RESUMEN
In patients on oral anticoagulant (OAC) therapy undergoing percutaneous coronary intervention with stent (PCI), international guidelines endorse the use of direct oral anticoagulants (DOAC) rather than vitamin K antagonists (VKA) and dual antithrombotic therapy (DAT) rather than triple antithrombotic therapy (TAT). Aim of this study was to evaluate contemporary real-world data on antithrombotic regimens and outcome in patients on OAC undergoing PCI with stent. Consecutive patients on OAC undergoing PCI were enrolled in the multicentre, prospective, observational PERSEO registry (NCT03392948). Primary end-point was net adverse clinical events (NACE) with VKA vs DOAC, whereas a secondary pre-specified end-point was NACE with DAT vs TAT both at 1-year follow-up. From February 2018 to February 2022, 1234 consecutive patients were included. The main indication for OAC was atrial fibrillation (86%) and the mean CHA2DS2VASc and HAS-BLED scores were 4±2 and 3.6±1, respectively. Of the 1228 patients discharged alive, 222 (18%) were on VKA and 1006 (82%) on DOAC (p<0.01). DAT was employed in 197 patients whereas TAT in 1028. At follow-up, NACE rate was significantly higher with VKA compared to DOAC (23% vs 16%, p=0.013) and confirmed after propensity score adjustment. TAT and DAT did not differ as regards NACE rate (17% vs 19%, p=0.864) even though, compared to TAT, DAT was associated with less major bleedings (2% vs 5%, p= 0.014), confirmed after propensity score adjustment. In conclusion, in patients on OAC undergoing PCI, DOAC, compared to VKA, was associated with a significantly lower occurrence of NACE and DAT reduced bleedings compared to TAT.
RESUMEN
BACKGROUND: Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a widely adopted strategy for the treatment of de novo coronary artery disease. DES implantation conveys an inherent risk for short- and long-term complications, including in-stent restenosis and stent thrombosis. Drug-coated balloons are emerging as an alternative approach to fulfill the "leaving nothing behind" principle and avoid long-term DES-related complications. DESIGN: TRANSFORM II is an investigator-initiated, multicenter, noninferiority, randomized clinical trial, testing a sirolimus-coated balloon (SCB) versus the standard of care for native coronary vessels with a 2-3 mm diameter, in terms of 12-month target lesion failure (TLF; primary endpoint) and net adverse cardiovascular events (coprimary endpoint). Patients undergoing PCI will be randomized to be treated with either SCB or new-generation everolimus-eluting stent and will be followed up clinically for up to 60 months. Assuming a TLF rate of 8% at 12 months with DES, a sample size of 1325 patients was chosen to ensure an 80% power to detect a 1.5% lower incidence in the SCB group with a type I error rate of 0.05. The TRANSFORM II trial is registered on clinicaltrials.gov (identification number NCT04893291). Several substudies, including an optical coherence tomography assessment at 9 months (intracoronary imaging substudy), will investigate the study device in different clinical and lesion settings. CONCLUSIONS: The randomized TRANSFORM II trial will determine whether a novel SCB is noninferior to a current everolimus-eluting stent when adopted for the treatment of de novo lesions in coronary vessels with a diameter between 2 and 3 mm.
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Fármacos Cardiovasculares , Enfermedad de la Arteria Coronaria , Reestenosis Coronaria , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea , Fármacos Cardiovasculares/efectos adversos , Angiografía Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Stents Liberadores de Fármacos/efectos adversos , Everolimus/efectos adversos , Humanos , Paclitaxel , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Sirolimus/efectos adversos , Stents/efectos adversos , Resultado del TratamientoRESUMEN
Transcatheter aortic valve implantation (TAVI) has proved beneficial in patients with severe aortic stenosis, especially when second-generation devices are used. We aimed at reporting our experience with Navitor, a third-generation device characterized by intrannular, large cell, and cuffed design, as well as high deliverability and minimization of paravalvular leak. Between June and December 2021, a total of 39 patients underwent TAVI with Navitor, representing 20% of all TAVI cases. Mean age was 80.0 ± 6.7 years, and 14 (36.8%) women were included. Severe aortic stenosis was the most common indication to TAVI (37 [97.4%] cases), whereas 2 (5.3%) individuals were at low surgical risk. Device and procedural success was obtained in all patients, with a total hospital stay of 6.6 ± 4.5 days. One (2.9%) patient required permanent pacemaker implantation, but no other hospital events occurred. At 1-month follow-up, a cardiac death was adjudicated in an 87-year-old man who had been at high surgical risk. Echocardiographic follow-up showed no case of moderate or severe aortic regurgitation, with mild regurgitation in 18 (47%), and none or trace regurgitation in 20 (53%). The Navitor device, thanks to its unique features, is a very promising technology suitable to further expand indications and risk-benefit profile of TAVI.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del TratamientoRESUMEN
Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.
