RESUMO
The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y12 inhibitor - preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y12 inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y12 inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y12 inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban plus P2Y12 inhibitor). With a sample size of 2,000 patients, this trial is powered to assess both superiority for major or clinically relevant non-major bleeding and non-inferiority for a composite of all-cause death, myocardial infarction, stroke, systemic embolism or stent thrombosis. In summary, the WOEST-3 trial is the first RCT temporarily omitting OAC in AF patients, comparing a 30-day DAPT strategy with guideline-directed therapy post-PCI to reduce bleeding events without hampering efficacy.
Assuntos
Anticoagulantes , Fibrilação Atrial , Hemorragia , Intervenção Coronária Percutânea , Inibidores da Agregação Plaquetária , Humanos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Anticoagulantes/efeitos adversos , Administração Oral , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/uso terapêutico , Inibidores da Agregação Plaquetária/efeitos adversos , Hemorragia/induzido quimicamente , Aspirina/uso terapêutico , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Masculino , Feminino , Idoso , Antagonistas do Receptor Purinérgico P2Y/administração & dosagem , Antagonistas do Receptor Purinérgico P2Y/efeitos adversos , Antagonistas do Receptor Purinérgico P2Y/uso terapêutico , Resultado do Tratamento , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Complete revascularisation is supported by recent trials in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease (MVD) without cardiogenic shock. However, the optimal timing of non-culprit lesion revascularisation is currently debated. AIMS: This prespecified analysis of the BioVasc trial aims to determine the effect of immediate complete revascularisation (ICR) compared to staged complete revascularisation (SCR) on clinical outcomes in patients with STEMI. METHODS: Patients presenting with STEMI and MVD were randomly assigned to ICR or SCR. The primary endpoint was the composite of all-cause mortality, myocardial infarction, any unplanned ischaemia-driven revascularisation, or cerebrovascular events at 1-year post-index procedure. RESULTS: Between June 2018 and October 2021, 608 (ICR: 305, SCR: 303) STEMI patients were enrolled. No significant differences between ICR and SCR were observed at 1-year follow-up in terms of the primary endpoint (7.0% vs 8.3%, hazard ratio [HR] 0.84, 95% confidence interval [CI]: 0.47-1.50; p=0.55): all-cause mortality (2.3% vs 1.3%, HR 1.77, 95% CI: 0.52-6.04; p=0.36), myocardial infarction (1.7% vs 3.3%, HR 0.50, 95% CI: 0.17-1.47; p=0.21), unplanned ischaemia-driven revascularisation (4.1% vs 5.0%, HR 0.80, 95% CI: 0.38-1.71; p=0.57) and cerebrovascular events (1.4% vs 1.3%, HR 1.01, 95% CI: 0.25-4.03; p=0.99). At 30-day follow-up, a trend towards a reduction of the primary endpoint in the ICR group was observed (ICR: 3.0% vs SCR: 6.0%, HR 0.50, 95% CI: 0.22-1.11; p=0.09). ICR was associated with a reduction in overall hospital stay (ICR: median 3 [interquartile range {IQR} 2-5] days vs SCR: median 4 [IQR 3-6] days; p<0.001). CONCLUSIONS: Clinical outcomes at 1 year were similar for STEMI patients who had undergone ICR and those who had undergone SCR.
