A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent–In-Stent Restenosis The RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent)

ObjectivesThis study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR).BackgroundTreatment of patients with ISR remains a challenge.MethodsThis was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up.ResultsA total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups.ConclusionsIn patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953

Avances en el tratamiento farmacológico coadyuvante en la intervención coronaria

El intervencionismo percutáneo genera una rotura de la placa aterosclerótica y una denudación del endotelio que estimulan la agregación plaquetaria y la coagulación. Por ello, los agentes antitrombóticos son la base del tratamiento farmacológico coadyuvante al cateterismo intervencionista. Además de la aspirina, fármaco de beneficio indiscutible en la cardiopatía isquémica, el clopidogrel, administrado antes y después del cateterismo, ha demostrado su utilidad en la reducción de las tasas de trombosis tras la implantación de stent. A su vez, la introducción de los inhibidores de la glucoproteína IIb/IIIa ha mejorado los resultados de la revascularización percutánea, especialmente en los pacientes de mayor riesgo. Por su parte, los fármacos anticoagulantes son indispensables para evitar las complicaciones trombóticas agudas derivadas de las características invasivas del procedimiento. Las heparinas de bajo peso molecular, los inhibidores directos de la trombina (hirudina y derivados) y los inhibidores directos del factor X son las nuevas alternativas a la heparina no fraccionada clásica, que han demostrado reducir las complicaciones hemorrágicas sin requerir una monitorización tan exhaustiva. Finalmente, con objeto de reducir la reestenosis coronaria a medio plazo, se han ensayado fármacos con actividad antiproliferativa. Es el caso de la rapamicina oral

Espasmo radial en el cateterismo cardíaco transradial: Análisis de los factores asociados con su aparición y de sus consecuencias tras el procedimiento

Introducción y objetivos. El espasmo radial es la complicación más frecuente en el cateterismo cardíaco transradial y ocasiona un procedimiento más doloroso para el paciente, con una menor tasa de éxito. El objetivo es analizar los factores que se asocian con el espasmo radial durante el cateterismo cardíaco (variables clínicas, características angiográficas de la arteria radial y variables del procedimiento), así como sus consecuencias (clínicas y de permeabilidad de la arteria radial) en el seguimiento. Pacientes y método. Se ha incluido a 637 pacientes en los que se realizó un cateterismo cardíaco por vía radial. El espasmo radial se registró según una escala que valora las molestias del paciente y las dificultades técnicas. Resultados. Se produjo espasmo radial en 127 pacientes (20,2%). El análisis multivariable mostró que las variables relacionadas con el espasmo radial fueron: una anomalía anatómica radial (odds ratio [OR] = 5,1; intervalo de confianza [IC] del 95%, 2,1-11,4), el empleo > 3 catéteres (OR = 3,0; IC del 95%, 1,9-4,7), el dolor moderado-intenso en la canulación radial (OR = 2,6; IC del 95%, 1,4-4,9), la utilización de fentolamina como vasodilatador (OR = 1,8; IC del 95%, 1,1-2,9) y el diámetro radial tras el empleo del vasodilatador (OR = 0,98; IC del 95%, 0,98-0,99). Durante el seguimiento (20 ± 18 días), los pacientes con espasmo radial presentaron un mayor porcentaje de dolor moderado-intenso en el antebrazo (el 12,4 frente al 5,3%), pero sin diferencias significativas en la tasa de oclusión radial (el 4,5 frente al 2,2%). Conclusión. La aparición del espasmo radial tiene un componente multifactorial en el que predominan las características de la arteria y las variables del procedimiento. Durante el seguimiento, el espasmo no condicionó una mayor tasa de oclusión radial, aunque sí de persistencia de dolor importante en el antebrazo

Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p 1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953)

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p 1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940)