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Intervención Coronaria Percutánea , Trombosis , Anciano , Femenino , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Sistema de Registros , Reperfusión , Trombosis/etiología , Tirofibán/efectos adversos , Resultado del Tratamiento , Tirosina/efectos adversosRESUMEN
OBJECTIVES: Several randomized controlled trials (RCTs) consistently reported better clinical outcomes with radial as compared to femoral access for primary percutaneous coronary intervention (PCI). Nevertheless, heterogeneous use of potent antiplatelet drugs, such as Gp IIb/IIIa inhibitors (GPI), across different studies could have biased the results in favor of radial access. We performed an updated meta-analysis and meta-regression of RCTs in order to appraise whether the use of GPI had an impact on pooled estimates of clinical outcomes according to vascular access. METHODS: We computed pooled estimates by the random-effects model for the following outcomes: mortality, major adverse cardiovascular events (death, myocardial infarction, stroke, and target vessel revascularization), and major bleedings. Additionally, we performed meta-regression analysis to investigate the impact of GPI use on pooled estimates of clinical outcomes. RESULTS: We analyzed 14 randomized controlled trials and 11090 patients who were treated by radial (5497) and femoral access (5593), respectively. Radial access was associated with better outcomes for mortality (risk difference 0.01 (0.00, 0.01), p=0.03), MACE (risk difference 0.01 (0.00, 0.02), p=0.003), and major bleedings (risk difference 0.01 (0.00, 0.02), p=0.02). At meta-regression, we observed a significant correlation of mortality with both GPI use (p=0.011) and year of publication (p=0.0073), whereas no correlation was observed with major bleedings. CONCLUSIONS: In this meta-analysis, the use of radial access for primary PCI was associated with better clinical outcomes as compared to femoral access. However, the effect size on mortality was modulated by GPI rate, with greater benefit of radial access in studies with larger use of these drugs.
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Intervención Coronaria Percutánea/métodos , Inhibidores de Agregación Plaquetaria/uso terapéutico , Complejo GPIIb-IIIa de Glicoproteína Plaquetaria/antagonistas & inhibidores , Arteria Femoral , Hemorragia/epidemiología , Humanos , Arteria Radial , Ensayos Clínicos Controlados Aleatorios como Asunto , Infarto del Miocardio con Elevación del ST/mortalidad , Infarto del Miocardio con Elevación del ST/terapia , Accidente Cerebrovascular/epidemiologíaRESUMEN
COVID-19 pandemic raised the issue to guarantee the proper level of care to patients with acute cardiovascular diseases and concomitant suspected or confirmed COVID-19 and, in the meantime safety and protection of healthcare providers. The aim of this position paper is to provide standards to healthcare facilities and healthcare providers on infection prevention and control measures during the management of suspected and confirmed cases of 2019-nCoV infection accessing in cath-lab. The document represents the view of the Italian Society of Interventional Cardiology (GISE), and it is based on recommendations from the main World and European Health Organizations (WHO, and ECDC) as well as from the Italian Society of Anesthesia, Analgesia, Resuscitation and Intensive Care (SIAARTI).