Assuntos
Doença da Artéria Coronariana , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Infarto do Miocárdio com Supradesnível do Segmento ST/mortalidade , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Masculino , Feminino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Idoso , Resultado do Tratamento , Doença da Artéria Coronariana/cirurgia , Doença da Artéria Coronariana/mortalidade , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Fatores de Tempo , Tempo para o Tratamento , Revascularização Miocárdica/métodosRESUMO
BACKGROUND: Transcatheter aortic valve implantation (TAVI) serves a growing range of patients with severe aortic stenosis (AS). TAVI has evolved to a streamlined procedure minimizing length of hospital stay. AIMS: To evaluate the safety and efficacy of an early discharge (ED) strategy after TAVI. METHODS: We performed an international, multi-center, prospective observational single-arm study in AS patients undergoing TAVI with the ACURATE valve platform. Eligibility for ED was assessed prior to TAVI and based on prespecified selection criteria. Discharge ≤ 48 h was defined as ED. Primary Valve Academic Research Consortium (VARC)-3-defined 30-day safety and efficacy composite endpoints were landmarked at 48 h and compared between ED and non-ED groups. RESULTS: A total of 252 patients were included. The median age was 82 [25th-75th percentile, 78-85] years and the median Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score was 2.2% [25th-75th percentile, 1.6-3.3]. ED and non-ED were achieved in 173 (69%) and 79 (31%) patients respectively. Monitoring for conduction disturbances was the principal reason for non-ED (33%). Overall, at 30 days, all-cause mortality was 1%, new permanent pacemaker rate was 4%, and valve- or procedure-related rehospitalization was 4%. There was no difference in the primary safety and efficacy endpoint between the ED and non-ED cohorts (OR 0.84 [25th-75th percentile, 0.31-2.26], p = 0.73, and OR 0.97 [25th-75th percentile, 0.46-2.06], p = 0.94). The need for rehospitalization was similarly low for ED and non-ED groups. CONCLUSION: Early discharge after TAVI with the ACURATE valve is safe and feasible in selected patients. Rhythm monitoring and extended clinical observation protracted hospital stay.
RESUMO
BACKGROUND: The percutaneous treatment of calcified coronary lesions remains challenging and is associated with worse clinical outcomes. In addition, coronary artery calcification is associated with more frequent peri-procedural myocardial infarction. STUDY DESIGN AND OBJECTIVES: The ShOckwave ballooN or Atherectomy with Rotablation in calcified coronary artery lesions (SONAR) study is an investigator-initiated, prospective, randomized, international, multicenter, open label trial (NCT05208749) comparing a lesion preparation strategy with either shockwave intravascular lithotripsy (IVL) or rotational atherectomy (RA) before drug-eluting stent implantation in 170 patients with moderate to severe calcified coronary lesions. The primary endpoint is difference in the rate of peri-procedural myocardial infarction. Key secondary endpoints include rate of peri-procedural microvascular dysfunction, peri-procedural myocardial injury, descriptive study of IMR measurements in calcified lesions, technical and procedural success, interaction between OCT calcium score and primary endpoint, 30-day and 1-year major adverse clinical events. CONCLUSIONS: The SONAR trial is the first randomized controlled trial comparing the incidence of peri-procedural myocardial infarction between 2 contemporary calcium modification strategies (Shockwave IVL and RA) in patients with calcified coronary artery lesions. Furthermore, for the first time, the incidence of peri-procedural microvascular dysfunction after Shockwave IVL and RA will be evaluated and compared.
Assuntos
Aterectomia Coronária , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Calcificação Vascular , Humanos , Aterectomia Coronária/efeitos adversos , Estudos Prospectivos , Vasos Coronários/diagnóstico por imagem , Vasos Coronários/cirurgia , Cálcio , Angiografia Coronária , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Calcificação Vascular/terapia , Calcificação Vascular/etiologia , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/etiologia , Infarto do Miocárdio/etiologia , Intervenção Coronária Percutânea/efeitos adversos , AterectomiaRESUMO
BACKGROUND: Coronary computed tomography angiography (CCTA) -derived fractional flow reserve (FFRCT) is recommended to evaluate the functional consequences of obstructive coronary artery disease (OCAD). Real-world incremental impacts of FFRCT use still remains under debate. METHODS: 1601 patients with suspected OCAD on CCTA (>50 â% stenosis), including 808 (50.5 â%) patients evaluated by FFRCT, were included from a 2013-2021 registry. Propensity adjusted impacts of FFRCT use on rates of invasive coronary angiography (ICA), myocardial revascularization (MR) and post MR major adverse cardiac events (MACE) were reported, including a sensitivity analysis in severe OCAD (>70 â% stenosis) (n â= â450). Accuracy of numerical and comprehensive FFRCT interpretations in selection of patients requiring a MR were also compared. RESULTS: 1160 (72,5 â%) ICA, 559 (34.9 â%) MR and 137 (24.5 â%) post MR MACE occurred at 4.7 â± â1.9 years. FFRCT use was independently associated with decreased rate of ICA and MR (OR: 0.66; 95 â% CI 0.53-0.83, p â< â0.001 and OR: 0.71; 95 â% CI 0.58-0.88, p â< â0.01, respectively). Compared to the numerical interpretation, the FFRCT comprehensive assessment increased the ratio of MR per ICA (61.7 â% vs 50.1 â%, p â< â0.01) and was more accurate in selection of patients requiring MR. FFRCT reduced post MR MACE (OR: 0.64; 95 â% CI 0.43-0.96, p â< â0.05). All these associations were no longer observed in severe OCAD. CONCLUSION: Implementing FFRCT in OCAD patients reduces ICA use, improves selection of patients requiring MR and reduces post MR MACE. However, these incremental values of FFRCT were no longer observed in severe OCAD.
Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/terapia , Prognóstico , Constrição Patológica , Angiografia Coronária/métodos , Valor Preditivo dos Testes , Angiografia por Tomografia Computadorizada , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/terapia , Vasos Coronários/diagnóstico por imagemAssuntos
Implantes Absorvíveis , Stents Farmacológicos , Magnésio , Intervenção Coronária Percutânea , Pontuação de Propensão , Infarto do Miocárdio com Supradesnível do Segmento ST , Humanos , Infarto do Miocárdio com Supradesnível do Segmento ST/cirurgia , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Resultado do Tratamento , Masculino , Feminino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/métodos , Idoso , Alicerces TeciduaisRESUMO
Moderate to severe frailty is a predictor of a poor outcome after transcatheter aortic valve replacement (TAVR), but little is known about the prognostic importance of different geriatric frailty markers in an overall fit or pre-frail geriatric population undergoing TAVR. This retrospective study aimed to examine the incremental value of adding patient frailty markers to conventional surgical risk score to predict all-cause mortality in relatively fit elderly patients undergoing TAVR. Overall patient frailty was assessed using the comprehensive geriatric assessment frailty index (CGA-FI). Multivariable Cox regression models were used to evaluate relationships of different geriatric frailty markers with all-cause mortality and single and combined frailty models were compared to a baseline model that included EuroSCORE II factors. One hundred relatively fit geriatric patients (84 ± 4 years old, mean CGA-FI 0.14 ± 0.05) were included, and 28% died during a median follow-up of 24 months. After adjustment, risk of depression (geriatric depression scale 15 (GDS-15)) and malnutrition remained significantly associated with all-cause mortality (HR 4.381, 95% CI 1.787-10.743; p = 0.001 and HR 3.076, 95% CI 1.151-8.217; p = 0.025, respectively). A combined frailty marker model including both GDS-15 and malnutrition on top of EuroSCORE II improved the discriminative ability to predict all-cause mortality (change in c-index: + 0.044). Screening for those frailty markers on top of the traditionally used EuroSCORE II may improve risk stratification and prognosis in relatively fit geriatric patients undergoing TAVR.
Assuntos
Infarto do Miocárdio , Síndrome do Roubo Subclávio , Humanos , Choque Cardiogênico/diagnóstico , Choque Cardiogênico/etiologia , Choque Cardiogênico/terapia , Síndrome do Roubo Subclávio/diagnóstico por imagem , Síndrome do Roubo Subclávio/etiologia , Síndrome do Roubo Subclávio/terapia , Resultado do TratamentoRESUMO
OBJECTIVES: This study aimed to assess discordance between results of instantaneous wave-free ratio (iFR), fractional flow reserve (FFR), and intravascular ultrasound (IVUS) in intermediate left main coronary (LM) lesions, and its impact on clinical decision making and outcome. METHODS: We enrolled 250 patients with a 40%-80% LM stenosis in a prospective, multicenter registry. These patients underwent both iFR and FFR measurements. Of these, 86 underwent IVUS and assessment of the minimal lumen area (MLA), with a 6 mm2 cutoff for significance. RESULTS: Isolated LM disease was recognized in 95 patients (38.0%), while 155 patients (62.0%) had both LM disease and downstream disease. In 53.2% of iFR+ and 56.7% of FFR+ LM lesions, the measurement was positive in only one daughter vessel. iFR/FFR discordance occurred in 25.0% of patients with isolated LM disease and 36.2% of patients with concomitant downstream disease (P=.049). In patients with isolated LM disease, discordance was significantly more common in the left anterior descending artery and younger age was an independent predictor of iFR-/FFR+ discordance. iFR/MLA and FFR/MLA discordance occurred in 37.0% and 29.4%, respectively. Within 1 year of follow-up, major cardiac adverse events (MACE) occurred in 8.5% and 9.7% (P=.763) of patients whose LM lesion was deferred or revascularized, respectively. Discordance was not an independent predictor of MACE. CONCLUSIONS: Current methods of estimating LM lesion significance often yield discrepant findings, complicating therapeutic decision-making.
