Aim Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.44 to 0.96; pnon-inferiority <0.001; psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs 11.1%, HR 0.67, 95% CI 0.46 to 0.99; p = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusions In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. Clinical trial registration ClinicalTrials.gov: NCT03321032.

Tras su redacción, la presente memoria ha sido enviada por mí, encontrándola conforme para ser presentada y aspirar al grado de Doctor ante el Tribunal designado. 5.-DISCUSIÓN ............................................................................................................. 13 RESUMEN Introducción y objetivosEl incremento de la creatinina plasmática tras una intervención coronaria percutánea no es infrecuente y se ha asociado a un pronóstico adverso. Además, el desarrollo de nefropatía tras el intervencionismo coronario percutáneo se asocia a un importante aumento de la morbi-mortalidad (mortalidad intrahospitalaria en torno al 20%) y a un incremento de la estancia y de los costes hospitalarios.Las causas de insuficiencia renal aguda tras un procedimiento de revascularización coronaria percutánea son muy variadas, e incluyen nefrotoxicidad por el contraste, alteraciones hemodinámicas, toxicidad farmacológica o ateroembolia. El grado de insuficiencia renal preexistente es el mayor factor de riesgo para el desarrollo de nefropatía post-intervencionismo coronario y por lo tanto las medidas nefroprotectoras se focalizan en este subgrupo de pacientes. Sin embargo, los pacientes con síndrome coronario agudo tratados mediante revascularización percutánea pueden constituir también una población con un mayor riesgo de nefropatía post-intervencionismo coronario percutáneo.El mejor tratamiento de esta grave complicación es la prevención. En las guías actuales de la Sociedad Europea de Cardiología para el manejo de pacientes con síndrome coronario agudo sin elevación persistente del segmento ST solo se recomiendan medidas nefroprotectoras en pacientes con síndrome coronario agudo e insuficiencia renal crónica, por lo que la realización de estudios en los pacientes con función renal normal podría identificar un subgrupo de los mismos que también se beneficien de estas medidas preventivas.14 Existen pocos estudios que hayan evaluado de forma específica la prevalencia y pronóstico a largo plazo de la nefropatía post-intervencionismo coronario percutáneo en pacientes con síndrome coronario agudo y función renal normal.El objetivo de este estudio fue analizar la prevalencia, los factores de riesgo y el pronóstico hospitalario y a largo plazo de los pacientes con síndrome coronario agudo y función renal normal que desarrollan nefropatía tras un intervencionismo coronario percutáneo. MétodosEstudio observacional, retrospectivo y unicéntrico con seguimiento prospectivo de 470 pacientes consecutivos ingresados por síndrome coronario agudo sin shock cardiogénico y sometidos a intervencionismo coronario percutáneo sin insuficiencia renal pre-existente (creatinina al ingreso ≤ 1,3 mg/dl).La nefropatía post-intervencionismo coronario fue definida como un incremento de la creatinina basal de ≥ 0,5 mg/dl o ≥ 25% del valor basal.El intervencionismo coronario fue realizado según técnicas estándar utilizando el acceso radial en la mayoría de los casos (394 [83,8%]). En todos los casos los medios de contraste utilizados fueron e...

Background The objective of manual thrombectomy is the removal of occlusive thrombus to improve the results of primary angioplasty. The better understanding of the factors associated with successful manual thrombectomy may provide relevant information regarding thrombus formation and resolution. Methods Observational study of all consecutive patients remitted for emergent percutaneous coronary intervention (PCI) in a single centre. Successful manual thrombectomy was considered when TIMI 3 was achieved after using the device and a score to predict successful manual thrombectomy was designed. Results We included 618 patients, 65.1% treated with manual thrombectomy. No relevant differences in clinical features or time delays were observed between patients treated with vs. without manual thrombectomy, but manual thrombectomy treated patients received more often dual antiplatelet treatment (DAPT) before PCI. Final TIMI flow 3 was achieved in most patients and more frequently in manual thrombectomy treated patients (94.8 vs. 86.6%; P < 0.01). The successful manual thrombectomy rate was 81.3% and it was higher in patients pretreated with DAPT (89.0 vs. 73.3%; P < 0.01). The time delay to first medical contact was not related to the final TIMI 3, but it was significantly and negatively related to successful manual thrombectomy. According to the multivariate analysis, we designed the DDTA score: DAPT pretreatment (2), delay less than 2 h (3) or 2–4 h (2), TIMI flow improvement after wiring the lesion (2) and age less than 55 years (3). Patients with DDTA score at least 4 had lower no-reflow, mortality and major cardiovascular complications incidence. Conclusion The DDTA score (DAPT pretreatment, time delays, TIMI flow improvement after wiring the lesion and age) identifies patients who benefit mostly from manual thrombectomy.

This article has been peer reviewed and published immediately upon acceptance.It is an open access article, which means that it can be downloaded, printed, and distributed freely, provided the work is properly cited. Articles in "Cardiology Journal" are listed in PubMed.

No abstract