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Betacoronavirus , Cateterismo Cardíaco , Infecciones por Coronavirus/prevención & control , Control de Infecciones/organización & administración , Pandemias/prevención & control , Neumonía Viral/prevención & control , COVID-19 , Protocolos Clínicos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/transmisión , Humanos , Italia , Neumonía Viral/epidemiología , Neumonía Viral/transmisión , Guías de Práctica Clínica como Asunto , SARS-CoV-2 , Sociedades MédicasRESUMEN
BACKGROUND: Residual stent strut thrombosis after primary percutaneous coronary intervention (PCI), negatively affects myocardial perfusion, may increase stent thrombosis risk, and it is associated with neointima hyperplasia at follow-up. OBJECTIVES: To study the effectiveness of any bivalirudin infusion versus unfractionated heparin (UFH) infusion in reducing residual stent strut thrombosis in patients with ST-elevation myocardial infarction (STEMI). METHODS: Multi-vessel STEMI patients undergoing primary PCI and requiring staged intervention were selected among those randomly allocated to two different bivalirudin infusion regimens in the MATRIX (Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and angioX) Treatment-Duration study. Those receiving heparin only were enrolled into a registry arm. Optical coherence tomography (OCT) of the infarct-related artery was performed at the end of primary PCI and 3-5 days thereafter during a staged intervention. The primary endpoint was the change in minimum flow area (ΔMinFA) defined as (stent area + incomplete stent apposition [ISA] area) - (intraluminal defect + tissue prolapsed area) between the index and staged PCI. RESULTS: 123 patients in bivalirudin arm and 28 patients in the UFH arm were included. Mean stent area, percentage of malapposed struts, and mean percent thrombotic area were comparable after index or staged PCI. The ΔMinFA in the bivalirudin group was 0.25 versus 0.05 mm2 in the UFH group, which resulted in a between-group significant difference of 0.36 [95% CI: (0.05, 0.71); p = .02]. This was mostly related to a decrease in tissue protrusion in the bivalirudin group (p = .03). There was a trend towards more patients in the bivalirudin group who achieved a 5% difference in the percentage of OCT frames with the area >5% (p = .057). CONCLUSIONS: The administration of bivalirudin after primary PCI significantly reduces residual stent strut thrombosis when compared to UFH. This observation should be considered hypothesis-generating since the heparin-treated patients were not randomly allocated.
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Anticoagulantes/administración & dosificación , Antitrombinas/administración & dosificación , Trombosis Coronaria/terapia , Heparina/administración & dosificación , Hirudinas/administración & dosificación , Fragmentos de Péptidos/administración & dosificación , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST/terapia , Tomografía de Coherencia Óptica , Anciano , Anticoagulantes/efectos adversos , Antitrombinas/efectos adversos , Trombosis Coronaria/diagnóstico por imagen , Femenino , Hemorragia/inducido químicamente , Heparina/efectos adversos , Hirudinas/efectos adversos , Humanos , Infusiones Parenterales , Italia , Masculino , Persona de Mediana Edad , Neointima , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Valor Predictivo de las Pruebas , Estudios Prospectivos , Proteínas Recombinantes/administración & dosificación , Proteínas Recombinantes/efectos adversos , Infarto del Miocardio con Elevación del ST/diagnóstico por imagen , Stents , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Conflicting evidence exists on the efficacy and safety of bivalirudin administered as part of percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome. METHODS: We randomly assigned 7213 patients with an acute coronary syndrome for whom PCI was anticipated to receive either bivalirudin or unfractionated heparin. Patients in the bivalirudin group were subsequently randomly assigned to receive or not to receive a post-PCI bivalirudin infusion. Primary outcomes for the comparison between bivalirudin and heparin were the occurrence of major adverse cardiovascular events (a composite of death, myocardial infarction, or stroke) and net adverse clinical events (a composite of major bleeding or a major adverse cardiovascular event). The primary outcome for the comparison of a post-PCI bivalirudin infusion with no post-PCI infusion was a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events. RESULTS: The rate of major adverse cardiovascular events was not significantly lower with bivalirudin than with heparin (10.3% and 10.9%, respectively; relative risk, 0.94; 95% confidence interval [CI], 0.81 to 1.09; P=0.44), nor was the rate of net adverse clinical events (11.2% and 12.4%, respectively; relative risk, 0.89; 95% CI, 0.78 to 1.03; P=0.12). Post-PCI bivalirudin infusion, as compared with no infusion, did not significantly decrease the rate of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events (11.0% and 11.9%, respectively; relative risk, 0.91; 95% CI, 0.74 to 1.11; P=0.34). CONCLUSIONS: In patients with an acute coronary syndrome, the rates of major adverse cardiovascular events and net adverse clinical events were not significantly lower with bivalirudin than with unfractionated heparin. The rate of the composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events was not significantly lower with a post-PCI bivalirudin infusion than with no post-PCI infusion. (Funded by the Medicines Company and Terumo Medical; MATRIX ClinicalTrials.gov number, NCT01433627.).