Assuntos
Reserva Fracionada de Fluxo Miocárdico , Humanos , Estudos Prospectivos , Tomada de Decisão Clínica , Constrição Patológica , Sistema de RegistrosRESUMO
To evaluate coronary artery disease (CAD) with computed tomography coronary angiography (CTCA)-derived fractional flow reserve (FFR) in patients with atrial fibrillation (AF) requiring ablation. The study population consisted of 151 patients who underwent CTCA before AF ablation (AF group), and a control group of 151 patients from the outpatient clinic who underwent CTCA without any history of AF (non-AF group), matched for age, sex, BMI, and angina symptomatology. All study patients underwent CTCA with subdivision of coronary lesion type into severe (≥ 70% luminal narrowing), moderate (50% ≤ luminal narrowing < 70%), and mild stenosis (< 50% luminal narrowing). In patients with ≥ 1 moderate or severe stenosis, non-invasive FFR was calculated from CTCA (FFRCT). Baseline characteristics and CAD risk factors were similar between the 2 groups. During CTCA, 38% of the patients in the AF group were in ongoing atrial arrhythmia (either AF or regular atrial tachycardia). The number of patients with severe (10 (6.6%) vs 10 (6.6%), P = 1.00), moderate (14 (9.5%) vs 10 (6.7%), P = 0.4), and mild stenosis (43 (28.5%) vs 56 (37.1%), P = 0.11) was not significantly different between the 2 groups. Performance of FFRCT was feasible in 32/44 patients (73%), and failed in 27% of the patients (7 and 5 patients in the AF and non-AF group, respectively, P = 0.74). No difference was observed in the prevalence of hemodynamically significant stenosis (FFRCT ≤ 0.80) (15 (9.9%) vs 12 (7.9%), P = 0.85). Our study showed technical feasibility of CTCA in all patients of both groups, including the patients with AF as presenting rhythm. The FFRCT add-on analysis failed equally frequent in patients of the AF versus non-AF group. An equal rate of CAD was observed in the AF group and non-AF group, favoring the concept of shared associated risk factors for CAD and AF.
Assuntos
Fibrilação Atrial , Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/cirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Constrição Patológica , Angiografia Coronária/métodos , Tomografia Computadorizada por Raios X/métodos , Angiografia por Tomografia Computadorizada/métodos , Estenose Coronária/diagnóstico por imagem , Estenose Coronária/cirurgia , Valor Preditivo dos Testes , Vasos CoronáriosRESUMO
BACKGROUND: Cardiac stress tests remain the cornerstone for evaluating patients suspected of having obstructive coronary artery disease (CAD). Coronary microvascular dysfunction (CMD) can lead to abnormal non-invasive tests. AIMS: We sought to assess the diagnostic performance of exercise stress tests with indexes of epicardial and microvascular resistance as reference. METHODS: This was a prospective, single-arm, multicentre study of patients with an intermediate pretest probability of CAD and positive exercise stress tests who were referred for invasive angiography. Patients underwent an invasive diagnostic procedure (IDP) with measurement of fractional flow reserve (FFR) and index of microvascular resistance (IMR) in at least one coronary vessel. Obstructive CAD was defined as diameter stenosis (DS) >50% by quantitative coronary angiography (QCA). The objective was to determine the false discovery rate (FDR) of cardiac exercise stress tests with both FFR and IMR as references. RESULTS: One hundred and seven patients (137 vessels) were studied. The mean age was 62.1±8.7, and 27.1% were female. The mean diameter stenosis was 37.2±27.5%, FFR was 0.84±0.10, coronary flow reserve was 2.74±2.07, and IMR 20.3±11.9. Obstructive CAD was present in 39.3%, whereas CMD was detected in 20.6%. The FDR was 60.7% and 62.6% with QCA and FFR as references (p-value=0.803). The combination of FFR and IMR as clinical reference reduced the FDR by 25% compared to QCA (45.8% vs 60.7%; p-value=0.006). CONCLUSIONS: In patients with evidence of ischaemia, an invasive functional assessment accounting for the epicardial and microvascular compartments led to an improvement in the diagnostic performance of exercise tests, driven by a significant FDR reduction.
