommendation for the Heart Team regarding the treatment strategy (i.e., PCI or CABG) based on the predicted 4-year mortality. The purpose of this review is to describe the integration of a novel non-invasive functional coronary assessment with the angiographic risk score in patients with multivessel CAD.

18.
JACC Cardiovasc Interv ; 10(7): 658-666, 2017 04 10.
Artigo em Inglês | MEDLINE | ID: mdl-28385402

RESUMO

OBJECTIVES: This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions. BACKGROUND: PMI is a frequent component of primary endpoints in coronary device trials. Identification of all potential suspected events is critical for accurate event ascertainment. Automatic triggers based on study databases prevent underreporting of events. METHODS: We generated automated algorithms to trigger PMI based on each definition and compared results using data from the RESOLUTE all comers trial. RESULTS: The operationalization of current PMI definitions was achieved by defining programmable algorithms used to interrogate the study database. From a total of 636 PMI triggers, we identified 234 for the World Health Organization extended definition, 382 for the Third Universal definition, and 216 for the Society for Cardiovascular Angiography and Interventions definition. Differences among the biomarkers used, different cutoff values, and in the hierarchy among biomarkers within definitions, yielded a different number of triggers, and identified unique triggers for each definition. Only 38 triggers were consistently identified by all definitions. Availability of ECG data, eCRF data on clinical presentation, and the reporting of >2 post-procedural values of the same biomarker influenced considerably the number of PMI triggers identified. CONCLUSIONS: PMI definitions are not interchangeable. The number of triggers identified and consequently the potential number of events varies significantly, highlighting the importance of rigorous methodology when PMI is a component of a powered endpoint. Emphasis on collection of biomarkers, ECG data, and clinical status at baseline may improve the correct identification of PMI triggers.


Assuntos
Algoritmos , Ensaios Clínicos como Assunto/métodos , Mineração de Dados/métodos , Bases de Dados Factuais , Infarto do Miocárdio/diagnóstico , Intervenção Coronária Percutânea/efeitos adversos , Projetos de Pesquisa , Biomarcadores/sangue , Angiografia Coronária , Eletrocardiografia , Medicina Baseada em Evidências , Humanos , Infarto do Miocárdio/sangue , Infarto do Miocárdio/classificação , Infarto do Miocárdio/etiologia , Valor Preditivo dos Testes , Fatores de Risco , Terminologia como Assunto , Resultado do Tratamento
19.
EuroIntervention ; 12(16): 2001-2008, 2017 Mar 20.
Artigo em Inglês | MEDLINE | ID: mdl-27973335

RESUMO

AIMS: The aim of this study was to investigate whether a Heart Team decision-making process regarding the choice of revascularisation strategy based on non-invasive coronary multislice computed tomography angiography (MSCT) assessment of coronary artery disease (CAD) is equivalent to the standard-of-care invasive angiography-based assessment in patients with multivessel CAD. METHODS AND RESULTS: The SYNTAX III Revolution trial is a prospective, multicentre, all-comers randomised trial that will randomise two Heart Teams to select between surgical and percutaneous treatment according to either an invasive conventional angiography or a non-invasive MSCT angiography assessment in patients with multivessel CAD. The treatment selection by each Heart Team will be guided by the SYNTAX score II calculation. The primary endpoint is the level of agreement according to kappa of the initial decision by the Heart Teams on the modality of the revascularisation based on MSCT and angiography assessments. Secondary endpoints include agreement on the number of vessels requiring treatment and the coronary segments in need of revascularisation. CONCLUSIONS: The SYNTAX III Revolution trial will provide valuable information regarding the ability of a purely non-invasive coronary anatomy assessment to select accurately the most appropriate revascularisation strategy for patients with multivessel CAD.


Assuntos
Angiografia por Tomografia Computadorizada , Doença da Artéria Coronariana/diagnóstico por imagem , Idoso , Angiografia por Tomografia Computadorizada/métodos , Angiografia Coronária/métodos , Doença da Artéria Coronariana/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Seleção de Pacientes , Estudos Prospectivos , Medição de Risco , Índice de Gravidade de Doença
20.
EuroIntervention ; 12(2): e224-34, 2016 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-27290681

RESUMO

AIMS: The applicability of the results of the SYNTAX trial comparing percutaneous coronary intervention (PCI) using first-generation drug-eluting stents (DES) with coronary artery bypass graft (CABG) surgery for the treatment of patients with complex coronary artery disease (CAD) has been challenged by recent major technical and procedural developments in coronary revascularisation. Functional assessment of coronary lesions has contributed to marked improvements in both safety and efficacy of DES implantation. In addition, the recent development of the SYNTAX score II, a clinical tool based on anatomical and clinical factors, allows individualised objective decision making regarding the optimal revascularisation modality in patients with complex CAD. The ongoing SYNTAX II trial is currently evaluating the effectiveness of the clinical and technological advances in the treatment of patients with complex (de novo three-vessel) CAD. METHODS AND RESULTS: The SYNTAX II trial is a multicentre, all-comers, open-label, single-arm trial aiming to recruit 450 patients with de novo three-vessel CAD in approximately 25 European interventional cardiology centres. All patients will be selected and treated following the SYNTAX II strategy, which includes: a) establishing the appropriateness of revascularisation utilising the SYNTAX score II as a clinical tool to allow objective decision making by the Heart Team, b) ischaemia-driven revascularisation based on functional intracoronary assessment, c) implantation of the new-generation everolimus-eluting platinum chromium coronary stent with thin struts and abluminal bioabsorbable polymer coating to promote rapid vessel healing, d) intravascular ultrasound-guided DES implantation, and e) treatment at centres with expertise in CTO recanalisation. The primary endpoint is a composite of the major adverse cardiac and cerebral events (MACCE) rate at one-year follow-up compared to the historical PCI arm of the SYNTAX trial. An exploratory endpoint will be MACCE at five-year follow-up compared to the historical surgical arm of the SYNTAX trial. CONCLUSIONS: The SYNTAX II trial will provide valuable information on outcomes of state-of-the-art PCI for the contemporary management of complex (de novo three-vessel) CAD. SYNTAX II will be of critical value in the design of future trials in this arena.


Assuntos
Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Intervenção Coronária Percutânea , Idoso , Angioplastia Coronária com Balão/métodos , Ponte de Artéria Coronária/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Índice de Gravidade de Doença , Tempo , Fatores de Tempo , Resultado do Tratamento
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