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Síndrome Coronario Agudo/tratamiento farmacológico , Anticoagulantes/uso terapéutico , Heparina/uso terapéutico , Fragmentos de Péptidos/uso terapéutico , Síndrome Coronario Agudo/mortalidad , Anciano , Anticoagulantes/efectos adversos , Terapia Combinada , Trombosis Coronaria/prevención & control , Femenino , Heparina/efectos adversos , Hirudinas/efectos adversos , Humanos , Incidencia , Infusiones Intravenosas , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Fragmentos de Péptidos/efectos adversos , Intervención Coronaria Percutánea/estadística & datos numéricos , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/uso terapéutico , Stents , Accidente Cerebrovascular/epidemiologíaRESUMEN
BACKGROUND: The RAD-MATRIX trial reported a large operator radiation exposure variability in right radial percutaneous coronary procedures. The reasons of these differences are not well understood. Our aim was to appraise the determinants of operator radiation exposure during coronary right transradial procedures. METHODS: Patient arrangement during transradial intervention was investigated across operators involved in the RAD-MATRIX trial. Operator radiation exposure was analyzed according to the position of the patient right arm (close or far from the body) and in relation to the size of the upper leaded glass. RESULTS: Among the 14 operators who agreed to participate, there was a greater than 10-fold difference in radiation dose at thorax level (from 21.5 to 267 µSv) that persisted after normalization by dose-area product (from 0.35 to 3.5 µSv/Gy*cm2). Among the operators who positioned the instrumented right arm far from the body (110.4 µSv, interquartile range 71.5-146.5 µSv), thorax dose was greater than that in those who placed the instrumented arm close to the right leg (46.1 µSv, 31.3-56.8 µSv, P = .02). This difference persisted after normalization by dose-area product (P = .028). The use of a smaller full glass shield was also associated with a higher radiation exposure compared with a larger composite shield (147.5 and 60 µSv, respectively, P = .016). CONCLUSIONS: In the context of the biggest radiation study conducted in patients undergoing transradial catheterization, the instrumented right arm arrangement close to the leg and greater upper leaded shield dimensions were associated with a lower operator radiation exposure. Our findings emphasize the importance of implementing simple preventive measures to mitigate the extra risks of radiation exposure with right radial as compared with femoral access.
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Exposición Profesional/efectos adversos , Salud Laboral , Intervención Coronaria Percutánea/efectos adversos , Exposición a la Radiación/efectos adversos , Protección Radiológica/métodos , Infarto del Miocardio con Elevación del ST/terapia , Anciano , Femenino , Arteria Femoral , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Arteria Radial , Dosis de Radiación , Radiometría/métodos , Administración de la Seguridad , Estadísticas no ParamétricasAsunto(s)
Oclusión Coronaria , Intervención Coronaria Percutánea , Humanos , Resultado del Tratamiento , Oclusión Coronaria/diagnóstico por imagen , Oclusión Coronaria/terapia , Angiografía Coronaria , Intervención Coronaria Percutánea/efectos adversos , Enfermedad Crónica , Factores de Riesgo , Sistema de RegistrosRESUMEN
OBJECTIVES: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions. BACKGROUND: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications. METHODS: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings. RESULTS: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients. CONCLUSIONS: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc.