Assuntos
Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Humanos , Feminino , Masculino , Doença da Artéria Coronariana/diagnóstico , Teste de Esforço , Estenose Coronária/diagnóstico , Constrição Patológica , Estudos Prospectivos , Angiografia Coronária/métodos , Vasos Coronários/diagnóstico por imagem , Valor Preditivo dos Testes , Índice de Gravidade de DoençaRESUMO
BACKGROUND: Transcatheter aortic valve replacement (TAVR) is now an established treatment strategy for elderly patients with symptomatic aortic stenosis (AS) across the entire operative risk spectrum. Streamlined TAVR protocols along with reduced procedure time and expedited ambulation promote early hospital discharge. Selection of patients suitable for safe early discharge after TAVR might improve healthcare efficiency. STUDY DESIGN: The POLESTAR trial is an international, multi-center, prospective, observational study which aims to evaluate the safety of early discharge in selected patients who undergo TAVR with the supra-annular functioning self-expanding ACURATE Neo transcatheter heart valve (THV). A total of 250 patients will be included based on a set of baseline criteria indicating potential early discharge (within 48 h post-TAVR). Primary study endpoints include Valve Academic Research Consortium (VARC)-3 defined safety at 30 days and VARC-3 defined efficacy at 30 days and 1 year. Endpoints will be compared between early discharge and non-early discharge cohorts with a distinct landmark analysis at 48 h post-TAVR. Secondary endpoints include quality of life assessed using EQ5D-5L and Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires and resource costs compared between discharge groups. SUMMARY: The POLESTAR trial prospectively evaluates safety and feasibility of an early discharge protocol for TAVR using the ACURATE Neo THV.
Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Humanos , Idoso , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/etiologia , Qualidade de Vida , Estudos Prospectivos , Alta do Paciente , Desenho de Prótese , Resultado do Tratamento , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Fatores de RiscoRESUMO
BACKGROUND: Currently, transradial access (TRA) is the recommended access for coronary procedures because of increased safety, with radial artery occlusion (RAO) being its most frequent complication, which will increasingly affect patients undergoing multiple procedures during their lifetimes. Recently, distal radial access (DRA) has emerged as a promising alternative access to minimize RAO risk. A large-scale, international, randomized trial comparing RAO with TRA and DRA is lacking. OBJECTIVES: The aim of this study was to assess the superiority of DRA compared with conventional TRA with respect to forearm RAO. METHODS: DISCO RADIAL (Distal vs Conventional Radial Access) was an international, multicenter, randomized controlled trial in which patients with indications for percutaneous coronary procedure using a 6-F Slender sheath were randomized to DRA or TRA with systematic implementation of best practices to reduce RAO. The primary endpoint was the incidence of forearm RAO assessed by vascular ultrasound at discharge. Secondary endpoints include crossover, hemostasis time, and access site-related complications. RESULTS: Overall, 657 patients underwent TRA, and 650 patients underwent DRA. Forearm RAO did not differ between groups (0.91% vs 0.31%; P = 0.29). Patent hemostasis was achieved in 94.4% of TRA patients. Crossover rates were higher with DRA (3.5% vs 7.4%; P = 0.002), and median hemostasis time was shorter (180 vs 153 minutes; P < 0.001). Radial artery spasm occurred more with DRA (2.7% vs 5.4%; P = 0.015). Overall bleeding events and vascular complications did not differ between groups. CONCLUSIONS: With the implementation of a rigorous hemostasis protocol, DRA and TRA have equally low RAO rates. DRA is associated with a higher crossover rate but a shorter hemostasis time.