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Cateterismo Cardíaco/métodos , Cateterismo Periférico/métodos , Enfermedad de la Arteria Coronaria/terapia , Procedimientos Endovasculares/métodos , Arteria Femoral , Enfermedades Vasculares Periféricas/terapia , Arteria Radial , Anciano , Anciano de 80 o más Años , Cateterismo Cardíaco/efectos adversos , Cateterismo Periférico/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Procedimientos Endovasculares/efectos adversos , Femenino , Arteria Femoral/diagnóstico por imagen , Hemorragia/etiología , Hemorragia/prevención & control , Humanos , Italia , Masculino , Persona de Mediana Edad , Enfermedades Vasculares Periféricas/diagnóstico por imagen , Punciones , Arteria Radial/diagnóstico por imagen , Sistema de Registros , Estudios Retrospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Functional assessment of non-infarct-related artery lesions during primary percutaneous coronary intervention (PCI) might be useful to avoid revascularization of nonsignificant stenosis and staged procedures, thus reducing hospital stay. We aimed to assess the diagnostic performance of instantaneous wave-free ratio (iFR) as compared with fractional flow reserve (FFR) in this setting. METHODS: In the WAVE study, a prospective, observational, single-center registry (NCT02869906), paired iFR and FFR measurements were performed at the level of non-IRA lesions in patients with ST-segment elevation myocardial infarction both during primary PCI and during staged procedures (5-8 days after). RESULTS: Paired iFR and FFR measurements were available for 66 non-IRA lesions in 50 patients. The iFR and FFR values of non-IRA lesions did not change significantly between the index and staged procedure. Bland-Altman analysis did not show systematic bias for either iFR or FFR repeated measures. Receiver operating characteristic curve analysis showed high accuracy of iFR to identify positive (≤0.80) FFR measurements in the index procedure with an area under the curve of 0.95. A cutoff of ≤0.89 for iFR in the index procedure had the best combination of sensitivity (95%) and specificity (90%) with positive and negative predictive values of 86% and 97%, respectively. Finally, iFR measured during the index procedure was significantly correlated with FFR (r=0.71, r2=0.51; P<.0001). CONCLUSIONS: The WAVE study shows that iFR yields similar diagnostic accuracy to FFR in functional evaluation of non-IRA stenosis in patients with STEMI and multivessel CAD, with the advantage of being adenosine free.
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Vasos Coronarios/diagnóstico por imagen , Reserva del Flujo Fraccional Miocárdico/fisiología , Infarto del Miocardio con Elevación del ST/fisiopatología , Anciano , Angiografía por Tomografía Computarizada , Angiografía Coronaria , Vasos Coronarios/fisiopatología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Revascularización Miocárdica , Valor Predictivo de las Pruebas , Estudios Prospectivos , Curva ROC , Reproducibilidad de los Resultados , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/cirugíaRESUMEN
BACKGROUND: Radiation exposure is an important issue for interventional cardiologists that is often underevaluated. Our aim was to evaluate determinants of operator radiation exposure during percutaneous coronary procedures. METHODS: The RADIANT (NCT01974453) is a prospective, single-center observational study involving 4 expert operators and 2 fellows performing percutaneous coronary procedures. The operator radiation dose was evaluated using dedicated electronic dosimeters in 2,028 procedures: 1,897 transradial access (TRA; 1,120 right and 777 left TRA) and 131 transfemoral access (TFA). RESULTS: In the whole population, operator radiation dose at the thorax did not differ between TFA (9µSv [interquartile range 5-18µSv]) and TRA (9µSv [4-21µSv]), but after propensity score matching analysis, TFA showed lower dose (9µSv [5-18µSv]) compared with TRA (17µSv [9-28µSv], P<.001). In the whole transradial group, left TRA (5µSv [2-12µSv]) was associated with significant lower operator dose compared with right TRA (13µSv [6-26µSv], P<.001).The use of adjunctive protective pelvic drapes was significantly associated with lower radiation doses compared with procedures performed without drapes (P<.001). Among the operators, an inverse relation between height and dose was observed. Finally, left projections and the use of angiographic systems not dedicated for coronary and high frame rates were all associated with a significant higher operator radiation exposure. CONCLUSIONS: In a high-volume center for transradial procedures, TFA is associated with lower operator radiation dose compared with TRA. The use of adjunctive anti-rx drapes seems a valuable tool to reduce the higher operator radiation exposure associated with TRA.