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Arteriopatias Oclusivas , Cateterismo Periférico , Intervenção Coronária Percutânea , Cateterismo Periférico/efeitos adversos , Cateterismo Periférico/métodos , Angiografia Coronária/efeitos adversos , Angiografia Coronária/métodos , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/métodos , Artéria Radial/diagnóstico por imagem , Resultado do TratamentoRESUMO
Magmaris® (Biotronik AG, Switzerland) is the first RMS and early experience has shown promising results in stable coronary artery disease. Acute coronary syndromes have been hypothesized as a potential target group for bioresorbable scaffolds, but the efficacy and safety of RMS has not been extensively studied in ST-segment elevation myocardial infarction (STEMI). BEST-MAG is a prospective multicenter trial designed to evaluate optical coherence tomography (OCT-)guided implantation of resorbable magnesium scaffold (RMS) in STEMI. Consecutive STEMI patients fulfilling inclusion/exclusion criteria were treated with RMS following a standardized OCT-based implantation technique including systematic pre- and post-dilatation, and baseline plus final OCT imaging. The primary endpoint was a device oriented composite endpoint (DOCE) including cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR) within 12 months. Clinical outcomes were compared after propensity score matching (PSM) to the results of the randomized controlled BIOSTEMI trial comparing biodegradable polymer sirolimus eluting (BP-SES) and durable polymer everolimus eluting stents (DP-EES) in STEMI. Between 15th February 2019 and 25th May 2020, 30 patients were included in 5 centers. Procedural success was achieved in all cases based on OCT control with final scaffold expansion of 82 ± 11%. At twelve-months, DOCE rate was 13.3% (n = 4), including 4 cases of TLR (13.3%) and one case of TV-MI (3.3%). No cardiac death occurred, and no scaffold thrombosis (ScT) was observed. Using PSM, DOCE rates in BP-SES and DP-EES groups were 10% and 6% respectively and TLR rates were 3.3% and 0.0%. In this study, OCT-guided RMS implantation in selected STEMI patients appeared feasible but was associated with numerically higher rates of TLR as compared with conventional drug-eluting stents, although the limited number of patients included in this analysis does not allow drawing statistically significant conclusions.
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Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Infarto do Miocárdio com Supradesnível do Segmento ST , Implantes Absorvíveis , Everolimo , Humanos , Magnésio , Polímeros , Pontuação de Propensão , Estudos Prospectivos , Desenho de Prótese , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Sirolimo , Resultado do TratamentoRESUMO
The long-term variations of fractional flow reserve derived from coronary computed tomography (FFRCT) after surgical (SAVR) or transcatheter (TAVR) aortic valve replacement in patients with severe aortic valve stenosis (AS) have not been investigated. A total of 25 patients with isolated, severe AS underwent coronary computed tomography with 3-vessel FFRCT analysis (Heartflow Inc.-Redwood City, California, USA) and measurement of total coronary volume (V), left ventricular mass (M) and their ratio (V/M) before and 6 months after SAVR or TAVR. A significant increase in V/M due to a decrease in left ventricular mass 6 months after intervention was observed, whereas total coronary volume did not change (coronary volume pre: 2924.5 ± 867.9 mm3, coronary volume post: 2844.2 ± 792.8 mm3, P = 0.158; LV mass pre: 151.7 ± 40.7 g, LV mass post: 127.3 ± 34.7 g, P < 0.001; V/M pre: 19.5 ± 4.1 mm3/g, V/M post: 22.7 ± 4.28 mm3/g, P = 0.002). FFRCT (expressed as area under the virtual pullback curve) remained constant. This proof-of-concept study showed that FFRCT was not subject to the confounding effect of left ventricular mass regression after SAVR or TAVR. Despite significant left ventricular remodeling at 6 months after AS treatment, FFRCT values remained constant. Further studies are needed comparing the performance of the different invasive and non-invasive coronary physiological indices in this patient cohort.
Assuntos
Estenose da Valva Aórtica , Reserva Fracionada de Fluxo Miocárdico , Implante de Prótese de Valva Cardíaca , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Valor Preditivo dos Testes , Índice de Gravidade de Doença , Tomografia Computadorizada por Raios X , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do TratamentoRESUMO
BACKGROUND: Transradial access (TRA) has become the default access method for coronary diagnostic and interventional procedures. As compared to transfemoral access, TRA has been shown to be safer, cost-effective and more patient-friendly. Radial artery occlusion (RAO) represents the most frequent complication of TRA, and precludes future coronary procedures through the radial artery, the use of the radial artery as a conduit for coronary artery bypass grafting or as arteriovenous fistula for patients on hemodialysis. Recently, distal radial access (DRA) has emerged as a promising alternative to TRA, yielding potential for minimizing the risk of RAO. However, an international multicenter randomized comparison between DRA, and conventional TRA with respect to the rate of RAO is still lacking. TRIAL DESIGN: DISCO RADIAL is a prospective, multicenter, open-label, randomized, controlled, superiority trial. A total of 1300 eligible patients will be randomly allocated to undergo coronary angiography and/or percutaneous coronary intervention (PCI) through DRA or TRA using the 6 Fr Glidesheath Slender sheath introducer. Extended experience with both TRA and DRA is required for operators' eligibility and optimal evidence-based best practice to reduce RAO systematically implemented by protocol. The primary endpoint is the incidence of forearm RAO assessed by vascular ultrasound at discharge. Several important secondary endpoints will also be assessed, including access-site cross-over, hemostasis time, and access-site related complications. SUMMARY: The DISCO RADIAL trial will provide the first large-scale multicenter randomized evidence comparing DRA to TRA in patients scheduled for coronary angiography or PCI with respect to the incidence of RAO at discharge.
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Arteriopatias Oclusivas , Intervenção Coronária Percutânea , Angiografia Coronária/métodos , Humanos , Intervenção Coronária Percutânea/métodos , Estudos Prospectivos , Artéria Radial , Resultado do TratamentoRESUMO
A patient with recurrent sepsis caused by an infected ascending aortic pseudoaneurysm was deemed unsuitable for surgery after the heart team evaluation. He successfully underwent percutaneous treatment with a combination of a septal occlusion device and coil embolization and remained free of sepsis 24 months after implantation.
RESUMO
Background Early generation drug-eluting stents (DESs) showed a high grade of coronary endothelial dysfunction that was attributed to lack of stent reendothelialization. Endothelium-dependent vasomotor response of current DESs and bioresorbable scaffolds (BRSs) remains unknown. This study sought to assess the device-related endothelial function of current devices and to correlate neointima healing with endothelial function. Methods and Results A total of 206 patients from 4 randomized trials treated with the durable-polymer everolimus-eluting Xience (n=44), bioresorbable-polymer sirolimus-eluting Orsiro (n=35), polymer-free biolimus-eluting Biofreedom (n=24), bioactive endothelial-progenitor cell-capturing sirolimus-eluting Combo DES (n=25), polymer-based everolimus-eluting Absorb (n=44), and Mg-based sirolimus-eluting Magmaris BRS (n=34) underwent endothelium-dependent vasomotor tests and optical coherence tomography imaging, as per protocol, at follow-up. Crude vasomotor responses of distal segments to low-dose acetylcholine (10-6 mol/L) were different between groups: bioresorbablepolymer DEShad the worst (-8.4%±12.6%) and durable-polymer DES had the most physiologic (-0.4%±11.8%; P=0.014). High-dose acetylcholine (10-4 mol/L) showed similar responses between groups (ranging from -10.8%±11.6% to -18.1%±15.4%; P=0.229). Device healing was different between devices. Uncovered struts ranged from 6.3%±7.1% (bioresorbable-polymer DES) to 2.5%±4.5% (bioactive DES; P=0.056). In multivariate models, endothelium-dependent vasomotor response was associated with age, bioresorbable-polymer DES, and angiographic lumen loss, but not with strut coverage nor plaque type. Endothelial dysfunction (defined as ≥4% vasoconstriction) was observed in 46.6% of patients with low-dose and 68.9% with high-dose acetylcholine, without differences between groups. Conclusions At follow-up, endothelial dysfunction was frequently observed in distal segments treated with current stents without remarkable differences between devices. Although neointima healing was different between devices, poor healing was not associated with endothelial dysfunction.