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Angiografía Coronaria/métodos , Intervención Coronaria Percutánea/métodos , Exposición a la Radiación , Protección Radiológica , Adulto , Cardiólogos , Angiografía Coronaria/efectos adversos , Femenino , Arteria Femoral , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Arteria RadialRESUMEN
BACKGROUND: It is unclear whether radial compared with femoral access improves outcomes in unselected patients with acute coronary syndromes undergoing invasive management. METHODS: We did a randomised, multicentre, superiority trial comparing transradial against transfemoral access in patients with acute coronary syndrome with or without ST-segment elevation myocardial infarction who were about to undergo coronary angiography and percutaneous coronary intervention. Patients were randomly allocated (1:1) to radial or femoral access with a web-based system. The randomisation sequence was computer generated, blocked, and stratified by use of ticagrelor or prasugrel, type of acute coronary syndrome (ST-segment elevation myocardial infarction, troponin positive or negative, non-ST-segment elevation acute coronary syndrome), and anticipated use of immediate percutaneous coronary intervention. Outcome assessors were masked to treatment allocation. The 30-day coprimary outcomes were major adverse cardiovascular events, defined as death, myocardial infarction, or stroke, and net adverse clinical events, defined as major adverse cardiovascular events or Bleeding Academic Research Consortium (BARC) major bleeding unrelated to coronary artery bypass graft surgery. The analysis was by intention to treat. The two-sided α was prespecified at 0·025. The trial is registered at ClinicalTrials.gov, number NCT01433627. FINDINGS: We randomly assigned 8404 patients with acute coronary syndrome, with or without ST-segment elevation, to radial (4197) or femoral (4207) access for coronary angiography and percutaneous coronary intervention. 369 (8·8%) patients with radial access had major adverse cardiovascular events, compared with 429 (10·3%) patients with femoral access (rate ratio [RR] 0·85, 95% CI 0·74-0·99; p=0·0307), non-significant at α of 0·025. 410 (9·8%) patients with radial access had net adverse clinical events compared with 486 (11·7%) patients with femoral access (0·83, 95% CI 0·73-0·96; p=0·0092). The difference was driven by BARC major bleeding unrelated to coronary artery bypass graft surgery (1·6% vs 2·3%, RR 0·67, 95% CI 0·49-0·92; p=0·013) and all-cause mortality (1·6% vs 2·2%, RR 0·72, 95% CI 0·53-0·99; p=0·045). INTERPRETATION: In patients with acute coronary syndrome undergoing invasive management, radial as compared with femoral access reduces net adverse clinical events, through a reduction in major bleeding and all-cause mortality. FUNDING: The Medicines Company and Terumo.
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Síndrome Coronario Agudo/cirugía , Cateterismo Periférico/métodos , Arteria Femoral , Intervención Coronaria Percutánea/métodos , Arteria Radial , Síndrome Coronario Agudo/mortalidad , Anciano , Pérdida de Sangre Quirúrgica/mortalidad , Pérdida de Sangre Quirúrgica/prevención & control , Cateterismo Periférico/efectos adversos , Causas de Muerte , Angiografía Coronaria , Femenino , Humanos , Masculino , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
OBJECTIVES: To compare the incidence of major adverse cardiac and cerebrovascular events (MACCE) and thrombolysis in myocardial infarction (TIMI) bleedings in primary percutaneous coronary intervention (pPCI) performed through transradial approach (TRA) or transfemoral approach (TFA) with systematic closure by FemoSeal™. BACKGROUND: Although the risk of bleeding can be reduced using vascular closure devices (VCD), there are few data comparing TRA and TFA with VCD, particularly in the setting of pPCI. METHODS: we included in this retrospective registry 777 patients who underwent pPCI at two centers from years 2010 to 2013. Exclusion criteria were implantation of intra-aortic balloon pump and achievement of femoral hemostasis by other means than FemoSeal™. We performed propensity-score matching and multivariate analysis to adjust for clinical and procedural confounders. RESULTS: We enrolled 511 patients in TRA group and 266 in TFA group. Both in the general population and in the propensity-matched population, the incidence of MACCE was comparable in TRA vs. TFA patients (3.5 vs. 3.4% and 4.4 vs. 2.6%, respectively; P = ns). On the contrary, we observed a higher incidence of TIMI bleedings in TFA vs. TRA patients (5.6 vs. 2.2% in the general population and 6.6 vs. 1.3% in the propensity-matched population; P < 0.05); this difference was mainly driven by TIMI major bleedings. TFA was an independent predictor of bleeding at multivariate analysis. CONCLUSIONS: In pPCI the rate of TIMI major bleedings was higher in TFA with closure by FemoSeal™ as compared to TRA, whereas the rates of minor bleedings and of MACCE were similar.
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Cateterismo Cardíaco/métodos , Cateterismo Periférico/métodos , Arteria Femoral , Hemorragia/prevención & control , Técnicas Hemostáticas/instrumentación , Intervención Coronaria Percutánea/métodos , Arteria Radial , Dispositivos de Cierre Vascular , Cateterismo Cardíaco/efectos adversos , Cateterismo Periférico/efectos adversos , Trastornos Cerebrovasculares/etiología , Trastornos Cerebrovasculares/prevención & control , Distribución de Chi-Cuadrado , Diseño de Equipo , Arteria Femoral/diagnóstico por imagen , Hemorragia/etiología , Técnicas Hemostáticas/efectos adversos , Humanos , Modelos Logísticos , Análisis Multivariante , Infarto del Miocardio/etiología , Infarto del Miocardio/prevención & control , Oportunidad Relativa , Intervención Coronaria Percutánea/efectos adversos , Puntaje de Propensión , Punciones , Arteria Radial/diagnóstico por imagen , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , Ciudad de Roma , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this prospective study was to evaluate muscle force of the hand, thumb, and forefinger in patients with prolonged radial occlusion after transradial percutaneous coronary procedures. BACKGROUND: There are no data on hand strength and function in patients with prolonged radial occlusion after percutaneous coronary procedures. METHODS: Elective patients with chronic stable angina undergoing percutaneous coronary procedures were evaluated the day before the procedure for radial artery patency, Allen test, hand grip, and thumb and forefinger pinch tests. The same measures were performed the day after the procedure and at follow-up. At follow-up, patients were divided in two groups according to the radial patency (group 1) or occlusion (group 2). RESULTS: Of the 99 patients included in the study, 90 patients had a patent radial artery (group 1), and nine (9.1%) patients had an occluded artery (group 2). At baseline, there were no significant differences in hand grip test between the two groups (42 ± 11 kg in group 1 and 41 ± 17 kg in group 2, P = 0.74). In both groups, after the procedure, the hand grip test values was significantly reduced compared with baseline values (40 ± 11 kg in group 1, P < 0.0001 and 37 ± 17 kg in group 2, P = 0.007). Finally, at follow-up, in both groups, the hand grip test values returned to baseline values. Thumb and forefinger pinch tests did not show significant differences after the procedure and at follow-up, compared with baseline. CONCLUSIONS: Radial artery occlusion after percutaneous coronary procedures was not associated with a reduction in hand and finger strength.
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Angina Estable/terapia , Arteriopatías Oclusivas/etiología , Cateterismo Cardíaco/efectos adversos , Fuerza Muscular , Músculo Esquelético/irrigación sanguínea , Intervención Coronaria Percutánea/efectos adversos , Arteria Radial , Anciano , Angina Estable/diagnóstico por imagen , Arteriopatías Oclusivas/diagnóstico por imagen , Arteriopatías Oclusivas/fisiopatología , Cateterismo Cardíaco/métodos , Enfermedad Crónica , Constricción Patológica , Angiografía Coronaria , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Estudios Prospectivos , Punciones , Arteria Radial/diagnóstico por imagen , Arteria Radial/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Grado de Desobstrucción VascularRESUMEN
Percutaneous left atrial appendage occlusion (LAAO), currently recognized as a procedure with relatively low risk, is increasingly being adopted in clinical practice. However, due to the preventive nature of the procedure and the necessity to compare it with newer and safer oral anticoagulants, further optimization is required to address remaining challenges. These latter include acquiring comprehensive data on safety and efficacy, establishing standardized pre-procedural planning, and simplifying procedural process. Consequently, we have provided an overview that encompasses future opportunities for enhancing procedural safety and efficacy, thereby establishing LAAO as the mainstream strategy for stroke and systemic embolism prevention in patients with atrial fibrillation and absolute contraindications to anticoagulant drugs.
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Background: in patients undergoing percutaneous coronary interventions (PCI), radial access should be favoured over femoral access as it reduces the risk of vascular complications and bleeding. Furthermore, a preventive role of radial access in the occurrence of acute kidney injury (AKI), mainly mediated by the reduction of bleeding and cholesterol crystal embolization into renal circulation, has been investigated in several studies, yielding conflicting results. Methods: we designed a retrospective study to appraise the effect of the use of a vascular access site on the occurrence of AKI in a cohort of 633 patients with acute myocardial infarction treated by PCI at our centre from 2018 to 2020. Results: after propensity score adjustment, radial access was associated with a reduced, albeit statistically not significant, incidence of AKI (14.7% vs. 21.0%; p = 0.06) and major bleeding (12.5% vs. 18.7%; p = 0.04) as compared to femoral access. At multivariate analysis, femoral access was an independent predictor of AKI, together with in-hospital occurrence of BARC 3-5 bleeding, Killip class >1 at presentation, female gender, baseline eGFR <60 mL/min, and baseline haemoglobin <12 g/dL. Conclusions: although limited by the observational design, our study supports the hypothesis that radial access may exert a protective role on the occurrence of AKI in patients with acute myocardial infarction undergoing PCI.
RESUMEN
BACKGROUND: To assess the reproducibility of coronary tissue characterization by an Artificial Intelligence Optical Coherence Tomography software (OctPlus, Shanghai Pulse Medical Imaging Technology Inc.). METHODS: 74 patients presenting with multivessel ST-segment elevation myocardial infarction (STEMI) underwent optical coherence tomography (OCT) of the infarct-related artery at the end of primary percutaneous coronary intervention (PPCI) and during staged PCI (SPCI) within 7 days thereafter in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and angioX) Treatment-Duration study (ClinicalTrials.gov, NCT01433627). OCT films were run through the OctPlus software. The same region of interest between either side of the stent and the first branch was identified on OCT films for each patient at PPCI and SPCI, thus generating 94 pairs of segments. 42 pairs of segments were re-analyzed for intra-software difference. Five plaque characteristics including cholesterol crystal, fibrous tissue, calcium, lipid, and macrophage content were analyzed for various parameters (span angle, thickness, and area). RESULTS: There was no statistically significant inter-catheter (between PPCI and SPCI) or intra-software difference in the mean values of all the parameters. Inter-catheter correlation for area was best seen for calcification [intraclass correlation coefficient (ICC) 0.86], followed by fibrous tissue (ICC 0.87), lipid (ICC 0.62), and macrophage (ICC 0.43). Some of the inter-catheter relative differences for area measurements were large: calcification 9.75 %; cholesterol crystal 74.10 %; fibrous tissue 5.90 %; lipid 4.66 %; and macrophage 1.23 %. By the intra-software measurements, there was an excellent correlation (ICC > 0.9) for all tissue types. The relative differences for area measurements were: calcification 0.64 %; cholesterol crystal 5.34 %; fibrous tissue 0.19 %; lipid 1.07 %; and macrophage 0.60 %. Features of vulnerable plaque, minimum fibrous cap thickness and lipid area showed acceptable reproducibility. CONCLUSION: The present study demonstrates an overall good reproducibility of tissue characterization by the Artificial Intelligence Optical Coherence Tomography software. In future longitudinal studies, investigators may use discretion in selecting the imaging endpoints and sample size, accounting for the observed relative differences in this study.